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Clarithromycin tablets instructions for use for children. The drug Clarithromycin: the most accurate instructions for use. What group of antibiotics does Clarithromycin belong to?

Clarithromycin (also Clarithromycin CP) is an antibiotic from macrolide group with a wide range of applications. The drug has antibacterial properties, affecting a wide variety of harmful microorganisms.

The active ingredients of this medication come into contact with the structure of the bacterium, suppressing protein synthesis in it, which is inevitable leads to its destruction.

Clarithromycin affects bacteria such as Moraxella, Helicobacter pylori, Staphylococcus aureus, Haemophilus influenzae, mycobacteria, etc. Based on this, it can be noted indications for use of this medicine: respiratory tract diseases - pneumonia, bronchitis, etc., pharyngitis, otitis and sinusitis, infectious processes localized on the skin, mycobacterial infections, burns, general therapy for duodenal ulcers.

An important area of use is the treatment of diseases such as sore throat and pneumonia. The drug is a means second line and is used when the patient is contraindicated in the use of first-line drugs - Amoxicillin and other similar drugs.

In addition, Clarithromycin is used in the field of venereology and is used in the treatment of mycoplasmosis and urogenital chlamydia.

Antibiotic Clarithromycin dosage 250, 500 mg: instructions for use

The dosage regimen must be prescribed by the attending physician, having carried out all the necessary lab tests. The diagnosis also affects the dosage, frequency and duration of drug therapy, so you should not take Clarithromycin on your own without visiting a doctor.

The drug is available in several forms:

Capsules 250 and 500 mg.
Pills. The content of the active substance is 250 and 500 mg.
Special powder for preparing the suspension.
Solution for infusion.

If we evaluate the effectiveness of these products, then tablets are no different from capsules. As for the powder, it is used to prepare a suspension for children up to 12 years.

Adult patients and children over 12 years old appointed from 250 to 500 mg of the drug twice a day. Dose in 500 mg is retained in the body for approximately 12 hours, therefore, the drug is taken twice.

You can take tablets or capsules with plain water or other liquids, but not with milk, as this can lead to improper absorption.

How to take for a bacterial infection, before or after meals?

The antibiotic Clarithromycin is widely used in the treatment of gastroenterological diseases. The application diagram includes taking capsules twice a day or tablets in a day. The daily dose is 500 mg.

Reception is carried out after meal. Duration of therapy varies from one to two weeks. Only the attending physician decides how many days to take the drug.

Taking the drug by pregnant women and children

Any antibiotic has a rather aggressive effect on the body, so most of them are not prescribed to women during pregnancy and young children. Clarithromycin is widely used in therapy various diseases not only in adults, but also in children.

However, there is one small nuance. The drug in the form of capsules and tablets is prescribed only to those children whose age exceeds 12 years.

Dosage for children over 12 years old will be identical to the dosage regimen for adults, i.e. 250 to 500 mg twice daily. Small children are given from 7.5 to 15 mg per kilogram of weight. They are shown the drug in powder form, with which a suspension is prepared. The suspension is administered orally using a dispenser syringe containing 5 ml medications that correspond 125 mg Clarithromycin.

The advisability of taking this particular medication is determined by the pediatrician. The average duration of treatment is from 6 to 14 days.

As for pregnant women, the issue is ambiguous.

Some experts do not recommend using this drug at all during pregnancy, but if infectious diseases admission may be permitted if the woman is in the third trimester of pregnancy.

When taking Clarithromycin in the first and second trimester, there is a real danger of intrauterine pathologies in the unborn child.

Dosage of the drug

The average size dosage is 500 mg of the drug per day. This dose is intended for both adults and children over 12 years of age. In this case, we are talking about oral administration, but if the patient for some reason cannot take this medicine orally, he is prescribed the injection of the substance intravenously using droppers. In this case, the dosage is also 500 mg per day. Intravenous administration continues for 2-5 days, after which the patient is transferred to tablets or capsules.

When treating diseases caused by various mycobacteria, the maximum daily dose may be increased up to 1 gram per day. If the disease is severe, the maximum dose is doubled - up to 2 grams. With this regimen, treatment can continue up to six months.

If the patient is diagnosed with chronic renal failure, the dosage of Clarithromycin should be no more than 250 mg. Accordingly, the drug is taken once.

Important! The maximum daily dose for children over 12 years of age should be no more than 1 gram.

Dosage for tuberculosis

Clarithromycin is a macrolide, which means it can be used in the treatment of tuberculosis. It is used only in the composition complex therapy, together with first-line drugs - Isoniazid, Ethambutol, Rifampin etc.

Photo 1. Packaging of the drug Isoniazid in the form of tablets with a dosage of 300 mg. Manufacturer: Moskhimfarmpreparaty.

The dosage is 1 gram twice a day. The average duration of such therapy is six months.

There is a certain dependence of the dosage on the weight and age of the individual patient. For adult patients over the age of 18 years, dosage in the first 8 weeks - 25 mg per 1 kg of weight. Then the course changes a little, and the dosage will be 35 mg per 1 kg of weight.

Dosage for children - 15 mg per 1 kg of weight.

Main contraindications

Despite its undeniable effectiveness, this drug cannot be used in all cases. The main contraindications include:

First and second trimester of pregnancy.
Lactation period.
Individual intolerance to the substances included in the composition.
Hepatitis.
Cholestatic jaundice.
Acute liver failure, occurring simultaneously with renal failure.
A patient has a lactose allergy.
Potassium deficiency.
Ventricular arrhythmia.

If you have any liver disease, there is a possibility of complications. That is why it is necessary to strictly follow the doctor’s instructions.

Clarithromycin cannot be used in the treatment of sore throat and otitis media in children.

It is also worth noting that the drug interacts with other means.

Medicines, excluding simultaneous use with this drug:

Heart medications made from ergot.
Ticagrelor, i.e. a blood thinner.
Atorvastatin, Rosuvastatin and other drugs that reduce cholesterol levels.
Terfenadine, Pimozide and Cisapride.

Concomitant use with these drugs may cause significant deterioration of condition And many side effects.

Attention! Clarithromycin belongs to the category of antibiotics, therefore It is forbidden to drink alcohol with it.

The fact is that alcohol significantly weakens the effect of the drug on the body, as a result of which the patient does not receive the necessary treatment.

The antibiotic acts quite aggressively on the body. It negatively affects not only microorganisms and bacteria, but also healthy cells. If we add to this the consumption of alcoholic beverages, the body will be doubly loaded. Very much, including the liver. If the organ is healthy, it will cope with all the loads, but if there are certain problems, then complications may arise.

Side effects

Individual characteristics and non-compliance with the dosage can cause a negative reaction from the body to taking Clarithromycin. You can select main side effects:

Panic attacks.
Sleep disturbance.
Pain in the head.
Dizziness.
Constant feeling of anxiety.
Hallucinations (rare).
Vomiting and diarrhea.
Change in taste.
Noise in ears. In very rare cases, partial loss of auditory activity may occur after discontinuation of the drug.
Various allergic reactions on the skin, itching.
Anaphylactic reaction.

Reference. In some cases (about 0.1%) changes in blood composition may be observed. Cases of change recorded heart rate.

When taking the drug possible exacerbation of chronic liver and kidney diseases. People with these problems should take it with extreme caution. As for the complex therapy of tuberculosis, the side effects are not much different from ordinary cases. The most common symptoms are dizziness, ringing in the ears and partial hearing loss, which recovers quickly. But you should still strictly follow the official instructions to reduce the likelihood of their occurrence.

Conclusion

If we talk about the specifics of taking Clarithromycin, then several nuances can be noted.

The frequency of administration, dosage and duration of therapy is determined by only the attending physician. The dosage and duration of use of the drug will vary and depend on many factors; The specific disease, the presence of chronic ailments and other pathologies in the patient are of great importance.

Photo 2. Packaging of the drug Clarithromycin in the form of tablets with a dosage of 500 mg. Manufacturer: Rafarma.

With extreme caution It is worth using this drug during pregnancy. Doctors allow this to be done only in the third trimester of pregnancy, but the final decision on the advisability of taking it is made by the gynecologist.

Women who are breastfeeding must stop breastfeeding if you start taking this medicine. The fact is that the active components of the drugs penetrate into the mother’s milk, which can negatively affect the baby’s health.

The maximum daily dose should not exceed 2 grams, but such an amount is indicated only in individual, most severe cases. The drug belongs to the group of antibiotics, so it can negatively affect the functioning of the heart, liver, kidneys and digestive system if the dose is exceeded.

Regarding use in the treatment of tuberculosis, Clarithromycin is perceived as a drug 2 rows, i.e. it can only be used as an auxiliary tool. As a rule, the drug is taken together with Ethambutol or Rifabutin. With this method of therapy, the daily dose of the drug is 1 gram - 500 mg twice a day. Depending on the specific clinical picture of the disease, treatment may last no more than six months, but there are cases when therapy continues throughout the patient’s life. Share with friends!

Children's Clinical Hospital N 13 named after. N.F. Filatova, Moscow

The review determined the place of new macrolides as first-choice antibiotics in the treatment of outpatient respiratory tract infections in children. The mechanism of action, spectrum of antibacterial activity, pharmacokinetic features and the formation of resistance to new macrolides are considered. Attention is focused on the drug clarithromycin, due to the presence of a number of advantages. Data from numerous randomized studies on the effectiveness of clarithromycin in pediatrics for otitis, sinusitis, tonsillitis, pharyngitis, bronchitis and pneumonia are presented. New indications for use are highlighted, in particular for whooping cough and bronchial asthma in children. Based on published data, the effectiveness of a new convenient regimen for the use of clarithromycin at a dose of 15 mg/kg once a day, for a short course of 5 days, has been shown.

History of macrolides

The first macrolide antibiotic, erythromycin, was synthesized in 1952 and is still widely used in clinical practice. The use of erythromycin in children is limited due to the bitter taste, the high frequency of adverse events from the gastrointestinal tract, as well as due to low bioavailability and inconvenient frequency of administration (4 times a day).

Recently, new macrolide antibiotics of the next generation have been developed: roxithromycin, midecamycin, dirithromycin, clarithromycin and azithromycin. These drugs differ from erythromycin in significantly improved pharmacokinetics, a lower incidence of side effects, high activity against a number of important pathogens, and a reduced ability to interact with other drugs. The creation of modern macrolides coincided with intensive study of intracellular pathogens. Clinicians appreciated the ability of new macrolides to accumulate inside cells, taking into account their activity against mycoplasmas, chlamydia, and legionella. The period has come<ренессанса>for this pharmacological group, especially in pediatric practice, where new macrolides are quickly gaining popularity due to their safety, ease of use, high efficiency, and rapid effect on the main symptoms of the disease. Macrolide antibiotics have become the drugs of choice in the treatment of community-acquired infections of the upper and lower respiratory tract, otitis media and many other diseases of the ENT organs and seriously compete with penicillins and cephalosporins.

Mechanism of action

Clarithromycin, like other macrolides, inhibits protein synthesis in bacteria by binding to the active site of ribosomes and suppressing the synthesis of the peptide chain. At the same time, the activity of clarithromycin is 2 times higher than that of erythromycin, and significantly higher than that of other new macrolides.

The nature of action of macrolides is usually bacteriostatic, but in high concentrations they can have a bactericidal effect on streptococci.

Antibacterial activity

Clarithromycin has activity against gram-positive and gram-negative bacteria, as well as against mycoplasmas, chlamydia and some mycobacteria. Clarithromycin is slightly superior to other macrolides in its action against methicillin-sensitive staphylococci, streptococci, Haemophilus influenzae, moraxella and legionella (the main causative agents of respiratory tract infections).

It is known that erythromycin is ineffective in the treatment of infections caused by Haemophilus influenzae; of the macrolides, only azithromycin is sufficiently active against it. This feature is significant since Haemophilus influenzae is one of the three most common causative agents of respiratory tract infections. It turned out that clarithromycin, like azithromycin, is highly effective against this pathogen. This is partly due to the antibacterial activity of the main metabolite of clarithromycin, namely 14-hydroxyclarithromycin, which is 3 times more active against Haemophilus influenzae than clarithromycin itself. Synergism is observed in the interaction of the drug with its metabolite. In vitro activity of clarithromycin may be lower than the actual effectiveness of the drug, since active metabolites are not formed under these conditions.

Macrolides are highly active against most intracellular pathogens - chlamydia, mycoplasmas, ureaplasmas. Clarithromycin is somewhat superior to other drugs in its effect on Chlamydia trachomatis.

Of the macrolides, clarithromycin is the most active against Helicobacter pylori, including intracellular forms of the pathogen, and is therefore used in pediatric gastroenterology.

Unlike other macrolides, clarithromycin is highly active against atypical mycobacteria (Mycobacterium avium, M. leprae); its effect on these bacteria is 4 times greater than azithromycin in vitro. This is important in the treatment of opportunistic infections in patients with immunodeficiencies.

Almost all macrolides inhibit the growth of the causative agent of toxoplasmosis; new macrolides, including clarithromycin, have the highest activity. Clarithromycin is effective against rickettsia, the causative agent of wound infections resulting from animal bites. Also active against some anaerobes, including Bacteroides fragilis.

Many gram-negative bacteria are naturally resistant to macrolides. Clarithromycin exhibits significant activity in vitro and in vivo against gram-negative pathogens of respiratory tract infections such as Legionella pneumophilia, Moraxella catarrhalis, Bordetella pertussis.

However, macrolides do not act on gram-negative bacteria of the family Enterobacteriaceae, Pseudomonas and Acinetobacter, therefore, for chronic respiratory diseases, cystic fibrosis and intestinal infections, macrolides are much less often used as first-choice drugs.

Indications

Considering the spectrum of antibacterial activity, as well as the good tolerability of clarithromycin, it is usually recommended as the drug of first choice for the treatment of the following infections in children:

Upper respiratory tract infections (tonsillitis, pharyngitis, laryngitis);

Lower respiratory tract infections (bronchitis, pneumonia);

Acute otitis media;

Acute sinusitis;

Skin and soft tissue infections;

Sexually transmitted infections;

Chlamydial and gonorrheal conjunctivitis;

Peptic ulcer of the stomach and duodenum.

To date, extensive experience has been accumulated in the use of clarithromycin in pediatrics. In particular, it is shown high efficiency in the treatment of bacterial respiratory tract infections in children.

Anti-inflammatory effect

In addition to antibacterial activity, some macrolides have another ability - anti-inflammatory action. This property has been described in new macrolides such as azithromycin and roxithromycin. Recently, an anti-inflammatory effect was also discovered in clarithromycin. The latter increased the production of the anti-inflammatory cytokine interleukin-10 by monocytes. The production of pro-inflammatory mediators by monocytes (interleukin-1, tumor necrosis factor) and lymphocytes (interleukin-2), on the contrary, decreased. This effect can have a beneficial effect on the dynamics of the disease, when after eradication of bacteria the inflammatory process subsides faster and the main symptoms stop.

Pharmacokinetics

Clarithromycin belongs to the group of 14-membered macrolides and is a methylated derivative of erythromycin. Due to this slight chemical modification, clarithromycin is significantly more resistant to hydrolysis in an acidic environment compared to erythromycin. This increased its bioavailability, reduced the number of adverse events from the gastrointestinal tract and made its administration independent of food intake. Erythromycin is recommended to be taken only on an empty stomach due to increased hydrolysis in the acidic environment of the stomach. Food slows down the rate of absorption of roxithromycin and azithromycin, so it is better not to take these drugs immediately before a meal or earlier than 2 hours after a meal.

It has already been mentioned that approximately half the dose of clarithromycin is metabolized by liver microsomal enzymes to form the active metabolite 14-hydroxyclarithromycin. It is noteworthy that in terms of antibacterial activity, 14-hydroxyclarithromycin is not inferior to its predecessor. Therefore, the effect of the first passage through the liver has virtually no effect on the activity of the drug; from this point of view, parenteral administration has few advantages over enteral administration. Due to synergism with its active metabolite, clarithromycin remains highly active even if the drug level in the blood is slightly below the minimum inhibitory concentration. Metabolites of other macrolides do not have such antibacterial activity.

Plasma protein binding varies among macrolides. The highest (up to 96%) binding is characterized by roxithromycin. According to some authors, this may cause adverse reactions when prescribed to children prone to hypoproteinemia (premature babies, children with parenchymal liver diseases, nephrotic syndrome, malnutrition, cachexia, enzymopathies), due to the risk of developing toxic reactions. Clarithromycin is significantly less protein bound (approximately 50%) and can be prescribed to all children, regardless of the state of protein metabolism.

The maximum serum concentration of the drug is achieved within 2 hours after oral administration. The half-life of clarithromycin when taken 2 times a day is about 5 hours.

The advantage of new macrolides is their ability to create very high and stable concentrations in tissues, exceeding the level of the drug in the blood serum. Clarithromycin, in terms of distribution in the body, occupies an intermediate position among other macrolides. The highest serum concentrations are observed with roxithromycin, but its concentrations in tissues are lower than in the blood due to binding to plasma proteins. The lowest concentrations in the blood due to rapid accumulation in tissues are characteristic of azithromycin. Reaching a high serum concentration, clarithromycin penetrates well into tissues and accumulates in them, but at the same time fairly high concentrations of the drug are maintained in the blood.

Clarithromycin, due to its good solubility in both water and lipids, easily penetrates into cells and accumulates in them in high concentrations (Table 1). During inflammation, the permeability of the drug into the lesion increases. Macrolides, primarily clarithromycin and azithromycin, have a special tropism for cells of the immune system. Thus, the ratio of the intracellular to extracellular concentration of clarithromycin for polymorphonuclear leukocytes is 20-38 to 1, for mononuclear cells - 16-24 to 1. As a result, macrophages loaded with clarithromycin, during migration, transport the drug to the site of inflammation, creating especially high concentrations of the drug there. High intracellular concentrations of clarithromycin are of great importance for the treatment of infections caused by intracellular pathogens (chlamydia, mycoplasma, legionella). Clarithromycin exchanges freely between the intercellular and intracellular environments, and the level of antibiotic at the site always exceeds the minimum inhibitory concentration for many pathogens.

Tissue accumulation of clarithromycin ensures its constant presence in high concentrations at the site of infection, including in the interval between doses of the drug and some time after the end of the course of treatment (see Table 1). This made it possible to obtain good therapeutic results when taking clarithromycin once a day and when treating with a shortened course of 5 days.

Clarithromycin is eliminated from the body through the liver, kidneys and intestines. In case of renal failure, it is necessary to reduce the dose of the drug, but in case of liver failure, the dose should not be reduced.

It is necessary to point out that the clarithromycin suspension used in pediatrics does not have significant differences in pharmacokinetic characteristics from the tablet form of the drug. It was noted that after taking the suspension, a slightly smaller amount of the 14-hydroxyclarithromycin metabolite is formed, but the average serum concentration of the drug is higher.

Resistance to macrolides of microorganisms

Clarithromycin, like other 14-membered macrolides and azithromycin, is ineffective against bacteria that are naturally resistant to erythromycin. The latter produce the enzyme methylase, which modifies the very structure of drug molecules. Resistance to macrolides develops quickly, but resistant strains, after removing the antibiotic from the environment after some time, lose the ability to produce methylase and become sensitive again.

Methicillin-resistant strains of staphylococci are always resistant to macrolides, including clarithromycin. Other gram-positive bacteria that produce $\beta$-lactamase may remain sensitive to clarithromycin. Thus, ampicillin-resistant Haemophilus influenzae remains sensitive to clarithromycin and azithromycin. At the same time, penicillin-resistant pneumococci are likely to be resistant to macrolides, including clarithromycin.

Resistance to macrolides develops most quickly in pathogens such as pneumococci and group A streptococci. Macrolide resistance was found in 90-95% of hospital strains of penicillin-resistant pneumococci. In this regard, macrolides are reliable drugs of choice only for infections caused by community-acquired strains, since the resistance of the latter to these drugs is not so significant.

Penicillin- and macrolide-resistant strains of pneumococci, Haemophilus influenzae, and Moraxella are also found at home. Thus, community-acquired Haemophilus influenzae resistant to clarithromycin is detected in 1-5% of children in Germany, and group A streptococcus in approximately 4%. It is noted that the frequency of occurrence of resistant strains is increasing every year. Thus, according to Italian researchers, the frequency of isolation of community-acquired strains of group A streptococci in children with pharyngotonsillitis in 1990 was 4%, in 1991 - 4.4%, and in 1994 - already 15.5%. . Recent reports from Spain indicate that S. pyogenus resistance to the macrolides erythromycin, clarithromycin and azithromycin occurs in children with an incidence of up to 19%.

We should not forget that when treating an infectious process, antibiotics act not only on the direct pathogens, but also on all sensitive microorganisms that are part of the normal microflora. In the case of selection of resistant strains, natural biocenoses become a reservoir of resistant microorganisms and resistance determinants. Long-term action of the drug contributes to the development of resistance, especially if the concentration of the antibiotic on the mucous membranes remains at a subinhibitory level for a long time. The use of macrolides should be rational; drugs that have a lower ability to induce resistance have an advantage. In this regard, clarithromycin has some advantages over azithromycin. Let's consider this issue in more detail. The new macrolides, azithromycin and clarithromycin, rapidly reach high tissue concentrations. After completion of the course of treatment, azithromycin, which has a long (50-100 hours) half-life, is present in tissues for 4-6 weeks in concentrations that are below the minimum inhibitory and above the minimum active. Theoretically, favorable conditions are created for the selection of resistant strains. Unlike azithromycin, clarithromycin concentrations at the end of treatment quickly, within a few hours, fall below the minimum active threshold, and the drug ceases to act on the microflora.

A. Leach reports that 2 months after successful treatment with azithromycin in children with trachoma, 21% of them were colonized with azithromycin-resistant S. pneumoniae, whereas before treatment - only 1.3%.

J. Guggenblicher et al. conducted a randomized study that analyzed the effect of antibiotics on the oral microflora in children aged 6 months to 15 years. 100 patients with respiratory tract infections were observed. However, a group of children received clarithromycin 2 times a day at a daily dose of 15 mg/kg for 7 days, another group received azithromycin 10 mg/kg once for 3 days. Microbiological monitoring of microflora resistance to macrolides was carried out: samples were taken weekly. In both groups, in the first 2 weeks there was an increase in the number of patients carrying macrolide-resistant strains of bacteria, but then the picture changed. In the group of children receiving clarithromycin, the detection of resistant microorganisms decreased from the 2nd week, while in the group of children receiving azithromycin, their number even increased slightly. By week 6, macrolide-resistant microorganisms were detected in 86% of patients in the azithromycin group, whereas in only 18% of patients in the clarithromycin group.

According to the authors, the advantage of azithromycin in the form of a long half-life may turn against it in terms of increasing resistance. Macrolide-resistant microorganisms identified at week 6 in the azithromycin group were H. influenzae, M. catarrhalis, S. aureus, S. pneumoniae.

Does this data have any practical significance- remains unclear and controversial for both clinicians and microbiologists. Apparently, the reproducibility of the results obtained in this work and the consequences of such resistance remain to be assessed in further studies and clinical observations.

Lower respiratory tract infections in children

For a long time, the main causative agents of lower respiratory tract infections in children were pneumococcus and Haemophilus influenzae, and then traditional drugs were quite effective against these pathogens. In the last decade, against the background of a dramatic increase in the resistance of streptococci, staphylococci and other pathogens to penicillin drugs and other widely used antibiotics, there has been an increase in the importance of atypical pathogens, which include chlamydia, mycoplasma, and legionella. The incidence of pneumonia caused by these intracellular pathogens is constantly increasing and currently ranges from 5 to 30%. Atypical pneumonia is especially typical for children school age. In addition, pneumonia is increasingly becoming a mixed infection, in which traditional bacteria, intracellular microorganisms, and even anaerobes can simultaneously participate. Associations of pathogens with sufficient thoroughness of the study can be identified in almost half of the cases.

In these conditions, for the treatment of lower respiratory tract infections, drugs should be used that are active against all the most likely pathogens: streptococci, pneumococci, staphylococci, Haemophilus influenzae, moraxella, chlamydia, mycoplasma, legionella, anaerobes. New macrolides have such an antimicrobial spectrum, not inferior to traditional drugs, and often surpassing them in effectiveness, and are well tolerated. Many authors recommend clarithromycin as the first choice drug in the treatment of community-acquired lower respiratory tract infections in children.

According to a multicenter study, the effectiveness of clarithromycin in the treatment of typical community-acquired pneumonia in 131 children was 94%, atypical pneumonia in 64 children - 98%, and effectiveness in the treatment of bronchitis in 179 children - 95%. In general, in the treatment of respiratory tract infections in almost 3000 children, the effectiveness of clarithromycin was assessed as excellent (disappearance of all symptoms) - in 74.6%, as good (disappearance of main symptoms) - in 21.7%, as moderate (reduction of symptoms) - at 1.3%. Clarithromycin was ineffective in 0.5% of patients. When treating 150 children with pneumonia in Pakistan with clarithromycin, a clinical effect was obtained in 90% of patients.

Compared to erythromycin, clarithromycin shows similar effectiveness, but the number of adverse events is significantly lower. Thus, a multicenter, randomized, double-blind study compared erythromycin and clarithromycin in the treatment of pneumonia in 268 adolescents. The clinical, radiological and microbiological effectiveness of the drug was the same for both typical and atypical pneumonia and was 97% for clarithromycin and 96% for erythromycin. But patients receiving erythromycin were 2 times more likely to suffer from gastrointestinal side effects and 5 times more likely to have to interrupt treatment with the drug.

In the treatment of pneumonia caused by Mycoplasma pneumoniae in 32 children, clarithromycin showed 100% effectiveness, as did erythromycin, while the disappearance of radiological signs of pneumonia was observed faster in the group of children receiving clarithromycin compared with children taking erythromycin. Another randomized trial compared the effectiveness of clarithromycin and erythromycin in the treatment of 260 children with pneumonia. According to cultural and enzyme immunoassay studies, as well as polymerase chain reaction, in 28% of patients pneumonia was caused by Chlamydia pneumoniae, and in 27% - by M. pneumoniae. Clinical and radiological cure in the clarithromycin group was achieved in 98%, in the erythromycin group - in 95%, eradication of mycoplasmas was observed in 100% of patients in both groups, and chlamydia - in 79 and 86%, respectively. In an in vitro study, all 49 strains of Chlamydia pneumoniae isolated from children with pneumonia were sensitive to macrolides, but clarithromycin was an order of magnitude more active than erythromycin.

In terms of clinical effectiveness, there are no significant differences between erythromycin and new macrolides in the treatment of respiratory tract infections. But new macrolides have a number of advantages as drugs with significantly better tolerability and a more convenient regimen, which is especially important for children.

In terms of effectiveness, clarithromycin is not inferior not only to other macrolides, but also to cephalosporins of the first and second generations, protected and unprotected penicillins. Some studies indicate that clarithromycin may be more active against staphylococci, pneumococci and Haemophilus influenzae than the antibiotics widely used in the treatment of respiratory infections such as roxithromycin, cefaclor and amoxicillin.

J. Macklin et al. A multicenter, blinded, randomized study compared the effectiveness of clarithromycin and amoxicillin suspension in the treatment of lower respiratory tract infections in 145 children. There were no differences in the clinical effectiveness of the drugs between the groups. Clarithromycin was effective in 96%, and amoxicillin in 95% of patients. The frequency and nature of side effects in the groups also did not differ. Another blinded, randomized study compared the effectiveness of a suspension of clarithromycin, cefaclor and amoxicillin/clavulanate for pneumonia in 49 children. All three drugs were highly effective and did not differ in cure rates or side effects.

Some authors note that the main symptoms of the disease disappear much faster with treatment with clarithromycin than with other macrolides, as well as fluoroquinolones, penicillin, amoxicillin and cephalosporins. This fact has pharmacoeconomic significance, as it reduces the cost of symptomatic therapy.

IN Lately appeared interesting messages, indicating a connection between bronchial asthma and Chlamydia pneumoniae infection. Thus, in the work of U. Emre et al. Antibodies to this intracellular pathogen were found in 11% of children with an attack of suffocation. In 75% of children, after eradication of chlamydia with erythromycin or clarithromycin, there was an improvement in their condition according to clinical and laboratory studies. The authors propose to include macrolides in the course of treatment of children with an attack of bronchial asthma infected with Chlamydia pneumoniae.

Tonsillitis and pharyngitis

Almost 30% of children experience streptococcal tonsillopharyngitis at least once in their lives. Macrolides are traditionally considered as an alternative to penicillins for sore throat caused by group A β-hemolytic streptococcus, and are considered the first choice drugs in patients with an allergy to penicillin. Macrolides are as effective as penicillins and provide eradication of the pathogen from the tonsils in more than 90-95% of patients, thereby providing reliable prevention of serious complications of tonsillitis - rheumatism and glomerulonephritis. It is important that treatment with new macrolides is much more convenient and comfortable for young patients than erythromycin.

According to a large European multicenter study, in the treatment of tonsillitis or pharyngitis in 1065 children, clarithromycin was effective in 95% of patients.

Thus, J. Still et al. conducted a randomized trial involving 367 children suffering from streptococcal, serologically confirmed pharyngitis. The work compared the effectiveness of clarithromycin and penicillin. Both drugs were highly effective clinically, but in terms of the frequency of pathogen eradication (culture on the 10th day after the end of treatment), clarithromycin was significantly more effective. Clinical cure was observed in 96% in the clarithromycin group, and in 94% in the penicillin group. Eradication of streptococcus was achieved in 92 and 81% of patients, respectively. Similar data indicating equal clinical effectiveness of macrolide and penicillin, but better eradication of the pathogen when treated with clarithromycin, were obtained in other controlled studies. More reliable eradication in the clarithromycin group may be due to the fact that macrolides are not destroyed by β-lactamases of staphylococci, Haemophilus influenzae and Moraxella present in the oropharynx. And when treated with penicillin drugs, sometimes even if streptococcus shows sensitivity in vitro, then in vivo, due to the presence of β-lactamases produced by the accompanying microflora, complete eradication of the pathogen is not observed.

When clarithromycin was compared with azithromycin in a controlled study for the treatment of confirmed streptococcal tonsillitis in children, both drugs showed equal effectiveness. The cure rate in the clarithromycin group was 96.8%, in the azithromycin group - 95.9%. The rate of bacteriological eradication on the 20th day after treatment was 95.2 and 94.6%, respectively. However, after including children in the analysis who, for one reason or another, did not receive the entire course of therapy, due to the better azithromycin complex (3-day treatment course), its effectiveness turned out to be slightly higher (93% versus 82%).

Data on equal high clinical (98 and 97%) and bacteriological (86 and 88%) effectiveness of clarithromycin and amoxicillin for tonsillopharyngitis were obtained in a controlled study involving 191 children.

Shortened courses of clarithromycin - for 5 days - were no less effective for sore throats in children. Thus, when comparing clarithromycin prescribed at a standard dose for 5 days with a 10-day course of penicillin therapy, both drugs were highly effective clinically, but the eradication rate was significantly higher in the clarithromycin group (94%) than in the penicillin group (78%). .

In some regions of Russia, the occurrence of streptococcal strains resistant to erythromycin and other macrolides among children and adults reaches 13%; according to Spanish pediatricians, clarithromycin-resistant strains were found in 7.8% of 750 observations, while in the USA, According to a large-scale study, among 700 children, resistance of streptococcus pyogenes to clarithromycin is less than 2% and is not a significant clinical problem. Apparently, in case of relapse due to rapid development resistance, repeated treatment with macrolides is undesirable. The primary course of treatment for sore throats is best carried out not with erythromycin, but with clarithromycin, since, due to its pharmacokinetic properties, it is less conducive to the induction of resistance.

Acute otitis media

The main causative agents of otitis media are Streptococcus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae. In older children, the causative agent may also be pyogenic streptococcus, and in younger children - chlamydia. In the treatment of otitis, erythromycin has limited opportunities due to low activity against Haemophilus influenzae. The spectrum of action of clarithromycin includes all the main pathogens of otitis media, in addition, the high activity of the main metabolite of the drug, 14-hydroxyclarithromycin, against Haemophilus influenzae has already been mentioned.

In acute otitis media, macrolides can be used as a good alternative to aminopenicillins and co-trimoxazole. The pharmacokinetics of the latter do not allow reaching high concentrations in the middle ear cavity, while clarithromycin has the ability to accumulate in the site of inflammation. Thus, the study showed that the concentration of clarithromycin in the middle ear fluid of children suffering from acute otitis media was 3-5 times higher than in the blood plasma. In addition, β-lactam antibiotics (penicillins, cephalosporins) can be destroyed by β-lactamases of penicillin-resistant strains of pyogenic streptococcus and Haemophilus influenzae, as well as other bacteria that make up the microflora of the nasopharynx. Therefore, many authors today recommend using macrolides not as alternative drugs, but as first-choice drugs.

According to multicenter studies, clarithromycin suspension is highly effective for acute otitis media in children. In a study by German colleagues involving 102 children, on the 5th day of clarithromycin therapy, clinical cure was achieved in 99% of children. Adverse events were observed in 3% of patients. A study by colleagues from Spain to study the effectiveness of clarithromycin in respiratory infections involved 310 children with acute otitis media. The drug showed its effectiveness in 96.1% of children.

Numerous controlled comparative studies have shown that clarithromycin is not inferior to penicillins, cephalosporins, and other new macrolides, and is often superior to some drugs, especially penicillins, in effectiveness or safety. Thus, in a randomized study involving 736 children, clarithromycin showed equal efficacy compared to amoxicillin/clavulanate and cefaclor. Moreover, the frequency of adverse events in children receiving clarithromycin was 2 times less than in the group of children receiving amoxicillin/clavulanate and was 16% (36 out of 221) for clarithromycin and 30% (74 out of 244) for protected penicillin. In a randomized comparison of long-term results of treatment of acute otitis with a suspension of clarithromycin or amoxicillin, the effect of complete clinical cure was obtained in the clarithromycin group in 95% (20 out of 21) of children, and in the amoxicillin group in 86% (19 out of 22). The frequency of side effects did not differ and amounted to one child in each group. A blind randomized comparison of clarithromycin and cefuroxime axetil showed that the drugs are equally highly effective in otitis media, are well tolerated by children and do not differ in the frequency of side effects.

The usual course of treatment for acute otitis media is 10 days. It turned out that a short 5-day course of clarithromycin therapy is no less effective, but is much more convenient for the patient. A randomized, blinded, placebo-controlled trial involving 138 children showed that clarithromycin given for 5 days was as effective and safe as a 10-day course of treatment. When comparing clarithromycin and azithromycin given for 5 days, both drugs were equally effective (99%) in treating children with otitis media. They did not differ in the frequency of adverse events they caused.

Acute sinusitis

Clarithromycin is highly active against the main pathogens of sinusitis in children and is superior to erythromycin in activity against Haemophilus influenzae. Clarithromycin penetrates well into the mucous membrane of the paranasal sinuses and accumulates there in concentrations exceeding serum and minimum inhibitory concentrations for sinusitis pathogens.

According to a multicenter European study involving 310 children suffering from acute sinusitis and 15 children with rhinitis, the effectiveness of clarithromycin for sinusitis was 97.3%, and for rhinitis - 93.8%.

There have been no controlled comparative studies of the effectiveness of clarithromycin for sinusitis in children. But based on multicenter, blinded, randomized comparative studies conducted in adults, it can be argued that clarithromycin is comparable in effectiveness to azithromycin and fluoroquinolones.

Whooping cough

It has been shown that in children with whooping cough, macrolides do not affect the duration of the disease, but reduce the severity of clinical manifestations and cause rapid eradication of Bordetella pertussis from the nasopharynx. Therefore, macrolides, including clarithromycin, can be used as the drugs of choice for the treatment of whooping cough in children, as well as for the preventive treatment of family members of the patient.

A 12-day regimen of erythromycin is usually recommended. Due to improved pharmacokinetic characteristics, the new macrolides, clarithromycin and azithromycin, can be used for 7 days. It has been shown that the effectiveness of treatment does not decrease.

Dosage

The standard regimen for clarithromycin is twice daily, due to the half-life of clarithromycin being 4 hours. Twice daily is much more convenient than the erythromycin regimen, which requires dosing 4 times daily.

Considering that clarithromycin concentrations at the site of inflammation are much higher than serum concentrations, publications are increasingly appearing on the possibility of using a single daily dose of the drug and shortening the course of therapy. A randomized crossover study in volunteers showed that when clarithromycin was administered once a day at a daily dose of 500 mg or twice a day at a dose of 250 mg, the shape of the pharmacokinetic curve was the same. When the drug was administered once a day, high concentrations of clarithromycin remained constant in the lung tissues. Concentrations in alveolar fluid exceeded the minimum inhibitory concentration for typical bacterial pathogens of respiratory tract infections, and concentrations in alveolar macrophages exceeded the minimum inhibitory concentration for important intracellular pathogens. Thus, the theoretical premises for the once-daily use of clarithromycin have already received clinical confirmation.

In a double-blind, randomized, multicenter study in the treatment of acute exacerbations of chronic bronchitis in 265 adult patients, the effectiveness of clarithromycin administered twice daily or once daily was equal. The frequency of side effects in general was also the same, but adverse events from the gastrointestinal tract were more often observed in the group receiving clarithromycin 2 times a day.

In a study where the course of treatment with clarithromycin was much shorter than the traditional 5 days, the effectiveness was 97.5%. A number of other studies in children have also shown that short (5 days) courses are equal in effectiveness to conventional 7 and 10 day regimens, but are undoubtedly much more convenient for patients with pharyngitis, acute otitis media and whooping cough.

Currently, for respiratory tract infections in children, clarithromycin is usually prescribed at a dose of 15 mg per 1 kg of body weight per day, divided into two doses. The maximum daily dose is 500 mg. Duration of treatment is 7-10 days.

It is likely that with the accumulation of a sufficient number of studies, the possibility of using clarithromycin once a day in the treatment of respiratory tract infections in children with a short 5-day course will be shown. In this case, clarithromycin's complex will be equal to its main competitor - azithromycin, which is used once a day for 3 days.

For respiratory tract infections, especially severe pneumonia requiring hospital treatment, intravenous macrolides may be required. Unfortunately, until recently, parenteral forms of new macrolides were not available on the Russian market. An intravenous form of clarithromycin is available in Russia.

In hospitals, the so-called step therapy is currently popular, when treatment begins with intravenous administration of the drug, and then, after 1-3 days, switches to the oral form of the same drug. This ensures a more gentle regimen for the patient and reduces treatment costs with equal effectiveness. Due to the availability of an intravenous form and an oral suspension, step-down therapy with clarithromycin can be used in the treatment of pneumonia in children. A multicenter study compared clarithromycin with the combination of cefuroxime and erythromycin in the stepwise treatment of community-acquired pneumonia in 235 patients. There were no significant differences between groups in the incidence of clinical or bacteriological effectiveness, while adverse events (nausea, vomiting, diarrhea, abdominal pain) were significantly higher in the group receiving cefuroxime and erythromycin.

Tolerability and drug interactions

In general, macrolides, especially representatives of the new generation, are drugs with a favorable safety profile and are well tolerated by children. The most common gastrointestinal adverse events for clarithromycin are nausea (1%), vomiting (6%), diarrhea (7%), abdominal pain (2%) and headache (2%). Allergic reactions, symptoms of hepato- and ototoxicity, and adverse events from the nervous system are much less common. In general, adverse events with erythromycin, clarithromycin and azithromycin are observed in 4-27% of cases. This is comparable to the frequency of side effects when children take suspensions of $\beta$-lactam antibiotics - ampicillin, ampicillin/clavulanate, cefaclor, etc.

One of the differences between new macrolides and traditional erythromycin is a smaller number of gastrointestinal disorders. Metabolites of new macrolides stimulate intestinal motilin receptors less, which increase tone and peristalsis; accordingly, nausea and vomiting occur less frequently, which are observed in 10-20% of patients after taking erythromycin.

Deviations from laboratory parameters (usually increased levels of liver enzymes) occur when using clarithromycin in 0-1% of cases, while when using erythromycin - in 2-4%.

The active use of macrolides in complex therapy increases the likelihood of developing drug interactions with drugs that are inactivated by the microsomal cytochrome P-450 enzyme system. Since the metabolism of clarithromycin is carried out by microsomal liver enzymes with the participation of the cytochrome P-450 system, clarithromycin can affect the metabolism of all drugs passing through this system. Clarithromycin has a lesser ability than erythromycin to increase serum concentrations of drugs such as cyclosporine, warfarin, theophylline, carbamazepine, terfenadine, but co-administration of clarithromycin with the latter three drugs is contraindicated.

Conclusion

There is ongoing debate regarding the advantages and disadvantages of erythromycin compared to new macrolides. It is not easy to understand the differences between the most successful new macrolides - azithromycin and clarithromycin. Despite equal clinical efficacy, macrolides have significant differences in pharmacokinetic characteristics, safety profile, complex, eradication frequency, etc., which must be taken into account by the physician (Table 2).

Table 2. Comparison of erythromycin and the new macrolide clarithromycin
Characteristic	Erythromycin	Clarithromycin
Activity against Haemophilus influenzae	0	++
Activity against staphylococci, pneumococci, streptococci, chlamydia	+	++
Food independence	0	+
Metabolite activity	0	+
Accumulation at the site of inflammation	0	+
Anti-inflammatory activity	0	+
Reception frequency	4 times a day	2 times a day
Adverse events	++	+
Drug interactions	++	+
Note. 0 - absent; + - moderate activity; ++ - pronounced activity.

Currently, the choice of a drug for empirical treatment of infections in children should be based on the following properties: effectiveness, safety (adverse events), compliance (possibility of oral administration, independence from food intake, administration 1-2 times a day, pleasant taste, short course of therapy ) .

Clarithromycin has almost all the characteristics of an antibiotic for the empirical treatment of respiratory infections in children: high bioavailability when administered orally, high efficiency at relatively low doses of the drug, long interval between doses, balanced concentration in tissues and blood, high intracellular concentration, high activity of the main metabolites, wide spectrum of antibacterial activity, including all major pathogens of respiratory tract infections, and, finally, safety and good tolerability.

Literature

1. Klein J.O. History of macrolide use in pediatrics. Pediatr Infect Dis J 1997; 16(4): 427-431.

2. Guay D.R. Macrolide antibiotics in pediatric infectious diseases. Drugs 1996; 51(4): 515-536.

3. Klein J.O. Clarithromycin: where do we go from here? Pediatr Infect Dis J 1993; 12(3): 148-151.

4. Rodriguez W.J., Wiedermann B.L. The role of newer oral cephalosporins, fluoroquinolones, and macrolides in the treatment of pediatric infections. Adv Pediatr Infect Dis 1994; 9: 125-159.

5. Champney W.S., Burdine R. Azithromycin and clarithromycin inhibition of 50S ribosomal subunit formation in Staphylococcus aureus cells. Curr Microbiol 1998; 36: 119-123.

6. Strachunsky L.S., Kozlov S.N. Clinical pharmacology of macrolides. GRM 1997; 5 (21): 1392-1404.

7. Langtry H.D., Brogden R.N. Clarithromycin. A review of its efficacy in the treatment of respiratory tract infections in immunocompetent patients. Drugs 1997; 53(6): 973-1004.

8. Paters D.H., Clissold S.P. Clarithromycin: a review of its antimicrobial activity, pharmacocinetic properties and theraupeutic potential. Drugs 1992; 44(1): 117-164.

9. Fong I.W. An overview of the activity of clarithromycin against H.influenzae. Infect Med 1993; Dec: 41-46.

10. Langtry H.D., Balfour J.A. Azithromycin. A review of its use in pediatric infectious diseases. Drugs 1998; 56 (2): 273-297.

11. Piccolomini R., Di Bonavetura C., Catamo G., Neri M. In vitro activity of clarithromycin against intracellular Haelicobacter pylori ICMASK. Barcelona 1998.

12. Charles L., Segreti G. Choosing the right macrolide antibiotic. A guide to selection. Drugs 1997; 53 (3): 349-357.

13. Fraschini F., Scaglione F., Demartini G. Clarithromycin clinical pharmacocinetics. Clin Pharmacocinet 1993; 25(3): 189-204.

14. Beloborodova N.V., Bogdanov M.B., Chernenkaya T.V. Antibiotic therapy algorithms. Guide for doctors. M 1999; 145.

15. Wiedermann B.L. Macrolides: clarithromycin and azithromycin. Pediatr Rev 1998; 19(7): 238-239.

16. Salpietro C.D., Bisignano G., Fulia F., Marino A., Barberi I. Chlamydia trachomatis conjunctivitis in the newborn. Arch Pediatr 1999; 6(3): 317-320.

17. Tarlow M.J., Block S.L., Harris J., Kolokathis A. Future indications for macrolides. Pediatr Infect Dis J 1997;16(4):457-462.

18. Jun-ichi Kadota. Njn-antibiotic effect of antibiotics. Clin Microb Infect 1996; 1(2): 20-22.

19. Samsygina G.A., Brashnina N.P., Bogomilsky M.R. Rulid (roxithromycin) in the treatment of respiratory tract diseases in children. M 1997; 15.

20. MacLeon C.M. Novel clarithromycin research. In: Macrolides in New Millenium 1998; Crete: 34-35.

21. Periti P., Mazzei T. Clarithromicin: pharmacokinetic and pharmacodynamic interrelationships and dosage regimen. J Chemother 1999; 11(1): 11-27.

22. Guay D.R.P. Macrolide antibiotics in pediatric infectious diseases. Drugs 1996; 51: 515-536.

23. Carbon C. Clinical relevance of intracellular and extracellular concentrations of macrolides Infecc 1995; 23: 10-14.

24. Nightingale C.H. Pharmacocinetics and pharmacodynamics of new macrolides. Pediatr Infect Dis J 1997; 16:438-443.

25. Ishi K., Saito Y., Itai S., Nemoto M., Takayama K., Nagai T. Comparative study of pharmacokinetic parameters between clarithromicin and erythromycin stearate in relation to their physicochemical properties. Drug Develop Pharm 1998; 24 (2): 129-137.

26. Rodvold K.A., Gotfrierd M.H., Danziger L.H., Servi R.J. Intrapulmonary steady state concentrations of clarithromycin and azithromycin. Antimicrob Agents Chemother 1997; 41(6): 1399-1402.

27. Drusano G.L., Craig W.A. Relevance of pharmacokinetics and pharmacodynamics in the selection of antibiotics for respiratory tract infections. J Chemother 1997; 9(3): 38-44.

28. Bouros D. Clarithromycin once-a-day: safety and efficacy. In: Macrolides in New Millenium 1998; Crete: 10-11.

29. Ramet J. A comparative safety and efficacy study of clarithromycin and azithromycin suspensions in the short course treatment of children with acute otitis media. In: Macrolides in the New Millennium. Crete 1998; 4:26-27.

30. McCarthy J., Hedrick J., Gooch M. A short course of clarithromycin suspension vs. penicillin V suspension in children with streptococcal pharyngitis. ICMASK. Barcelona 1998; 140-141.

31. Aoyama T., Sunakawa K., Iwata S., Takeuchi Y., Fujii R. Efficacy of short-term treatment of pertussis with clarithromycin and azithromycin. J Pediatr 1996; 129(5): 761-764.

32. Guay D.R., Craft J.C. Overview of the pharmacology of clarithromycin suspension in children and a comparison with that in adults. Pediatr Infect Dis J 1993; 12(3): 106-111.

33. Hsueh P.R., Teng L.J., Lee L.N., Yang P.C., Ho S.W., Luh K.T. Extremely high incidence of macrolide and trimethoprim-sulfameth-oxazole resistance among clinical isolates of Streptococcus pneumoniae in Taiwan. J Clin Microbiol 1999; 37 (4): 897-901.

34. Farhat C.K. Use of clarithromicin in respiratory infection in pediatrics. Modern Pediatr 1995; 31 (2): 4-12.

35. Alvarez-Elcoro S., Enzler M.J. The macrolides: erythromycin, clarithromycin, and azithromycin. Mayo Clin Proc 1999; 74 (6): 613-634.

36. Chiou C.C., Liu Y.C., Huang T.S., Hwang W.K., Wang J.H., Lin H.H., Yen M.Y., Hsieh K.S. Extremely high prevalence of nasopharyngeal carriage of penicillin-resistant Streptococcus pneumoniae among children in Kaohsiung, Taiwan. J Clin Microbiol 1998; 36(7): 1933-1937.

37. Pichichero M.E. Empirical antibiotic selection criteria for respiratory infections in pediatric practice. Pediatr Infect Dis J 1997; 16(3): 60-64.

38. Doern G.V. Resistance among respiratory problem pathogens in pediatrics. Pediatr Infect Dis J 1995; 14(5): 420-423.

39. Millesimo M., Savoia D. Group A streptococci: evaluation of in vitro resistance to two macrolides. Microbios 1995; 82(3): 141-147.

40. Gene A., Gonzalez-Cuevas A., Juncosa T., Luaces S., Latorre S. Sensibilidad antibiotica de Streptococcus pyogenes en pediatria. Enferm Infecc Microbiol Clin 1998; 16(6): 272-274.

41. Low D.E. The evolution and dissemination of resistance: antibiotic influence on the normal flora. Infect Med 1999; 16: 18-23.

42. Leach A.J. A prospective study of the impact of community-based azithromicin treatment of trachoma on carriage and resistance of Streptococcus pneumoniae. Clin Infect Dis 1997; 24: 356-362.

43. Kastner U., Guggenbichler J.P. Influence of macrolide antibiotics on the oral flora. European Congress of Chemotherapy (ECC). Hamburg, Germany 1998; May.

44. Kastner U., Guggenbichler J.P. Influence of macrolide antibiotics on the oral flora. ICMASK. Barcelona 1998; 145-146.

45. Harris J.A. Antimicrobial therapy of pneumonia in infants and children. Sem Res Infect 1996; 11(3): 139-147.

46. LoCicero S.C., Vetter N. Emerging pathogens and mixed infections In: Macrolides in New Millenium 1998; Crete: 2-3.

47. Schaad U.B. Antibiotic therapy of childhood pneumonia. Pediatr Pulmonol Suppl 1999;18:146-149.

48. Bhutta T.I., Sheikh M.I., Khan M.I., Javed T. Efficacy of clarithromycin oral suspension in pediatric pneumoniae and follicular tonsillitis in Pacistan. ICMASK 1998; 134-135.

49. Chien S.M., Pichotta P., Siepman N., Chan C.K. Treatment of community-acquired pneumonia. A multicenter, double-blind, randomized study comparing clarithromycin with erythromycin. Canada-Sweden. Clarithromycin Pneumonia Study Group. Chest 1993; 103(3): 697-701.

50. Craft J.C., Aynilian G., Cox S. Clarithromycin in the treatment of community-acquired pneumonia due to M. pneumoniae in adult and pediatric patients. ICMASK 1996; 10-11.

51. Block S., Hedrick J., Hammerschlag M.R., Cassell G.H., Craft J.C. Mycoplasma pneumoniae and Chlamydia pneumoniae in pediatric community-acquired pneumonia: comparative efficacy and safety of clarithromycin vs. Erythromycin ethylsuccinate. Pediatr Infect Dis J 1995; 14(6): 471-477.

52. Roblin P.M., Montalban G., Hammerschlag M.R. Susceptibilities to clarithromycin and erythromycin of isolates of Chlamydia pneumomae from children with pheumoma. Antimicrob Agents Chemother 1994; 38 (7): 1588-1589.

53. Paffetti A., MastropietroC., Mannozzi P., Croce G.F., Del-Grosso V., le-Foche F., Summonti D., Chang G., Rossi F. La claritromicina nell "eta pediatrica. Esperienza personale. Minerva Pediatr 1994;46(4):181-183.

54. Macklin J.L., James I., Kearsley N.J., Coles S.J. A single-blind, randomized, comparative study of clarithromycin and amoxycillin suspensions in the treatment of children with lower respiratory tract infections. J Chemother 1993; 5(3): 174-180.

55. Gatchhalian S.R., Tiangco V., Medalla C., Lim T., Lupisan S. A singleblind randomized, phase III comparative study of clarithromycin, cefaclor and amoxicillin/clavulanic acid suspensions in the treatment of patients with lower respiratory tract infections. ICMASK 1998; 275-276.

56. Vogel F., Oberender P. Pharmacoeconomic evaluation therapy with clarithromycin versus other antibiotics in the treatment of lower respitatory tract infections ICMASK 1996; 40-41.

57. Emre U., Roblin P.M., Gelling M., Dumornay W., Rao M., Hammer-schlag M.R., Schachter J. The association of Chlamydia pneumoniae infection and reactive airway disease in children. Arch Pediatr Adoles Med 1994; 148(7): 727-732.

58. Pichichero M.E. Group A streptococcal tonsillopharyngitis: cost-effective diagnosis and treatment. Ann Emerg Med 1995; 25(3): 390-403.

59. Tarlow M.J. Macrolides in the management of streptococcal pharyngitis/tonsillitis. Pediatr Infect Dis J l997; 16(4):444-448.

60. Still J.G., Palmer R. An evaluation of clarithromycin and penicillin in patients with streptococcal pharyngitis. ICMASK 1996; 22-23.

61. Still J.G., Hubbard W.C., Poole J.M., Sheaffer C.I., Chartrand S., Jacobs R. Comparison of clarithromycin and penicillin VK suspensions in the treatment of children with streptococcal pharyngitis and review of currently available alternative antibiotic therapies. Pediatr Infect Dis J 1993; 12(3): 134-141.

62. Venuta A., Laudizi L., Beverelli A., Bettelli F., Milioli S., Garetti E. Azithromycin compared with clarithromycin for the treatment of streptococcal pharyngitis in children. J Int Med Res 1998 Jun-Jul; 26(3): 152-158.

63. Kearsley N.L., Campbell A., Sanderson A.A., Weir R.D., Kamdar M.K., Coles S.J. Comparison of clarithromycin suspension and amoxycillin syrup for the treatment of children with pharyngitis and/or tonsillitis. Br J Clin Pract 1997; 51(3): 133-137.

64. Garcia de Lomas J., Gimeno C., Diez J., Bermejo M., Navarro D., Garcia-Ponte L. Sensibilidad a eritromicina y claritromicina de aislados de Streptococcus betahemolitico del grupo A productores de faringoamigdalitis en la edad pediatrica: Estudio multicentrico en atencion primaria. Grupo Espanol para el Estudio de la Sensibilidad a Macrolidos en Atencion Primaria. Enferm Infecc Microbiol Clin 1999; 17(1): 24-28.

65. Kaplan E.L., Jonhson D.R. The spectrum of macrolide susceptibility among group A streptococci isolated from the upper respiratory tract in the United States, 1996-1997. ICMASK 1998; 244-245.

66. Block S.L. Causative pathogens, antibiotic resistance and therapeutic considerations in acute otitis media. Pediatr Infect Dis J 1997; 16(4): 449-456.

67. Jacobs R.F., Schutze G.E., Young R.A. et al. Antimicrobial agents. In: Principles and practice of pediatric infectious diseases. S.S. Long, L. K. Pickering, C.G. Prober (Eds.). New York 1997; 1604-1662.

68. Gan V.N., McCarty J.M., Chu S.Y., Carr R. Penetration of clarithromycin into middle ear fluid of children with acute otitis media. Pediatr Infect Dis J 1997; 16(1): 39-43.

69. Cohen R. The antibiotic treatment of acute otitis media and sinusitis in children. Diagn Microbiol Infect Dis 1997; 27 (1-2): 35-39.

70. Horst S. Study of the efficacy and toleration of clarithromycin suspension in children with acute otitis media. The Pediatrician 1996; 4(27): 540-543.

71. Craft J.C., Siepman N., Palmer R.N., Hom R. Treatment of acute otitis media in chidren comparing clarithromycin and amoxicillin suspension. In: Macrolides in New Millenium, Crete 1998; 2:4-5.

72. McCarthy J., Good C., Renteria A., Siepman N., Craft J.C. Comparative safety of clarithromycin vs amoxicillin/clavulanate or cefaclor in the treatment of acute otitis media in chidren. ICMASK 1996; 24-5.

73. Kafetzis D.A., Makaka-Zafiriou C., Bairamis T. Comparison of the efficacy and tolerability of clarithromycin suspension in the treatment of acute otitis media in pediatric patients. Clin Drug Invest 1997; 14(3): 192-199.

74. Lebel M.H., Schloss M., Mehra S. A Prospective, Double-Blinded, Placebo-Controlled Study of a 5-Day Versus 10-Day Course of Clarithromycin Suspension in Canadian Children with Acute Otitis Media. ICMASK, Barcelona 1998; 148-149.

75. Miyazawa T., Iino Y., Ogawa K., Kishimoto H., Kakinuma M., Shiga J. Mucous pathology and macrolide treatment of paranasal sinusitis in children. Jpn J Antibiot 1998; 51: 100-102.

76. Muller O. Comparison of azithromycin versus clarithromycin in the treatment of patients with upper respiratory tract infections. J Antimicrob Chemother 1993; 31(E): 137-146.

77. Adelglass J., Jones T.M., Ruoff G., Kahn J.B., Wiesinger B.A., Rielly-Gauvin K., Siu C.O. A multicenter, investigator-blinded, randomized comparison of oral levofloxacin and oral clarithromycin in the treatment of acute bacterial sinusitis. Pharmacotherapy 1998; 18(6): 1255-1263.

78. Clifford K., Huck W., Shan M., Tosiello R., Echols R.M. Heyd A Double-blind comparative trial of ciprofloxacin versus clarithromycin in the treatment of acute bacterial sinusitis. Sinusitis Infection Study Group. Ann Otol Rhinol Laryngol 1999; 108 (4): 360-367.

79. Sturmberg J.P., Watt P. Could it be whooping cough? Aust Fam Physician 1999; 28 (2): 129-131.

80. Vetter N., Stamler D., J"Neill S. et al. Clarithromycin versus combined cefuroxime and erythromycin in the treatment of hospitalized community acquired pneumoniae patients-introvenous followed by oral therapy. Clin Drug Invest 1997; 14(6): 439-449.

81. Craft J.C., Siepman N. Overview of the safety profile of clarithromycin suspension in pediatric patients. Pediatr Infect Dis J 1993; 12(3): 142-147.

82. Amsden G.W. Erythromycin, clarithromycin, and azithromycin: are the differences real? Clin Ther 1996; 18(1): 56-72.

83. Principi N., Esposito S. Comparative tolerability of erythromycin and newer macrolide antibacterials in pediatric patients. Drug Saf 1999; 20(1): 25-41.

Registration number: LSR-002475/09-090810

Trade name of the drug: Clarithromycin

Dosage form: film-coated tablets.

International nonproprietary name: clarithromycin

Compound:
Active substance : clarithromycin - 250 mg;
Excipients: microcrystalline cellulose - 33.0 mg, potato starch - 15.0 mg, povidone (polyvinylpyrrolidone) - 12.0 mg, sodium carboxymethyl starch - 7.0 mg, magnesium stearate - 3.0 mg.
Excipients (shell): hypromellose - 5.4 mg, macrogol 4000 - 1.6 mg, titanium dioxide -3.0 mg.

Description: Biconvex tablets without marks, film-coated, white or almost white. Slight surface roughness is acceptable.

Pharmacotherapeutic group: macrolide antibiotic
ATX Code J01FA09

Pharmacological properties
Pharmacodynamics
Clarithromycin is a semisynthetic antibiotic of the macrolide group and has an antibacterial effect by interacting with the 50S ribosomal subunit of sensitive bacteria and inhibiting protein synthesis.
Clarithromycin has been shown to have an antibacterial effect against the following pathogens:
Aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumonia, Streptococcus pyogenes, Listeria monocytogenes.
Aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Branhamella (Moraxella) catarrhalis, Neiserria gonorrhoeae, Legionella pneumophila. Other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae. Mycobacteria: Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC): Mycobacterium avium, Mycobacterium intracellulare.
The production of beta-lactamase does not affect the activity of clarithromycin. Most strains of staphylococci resistant to methicillin and oxacillin are also resistant to clarithromycin.
Clarithromycin has an effect in vitro and for most strains of the following microorganisms: aerobic gram-positive microorganisms Streptococcus agalactiae, Streptococci (groups C,F,G), Viridans group streptococci; aerobic gram-negative microorganisms - Bordetella pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms Clostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms - Bacteroides melaninogenicus; spirochetes - Borrelia burgdorferi, Treponema pallidum; Campylobacter jejuni, Helicobacter pylori.

Pharmacokinetics
Rapidly absorbed from the gastrointestinal tract after oral administration.
Absolute bioavailability is about 50%. With repeated doses of the drug, no accumulation was detected, and the nature of metabolism in the human body did not change. Eating immediately before taking the drug increased the bioavailability of the drug by an average of 25%. Clarithromycin can be taken before or with meals. Communication with plasma proteins is more than 90%. After a single dose, 2 peaks of maximum concentration are recorded. The second peak is due to the ability of the drug to concentrate in the gallbladder, followed by gradual or rapid entry into the intestine and absorption. The time to reach maximum concentration after oral administration of 250 mg g is 1-3 hours.
After oral administration, 20% of the dose taken is quickly hydroxylated in the liver by cytochrome enzymes CYP3A4, CYP3A5, CYP3A7 to form the main metabolite - 14-hydroxyclarithromycin, which has pronounced antimicrobial activity against Haemophilus influenzae. When taken regularly at 250 mg/day, the concentration of the unchanged drug and its main metabolite is 1 and 0.6 μg/ml, respectively; half-life is 3-4 and 5-6 hours, respectively. When the dose is increased to 500 mg/day, the concentration of the unchanged drug and its metabolite in plasma is 2.7-2.9 and 0.83-0.88 mcg/ml, respectively; the half-life is 4.8-5 and 6.9-8.7 hours, respectively. At therapeutic concentrations it accumulates in the lungs, skin and soft tissues (concentrations there are 10 times higher than the level in blood serum).
It is excreted by the kidneys and through the gastrointestinal tract (GIT) (20-30% in unchanged form, the rest in the form of metabolites). With a single dose of 250 and 1200 mg, 37.9 and 46% are excreted by the kidneys, and 40.2 and 29.1%, respectively, through the gastrointestinal tract.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug;
Infections of the upper respiratory tract; infections of the upper respiratory tract (pharyngitis, sinusitis);
Lower respiratory tract infections (pneumonia, bronchitis);
Skin and soft tissue infections (folliculitis, cellulitis, erysipelas);
Odontogenic infections;
Mycobacterial infections caused by Mycobacterium avium, Mycobacterium intracellular localized infections caused by Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum.
Prevention of the spread of infection caused by the Mycobacterium avium complex (MAC) to HIV-infected patients with a content of CD 4 lymphocytes (T-helper lymphocytes) of no more than 100 per 1 mm 3.
To eradicate Helicobacter pylori and reduce the frequency of relapses of duodenal ulcer.

Contraindications

Hypersensitivity to clarithromycin or other components of the drug;
First trimester of pregnancy;
Lactation period;
Porphyria;
Concomitant use of clarithromycin with the following drugs: astemizole, cisapride, pimozide, terfenadine, ergotamine, dihydroergotamine (see Interactions with other drugs);
Childhood up to 12 years of age or with a body weight of less than 40 kg (for this dosage form).

Carefully prescribed to patients with impaired liver and kidney function.

Pregnancy and lactation
Clarithromycin is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug is prescribed only if there are clear indications, if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to prescribe during lactation, the issue of stopping breastfeeding should be decided.

Directions for use and doses
Inside, regardless of food intake.
Adults and children over 12 years old (for body weight more than 40 kg): the standard dose is 250 mg 2 times a day, with an interval of 12 hours. For sinusitis and severe infections, including those caused by Haemophilus influenzae, the dose can be increased to 500 mg 2 times a day, with an interval of 12 hours.
The average duration of treatment is 7-14 days.
For patients with liver failure The recommended dose is 250 mg every 24 hours.
For patients with renal failure (creatinine clearance less than 30 ml/min.) The recommended dose is 250 mg every 24 hours or, for more severe infections, 250 mg 2 times a day, with an interval of 12 hours.
For mycobacterial infections Prescribe 500 mg of the drug 2 times a day, with an interval of 12 hours.
For common MAC infections in patients with AIDS :
Treatment should be continued as long as there is clinical and microbiological evidence of benefit. Clarithromycin should be prescribed in combination with other antimicrobial drugs.
To prevent infections caused by MAC :
The recommended dose of clarithromycin for adults and children over 12 years of age (with body weight more than 40 kg) is 500 mg 2 times a day, with an interval of 12 hours.
For odontogenic infections The dose of clarithromycin is 250 mg 2 times a day for 5 days.
For eradication of H. pylori
Combination treatment with three drugs :
Clarithromycin, 500 mg 2 times a day, in combination with lansoprazole, 30 mg 2 times a day, and amoxicillin, 1000 mg 2 times a day, for 10 days.
Clarithromycin, 500 mg 2 times a day, in combination with amoxicillin, 1000 mg 2 times a day, and omeprazole, 20 mg/day, for 7-10 days.
Combination treatment with two drugs
Clarithromycin, 500 mg 3 times a day, in combination with omeprazole at a dose of 40 mg/day, for 14 days, with the appointment of omeprazole at a dose of 20-40 mg/day over the next 14 days.
Clarithromycin, 500 mg 3 times a day, in combination with lansoprazole at a dose of 60 mg/day, for 14 days. For complete healing of the ulcer, additional reduction in the acidity of gastric juice may be required.

Side effects
From the outside digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, stomatitis, glossitis, pancreatitis, discoloration of the tongue and teeth; extremely rarely - pseudomembranous enterocolitis. Tooth discoloration is reversible and can usually be restored with special treatment at a dental clinic. As with other antibiotics from the macrolide group, liver dysfunction is possible, including increased activity of liver enzymes, hepatic cell and/or cholestatic hepatitis with or without jaundice. These liver problems can be severe, but are usually reversible. Very rare cases of liver failure and death have been observed, mainly due to severe concomitant diseases and/or concomitant drug therapy.
From the outside nervous system: dizziness, headache, paresthesia, olfactory disorders, changes in taste, agitation, insomnia, nightmares, fear, ringing in the ears; rarely - disorientation, hallucinations, psychosis, depersonalization, confusion.
From the outside of cardio-vascular system: as with other macrolides, prolongation of the QT interval, ventricular tachycardia; polymorphic ventricular tachyarrhythmia (torsade de pointe).
From the outside hematopoietic organs and hemostasis system: rarely - leukopenia and thrombocytopenia (unusual bleeding, hemorrhage). From the musculoskeletal system: arthralgia, myalgia.
From the outside urinary system: isolated cases of increased plasma creatinine, interstitial nephritis, renal failure.
Allergic reactions: skin hyperemia, urticaria, skin rash, angioedema, bronchospasm, eosinophilia; rarely - anaphylactic shock, Stevens-Johnson syndrome.
Others: increased body temperature, possible development of superinfection, candidiasis, development of resistance of microorganisms.

Overdose
Symptoms: symptoms from the gastrointestinal tract; In one patient with a history of bipolar disorder, mental status disturbances, paranoid behavior, hypoglycemia, and hypoxemia were described after taking 8 g of clarithromycin.
Treatment: gastric lavage, symptomatic therapy.
There is no specific antidote.

Interaction with other drugs
Clarithromycin is not prescribed simultaneously with cisapride, pimozide, or terfenadine.
Concomitant use of clarithromycin with drugs metabolized by cytochrome P450 may lead to an increase in the concentration of drugs in the blood plasma such as: triazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (eg warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam, vinblastine, phenytoin, theophylline and valproic acid.
With simultaneous use of clarithromycin with cisapride, an increase in the concentration of cisapride was observed. This may cause QT prolongation, arrhythmia, ventricular tachycardia, fibrillation, and torsade de pointes. Similar effects have been observed in patients taking clarithromycin concomitantly with pimozide.
Macrolide drugs affect the metabolism of terfenadine. The level of terfenadine in the blood increases, which may be accompanied by the development of arrhythmia, an increase in the QT interval, ventricular tachycardia, fibrillation and ventricular fibrillation. The content of acid metabolites of terfenadine increases 2-3 times, the QT interval increases, however, this does not cause any clinical manifestations. The same picture was observed when taking astemizole simultaneously with drugs from the macrolide group.
There are reports of the development of ventricular flutter-fibrillation with the simultaneous use of clarithromycin and quinidine, and disopyramide. When prescribing these drugs simultaneously, monitoring their concentrations in the blood is required. With simultaneous use of clarithromycin with digoxin, an increase in serum digoxin levels was observed. Serum digoxin levels should be monitored in such patients.
With the simultaneous use of theophylline and carbamazepine with clarithromycin, a moderate but significant (p)<0.05) повышение содержания теофиллина и карбамазепина в плазме крови.
Rare cases of rhabdomyolysis have been reported when clarithromycin is taken concomitantly with hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors (for example, lovastatin and simvastatin).
Colchicine is a substrate for CYP3A and P-glycoprotein. Clarithromycin and other macrolides are inhibitors of CYP3A and P-glycoprotein. When colchicine and clarithromycin are coadministered, inhibition of 3-gp and/or CYP3A may result in increased effects of colchicine. Patients should be closely monitored for symptoms of colchicine toxicity.
With simultaneous oral administration of clarithromycin and zidovudine in HIV-infected patients, a decrease in the equilibrium concentration of zidovudine was observed. Because clarithromycin interferes with the absorption of zidovudine, the two drugs should be taken separately.
Ritonavir significantly slows down the metabolism of clarithromycin when administered concomitantly. At the same time, the Cmax value of clarithromycin increases by 31%, the minimum concentration (Cmin) by 182%, and the area under the concentration-time curve by 77%. There is a significant slowdown in the formation of 14-hydroxyclarithromycin. In this case, in patients without renal impairment, there is no need to adjust the dose of clarithromycin. When taking ritonavir, do not simultaneously prescribe a dosage of clarithromycin greater than 1 g per day.
Cross-resistance may develop between clarithromycin and other macrolide drugs, such as lincomycin and clindamycin. With the simultaneous use of clarithromycin and hypoglycemic agents, including insulin, in rare cases, hypoglycemia may develop.

special instructions
In the presence of chronic liver diseases, it is necessary to regularly monitor liver enzymes in the blood serum.
In case of co-administration with warfarin or other indirect anticoagulants, it is necessary to monitor the prothrombin time.

Release form
Film-coated tablets 250 mg.
10 tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil. 10, 20, 30, 40, 50 or 100 tablets in a polymer container for medicines. One container or 1, 2, 3, 4, 5, 6, 8 or 10 blister packs along with instructions for use are placed in a cardboard pack.

Storage conditions
List B.
Store in a dry place, protected from light, at a temperature not exceeding 25°C.
Keep out of the reach of children.

Best before date
3 years.
Do not use after expiration date.

Conditions for dispensing from pharmacies
On prescription

Manufacturer
Ozon LLC
Legal address:
445351, Russia, Zhigulevsk, Samara region, st. Pesochnaya, 11.
Address for correspondence (actual address, including for receiving claims):
445351, Russia, Zhigulevsk, Samara region, st. Hydrostroiteley, 6.

Part Clarithromycin tablets active ingredient included clarithromycin , as well as additional components: MCC, potato starch, pregelatinized starch, low molecular weight PVP, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate.

Part Clarithromycin capsules also contains the active substance clarithromycin , as well as additional components: corn starch, lactose monohydrate, povidone, croscarmellose sodium, calcium stearate, polysorbate 80. The hard capsule consists of gelatin and titanium dioxide.

Release form

Side effects

During the course of treatment, the following side effects may occur:

nervous system:, fear, bad dreams, , feeling of anxiety; in rare cases - , disturbances of consciousness, psychosis ;
digestion: vomit, nausea , gastralgia , cholestatic jaundice, , increased activity of liver transaminases, in rare cases pseudomembranous enterocolitis occurs;
hematopoiesis, hemostatic system: in rare cases – thrombocytopenia ;
sense organs: feeling of tinnitus, taste disturbance, isolated cases of hearing loss were noted after the drug was discontinued;
allergy: skin rash, anaphylactoid reactions, Stevens-Johnson syndrome;
other actions: manifestation of resistance of microorganisms.

Instructions for use of Clarithromycin (Method and dosage)

Instructions for use of Clarithromycin Teva stipulate that adults and children over 12 years of age take, depending on the diagnosis, 250–500 mg twice a day. Therapy lasts from 6 to 14 days.

If the patient is diagnosed with a severe infection or for a certain reason it is impossible to take the drug orally, clarithromycin is prescribed IV, the dose is 500 mg per day. The drug is taken for 2 to 5 days, after which, if possible, the patient is transferred to oral administration of the medication. In general, treatment lasts up to 10 days.

If the drug is prescribed for the treatment of diseases caused by Mycobacterium avium, as well as severe infections (including those caused by Haemophilus influenzae), it is recommended to take 0.5–1 g of the drug twice a day. The largest daily dose is 2 g. Treatment can last about 6 months.

People with chronic renal failure receive a single dose of 250 mg per day; if a severe infection is diagnosed, they are prescribed 250 mg twice a day. Treatment can last up to 14 days.

Overdose

If an overdose occurs, the patient may experience problems with gastrointestinal function, disturbances of consciousness, and headaches. In this case, gastric lavage is performed and, if necessary, symptomatic treatment is prescribed.

Interaction

Clarithromycin should not be used concomitantly with Pimozide , Terfenadine And Cisapride .

Taking with indirect anticoagulants, drugs that are metabolized in the liver using cytochrome P450, as well as , Cisapride, Carbamazepine, Terfenadine, , Triazolam, Disopyramide, Lovastatin, , Midazolam, ergot alkaloids, , Phenytoin increases the concentration of these drugs in the blood.

Clarithromycin reduces absorption Zidovudine .

Cross-resistance may develop between Clarithromycin and Lincomycin.

Reduces the rate of Astemizole, therefore, with simultaneous use, an increase in the QT interval may develop, and the risk of ventricular arrhythmia of the “pirouette” type increases.

The concentration increases significantly in Omeprazole and slightly in Clarithromycin.

If the drug is used simultaneously with Pimozide , the concentration of the latter increases, which increases the likelihood of severe cardiotoxicity.

Application with Tolbutamide increases the risk of hypoglycemia.

When used simultaneously with toxic effects are likely.

Terms of sale

You can buy it at the pharmacy with a doctor's prescription; the specialist gives the prescription in Latin.

Storage conditions

Clarithromycin should be protected from moisture and light, storage temperature should not exceed 25 °C.

Keep out of reach of children.

Best before date

You can store the medicine for 2 years. Do not use after this period.

special instructions

If a patient is diagnosed with chronic diseases, he must monitor serum enzymes.

The drug should be prescribed with caution when taking medications whose metabolism takes place in the liver.

There is cross-resistance between antibacterial drugs that belong to the macrolide group.

Normal during antibiotic therapy intestines changes, so the likelihood of manifestation should be taken into account superinfections caused by resistant microorganisms.

It should be taken into account that severe manifestations may be associated with pseudomembranous colitis.

To make it easier for children to take the drug, a suspension whose active ingredient is clarithromycin can be prescribed.

Analogues of Clarithromycin

Level 4 ATX code matches:

The price of Clarithromycin analogues depends on their manufacturer and other factors. Analogs of this drug are: Clarithromycin Teva , Arvitsin , , Clarexide , Zimbaktar , Clarithrosin , and etc.

For children

In pediatrics, the drug can be used for children after 6 months of age. The most commonly used suspension is for children, the active ingredient of which is clarithromycin. Application must be carried out strictly according to the regimen prescribed by the doctor.

During pregnancy and lactation

This antibiotic cannot be used in the first trimester. In subsequent months of pregnancy, the use of the drug is possible only if the doctor correlates the expected benefits for the woman and harm to the fetus. During lactation, if you need to take medication, you should stop breastfeeding.

Reviews of Clarithromycin

Patients leave different reviews about Clarithromycin online. It is often written that with the help of an antibiotic it was possible to get rid of the symptoms of infectious diseases within a few days. However, there are many opinions about the fact that the drug provokes a large number of side effects, in particular, headaches, digestive problems, and imbalance of intestinal microflora. In most cases, it is noted that it is advisable to take the medicine only with a doctor’s prescription and according to the regimen prescribed by the specialist.

Clarithromycin price, where to buy

The price of Clarithromycin 250 mg tablets is on average 120 rubles per pack of 10 pcs. Price Clarithromycin 500 mg – on average 240 rubles per pack. 10 pieces. You can buy medicine in Ukraine (Kyiv, Kharkov, etc.) for a price starting from 50 UAH. For 10 pcs. The price of Clarithromycin IV (drug Klacid) averages 600 rubles.

Online pharmacies in Russia Russia
Online pharmacies in Ukraine Ukraine

ZdravCity

Clarithromycin tablets p.p.o. 500mg No. 10 Ozone Ozone LLC

Clarithromycin-acriquin tab. p/o captivity. 250 mg No. 10Micro Labs Limited

Clarithromycin caps. 250mg n14 Vertex JSC

Clarithromycin tablets p.p.o. 500 mg No. 10 Dalkhimpharm JSC Dalkhimfarm

Clarithromycin tab. p.o 250 mg n10 Ozone LLC

Pharmacy Dialogue

Clarithromycin SR tablets 500 mg No. 7

Clarithromycin (caps. 250 mg No. 14)

How to take Clarithromycin is prescribed by your doctor after clinical and laboratory tests and an accurate diagnosis. The drug is a semi-synthetic derivative of erythromycin, synthesized as a result of chemical changes in the molecular composition of the active substance.

The drug is characterized by high bioavailability, increased stability in an acidic environment, and a wide spectrum of antibacterial action. Unlike other representatives of the macrolide group, the drug concentration of clarithromycin in tissues is much higher.

The drug is prescribed for infections of the upper respiratory tract (sinusitis, pharyngitis, tonsillitis, tonsillitis), lower respiratory tract (bronchitis, pneumonia, tracheitis), infectious lesions of the skin (streptoderma, carbuncles, boils, furunculosis, erysipelas), infectious diseases in patients with human immunodeficiency virus (HIV), mycobacterial generalized lesions, gastric ulcer, duodenal ulcer, in combination with drugs that reduce the acidity of gastric juice.

The antibiotic Clarithromycin inhibits the proliferation of pathogenic bacteria in the affected area; the maximum concentration of the drug in the blood is achieved two hours after the first dose. The differences in the use of the drug in tablets and in suspension are due to the possibility of using the antibiotic in both adults and children.

When prescribing Clarithromycin to a child, it is recommended to use small light yellow granules to prepare a suspension. In addition to the instructions, the package contains a syringe dispenser, which allows you to accurately select the volume of the drug based on the doctor’s prescription.

Recently, the antibiotic Clarithromycin has been used in urology to treat chronic and acute prostatitis. The improved pharmacokinetic and antibacterial properties of Clarithromycin cause its increased acid stability, which leads to rapid accumulation of the required concentration at the site of infection.

The antimicrobial effect of the drug is realized by disrupting protein synthesis by the ribosomal structures of the microbial organism. The high degree of solubility in lipids allows Clarithromycin to distribute in a balanced manner throughout the entire infectious focus.

How to take Clarithromycin: the dosage regimen is prescribed individually by your doctor, regardless of meals, but usually after meals. Prescribed from 0.25 to 0.5 grams every 12 hours, the duration of administration is adjusted by the attending physician and depends on the results of clinical blood tests.

As a rule, the drug is well tolerated by patients. Side effects are:

digestive disorders (dyspepsia, nausea, vomiting);
disorders of the central nervous system (dizziness, paresthesia, numbness of the limbs, insomnia);
disorders of the cardiovascular system (ventricular tachycardia, ventricular arrhythmias);
allergic phenomena (urticaria, Quincke's edema, rarely - anaphylactic shock);
hypoglycemia, loss of consciousness.

The antibiotic Clarithromycin should not be used:

when taking ergot derivatives in parallel;
in children under 12 years of age;
with simultaneous use of cisapride, pimozide, terfenadine;
during pregnancy and breastfeeding;
increased allergic sensitivity to macrolides.

Antibiotic Clarithromycin for resistant bacterial infection

Due to the fact that Clarithromycin has a predictable effect, unlike other broad-spectrum antibiotics, it has few side effects; the semi-synthetic drug is used to treat gastritis with proven Helicobacter pylori activity, chlamydia, and ureaplasmosis.

The pronounced post-antibiotic effect, which is expressed in maintaining the concentration of the drug in the blood after stopping its use, makes it possible to prescribe short courses of Clarithromycin. The treatment-resistant bacterium Helicobacter pylori causes chronic peptic ulcers of the stomach and duodenum and increases the risk of developing gastric cancer. The acid resistance of the antibiotic Clarithromycin determines the relevance of its widespread use in gastroenterological practice.

The drug is prescribed 500 mg per day, twice after meals, the course is prolonged from 7 to 14 days, depending on the level of microbial activity.

The solution to such a complex urological problem as the treatment of chlamydia and ureaplasmosis is possible due to the rapid blocking of the synthesis of ribosomal protein subunits of microorganisms. Due to its long half-life and wide balanced distribution in affected tissues, the antibiotic Clarithromycin is actively used in international practice in the form of tablets or suspension. Courses of the drug for urogenital pathology are prescribed by the doctor strictly individually.

Clarithromycin tablets for children and pregnant women, analogues of the drug

Clarithromycin tablets are used in both children and adults. A special feature of the drug is the intensive saturation of the body’s enzymatic systems, which increases the bioavailability of the active substance.

The drug should be used with caution in patients with impaired renal excretory function or renal failure.

Impaired excretion of the substance leads to toxic tissue poisoning and recurrent impairment of renal function. They try not to prescribe the drug to pregnant women in the first and second trimester of pregnancy. to exclude intrauterine pathology of the fetus.

It is strictly forbidden to use an antibiotic during alcohol consumption; a decrease in the effectiveness of the antibiotic occurs in parallel with the increasing load on the organs and tissues of the body.
The release of toxic components formed as a result of the interaction of ethanol with the excipients magnesium stearate, talc and starch, which are part of the antibiotic, leads to severe poisoning of liver cells, including the development of acute hepatitis.
Clarithromycin tablets should be combined with other medications with caution, after consulting your doctor. Severe consequences of unorganized use of drugs can develop after combining Clarithromycin with other potent drugs. The consequences are manifested by toxic damage to various organs.

For children over 12 years of age, the drug is prescribed according to 250-500 mg twice a day, lasting from six days to two weeks. For pregnant women, starting from the third trimester of pregnancy, the drug is prescribed for infectious diseases strictly as prescribed by a gynecologist.

Analogs of Clarithromycin are medicines whose composition is represented by substances that are interchangeable in their effect on the microbial cell.

Analogues include:

Clarithromycin-Teva.
Clarithromycin-OBL.
Klabaks OD.
Clarbuckt.
Clarithromycin-VERTE.
Klacid.
Claricin.

Clarithromycin tablets have good reviews among adults and children and are noted as an effective medicine that quickly helps get rid of the disease. The absence of side effects and good tolerability of the drug make it the drug of choice.

The price of the drug ranges from 160 to 950 rubles. Analogues of the drug, such as Claritrosin Synthesis in capsules, can be purchased in pharmacies at a price of 163 rubles per pack. The maximum cost is noted for Klacid SR Retard in a blister, which currently costs 901 rubles.

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Dosage of the drug

Dosage for tuberculosis

Main contraindications

Side effects

Conclusion

Release form

Side effects

Instructions for use of Clarithromycin (Method and dosage)

Overdose

Interaction

Terms of sale

Storage conditions

Best before date

special instructions

Analogues of Clarithromycin

For children

During pregnancy and lactation

Reviews of Clarithromycin

Clarithromycin price, where to buy

ZdravCity

Pharmacy Dialogue

Antibiotic Clarithromycin for resistant bacterial infection

Clarithromycin tablets for children and pregnant women, analogues of the drug

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