Is it possible to klacid. Klacid: instructions for use, contraindications. Klacid: variety of forms

Instruction

Tradename

Klacid 

International non-proprietary name

Clarithromycin

Dosage form

Coated tablets, 500 mg

Compound

One tablet sheathed, contains:

active substance - clarithromycin 500 mg

Excipients: croscarmellose sodium, microcrystalline cellulose, silicon dioxide,povidone, stearic acid, magnesium stearate,talc.

shell composition: hypromellose, sorbitan monooleate, propylene glycol, titanium dioxide (E171), vanillin, yellow dye (quinoline yellow) (E 104)aluminum varnish, hydroxypropyl cellulose, sorbic acid.

Description

Pale yellow, oval-shaped, film-coated tablets.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Clarithromycin.

ATX code J01 FA09

Pharmacological properties

PharmacokineticsAbsorption

Pharmacokinetics of the drug Klacid® has been extensively studied in experimental animals and adults. These studies have shown that clarithromycin is completely and rapidly absorbed. Absolute bioavailability is about 50%. With repeated administration of the drug, unexpected cumulation is not determined or is determined in small quantities. At the same time, the nature of metabolism in the human body does not change. Eating immediately before the administration of the drug increases the bioavailability of clarithromycin by an average of 25%. In general, this increase is not significant and is of little clinical significance at the recommended dosing regimens. Therefore, clarithromycin may be given with or without food.

Distribution, biotransformation and elimination

In vitro

Research in vitroshowed that clarithromycin binds to human plasma proteins at an average level of about 70%, at clinically significant concentrations from 0.45 µg/ml to 4.5 µg/ml. The decrease in binding to 41% at 45.0 µg/mL suggested that binding sites might saturate, but this only occurred at concentrations well above therapeutic concentrations of the drug.

The results of animal studies have shown that the levels of clarithromycin in all tissues, except the central nervous system, were several times higher than the levels of the drug circulating in the blood. The highest concentrations were usually found in the liver and lungs, where the tissue/plasma ratio reached 10-20.

Healthy Subjects

With a dosing regimen of 250 mg 2 times a day, the equilibrium maximum concentration (C max ) was achieved after 2-3 days and averaged approximately 1 μg/ml for clarithromycin and 0.6 μg/ml for 14-OH-clarithromycin, respectively. The elimination half-lives of the parent drug and metabolite are 3-4 hours and 5-6 hours, respectively. With a dosing regimen of 500 mg 2 times a day C max clarithromycin and 14-OH-clarithromycin in an equilibrium state was achieved after taking the 5th dose of the drug. After taking the 5th and 7th doses Cmax clarithromycin in the equilibrium state in the average state were 2.7 and 2.9 μg/ml, and 14-OH-clarithromycin - 0.88 and 0.83 μg/ml, respectively. The half-life of the parent drug at a dose of 500 mg was 4.5-4.8 hours, and 14-OH-clarithromycin - 6.9-8.7 hours. At steady state, the concentration of 14-OH-clarithromycin does not increase in proportion to the dose of clarithromycin, and the elimination half-lives of clarithromycin and its hydroxylated metabolite tended to lengthen at higher doses. This non-linear pharmacokinetics of clarithromycin, together with the cumulative reduction in the formation of 14-hydroxylation and N-demethylation products at higher doses, indicates that the non-linear metabolism of clarithromycin becomes more pronounced at higher doses.

In adults who received a single dose of clarithromycin 250 mg or 1200 mg orally, excretionwith urine was 37.9% of the low dose of the drug and 46.0% of its high dose. Excretion through the intestines was 40.2% and 29.1% of the respective doses of clarithromycin (including a subject with only one fecal sample containing 14.1% of the drug).

Patients

Clarithromycin and its 14-OH metabolite are readily distributed into tissues and body fluids. Limited data from a study with a small number of patients suggest that the concentration of clarithromycin in the cerebrospinal fluid after oral administration is negligible (in particular, only 1-2% of the serum concentration in the cerebrospinal fluid with normal permeability of the blood-brain barrier ). Tissue concentrations are usually several times higher than serum concentrations.

Impaired liver function

In a study comparing a group of healthy volunteers with a group of patients with hepatic impairment who took 250 mg of immediate-release clarithromycin twice daily for two days and a single dose of 250 mg on the third day, steady-state plasma concentrations and systemic clearance of clarithromycin did not differ significantly in both groups. In contrast, equilibrium concentrations of 14- Oh -metabolites were markedly lower in the group of patients with impaired liver function. This reduced metabolic clearance of the parent compound by 14-hydroxylation was partially offset by increased renal clearance of the parent drug, resulting in comparable steady-state concentrations of the parent drug in patients with impaired hepatic function and healthy volunteers. These results indicate that no dose adjustment is required in individuals with moderate or severe liver damage but normal renal function.

Impaired kidney function

A study was conducted to evaluate and compare the pharmacokinetic profile of multiple 500 mg oral doses of immediate release clarithromycin in patients with normal and reduced renal function. Plasma concentrations, half-life, Cmax and Cmin for clarithromycin and its 14- Oh -metabolites were higher, and AUC - more in patients with impaired renal function. The elimination rate and urinary excretion were lower. The degree of change in these parameters depends on the degree of impaired renal function: the more severe the damage to the kidneys, the more significant the difference (see section "Method of application and dosage").

Elderly patients

A study was also conducted to evaluate and compare the safety and pharmacokinetic profile of multiple oral doses of clarithromycin 500 mg in healthy elderly male and female patients and healthy young adult males. In the elderly group, plasma concentrations of the parent drug and 14- Oh -metabolites were higher, and excretion was slower than in the young group. However, no difference was found between the ratio of renal clearance and creatinine clearance. From these results, it was concluded that any change in pharmacokinetics is related to renal function, and not age per se.

Infections caused Mycobacterium avium

Equilibrium concentrations of clarithromycin and 14- Oh -clarithromycin in adult patients with HIV infection who received clarithromycin at a dose of 500 mg every 12 hours were similar to those in healthy individuals. However, at higher doses, which may be required for the treatment of infections caused byMycobacterium avium, clarithromycin concentrations were significantly higher than those observed at usual doses. In adult HIV-infected patients who took the drug at a dose of 1000 and 2000 mg / day in two doses, the values Cmax clarithromycin at steady state ranged from 2 to 4 µg/mL and from 5 to 10 µg/mL, respectively. The elimination half-life at these higher doses was prolonged compared to that in healthy subjects receiving clarithromycin at normal doses. Higher plasma concentrations and prolongation of the half-life of clarithromycin at these doses are associated with non-linear pharmacokinetics of the drug.

Use simultaneously with omeprazole

A pharmacokinetic study of clarithromycin at a dose of 500 mg 3 times a day and omeprazole 40 mg 1 time per day was carried out. With the introduction of clarithromycin in mono mode at a dose of 500 mg every 8 hours, the average values Cmax were approximately 3.8 µg/ml, and the mean values Cmin were approximately 1.8 μg/ml. Averages AUC0-8 clarithromycin were 22.9 µg/h/ml. Tmax and half-life with the introduction of clarithromycin at a dose of 500 mg 3 times a day were 2.1 hours and 5.3 hours, respectively.

In the same study, administration of clarithromycin 500 mg three times daily with omeprazole 40 mg once daily resulted in an increase in elimination half-life and AUC0-24 omeprazole. In all patients receiving combination therapy, the mean values AUC0-24 omeprazole were 89% higher and the harmonic mean T1/2 omeprazole - 34% higher than with omeprazole monotherapy. When prescribing clarithromycin with omeprazole Cmax, Cmin, and AUC0-8 clarithromycin increased by 10%, 27%, and 15%, respectively, compared with values ​​achieved with clarithromycin plus placebo.

At steady state, gastric mucosal concentrations of clarithromycin 6 hours post-dose in the clarithromycin/omeprazole group were approximately 25-fold higher than those in the clarithromycin alone group. Mean concentrations of clarithromycin in the stomach tissue 6 hours after taking clarithromycin with omeprazole were approximately 2 times higher than those when using clarithromycin with placebo.

Pharmacodynamics

Clarithromycin is a semi-synthetic macrolide antibiotic obtained by substitution CH3 O -hydroxyl groups ( Oh ) group in the 6th position of the lactone ring of erythromycin. More precisely, clarithromycin is 6-O-methylerythromycin A. This antibiotic is a white or almost white powder with a bitter taste, practically odorless, virtually insoluble in water and sparingly soluble in ethanol, methanol and acetonitrile. Its molecular weight is 747.96

Microbiology

Antibacterial action of the drug Klacid® determined by hisbinding with 5 OS -ribosomal subunit of sensitive bacteria and inhibitionprotein biosynthesis.The drug shows high efficiencyin vitro against standard strains of bacteria and strains isolated in clinical practice. It is highly effective against a wide range of aerobic and anaerobic Gram-positive and Gram-negative microorganisms. Minimum inhibitory concentrations (MICs) of clarithromycin, on average per one log 2 dilution is lower than the MIC of erythromycin. Clarithromycinin vitro highly effective againstLegionella pneumophila andMycoplasma pneumoniae . Clarithromycin acts bactericidal againstHelicobacter pylori, the activity of clarithromycin at neutral pH is higher than at acidic pH.In vitro and in vivodata indicate the high efficacy of clarithromycin against clinically significant strains of mycobacteria. Research in vitro showed , what strains Enterobacteriaceae and Pseudomonas, as well as gram-negative bacteria that do not ferment lactose, are insensitive to clarithromycin.

The activity of clarithromycin against most strains of the microorganisms listed below is shown asin vitro, and in clinical practice for diseases listed in the section "Indications for use".

Staphylococcus aureus,

Streptococcus pneumoniae,

Streptococcus pyogenes,

Listeria monocytogenes.

Aerobic gram-negative microorganisms :

haemophilus influenzae,

haemophilus parainfluenzae,

Moraxella catarrhalis,

Neisseria gonorrhoeae,

Legionella pneumophila.

Other microorganisms :

Mycoplasma pneumoniae,

Chlamydia pneumoniae (TWAR).

Mycobacteria :

Mycobacterium leprae,

Mycobacterium kansasii,

Mycobacterium chelonae,

Mycobacterium fortuitum,

Mycobacterium avium complex (MAC), which includes Mycobacterium avium, Mycobacterium intracellulare.

The production of beta-lactamase does not affect the efficacy of clarithromycin.

Most methicillin- and oxacillin-resistant strains of staphylococci are not susceptible to clarithromycin.

Helicobacter:

H. pylori.

In cultures prepared before therapy, we isolatedH. pylori and before starting treatment, the minimum inhibitory concentration was determined in 104 patients. Of these, clarithromycin-resistant strains were identified in 4 patients.H. pylori, in 2 patients - strains with intermediate sensitivity, and in 98 patients isolatesH. pylori were sensitive to clarithromycin.

The following data are availablein vitro, but their clinical significance is not known . Clarithromycin shows activityin vitro against most strains of the following microorganisms; however, the safety and efficacy of clarithromycin in the treatment of clinical infections caused by these organisms has not been established in controlled clinical trials.

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 :

Bacteriodes melaninogenicus .

Spirochetes:

Borrelia burgdorferi ,

Treponema pallidum .

Campylobacter :

Campylobacter Jejuni .

The main metabolite of clarithromycin in humans is the microbiologically active metabolite 14- Oh - clarithromycin. For most microorganisms, this metabolite is as active or 1-2 times less active than the parent compound, with the exception ofH. influenzae, for which it is twice as active. The original connection and 14- Oh -metabolite cause an additive or synergistic effect in relation toH. influenzae in conditions in vitro and in vivo, depending on the bacterial strain. Data obtained in an experiment on models of infection in animals showed that clarithromycin is 2-10 times more active than erythromycin.

Indications for use

Clarithromycin is indicated for the treatment of infections caused by susceptible organisms:

Lower respiratory tract infections (bronchitis, pneumonia, etc.)

Upper respiratory tract infections (pharyngitis, sinusitis, etc.)

Infections of the skin and soft tissues (folliculitis, cellulitis, erysipelas, etc.)

Disseminated or localized mycobacterial infections caused byMycobacterium avium or Mycobacterium intracellulare, localized infections caused byMycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium kansasii;

For the prevention of dissemination irovann th infections caused by the complexMycobacterium avium (MAC) in HIV-infected patients with CD count 4 -lymphocytes ≤ 100/mm 3 ;

For eradication H. pylori , helping to reduce the recurrence of duodenal ulcer

- treatment of odontogenic infections

Sensitivity tests

Quantitative methods that require measurement of zone diameter provide the most accurate estimates of bacterial susceptibility to antimicrobials. One recommended procedure for susceptibility testing uses discs impregnated with 15 µg clarithromycin (Kirby-Bauer diffusion test); the inhibition zone diameter for this disc correlates with the minimum inhibitory concentration values ​​for clarithromycin. The minimum inhibitory concentration is determined by the method of dilution in broth or agar.

In these procedures, a susceptibility report from the laboratory indicates that the infecting organism is likely to respond to therapy. A report with the word "resistant" indicates that the infecting organism is not likely to respond to therapy. A report with the words "intermediate sensitivity" indicates that the therapeutic effect of this drug may be questionable or the microorganism will be susceptible if higher doses are used (intermediate sensitivity is also referred to as moderate sensitivity).

See your country or region-specific information regarding the range of absolute breakpoints for susceptibility, persistence, and intermediate susceptibility.

Dosage and administration

adults

The usual recommended dose of clarithromycin for adults and children over 12 years of age is 250 mg per tablet twice daily. For more severe infections, the dose may be increased to 500 mg twice daily. The usual duration of treatment is 5 to 14 days, except for community-acquired pneumonia and sinusitis, which require 6 to 14 days of therapy.

Mycobacterial infections

Treatment of disseminated MAC infections in AIDS patients should be continued for as long as clinical and microbiological benefit is demonstrated. Clarithromycin should be used in combination with other antimycobacterial agents.

Treatment of other nontuberculous mycobacterial infections should be continued at the discretion of the treating physician.

Odontogenic infections

In the treatment of odontogenic infections, the usual doseclarithromycin is250 mg 2 times a day for 5 days.

In patients with peptic ulcer caused byH. pylori -infection, clarithromycin may be given at a dose of 500 mg twice daily in combination with other appropriate antimicrobials and proton pump inhibitors for 7-14 days in accordance with national or international recommendations for eradicationH. pylori .

kidney failure

In patients with severe renal impairment (creatinine clearance less than 30 ml/min), the dose of clarithromycin should be halved to 250 mg once daily or 250 mg twice daily for more severe infections. Treatment of these patients should not last more than 14 days.

Children

The use of the drug Klacid® have not been studied in children under 12 years of age.

Side effects

The most frequent and common adverse reactions in the treatment of Klacid® adults and children are abdominal pain, diarrhea, nausea, vomiting and taste distortion. These adverse reactions are usually mild and consistent with the known safety profile of macrolide antibiotics. During clinical studies, there were no significant differences in the frequency of these gastrointestinal adverse reactions between groups of patients who had or did not have mycobacterial infections.

The following are adverse reactions that occurred during clinical trials and during post-marketing various dosage forms and dosages of the drug Klacid® . side reactions, at least, probably associated with clarithromycin, distributed by organ system and by frequency of occurrence: very often (≥1/10), often (≥ 1/100 to<1/10), нечасто (≥ 1/1000 до <1/100), с неизвестной частотой (побочные реакции, выявленные при постмаркетинговом наблюдении, частоту определить невозможно из имеющихся данных). В пределах каждой группы по частоте побочные реакции представлены в порядке убывания тяжести проявлений, если тяжесть удалось оценить.

Often

phlebitis at the injection site 1

Often

≥ 1/100 to<1/10

Insomnia

Headache

Dysgeusia, taste distortion

Vasodilation 1

Nausea, abdominal pain, vomiting, dyspepsia, diarrhea

Abnormal liver function tests

Rash, hyperhidrosis

Pain at the injection site 1 , inflammation at the injection site 1

Infrequently

≥ 1/1000 to<1/100

Cellulite 1 , candidiasis, gastroenteritis 2

Infection 3 , vaginal infection

- leukopenia, neutropenia 4 , thrombocythemia 3 , eosinophilia 4

Anaphylactoid reactions 1 , hypersensitivity

Anorexia, loss of appetite

Anxiety, anxiety and agitation 3

Loss of consciousness 1, dyskinesia 1 , dizziness, drowsiness, tremor

Vertigo, hearing loss, tinnitus

Heart failure 1 , atrial fibrillation 1 , prolongation of the QT interval on the ECG, extrasystoles 1 , sensation of heartbeat

Asthma 1 , nose bleed 2 pulmonary embolism 1

Esophagitis 1 , gastroesophageal reflux disease 2 , gastritis, proctalgia 2 , stomatitis, glossitis, bloating 4 , constipation, dry mouth, belching, flatulence

Cholestasis 4, hepatitis 4 , increased levels of ALT, AST, GGT 4

bullous dermatitis 1 , pruritus, urticaria, maculo-papular rash 3

Muscle spasms 3 , musculoskeletal rigidity 1, myalgia 2

Increase in blood creatinine 1 , increased blood urea 1

Malaise 4, fever 3 , asthenia, chest pain 4, chills 4, fatigue 4

Change in albumin-globulin ratio 1 , increased levels of alkaline phosphatase in the blood 4 , increased levels of lactate dehydrogenase in the blood 4

Frequency unknown*

(frequency cannot be determined from available data)

Pseudomembranous colitis, erysipelas

Agranulocytosis, thrombocytopenia

Anaphylactic reactions, angioedema

Psychosis, confusion, depersonalization, depression, disorientation, hallucinations, nightmares, mania

Convulsions, ageusia, parosmia, anosmia, paresthesia

hearing loss

Pirouette ventricular tachycardia (torsade sde pointes ), ventricular tachycardia, ventricular fibrillation.

Hemorrhage

Acute pancreatitis, discoloration of the tongue, discoloration of the teeth

Liver failure, hepatocellular jaundice

Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced skin reaction accompanied by eosinophilia and systemic manifestations (DRESS), acne

Rhabdomyolysis 2** , myopathy

Renal failure, interstitial nephritis

Increase in international normalized ratio, increase in prothrombin time, change in urine color.

*Frequency unknown as these reactions have been reported voluntarily in an unspecified patient population. It is not always possible to accurately establish their frequency or causal relationship with taking the drug. Total experience with clarithromycin is more than 1 billion patient days.

** In some reports of rhabdomyolysis, clarithromycin has been co-administered with other drugs known to be associated with rhabdomyolysis (such as statins, fibrates, colchicine, or allopurinol).

1. Reports of adverse reactions were only for the powder formulation for solution for infusion.

2. Reports of adverse reactions were only for the extended-release tablet formulation.

3. Reports of adverse reactions were only for the oral suspension granule formulation.

4. Reports of adverse reactions were only for the immediate release tablet formulation.

It is expected that the frequency, type and severity of adverse reactions in children are the same as in adults.

Patients with compromised immune systems In patients with AIDS and other patients with impaired immune systems who have used high doses of clarithromycin for a long time to treat mycobacterial infections,it is not always possible to distinguish between adverse reactions associated with the use of the drug, and symptoms of the underlying or concomitant diseases. In adult patients who received Klacid® at a daily dose of 1000 mg, the most common side effects were nausea, vomiting, taste perversion, abdominal pain, diarrhea, rash, bloating, headache, constipation, hearing loss, increased levels of AST and ALT in blood serum. Uncommon: dyspnea, insomnia and dry mouth. In these immunocompromised patients, laboratory parameters were assessed by analyzing their significant deviations from the normative values ​​(ie, extreme upper or lower limits) for certain tests. According to this criterion, 2-3% of patients who received 1000 mg of clarithromycin per day had a significant increase in AST and ALT levels and a significant decrease in the number of leukocytes and platelets in the blood. In a smaller percentage of patients, an increase in blood urea levels was also observed.

Contraindications

Hypersensitivity to macrolide antibiotics or to any auxiliary components of the drug.

Concomitant use of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide, terfenadine, as this can lead to prolongation of the QT interval and the development of arrhythmias, including ventricular tachycardia, ventricular fibrillation and ventricular torsades de pointes ( torsades de pointes) (see section "Drug Interactions").

The concomitant use of clarithromycin and ergot alkaloids (eg, ergotamine, dihydroergotamine) is contraindicated because it can lead to poisoning with ergot alkaloids (see section "Drug Interactions").

Simultaneous reception of clarithromycin and midazolam for oral use is contraindicated (see section "Drug interactions").

Clarithromycin should not be used in patients with a history of QT interval prolongation (congenital or established acquired QT interval prolongation) or ventricular arrhythmia, including torsades de pointes. torsades de pointes) (see "Drug Interactions" and "Special Instructions").

Clarithromycin should not be given to patients with hypokalemia (risk of QT interval prolongation).

Clarithromycin should not be given to patients with severe hepatic impairment with concomitant renal impairment.

Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins), which are largely metabolized by CYP3A4 (lovastatin or simvastatin), due to an increased risk of myopathy, including rhabdomyolysis (see section "Special Instructions").

Clarithromycin (and other strong inhibitors of CYP3A4) should not be used concomitantly with colchicine (see section "Drug Interactions" and "Special Instructions").

Co-administration with ticagrelor or ranolazine is contraindicated.

Children's age up to 12 years

Drug Interactions

The use of the following drugs is strictly contraindicated due to the possible development of serious consequences of the interaction

Cisapride, pimozide, astemizole and terfenadine .

An increase in cisapride levels has been reported in patients receiving Clacid.® and cisapride at the same time. This may lengthen the interval QT and the appearance of arrhythmias, including ventricular tachycardia, ventricular fibrillation and ventricular tachycardia of the "pirouette" type (torsades de points). Similar effects have been observed in patients taking

Klacid ® and pimozide at the same time (see section "Contraindications").

Macrolides affect the metabolism of terfenadine, causing an increase in blood levels of terfenadine, which is sometimes accompanied by arrhythmias, such as an increase in the interval QT , ventricular tachycardia, ventricular fibrillation and ventricular tachycardia of the "pirouette" type (torsades de points) (see section "Contraindications"). In a study involving 14 healthy volunteers, the simultaneous use of clarithromycin and terfenadine resulted in a 2-3-fold increase in the level of the acid metabolite of terfenadine in the blood serum and lengthening the interval QT , which did not cause any clinically significant effect.

Similar effects were noted with the simultaneous use of astemizole and other macrolides.

Ergot alkaloids . Post-marketing studies show that the simultaneous use of clarithromycin and ergotamine or dihydroergotamine leads to the toxic effect of ergot, manifested in the form of vasospasm, ischemia of the extremities and other tissues, including the central nervous system.Simultaneous administration of the drug Klacid® and ergot alkaloids are contraindicated (see section "Contraindications").

Midazolam for oral use

With the simultaneous use of midazolam and clarithromycin tablets (500 mg twice a day), AUC midazolam increased 7-fold after oral midazolam. Co-administration of oral midazolam and clarithromycin is contraindicated (see section "Contraindications").

. Simultaneous administration of the drugKlacid® contraindicated with lovastatin or simvastatin (see Contraindications section) as they are extensively metabolized CYP3 A 4, and simultaneous treatment with clarithromycin causes an increase in their plasma concentration, which increases the risk of developing myopathy and rhabdomyolysis. There are reports of cases of rhabdomyolysis in patients who simultaneously took clarithromycin with these statins. If the use of the drugKlacid® cannot be avoided, lovastatin or simvastatin should be withheld for the duration of the drugKlacid® .

Klacid® with statins. If the simultaneous use of the drugKlacid® and statins is inevitable, it is recommended to prescribe the lowest registered dose of a statin. Consider prescribing a statin that is not metabolized CYP3 A such as fluvastatin. Patients should be monitored for signs and symptoms of myopathy.

The effect of other drugs on Klacid ® . Drugs that induce CYP3 A (eg, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort) may accelerate the metabolism of clarithromycin. This can lead to sub-therapeutic levels of clarithromycin and reduce its effectiveness. In addition, it may be necessary to monitor the levels of other drugs that induce CYP3 A , which may increase due to the inhibitory effect of clarithromycin on CYP3 A (See also the prescribing information for the respective inhibitor CYP3 A four). Simultaneous reception of rifabutin and the drug Klacid® led to an increase in the level of rifabutin and a decrease in the concentration of clarithromycin in serum with an increased risk of uveitis.

The following drugs affect or are expected to affect the concentration of clarithromycin in the blood serum. Dose adjustment may be required Klacid ® or consideration of alternative treatment options

Efavirenz, nevirapine, rifampicin, rifabutin and rifapentine

Strong inducers of the cytochrome metabolic system P 450, such as efavirenz, nevirapine, rifampicin, rifabutin and rifapentine, can accelerate the metabolism of clarithromycin, thus reducing its plasma concentration while increasing the concentration of its active metabolite (14- Oh - clarithromycin). Since the microbiological activity of clarithromycin and 14- Oh -clarithromycin in relation to various bacteria is different, then the simultaneous administration of the drugKlacid® and inducers of cytochrome P450 enzymes may prevent the achievement of the desired therapeutic effect.

Etravirine : When taking etravirine, the exposure of the drug Klacid® decreases, and the concentration of its active metabolite, 14- Oh - clarithromycin, increased. Since 14- Oh -clarithromycin is less active againstMycobacterium avium complex (MAC ), the overall effectiveness of the drug against this pathogen may change. For this reason, for the treatment MAC alternative treatment options should be considered.

Fluconazole

Co-administration of fluconazole 200 mg daily and clarithromycin 500 mg twice daily in 21 healthy volunteers resulted in an increase in the mean steady-state trough concentration of clarithromycin ( Cmin ) and the area under the curve ( AUC ) by 33% and 18%, respectively.

Equilibrium concentrations of the active metabolite 14-OH-clarithromycin did not change significantly with the simultaneous use of fluconazole. Dose adjustmentKlacid® not required.

Ritonavir

A pharmacokinetic study showed that co-administration of ritonavir 200 mg every eight hours and Klacid® 500 mg every 12 hours results in a marked decrease in the metabolism of clarithromycin. Wherein Cmax clarithromycin increased by 31%, Cmin increased by 182%, AUC increased by 77% with the simultaneous appointment of ritonavir. Almost complete inhibition of the formation of 14- Oh - clarithromycin. Due to the wide therapeutic range, dose reductionKlacid® in patients with normal renal function is not required. In patients with renal insufficiency, dose adjustment is necessary: ​​for patients with creatinine clearance (CC) 30-60 ml / min dose of the drugKlacid® must be reduced by 50%. For patients with CC< 30 мл/мин дозу Клацид ® must be reduced by 75%. Doses of the drugKlacid® exceeding 1 g/day should not be co-administered with ritonavir. Similar dose adjustments should be made in patients with impaired renal function when ritonavir is used as a pharmacokinetic enhancer with other HIV protease inhibitors, including atazanavir and saquinavir (see section "Bidirectional drug interactions").

Influence drug Klacid ® for other medicines

Antiarrhythmic drugs .

In post-marketing practice, cases of ventricular tachycardia of the "pirouette" type have been recorded (torsades de points) while taking clarithromycin and quinidine or disopyramide.

While taking the drugKlacid® with these drugs, it is recommended to conduct ECG monitoring for the timely detection of prolongation of the interval QT . During drug therapyKlacid® Serum concentrations of these drugs should be monitored. There are also reports of cases of hypoglycemia while taking clarithromycin and disopyramide. While taking the drugKlacid® anddisopyramide should monitor blood glucose levels.

Oral hypoglycemic agents and insulin .

When used concomitantly with certain hypoglycemic agents such as nateglinide and repaglinide and drug Klacid® enzyme inhibition may occur CYP3 A clarithromycin, which can cause hypoglycemia. Close monitoring of glucose levels is recommended.

CYP3 A- related interactions .

Simultaneous use drug Klacid® , known as an enzyme inhibitor CYP3 A , and the drug primarily metabolized CYP3 A , may lead to an increase in the concentration of the latter in the blood plasma, which, in turn, may enhance or prolong its therapeutic effect and adverse reactions.

Care must be taken when using drug Klacid® in patients receiving drugs - substrates CYP3 A especially if the latter have a narrow therapeutic window (eg, carbamazepine) and/or are extensively metabolized by this enzyme.

It may be necessary to change the dose and, if possible, close monitoring of serum concentrations of drugs metabolized CYP3 A in patients who are taking concomitantKlacid® .

The following drugs or drug groups are known or suspected to be metabolized by the same CYP3 A isoenzyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, horn alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (eg, warfarin),atypical antipsychotics (eg quetiapine), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine,but this list is not complete. A similar mechanism of interaction was noted with the use of phenytoin, theophylline and valproate, which are metabolized by another isoenzyme of the cytochrome P system.450 .

Omeprazole . There are results of a study on adult healthy volunteers who took Klacid concomitantly.® (500 mg every 8 hours) and omeprazole (40 mg daily). When taken simultaneously with the drug Klacid® an increase in the steady-state plasma concentration of omeprazole was noted ( Cmax, AUC0-24 and t1/2 increased by 30%, 89% and 34%, respectively). Average value of the indicator pH in 24 hours in the stomach was 5.2 when taking omeprazole alone and 5.7 when taking omeprazole simultaneously with Klacid® .

Sildenafil, tadalafil and vardenafil .

Each of these phosphodiesterase inhibitors is metabolized at least in part by CYP3 A and CYP3 A may be inhibited by concomitant administration of clarithromycin. Simultaneous reception of Klacid® and sildenafil, tadalafil or vardenafil may lead to increased exposure to the phosphodiesterase inhibitor. When these drugs are used concomitantly with Klacid® dose reduction of sildenafil, tadalafil or vardenafil should be considered.

Theophylline, carbamazepine .

The results of clinical studies show that there is a small but statistically significant ( p ≤0.05) increase in circulating concentrations of theophylline or carbamazepine while taking any of these drugs with Klacid® .

tolterodine mainly metabolized 2 D6- cytochrome P isoform 450 (CYP2 D 6). However, in patients without CYP2D 6 metabolism occurs through CYP3 A . In this population, oppression CYP3 A leads to a significant increase in plasma concentrations of tolterodine. For these patients, dose reduction of tolterodine may be necessary when used with inhibitors. CYP3 A, such as Klacid® .

Triazolobenzodiazepines (eg, alprazolam, midazolam, triazolam).

With the simultaneous appointment of midazolam and clarithromycin tablets (500 mg twice a day), the AUC of midazolam increased 2.7 times with intravenous administration of midazolam. With intravenous use of midazolam with the drug Klacid® Careful monitoring of the patient's condition should be carried out for timely dose adjustment.

The oromucosal route of administration of midazolam may avoid pre-systemic elimination of the drug, which is more likely to result in an interaction similar to that observed with intravenous administration of midazolam, and not with oral administration.

The same precautions should be observed when using other benzodiazepines that are metabolized by CYP3A, including triazolam and alprazolam. For benzodiazepines whose elimination is independent of CYP3A (temazepam, nitrazepam, lorazepam), the development of a clinically significant interaction with Klacid® is unlikely.

There are post-marketing reports of drug interactions and the development of side effects from the central nervous system (such as drowsiness and confusion) with the simultaneous use of clarithromycin and triazolam. The patient's condition should be monitored, given the possibility of an increase in the pharmacological effects of the central nervous system.

Interaction with other drugs

Colchicine

Colchicine is the substrate for CYP3 A , and for the P-glycoprotein carrier protein ( pgp). It is known that Klacid® and other macrolides are inhibitors CYP3 A and P-glycoprotein. In the case of simultaneous use of the drugKlacid® and colchicine, clarithromycin inhibition of P-glycoprotein and/or CYP3 A may lead to increased exposure to colchicine. Simultaneous administration of the drugKlacid® and colchicine is contraindicated (see sections "Contraindications" and "Special Instructions").

Digoxin

Digoxin considered a carrier protein substrate P-glycoprotein (Pgp ). Clarithromycin is known to inhibit pgp . With the simultaneous useclarithromycin and digoxin, inhibition pgp clarithromycin may lead to increased digoxin exposure.In post-marketing surveillance, an increase in serum concentrations of digoxin in the blood of patients receiving Klacid has been reported.® along with digoxin. Some patients developed signs of digitalis intoxication, including potentially fatal arrhythmias. Serum concentrations of digoxin should be carefully monitored in patients receiving digoxin andKlacid® simultaneously.

Zidovudine .

Simultaneous oral administration of the drug Klacid® in tablets and zidovudine in adult HIV-infected patients can lead to a decrease in the equilibrium concentration of zidovudine. Due to the fact that Klacid® interferes with the absorption of concomitantly administered oral zidovudine, this can be largely avoided by observing a 4-hour interval between doses of Klacid® and zidovudine. This interaction does not occur in HIV-infected children receiving Klacid suspension.® concomitantly with zidovudine or dideoxyinosine. Such an interaction is unlikely in the case of clarithromycin administered as an intravenous infusion.

Phenytoin and valproate .

There have been spontaneous or published reports of inhibitor interactions CYP3 A , including clarithromycin, with drugs that are not considered to be metabolizable CYP3 A (eg, phenytoin and valproate). With the simultaneous appointment of such drugs with the drugKlacid® it is recommended to determine their level in serum. Increased serum concentrations of these drugs have been reported.

Bidirectional drug interactions

Atazanavir

Atazanavir and clarithromycin are substrates and inhibitors CYP3 A . There is evidence of a bilaterally directed interaction between these drugs. Simultaneous use of the drug Klacid® (500 mg twice daily) with atazanavir (400 mg once daily) resulted in a doubling of clarithromycin exposure, a decrease in 14- Oh -clarithromycin by 70% and increase AUC atazanavir by 28%. Due to the wide therapeutic range, dose reductionKlacid® in patients with normal renal function is not required. For patients with moderate renal insufficiency (creatinine clearance from 30 to 60 ml / min), the dose of the drugKlacid® should be reduced by 50%. For patients with creatinine clearance less than 30 ml / min, the dose of Klacid® should be reduced by 75% by using the appropriate dosage form. Doses of Klacid ® higher than 1000 mg per day should not be used simultaneously with protease inhibitors.

Calcium channel blockers .

Due to the risk of developingarterial hypotension should be used with cautionKlacid® concomitantly with calcium channel blockers metabolized CYP3 A 4 (eg, verapamil, amlodipine, diltiazem). Interaction may increase plasma concentrations of both clarithromycin and calcium channel blockers. Hypotension, bradyarrhythmia, and lactic acidosis have been observed in patients treated with clarithromycin and verapamil at the same time.

Itraconazole

Itraconazole and clarithromycin are both substrates and inhibitors CYP3 A leading to a two way drug interaction. Clarithromycin may increase plasma levels of itraconazole, while itraconazole may increase plasma levels of clarithromycin. When using itraconazole andKlacid® simultaneouslypatients should be under close medical supervision to identify manifestations and symptoms of enhanced or prolonged pharmacological effect.

Saquinavir

Saquinarir and clarithromycin are substrates and inhibitors of CYP3A, and there is evidence of a bilaterally directed interaction between these drugs. A study on 12 healthy volunteers showed that the simultaneous administration of Klacid® (500 mg twice a day) and saquinavir (soft gelatin capsules, 1200 mg three times a day) causes an increase in steady-state AUC and C max saquinavir by 177% and 187% compared with saquinavir alone. AUC and C max clarithromycin increased by approximately 40% compared with the rates observed when taking the drug Klacid® separately. There is no need to adjust doses if both drugs are used simultaneously for a limited period of time and in the studied doses / dosage forms. Results from drug interaction studies using soft gelatin capsules may not be consistent with the effects observed with saquinavir in the form of hard gelatin capsules. Results from drug interaction studies using saquinavir alone may not be consistent with the effects seen with saquinavir/ritonavir therapy. When saquinavir is co-administered with ritonavir, consideration should be given to the possible effects of ritonavir on clarithromycin (see Drug Interactions).

special instructions

Use of any antimicrobial therapy, in particular clarithromycin, to treatH . pylori -infections can cause the selection of resistant microorganisms.

Klacid® should not be administered to pregnant women without a thorough benefit/risk assessment, especially in the first three months of pregnancy.

Prolonged use, as with other antibiotics, may cause overgrowth of non-susceptible bacteria and fungi. If superinfection occurs, appropriate therapy should be initiated.

The drug should be used with caution in patients with severe renal insufficiency.

while taking clarithromycinhepatic dysfunction has been reported, including elevated levels of liver enzymes,hepatocellular and/or cholestatic hepatitis, with or without jaundice. This liver dysfunction can be severe and is usually reversible. There have also been cases of fatal liver failure that were associated with serious comorbidities and / or concomitant medication. If symptoms of hepatitis occur, such as anorexia, jaundice, dark urine, itching, or abdominal tenderness, clarithromycin should be discontinued immediately.

Pseudomembranous colitis, ranging in severity from mild to life-threatening, has been reported with virtually all antibacterial drugs, including macrolides. When using almost all antibacterial drugs, including Klacid® reported the development of diarrhea caused byClostridium difficile(CDAD ) and varying in severity from mild diarrhea to fatal colitis.

Taking antibiotics alters the normal intestinal flora, leading to overgrowthC. difficile. It is necessary to take into account the possibility of CDAD in all patients who suffer from diarrhea after taking antibiotics. Careful history taking should be taken as there have been cases of CDAD two months after taking antibiotics.

Klacid ® excreted mainly by the liver. Therefore, caution should be exercised when using the drug in patients with impaired liver function, as well as in patients with moderate or severe renal impairment.

Colchicine .

In p Post-marketing reports have reported toxicity of colchicine when clarithromycin and colchicine were co-administered, especially in elderly patients, some of these cases occurred in patients with renal insufficiency. In some of these patients, cases of death have been recorded (see the section "Drug Interactions"). Simultaneous reception of clarithromycin and colchicine is contraindicated (see section "Contraindications").

Should be administered with cautionclarithromycinsimultaneously with triazolobenzodiazepines, such as triazolam and midazolam for intravenous or oromucosal administration (see section "Drug Interactions").

QT interval prolongation

Prolongation of myocardial repolarization and QT interval, indicating the risk of developing cardiac arrhythmia and bidirectional tachycardia (torsades de pointes ), were observed during treatment with macrolides, including clarithromycin (see section "Side Effects"). Because the following situations may lead to an increased risk of ventricular arrhythmias (including bidirectional tachycardia (torsades de pointes )), clarithromycin should be used with caution in the following groups of patients:

.Patients with ischemic heart disease, severe heart failure, conduction disturbances, or clinically significant bradycardia.

.Patients with electrolyte disturbances such as hypomagnesaemia. Clarithromycin should not be given to patients with hypokalemia (see section "Contraindications").

.Patients concomitantly taking other medications, the action of which is accompanied by a prolongation of the QT interval (see section "Drug Interactions").

.The simultaneous appointment of clarithromycin with astemizole, cisapride, pimozide and terfenadine is contraindicated (see section "Contraindications").

.Clarithromycin should not be used in patients with congenital or established acquired prolongation of the QT interval or a history of ventricular arrhythmias (see section "Contraindications").

Pneumonia .

Due to the growing resistanceStreptococcus pneumoniaeto macrolides, it is important to test for sensitivity when prescribing clarithromycin for the treatment of community-acquired pneumonia. In case of nosocomial pneumonia clarithromycin should be used in combination with other appropriate antibiotics.

Infections of the skin and soft tissues of mild to moderate severity.

The most common causative agents of such infections areStaphylococcus aureus and Streptococcus pyogenes, which may also be resistant to macrolides. Therefore, it is necessary to conduct a sensitivity study. In cases where the use of beta-lactam antibiotics is not possible (for example, due to allergies), other antibiotics such as clindamycin may be the first choice. Currently, macrolides are only used to treat certain types of skin and soft tissue infections, such as those caused byCorynebacterium minutissimum, acne vulgaris and erysipelas and in situations where treatment with penicillin is not possible.

If severe acute hypersensitivity reactions are observed, such as anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug skin reaction, accompanied by eosinophilia and systemic manifestations ( DRESS ), the use of the drugKlacid® should be stopped immediately and promptly initiated appropriate treatment.

Klacid® should be administered with caution concomitantly with cytochrome C enzyme inducers YP3 A 4 (see section "Drug Interactions").

The possible cross-resistance between clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin, should also be considered.

HMG-CoA reductase inhibitors (statins) .

Simultaneous use of the drugKlacid® contraindicated with lovastatin or simvastatin (see section "Contraindications"). Caution should be exercised when prescribing the drugKlacid® with other statins. There is evidence of the occurrence of rhabdomyolysis in patients who simultaneously took Klacid® and statins. Patients should be monitored for signs and symptoms of myopathy. In the event that the simultaneous use of clarithromycin and statins is unavoidable, it is recommended to prescribe the minimum registered dose of a statin. Consideration should be given to prescribing a statin that is not dependent on metabolism CYP3 A , for example, fluvastatin (see section "Drug interactions").

Oral hypoglycemic agents/insulin .

Klacid® and oral hypoglycemic agents (such as sulfonylurea derivatives) and/or insulin, significant hypoglycemia may occur. Close monitoring of glucose levels is recommended.

Oral anticoagulants .

With the simultaneous use of the drugKlacid® with warfarin, there is a risk of serious bleeding and a significant increase in the INR (international normalized ratio) and prothrombin time. With the simultaneous useKlacida® and oral anticoagulants, it is necessary to frequently monitor the INR and prothrombin time.

Pregnancy and lactation

Pregnancy

The safety of clarithromycin during pregnancy has not been established. For this reason, the use of the drugKlacid® not recommended during pregnancy without careful benefit-risk analysis.

lactation period

There is no data on the safety of the drug Klacid ® during breastfeeding. Clarithromycin is excreted in breast milk.

Features of the effect of the drug on the ability to drive a vehicle and potentially dangerous mechanisms

Data on the effect of clarithromycin on the ability to drive vehicles and mechanisms are not available. Before driving vehicles and mechanisms, one should take into account the possible occurrence of dizziness, vertigo, confusion and disorientation, which may occur when using the drug.Klacid® .

Overdose

Symptoms:

Existing reports indicate that gastrointestinal adverse reactions should be expected with large oral doses of clarithromycin. There is a report of one patient with a history of bipolar disorder who took 8 grams of clarithromycin, after which he developed a change in mental status, paranoid behavior, hypokalemia and hypoxemia.

Treatment:

Adverse reactions accompanying an overdose should be treated with immediate elimination of the unabsorbed drug and supportive care. As with other macrolides, hemodialysis or peritoneal dialysis is unlikely to significantly affect serum levels of clarithromycin..

Incompatibility

Information is absent.

Release form and packaging

7 tablets are placed in a blister pack.

2 contour packs, together with instructions for medical use in the state and Russian languages, are placed in a pack of cardboard.

Storage conditions

Store in a place protected from light at a temperature not exceeding 30 ºС.

Keep out of the reach of children!

Shelf life

Do not take the drug after the expiration date indicated on the package.

Terms of dispensing from pharmacies

On prescription

Manufacturer

Abbvi S.r.l., Italy

S.R. 148 Pontina K

Registration certificate holder

Abbott Laboratories GmbH, Hannover, Germany

Packer

Abbvi S.r.l., Italy

S.R. 148 Pontina K M 52, SNS - Campoverde di Aprilia (loc. Aprilia) - 04011 Aprilia (LT)

The address of the organization that accepts claims from consumers on the quality of products (goods) in the territory of the Republic of Kazakhstan and is responsible for post-registration monitoring of the safety of the medicinal product:

Abbott Kazakhstan LLP

050059 Almaty, Republic of Kazakhstan.

Dostyk Ave. 117/6, Business Center "Khan Tengri-2",

tel.: +7 7272447544, +7 7272447644,

e-mail: [email protected]

SOLID 1000297883v6.0

New generation antibiotics are very effective and have fewer contraindications and side effects than their predecessors. In the article we will consider what a bright representative of such medicines is, its characteristics, indications and contraindications, reviews. "Klacid" is an antibiotic, which will be discussed below.

Manufacturer, release form, main active ingredient

The drug "Klacid" is produced by the company "Abbott Laboratories" in Italy, the USA or France. It is produced in the form of tablets of 250 or 500 mg or in the form of a powder from which to prepare a suspension - it is especially convenient to give it to young children. The main active ingredient is claritomycin. It is effective in combating many types of bacteria, the drug is used mainly for the treatment of respiratory tract infections, skin diseases, as well as for the prevention of stomach ulcers. More details about the indications for the use of the drug "Klacid" will be discussed later.

For what diagnoses is the medical preparation "Klacid" used?

Indications for the appointment of this medication are as follows:

• inflammatory diseases of the respiratory tract (upper) of an infectious nature (for example, the antibiotic "Klacid" treats almost all diseases of the upper respiratory tract, be it pharyngitis, sinusitis, bronchitis, and so on);
• it is prescribed for the treatment of skin diseases, including erysipelas, inflammation of the subcutaneous tissue, folliculitis;
• the drug is used to treat acne;
• the medication is prescribed to prevent relapses - repetitions of exacerbation of duodenal ulcers.

This antibiotic is used to treat even young children. They are prescribed the drug in the form of a suspension. The manufacturer produces a powder for its preparation with various fruit flavors, so it is relatively easy for a mother to give this medicine to a child, which is often why many parents give positive feedback to this medicine. "Klacid" according to indications is used for the treatment of very small children - children from 6 months.

Contraindications to the use of the drug, side effects

This antibiotic has a number of contraindications for use, among them are the following:

• severe renal failure;
• hypersensitivity to the components that make up the drug;
• with caution, the drug "Klacid" should be prescribed to patients who have problems with the kidneys and liver;
• the drug is contraindicated in pregnant women and women during lactation.

Judging by the reviews, the drug "Klacid" rarely causes any side effects, but some people may experience the following undesirable manifestations:

• nausea, vomiting, abdominal pain;
• discoloration of the tongue and teeth, stomatitis;
• deterioration of the liver;
• candidiasis in the mouth;
• headaches, anxiety, insomnia, dizziness.

Again, this drug, which belongs to the latest generation of antibiotics, does not often cause unpleasant consequences. Please note that the dosage of the drug for children depends on the weight of the child and the diagnosis, the doctor must calculate the volume. Adults are also not recommended to self-medicate, it is important to know that the maximum dose of the drug per day is 500 mg.

What do they say about the drug? Reviews. "Klacid" - the opinions of patients with a "plus" sign

So, doctors and patients unanimously note that this antibiotic is quite effective for the treatment of diseases that were listed in the indications for use. The course of its reception rarely lasts more than five days. The drug receives the following reviews:

• "Klacid" really quickly helps to cope with infectious ENT diseases, many patients noted improvements already on the first day of taking it;
• it is convenient to use: as a rule, you need to drink only one tablet per day (the drug intake does not depend on food intake);
• the drug rarely causes side effects from the gastrointestinal tract and central nervous system.

Negative Feedback

• Klacid, produced abroad (there are also Russian analogues), is quite expensive - from 800 to 1000 rubles per package of 14 tablets of 500 mg;
• the medication should be used with extreme caution if the patient has any problems with the liver, and, unfortunately, a large number of people have them;
• also carefully recommend the use of the drug for the treatment of children and the elderly, as well as for people with weakened immune systems;
• kids need to buy a powder for preparing a suspension, and it is not sold in every pharmacy.

Features of the use of drugs in children. Characteristics of Parents and Pediatricians

The drug "Klacid" for children receives mostly positive reviews, although many pediatricians warn parents against self-administering the remedy to the child. Remember: the doctor must prescribe the antibiotic, as well as calculate its dosage. Here is what those who used the drug "Klacid" in the form of a suspension for the treatment of children say:

• 99% of parents note that the child drinks this drug with pleasure or without any problems, since the manufacturer produces a product with a variety of fruit flavors, it can also be added to juice or milk;
• the medication effectively copes with the treatment of diseases according to indications, however, children are prescribed it only in extreme cases, when other medicines do not help.

Conclusions and conclusion

Please note that while taking the drug "Klacid", the child may experience abdominal pain, nausea, vomiting, restlessness. The fact is that the baby's immunity, especially against the background of the disease, is suppressed, and the gastrointestinal tract is not sufficiently adapted to take such strong drugs. When such reactions appear, especially if you see that the child is getting worse and worse, you should immediately contact your pediatrician. The remedy "Klacid" (suspension) receives reviews of this kind quite rarely, yet this antibiotic really successfully copes with severe cases of ENT infections and skin problems. If earlier the treatment of such diseases was complex and protracted, now a 5-7-day intake of the named drug is often enough.

Every time a pediatrician prescribes an antibiotic for a child, the mother has many questions. How effective is the drug? Will strong medicine harm the child? How to correctly calculate the dose so that the antibiotic works, but does not cause side effects? Of particular concern are new drugs, such as Klacid, which has recently appeared on the pharmaceutical market. Our review will help you, parents, draw conclusions about the appropriateness, effectiveness and possible consequences of its use.

Klacid does not kill pathogens, but deprives them of the opportunity to multiply. This is enough for recovery.

Features of the drug

Modern powerful drug Klacid belongs to the class of macrolides - the least toxic, and therefore the safest antibiotics. A similar action of a wide spectrum has a long-familiar and familiar Erythromycin. However, as evidenced by numerous reviews on parent forums, Klacid for children is a more effective and convenient tool. A new generation antibiotic, unlike its predecessor, has a relatively pleasant taste and fruity aroma. And this is important when the baby does not yet understand the purpose of stuffing him with bitter medicine. In addition, you need to take it only two, not four times a day, which reduces the risk of side effects and the negative effect of the drug on the delicate children's body.

Recently, microbes and pathogens have managed to adapt to antibiotics such as penicillin and cephalosporin, losing sensitivity to them. In this regard, Klacid often turns out to be one of the most effective and at the same time sparing options.

Suspension is the most convenient dosage form for children.

The drug is produced by Abbott Laboratories Limited (UK). The price of a medicine in the form of a powder for the preparation of suspensions varies between 300-400 rubles. A: The larger the dosage, the higher the cost. Tablets can be bought on average for 600-800 rubles. Their cost also depends on the dosage and the number of tablets in the pack.

Analogues

The drug has a number of analogues, which include the same basic substance - clarithromycin. These include Klarbakt, Clarithromycin, Fromilid, Exoterin and some others. The possibility of interchangeability of drugs in each case can only be confirmed by a pediatrician.

When is this medicine prescribed - indications for use

For children, the remedy is prescribed for inflammatory processes in the body caused by a large number of varieties of microbes. The appointment of the drug is advisable when there are:

• typically childhood infections - scarlet fever, whooping cough;
• diseases of the lower respiratory tract - lung abscess, pneumonia, bronchitis;
• upper respiratory tract infections - tonsillitis,;
• ENT diseases - otitis media;
• gonorrheal or chlamydial nature;
• ulcerative lesions of the stomach and duodenum (the medicine is used here as part of complex therapy);
• infections of the skin (for example, erysipelas) and soft tissues.

A more detailed list of problems eliminated by Klacid is given in the instructions for its use, which can be.

Klacid: variety of forms

The antibiotic is produced in the form:

• tablets;
• powder for the preparation of a suspension taken orally;
• powder for the preparation of a suspension used for infusions (droppers).

Children under the age of three years Klacid in the form of tablets is not prescribed.

Of course, in the case of pediatric patients, it is better to opt for the Klacid suspension: its semi-liquid consistency is the most convenient and pleasant for babies.

Many parents naturally have a question: what do the markings on the packages mean: 125, 250, 500? These figures indicate the amount of the active substance clarithromycin contained in one tablet or 5 ml of the prepared suspension. For example, if it is Klacid 125 powder, then 5 ml of suspension (about a teaspoon) contains 125 ml of the active ingredient. This information is important for the correct calculation of the dosage corresponding to the weight and age of the child.

The powder is available in vials (60 and 100 ml), in which the suspension is convenient to store and dilute.

Operating principle

Klacid acts extremely gently and sparingly: he does not kill pathogenic bacteria, but deprives them of the possibility of reproduction. In this case, the drug has a prolonged effect. Even after the end of the intake, it continues to be in the body for some time and perform its function, inhibiting the growth of microbes.

The effectiveness of the drug is also explained by its ability to accumulate in the same places where 99% of pathogens are usually concentrated - in the lungs and bronchi. At the same time, the antibiotic, unlike its predecessors, has a pronounced anti-inflammatory effect.

Suspension preparation and dosage calculation

Preparing the suspension is simple: just add water to the vial up to the risk and shake the liquid vigorously until the powder granules are completely dissolved. The result should be a white (or almost white) opaque liquid, which can be stored at room temperature (not higher than 30 degrees and away from sunlight) for about two weeks.

Shake the bottle before each use.

Before giving Klacid to a child, carefully read the instructions. The main criterion for the correct dosage is the weight of the patient. The medicine is given at the rate of 7.5 ml per 1 kg of the patient's body weight.

The numbers that complement the name of the medicine are also important. Children are usually prescribed suspensions of Klacid 125 or Klacid 250. The suspension drug is prescribed even to patients under two years of age in doses appropriate for age.

Consider the option of calculating the dosage of the drug Klacid 250 using a specific example.

The patient is a boy Egor, 8 years old. The child's weight is 25 kg. Therefore, for one dose (assuming the drug is taken twice a day), he needs an amount of syrup that would contain 187.5 ml of clarithromycin: 25 kg × 7.5 ml of the recommended dose per 1 kg of body weight. If the drug has a concentration of 250, then 5 ml contains 250 ml of the active substance, i.e. 1 ml of suspension contains 50 ml of clarithromycin (250 ml/5 ml). It turns out that Egor needs to take 3.75 ml of the suspension (187.5 ml / 50 ml - the dose of clarithromycin necessary for a particular child / the content of clarithromycin in 1 ml of the resulting syrup). This is 0.75 teaspoon, i.e. about 3/4.

The medication is taken twice a day. It is better to do this in the morning and in the evening at about the same time. Before or after a meal, it doesn't matter. A small child can be given a suspension along with milk.

You can add the suspension to milk.

The course lasts from 5 to 10 days. A specific scheme, depending on the severity of the disease and the patient's response to the medicine, is made by a pediatrician. If there is no improvement within three days, the drug is canceled, and an adequate replacement is selected for it.

The maximum allowable daily dose of the drug in any case is 500 ml.

It is important to know the symptoms of an overdose of Klacid:

• dizziness;
• mental changes, in particular, the appearance of signs of paranoia.

The listed signs are the basis for stopping the drug and carrying out procedures aimed at removing the patient from the dangerous state of overdose:

• removal from the stomach of the remnants of the drug that did not have time to be absorbed by taking activated charcoal;
• peritoneal dialysis;
• hemodialysis.

Side effects and contraindications

Klacid should be used with caution (or even stop using it) in children with problems with the liver, kidneys and biliary tract. The components of the drug with dysfunction of these organs are poorly excreted and accumulate in the body, overloading it. The same applies to young patients suffering from arrhythmia and increased anxiety, since the drug provokes the release of adrenaline. It is important for parents of allergic and asthmatic children to know that Klacid slows down the withdrawal of antihistamines from the body. If a child takes antiallergic drugs constantly, during treatment with macrolides, their components may accumulate in excessive (toxic) doses. Be careful not to get poisoned.

Klacid is a broad-spectrum antibiotic. Instructions for use prescribes taking 250 mg and 500 mg SR tablets, powder for suspension, injections in ampoules in the treatment of infectious diseases of the respiratory canals and soft tissues.

Release form and composition

Klacid in pharmacies comes in the following dosage forms:

1. Lyophilisate for solution for infusion (injections in ampoules).
2. Film-coated tablets 250 mg and 500 mg (SR or prolonged form of Klacida).
3. Powder for suspension for oral administration 125 mg and 250 mg.

The active substance is clarithromycin:

• 1 bottle of lyophilisate - 500 mg.
• 1 tablet - 250 or 500 mg.
• 5 ml of the finished suspension - 125 or 250 mg.

pharmachologic effect

The drug Klacid instructions for use refers to the group of macrolide antibiotics, which have an antibacterial effect. The drug is active against Staphylococcus aureus, pneumococcus, viridescent streptococcus, the causative agent of listeriosis, hemophilic infection, streptococci of groups A, B, F, C and G, the causative agent of pneumochlamydiasis, sporotrichosis, chlamydia, peptococcus.

The drug is effective for pneumonia (including pneumonia of mycoplasmal etiology), gonorrhea, leprosy, and legionnaires' disease. When using Klacid, pathogens of whooping cough, human toxic infections, pasteurellosis of birds, acne, syphilis, borreliosis and enterocolitis are suppressed.

However, the use of the drug is ineffective in the treatment of Pseudomonas aeruginosa, enterobacteria and various other gram-negative bacteria that are unable to decompose lactose. Clarithromycin, the main active ingredient of the drug, is released during the time of movement throughout the gastrointestinal tract due to the fact that the tablets are a homogeneous crystalline mass.

What helps Klacid?

Indications for the use of the drug include the following diseases and conditions:

• infectious lesions of soft tissues, skin (folliculitis, erysipelas, etc.);
• infectious diseases of the respiratory tract, lower sections (pneumonia, bronchitis, etc.);
• infectious diseases of the respiratory tract, upper sections (with tonsillitis, sinusitis, pharyngitis, etc.);
• infections provoked by Mycobacterium fortuitum, Mycobacterium chelonae, Mycobacterium kansasii;
• mycobacterial infections that provoked Mycobacterium intracellulare and Mycobacterium avium.

It is also practiced to take the remedy to prevent infection provoked by the Mycobacterium avium complex (MAC). It is prescribed to reduce the frequency of manifestations of recurrences of duodenal ulcers.

Instructions for use

Klacid tablets

The drug is taken orally, regardless of the meal. Usually adults are prescribed 250 mg 2 times a day. In more severe cases, the dose is increased to 500 mg 2 times a day. Usually the duration of treatment is from 5-6 to 14 days. With mycobacterial infections, 500 mg is prescribed 2 times a day.

For widespread MAC infections in AIDS patients, treatment should be continued as long as there is clinical and microbiological evidence of benefit. Clarithromycin should be given in combination with other antimicrobials. In infectious diseases caused by mycobacteria, except for tuberculosis, the duration of treatment is determined by the doctor.

For the prevention of MAC infections, the recommended adult dose of clarithromycin is 500 mg twice daily. For odontogenic infections, the dose of clarithromycin is 250 mg twice daily for 5 days.

For the eradication of Helicobacter pylori Combined treatment with three drugs: clarithromycin 500 mg 2 times a day + lansoprazole 30 mg 2 times a day + amoxicillin 1000 mg 2 times a day for 10 days; clarithromycin 500 mg 2 times a day + omeprazole 20 mg per day + amoxicillin 1000 mg 2 times a day for 7-10 days.

Combined treatment with two drugs: clarithromycin 500 mg 3 times a day + omeprazole 40 mg per day for 14 days with the appointment within the next 14 days of omeprazole at a dose of 20-40 mg per day; clarithromycin 500 mg 3 times daily + lansoprazole 60 mg daily for 14 days.

For complete healing of the ulcer, additional reduction in the acidity of gastric juice may be required.

Powder

To prepare the suspension, dilute with water, gradually adding it to the vial to the mark, then shake until a solution with a homogeneous structure is obtained. The suspension is taken orally before or after meals, it can be diluted with milk.

Recommended daily dosage for children: for non-mycobacterial infections - at the rate of 7.5 mg per 1 kg of the child's weight (but not more than 500 mg) 2 times a day for 5-10 days; with disseminated or local mycobacterial infections - 7.5-15 mg per 1 kg of body weight 2 times a day, treatment lasts until the moment of no clinical effect.

For the treatment of mycobacterial infections, the powder is prescribed in combination with other antimicrobial agents that are active against these pathogens. In case of renal insufficiency, the usual doses are halved, and the period of application is extended to 14 days. Before taking the contents of the vial should be shaken well;

Ampoules

The recommended dose for adults is 1 g per day, divided into 2 equal doses, each of which is administered intravenously after dissolution in an appropriate solvent by drip for 60 minutes or more. Data on the dosage of the drug Klacid in ampoules for children is not available.

Intramuscular and bolus administration of the drug is prohibited. In patients with impaired renal function and CC less than 30 ml / min, the dose of clarithromycin should be reduced by half of the normal recommended dose.

Solution preparation rules

Add 10 ml of sterile water for injection to a vial containing 500 mg of lyophilisate. It is recommended to use only sterile water for injection, as any other solvent may cause precipitation. Do not use solvents containing preservatives or inorganic salts.

The reconstituted solution of the drug, obtained as described above, contains a sufficient amount of preservative and has a concentration of 50 mg/ml clarithromycin. The solution is stable for 48 hours at 5°C or 24 hours at 25°C.

The reconstituted solution of the drug should be used immediately after its preparation. If the drug is not used immediately after receiving its reconstituted solution, it is recommended to store it for no more than 24 hours at a temperature of 2 ° C to 8 ° C under aseptic conditions.

Before administration, the prepared solution of the drug (500 mg in 10 ml of water for injection) must be added to at least 250 ml of one of the following solvents for intravenous administration: 5% glucose solution in Ringer's lactate solution, 5% glucose solution, lactate Ringer's solution, 5% glucose dextrose solution in 0.3% sodium chloride solution, Normosol-M solution in 5% glucose solution, Normosol-R solution in 5% glucose solution, 5% glucose solution in 0.45% sodium chloride solution, 0.9% sodium solution chloride.

Contraindications

• Age under 12 years (for Klacid tablets).
• Renal failure with creatinine clearance below 30 ml / min (only for prolonged-release tablets Klacid SR).
• The period of pregnancy and breastfeeding.
• Individual hypersensitivity to clarithromycin or macrolide antibiotics (for example, Lincomycin, Josamycin, Azithromycin, Roxithromycin, etc.).
• Porfiry.
• Cholestatic jaundice or hepatitis that developed in the past with the use of drugs containing clarithromycin.
• Age under 18 years (only for long-acting tablets Klacid SR and solution for infusion Klacid).
• Hypokalemia (lower than normal levels of potassium in the blood).
• Lactose intolerance, lactase deficiency or glucose-galactose malabsorption (only for Klacid SR).
• The presence in the past of episodes of ventricular arrhythmia or tachycardia of the "pirouette" type.
• Severe liver failure associated with renal failure.
• The presence in the past of prolongation of the QT interval on the ECG.

Side effects

During treatment with Klacid, patients sometimes develop negative reactions to clarithromycin:

• Inhibition of liver function when the dose is exceeded.
• Vaginal candidiasis in women.
• Allergic skin reactions - rashes, urticaria, angioedema, anaphylactic shock.
• From the digestive tract - nausea, vomiting, dry mouth, diarrhea, development of colitis and pancreatitis, flatulence, abdominal cramps, lack of appetite.
• Change in the clinical picture of the blood.
• From the side of the nervous system - dizziness, weakness, lethargy, fatigue, lethargy, sleep disturbance, irritability, aggression, development of depression.

Children, during pregnancy and lactation

The use of the drug in the first trimester of pregnancy is contraindicated. Taking pills in the II and III trimesters of pregnancy is permissible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, use during lactation should stop breastfeeding.

Klacid is not used in the form of tablets for the treatment of children under 3 years of age.

Before giving the antibiotic Klacid to children, you need to shake the suspension thoroughly. A day is recommended for children to use a dose of 7.5 mg per 1 kg of body weight twice a day. The highest allowable dose is 500 mg twice a day. Therapy can last from 5 to 10 days.

special instructions

Antibiotic treatment alters the normal intestinal flora, so superinfection caused by resistant microorganisms is possible. Severe persistent diarrhea may be due to the development of pseudomembranous colitis.

Prothrombin time should be monitored periodically in patients receiving clarithromycin concomitantly with warfarin or other oral anticoagulants.

drug interaction

With the simultaneous use of the drug Klacid with anticoagulants, ergot alkaloids, rifabutin, vinblastine, omeprazole, methylprednisolone, an increase in the concentration of these drugs in the blood serum is observed.

When the drug is combined with cisapride, the concentration of the latter in the blood increases, which can lead to the development of ventricular tachycardia or ventricular flutter.

Klacid's analogs

According to the structure, analogues are determined:

1. Seidon-Sanovel.
2. Klacid SR.
3. Arvicin retard.
4. SR-Claren.
5. Claricite.
6. Fromilid Uno.
7. Crixan.
8. Kispar.
9. Binocular.
10. Clarkkt.
11. Claricin.
12. Clubax.
13. Clasine.
14. Clarithrosin.
15. Clerimed.
16. Zimbaktar.
17. Ecositrin.
18. Claromin.
19. Coater.
20. Arvicin.