Klacid powder - official * instructions for use. Instructions for use

APPROVED

By order of the chairman
Medical and
pharmaceutical activities

Ministry of Health

Republic of Kazakhstan

From "_____" ____________201_

Instructions for medical use

medicinal product

Tradename

international generic name

Clarithromycin

Dosage form

Granules for suspension, 125 mg/5 ml or 250 mg/5 ml 60 ml, 100 ml

Compound

5 ml suspension contains

active substance- clarithromycin 125 mg or 250 mg,

Excipients:

Excipients of granules: carbopol 974 R, povidone (K90), purified water

Granule shell: hypromellose phthalate (HP-55), castor oil

Other excipients: silicon dioxide, maltodextrin, sucrose, titanium dioxide (E 171), xanthan gum, combined fruit flavor, potassium sorbate, anhydrous citric acid.

Description

Granules - free-flowing granules, from white to almost white color, with fruity aroma;

The reconstituted suspension is an opaque suspension containing white to off-white particles with a fruity aroma.

Pharmacotherapeutic group

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

ATX code J01F A09

Pharmacological properties

Pharmacokinetics

Clarithromycin is rapidly and well absorbed from digestive tract. Microbiologically active 14-OH-clarithromycin is formed during the first passage through the liver. Food does not significantly affect the bioavailability of the drug. Although the pharmacokinetics of clarithromycin is not linear, stable concentrations are established over 2 consecutive days of dosing.

Pharmacokinetic parameters after taking the fifth dose are: Cmax 1.98 µg/ml, AUC 11.5 µg.h/ml, Tmax 2.8 h and T½ 3.2 h for clarithromycin and 0.67 µg/ml, 5.33 µg.h/ml, 2.9 h and 4.9 h for 14-OH-clarithromycin, respectively.

Concentrations of clarithromycin in body tissues are several times higher than in blood serum. The highest concentrations are observed in the tonsillar and lung tissues. Middle ear fluid concentrations of clarithromycin are higher than serum concentrations. Plasma protein binding - 80%. 14-OH-clarithromycin is the main metabolite excreted by the kidneys and accounts for approximately 10-15% of the administered dose. The rest of the dose is excreted in the faeces, mainly in the bile. 5 - 10% of the original substance is excreted in the faeces.

In patients with impaired renal function, using 500 mg of clarithromycin, the values ​​of pharmacokinetic parameters increase according to the severity of renal failure.

The age of patients does not affect the pharmacokinetic parameters of clarithromycin.

In HIV-infected children, when taking clarithromycin at doses of 15-30 mg / kg / day (dose divided into two doses), higher plasma concentrations of clarithromycin and a longer half-life are observed.

Pharmacodynamics

Klacid® is a semi-synthetic macrolide antibiotic. The antibacterial action of Klacid® is determined by its binding to the 5OS-ribosomal subunit of sensitive bacteria and inhibition of protein biosynthesis. The drug exhibits high efficiency against a wide range aerobic and anaerobic gram-positive and gram-negative microorganisms, including hospital strains. The minimum inhibitory concentrations (MIC) of Klacid are usually two times lower than the MIC of erythromycin.

Klacid is highly effective against Legionella pneumophila and Mycoplasma pneumoniae. It acts bactericidal against H. Pylori, the activity of Klacid at neutral pH is higher than at acidic pH. Strains of Enterobacteriaceae and Pseudomonas, as well as gram-negative bacteria that do not produce lactose, are not sensitive to Klacid®.

The drug exhibits antibacterial activity against the following spectrum of microorganisms (in clinical practice):

Aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes.

Aerobic gram-negative bacteria: Haemophilus influenzae,

Haemophilus parainfluenzae, Moraxella catarrhlis, 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 include Mycobacterium avium, Mycobacterium intracellulare.

Beta-lactamases of microorganisms do not affect the effectiveness of clarithromycin.

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

Helicobacter: H. pylori.

Clarithromycin is active in vitro against most strains of the following microorganisms, but its clinical efficacy and safety have not been established.

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.

Clarithromycin has a bactericidal effect against several strains of bacteria: Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, H. Pylori, Campylobacter spp.

Indications for use

lower end infections respiratory tract(bronchitis, pneumonia, etc.);

Infections of the upper respiratory tract (sinusitis, pharyngitis, etc.);

Skin and soft tissue infections (folliculitis, inflammation subcutaneous tissue erysipeloid, etc.);

Spicy otitis media

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

Dosage and administration

Clinical studies with clarithromycin suspension have been conducted in children aged 6 months to 12 years. Therefore, in children under the age of 12 years, clarithromycin should be used in the form of a suspension.

For the treatment of non-mycobacterial infections, the recommended dose of Klacid in the form of a suspension for children ranges from 7.5 mg / kg 2 times a day to a maximum of 500 mg 2 times a day.

The duration of treatment is usually 5-10 days, depending on the type of pathogen and the severity of the disease. The suspension is used regardless of the meal (can be taken with milk).

Table 1

* For children weighing up to 8 kg, the dose should be calculated per kilogram of body weight (7.5 mg / kg 2 times a day).

Dosing in renal failure

For children with creatinine clearance less than 30 ml/min, the dose of Klacid should be reduced by 50%. Treatment should last no more than 14 days.

Mycobacterial infections

Treatment is continued until clinical efficacy is observed from the use of the drug (other antimycobacterial drugs may need to be added).

table 2

* For children weighing up to 8 kg, the dose should be calculated per kilogram of body weight (15 - 30 mg / kg / day).

Suspension preparation method

To prepare the suspension, add water to the vial containing the granules to the mark on it and shake well. If necessary, add water up to the specified mark.

Before each use of the drug, shake the vial with the prepared suspension vigorously.

Side effects

The most common and common adverse reactions in adults and children treated with clarithromycin are abdominal pain, diarrhea, nausea, vomiting, and taste disturbance. These adverse reactions are usually mild and consistent with the known safety profile of macrolide antibiotics. During clinical studies, no significant differences were found in the frequency of these adverse reactions between groups of patients with or without mycobacterial infections.

Adverse reactions are distributed according to the frequency of occurrence: more than 10% - very frequent, 1-10% - frequent, 0.1-1% - infrequent

Often

Phlebitis at the injection site1

Insomnia

Headache

Dysgeusia (impaired taste sensitivity), distortion of taste

Vasodilation1

Nausea, abdominal pain, vomiting, dyspepsia, diarrhea

Abnormal liver function tests

Rash, hyperhidrosis

Pain at the injection site1, inflammation at the injection site1, pain on palpation

Cellulitis1, candidiasis oral cavity, gastroenteritis2

Infection3, vaginal infections

Leukopenia, neutropenia4, thrombocythemia3, eosinophilia4

Anaphylactoid reactions1, hypersensitivity

Anorexia, loss of appetite

Anxiety, nervousness3, loudness3

Loss of consciousness1, dyskinesia1, dizziness, drowsiness, tremor

Dizziness, hearing loss, ringing in the ears

Cardiac arrest1, atrial fibrillation1, QT prolongation, extrasystoles1, palpitations

Asthma1, epistaxis2, pulmonary embolism1

Esophagitis1, gastroesophageal reflux disease2, gastritis, proctalgia2, stomatitis, glossitis, bloating4, constipation, dry mouth, belching, flatulence

Cholestasis4, hepatitis4, increased levels of ALT, AST, GGT4

Bullous dermatitis1, pruritus, urticaria, maculo-papular rash3

Muscle spasms3, musculoskeletal stiffness1, myalgia2

Increased blood creatinine1, increased blood urea1

Malaise4, fever3, asthenia, chest pain4, chills4, fatigue4

Change in the ratio of albumin-globulin1, increase in the level alkaline phosphatase in blood serum4, increased level of lactate dehydrogenase in blood serum4

Single messages

Colchicine toxicity (including fatal) with the combined use of clarithromycin and colchicine (in elderly patients, including against the background of renal failure).

1,2,3,4 These adverse reactions were reported only when using the drug in the form of: 1 - powder lyophilized for solution for infusion, 2 - prolonged-release tablets, 3 - suspensions, 4 - immediate release tablets.

Post-marketing messages (when practical application). The frequency is unknown, as these reactions have been reported voluntarily from an unidentified patient population. It is not always possible to accurately establish their frequency or causal relationship with the drug. The total experience with clarithromycin is more than 1 billion patient days.

Pseudomembranous colitis, erysipelas, erythrasma

Agranulocytosis, thrombocytopenia

Anaphylactic reactions

hypoglycemia

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

Convulsions, ageusia (loss of taste sensitivity), parosmia, anosmia, paresthesia.

hearing loss

Pirouette ventricular tachycardia (torsades de pointes), ventricular tachycardia

Hemorrhage

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

Liver failure, cholestatic jaundice, hepatocellular jaundice

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

Rhabdomyolysis2 (in some reports of rhabdomyolysis, clarithromycin was used concomitantly with other drugs that are associated with the development of rhabdomyolysis (such as statins, fibrates, colchicine or alopurinol)), myopathy

kidney failure, interstitial nephritis

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

Paresthesia, arthralgia, and angioedema have also been reported during clinical trials with oral formulations of clarithromycin.

There have been very rare reports of uveitis, mainly in patients taking rifabutin at the same time. Most cases were reversible.

Patients with impaired immune system.

In patients with AIDS and other immunocompromised patients who have used high doses of clarithromycin for longer than recommended for the treatment of 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 clarithromycin at a daily dose of 1000 mg, the most common side effects were nausea, vomiting, taste disturbance, abdominal pain, diarrhea, rash, bloating, headache, constipation, hearing impairment, increased levels of ALT and AST. Infrequently, dyspnea, insomnia and dry mouth occurred. In 2-3% of patients, there was a significant increase in ALT and AST levels and a significant decrease in the number of leukocytes and platelets in the blood. In several patients, an increase in the content of urea in the blood was observed.

Contraindications

Hypersensitivity to macrolide antibiotics and other components of the drug

Concomitant use of clarithromycin and any of the following: astemizole, cisapride, pimozide, terfenadine (because this may lead to QT prolongation and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and torsade de pointes), ergotamine, or dihydroergotamine (because it can lead to ergotoxicity), lovastatin, simvastatin (due to increased risk myopathies, including rhabdomyolysis)

Patients with a history of QT interval prolongation or ventricular cardiac arrhythmias, including torsades de pointes

Concomitant use of colchicine and P-glycoprotein or a strong CYP3A4 inhibitor (eg, clarithromycin) in patients with renal or hepatic impairment

Drug Interactions

The use of the following drugs is strictly contraindicated due to possible development severe consequences interactions.

Increased serum levels of cisapride, pimozide, and terfenadine have been observed when co-administered with clarithromycin, which may lead to QT interval prolongation and arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsade de pointes. Similar Effects were noted with the combined use of astemizole and other macrolides.

Ergotamine/dihydroergotamine

The simultaneous use of clarithromycin and ergotamine or dihydroergotamine was associated with signs of acute ergotism, which was characterized by vasospasm and ischemia of the limbs and other tissues, including the central nervous system.

Effect of other medicinal products on the pharmacokinetics of clarithromycin.

Drugs that are CYP3A inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort) may induce 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 plasma levels of the CYP3A inducer, which may be elevated due to inhibition of CYP3A by clarithromycin (see also instructions for medical use corresponding CYP3A4 inducer).

The simultaneous use of rifabutin and clarithromycin resulted in an increase in rifabutin levels and a decrease in serum levels of clarithromycin, with a simultaneous increase in the risk of uveitis.

Efavirenz, nevirapine, rifampicin, rifabutin and rifapentine - accelerate the metabolism of clarithromycin, reducing its plasma concentration, but increasing the concentration of 14-OH-clarithromycin - expected therapeutic effect may not be achieved.

Etravirine

The action of clarithromycin was attenuated by etravirine; however, concentrations of the active metabolite 14-OH-clarithromycin were increased. Because 14-OH-clarithromycin has reduced activity against the Mycobacterium avium complex (MAC), the overall activity against this pathogen may be altered. Therefore, alternative drugs to clarithromycin should be considered for the treatment of MAS.

Fluconazole No dose adjustment of clarithromycin is required.

Ritonavir - dose reduction of clarithromycin in patients with normal function kidneys are not required. In patients with kidney failure dose adjustment is necessary: ​​at CLCR 30 - 60 ml / min, the dose of clarithromycin should be reduced by 50%; with CLCR< 30 мл/мин - на 75 %. Дозы кларитромицина, превышающие 1 г/день, не следует применять вместе с ритонавиром.

The same dose adjustments should be made in patients with renal impairment when ritonavir is used as a pharmacokinetic enhancer with other HIV protease inhibitors, including atazanavir and saquinavir.

Effect of clarithromycin on the pharmacokinetics of other medicinal products.

During therapy with clarithromycin, serum concentrations of these drugs should be monitored.

CYP3A. Clarithromycin is an inhibitor of the CYP3A enzyme, which can lead to an increase in the plasma concentration of the drug metabolized by this enzyme. This may enhance or prolong its therapeutic effect and increase the risk of adverse reactions.

Caution should be exercised when using clarithromycin in patients receiving therapy with the following: medicines(CYP3A substrates): alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, methylprednisolone, midazolam, omeprazole, oral anticoagulants (eg, warfarin), pimozide, quinidine, rifabutin, sildenafil, tacrolimus, vinazol, terfenadine, and terfenadine , phenytoin, theophylline, valproate.

There is a possibility of an increase in plasma concentrations of phosphodiesterase inhibitors (sildenafil, tadalafil and vardenafil) when they are used together with clarithromycin, which may require a reduction in the dose of phosphodiesterase inhibitors.

There is a slight increase in the concentration of theophylline or carbamazepine in blood plasma when they are used simultaneously with clarithromycin. Dose reduction of tolterodine may be required when used with clarithromycin. The co-administration of triazolbenzodiazepines (eg, alprazolam, midazolam, triazolam) and clarithromycin tablets should be carefully monitored for timely dose adjustments. The combined use of oral midazolam with Klacid V.V. should be avoided. For benzodiazepines, the elimination of which does not depend on CYP3A (temazepam, nitrazepam, lorazepam), the development of a clinically significant interaction with clarithromycin is unlikely.

Other types of interactions

Colchicine: Co-administration of clarithromycin and colchicine may increase colchicine exposure. Patients should be monitored to identify clinical symptoms colchicine toxicity.

Digoxin: Serum concentrations of digoxin may increase in patients receiving clarithromycin concomitantly with digoxin. Some patients developed signs of digitalis toxicity, including potentially fatal arrhythmias. Serum concentrations of digoxin should be carefully monitored in patients treated with clarithromycin.

Zidovudine: a decrease in the equilibrium concentrations of zidovudine in the blood serum is possible.

Phenytoin and valproate

There have been spontaneous or published reports of interactions of CYP3A inhibitors, including clarithromycin, with drugs that are not thought to be metabolized by CYP3A (eg, phenytoin and valproate). It is recommended to determine the levels of these drugs in the blood serum while prescribing them with clarithromycin. An increase in their serum levels has been reported.

Possibly also bidirectional drug interaction between clarithromycin and atazanovir, itraconazole, saquinavir.

Verapamil: development has been reported arterial hypotension, bradyarrhythmia and lactic acidosis with the combined use of clarithromycin and verapamil.

special instructions

Prolonged or repeated antibiotic use may cause overgrowth of non-susceptible bacteria and fungi. If superinfection occurs, Klacid should be discontinued and appropriate therapy initiated.

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

Liver dysfunction has been reported with clarithromycin, including elevated level liver enzymes, and hepatocellular and/or cholestatic hepatitis with or without jaundice. This liver dysfunction can be severe and is usually reversible. In some cases, it has been reported liver failure With lethal outcome, which was mainly associated with serious underlying diseases and/or concomitant drug treatment. It is necessary to immediately stop taking clarithromycin if signs and symptoms of hepatitis occur, such as anorexia, jaundice, dark urine, itching, or abdominal pain.

The use of any antimicrobial therapy, incl. clarithromycin for the treatment of H. pylori infection may lead to the development of microbial resistance.

About the development of diarrhea from mild degree severity to fatal Clostridium difficile pseudomembranous colitis (CDAD) has been reported with virtually all antibacterial drugs, including clarithromycin. You should always remember about

Potential for Clostridium difficile diarrhea in all patients with diarrhea following antibiotic use. In addition, a careful history should be taken, as the development of diarrhea caused by Clostridium difficile has been reported 2 months after the use of antibacterial drugs.

Increased symptoms of myasthenia gravis have been reported in patients receiving clarithromycin.

The drug is excreted by the liver and kidneys. Caution should be exercised when using the drug in patients with impaired liver function, with moderate or severe renal insufficiency.

Caution should be used simultaneously with clarithromycin and triazolbenzodiazepines, for example, triazolam, midazolam (see "Drug Interactions").

Because of the risk of QT interval prolongation, clarithromycin should be used with caution in patients with an increased tendency to develop QT interval prolongation and torsade de pointes.

Pneumonia

Since Streptococcus pneumoniae resistance to macrolides may exist, it is important to perform a sensitivity test when prescribing clarithromycin for the treatment of community-acquired pneumonia. In the case of nosocomial pneumonia, clarithromycin should be used in combination with other appropriate antibiotics.

Infections of the skin and soft lung tissue and medium degree gravity

These infections are most commonly caused by Staphylococcus aureus and Streptococcus pyogenes, both of which may be resistant to macrolides. Therefore, it is important to conduct a sensitivity test. In cases where it is not possible to use beta-lactam antibiotics (for example, allergies), other antibiotics, such as clindamycin, can be used as first-choice drugs. Currently, macrolides play a role only in the treatment of certain infections of the skin and soft tissues, for example: infections caused by Corynebacterium minutissimum (erythrasma), acne vulgaris, erysipelas; and in situations where penicillin treatment cannot be used.

With the development of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, Henoch-Schonlein disease, clarithromycin therapy should be stopped immediately and appropriate treatment should be started immediately.

Clarithromycin should be used with caution when co-administered with cytochrome CYP3A4 enzyme inducers (see Drug Interactions).

Attention should be paid to the possibility of cross-resistance between clarithromycin and other macrolides, as well as lincomycin and clindamycin.

Oral hypoglycemic drugs/insulin.

The simultaneous use of clarithromycin and oral hypoglycemic drugs and / or insulin can lead to severe hypoglycemia. Hypoglycemia may occur when clarithromycin is co-administered with certain hypoglycemic drugs such as nateglinide, pioglitazone, repaglinide, rosiglitazone due to inhibition of the CYP3A enzyme by clarithromycin. Careful monitoring of blood glucose levels is recommended.

Oral anticoagulants.

There is a risk of serious bleeding and a significant increase in prothrombin time with the simultaneous use of clarithromycin and warfarin. Prothrombin time should be closely monitored combined application clarithromycin and oral anticoagulants.

HMG-CoA reductase inhibitors.

The simultaneous use of clarithromycin lovastatin and simvastatin is contraindicated, because. statins are extensively metabolized by CYP3A4 and joint treatment with clarithromycin increases their plasma concentration, which increases the risk of myopathy, including rhabdomyolysis. There have been reports of rhabdomyolysis in patients taking clarithromycin with these statins. If treatment with clarithromycin cannot be avoided, treatment with lovastatin or simvastatin should be suspended for the duration of treatment with clarithromycin.

Caution must be exercised when prescribing clarithromycin with statins.

In situations where the concomitant use of clarithromycin with statins cannot be avoided, it is recommended to prescribe the lowest registered dosage of statins.

The use of statins whose metabolism is not dependent on the CYP3A enzyme (eg, fluvastatin) may be considered.

A small number of patients may develop H. pylori resistance to clarithromycin.

Pregnancy and lactation

The safety of Klacid during pregnancy and lactation has not been established. Therefore, the use of the drug in this category of women is not recommended without a thorough assessment of the benefit / risk ratio. Klacid is excreted in breast milk.

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

Effect data not available. This form of the drug is intended for use in children. However, before driving vehicles and other mechanisms, it is necessary to take into account the possibility of adverse reactions from nervous system such as convulsions, dizziness, vertigo, hallucinations, confusion, disorientation, etc.

Overdose

Side symptoms gastrointestinal tract.

Treatment: gastric lavage and symptomatic therapy. It is unlikely that hemodialysis or peritoneal dialysis will significantly affect the content of Klacid in the blood serum.

Release form and packaging

Bottles of 60 or 100 ml polyethylene high density(HDPE), sealed with a polypropylene screw cap, with a low-density polyethylene gasket, with first opening control.

The bottle, together with a measuring spoon made of white polystyrene / a measuring syringe made of polypropylene and instructions for use in the state and Russian languages, is placed in a cardboard box.

Representation of Abbott Laboratories S.A. in the Republic of Kazakhstan

Almaty, Dostyk Ave. 117/6, BC Khan Tengri 2

Tel.: + 7 727 244 75 44, fax: + 7 727 244 76 44

Brief information on the drug

INN:

Registration number:

Powder for suspension for oral administration 125 mg/5 ml.
Powder for suspension for oral administration 250 mg/5 ml.

Indications for use:

Contraindications:

Carefully: moderate to severe renal failure; hepatic insufficiency of moderate and severe degree; myasthenia gravis (possibly increased symptoms); concomitant use of clarithromycin with benzodiazepines such as alprazolam, triazolam, midazolam for intravenous use; simultaneous administration with drugs that are metabolized by the CYP3A isoenzyme, for example, carbamazepine, cilostazol, cyclosporine, disopyramide, methylprednisolone, omeprazole, indirect anticoagulants (for example, warfarin), quinidine, rifabutin, sildenafil, tacrolimus, vinblastine; simultaneous administration with drugs that induce the CYP3A4 isoenzyme, for example, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort; simultaneous reception with calcium channel blockers that are metabolized by the CYP3A4 isoenzyme (for example, verapamil, amlodipine, diltiazem); patients with ischemic heart disease (CHD), severe heart failure, hypomagnesemia, severe bradycardia (less than 50 beats / min), as well as patients simultaneously taking class IA antiarrhythmic drugs (quinidine, procainamide) and III class(dofetilide, amiodarone, sotalol); pregnancy; diabetes mellitus (the preparation contains sucrose).

Use during pregnancy and during breastfeeding:

Dosage and administration:

Side effect:

Overdose:

Interaction with other drugs:

Special instructions:

Influence on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions:

In this article, you can read the instructions for use medicinal product Klacid. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Klacid in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Klacid in the presence of existing structural analogues. Use to treat infections in adults, children, and pregnancy and lactation.

Klacid- a semi-synthetic antibiotic of the macrolide group. Renders antibacterial action, interacting with the 50S ribosomal subunit of bacteria and inhibiting protein synthesis in the microbial cell.

Clarithromycin ( active substance Klacid) demonstrated high in vitro activity against standard and isolated bacterial cultures. Highly effective against many aerobic and anaerobic gram-positive and gram-negative microorganisms. In vitro studies confirm the high efficacy of clarithromycin against Legionella pneumophila, Mycoplasma pneumoniae and Helicobacter (Campylobacter) pylori.

Enterobacteriaceae, Pseudomonas spp., as well as other gram-negative bacteria that do not decompose lactose, are insensitive to clarithromycin.

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 is active in vitro and against most strains of the following microorganisms (however, the safety and efficacy of using clarithromycin in clinical practice has not been confirmed clinical research and practical value remains unclear): aerobic gram-positive microorganisms: Streptococcus agalactiae, streptococci (groups C, F, G), streptococci of the Viridans group; aerobic gram-negative microorganisms: Bordetella pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms: Clostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms: Bacteroides melaninogenicus; Borrelia burgdorferi, Treponema pallidum, Campylobacter jejuni.

Pharmacokinetics

With a single dose in adults, the bioavailability of the suspension was equivalent to the bioavailability of tablets (at the same doses) or slightly exceeded. Eating somewhat delayed the absorption of Klacid suspension, but did not affect the overall bioavailability of the drug. Clarithromycin is metabolized in the liver by the action of the CYP3A isoenzyme with the formation of a microbiologically active metabolite 14-hydroxyclarithromycin. Clarithromycin and its metabolite are well distributed in tissues and body fluids. Tissue concentrations are usually several times higher than serum levels. Approximately 40% of clarithromycin ingested is excreted by the kidneys; through the intestines - about 30%.

Indications

• infections lower divisions respiratory tract (bronchitis, pneumonia);
• infections upper divisions respiratory tract (pharyngitis, sinusitis);
• otitis;
• skin and soft tissue infections (folliculitis, cellulitis, erysipelas);
• common mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare;
• localized mycobacterial infections caused by Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii;
• eradication of Helicobacter pylori and reduction in the frequency of recurrence of duodenal ulcers;
• prevention of the spread of infection caused by the Mycobacterium avium complex (MAC) in HIV-infected patients;
• odontogenic infections.

Release form

Film-coated tablets 250 mg and 500 mg (SR or prolonged form of Klacida).

Powder for suspension for oral administration 125 mg and 250 mg.

Lyophilisate for solution for infusion (injections in ampoules).

Instructions for use and dosing regimen

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.

At 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 twice daily + lansoprazole 30 mg twice daily + amoxicillin 1000 mg twice daily 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 for suspension for oral administration

The finished suspension should be taken orally, regardless of the meal (you can with milk).

To prepare the suspension, water is gradually added to the vial with granules up to the mark, then the vial is shaken. The finished suspension can be stored for 14 days at room temperature.

Suspension 60 ml: in 5 ml - 125 mg of clarithromycin; suspension 100 ml: 5 ml - 250 mg clarithromycin.

The recommended daily dose of clarithromycin suspension for non-mycobacterial infections in children is 7.5 mg/kg 2 Maximum dose- 500 mg 2 The usual duration of treatment is 5-7 days, depending on the pathogen and the severity of the patient's condition. Shake the vial well before each use.

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

1) Add 10 ml of sterile water for injection to the 500 mg vial 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.

2) 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 , Ringer's lactate 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 chloride solution.

The physical and chemical parameters of the solution during storage for 48 hours at a temperature of 5°C or 6 hours at a temperature of 25°C do not change. However, the resulting solution of the drug is recommended to be used immediately after its preparation. If the resulting solution cannot be used immediately, it should be stored under aseptic conditions. The drug solution remains stable for 24 hours of storage at a temperature of 2° to 5°C. After this period, further storage and use of clarithromycin IV solution is not recommended.

The solution should not be mixed with any medicinal products or diluents unless their physical or chemical compatibility with IV clarithromycin has been first established.

Side effect

• diarrhea;
• nausea, vomiting;
• abdominal pain;
• pseudomembranous enterocolitis;
• glossitis;
• stomatitis;
• oral thrush;
• changing the color of the tongue;
• discoloration of teeth (these changes are usually reversible and can be corrected by a dentist);
• pancreatitis;
• dizziness;
• anxiety;
• insomnia;
• nightmares;
• noise in ears;
• confusion;
• disorientation;
• hallucinations;
• psychosis;
• prolongation of the QT interval;
• ventricular tachycardia;
• ventricular tachycardia of the "pirouette" type;
• hearing loss (hearing was usually restored after treatment was stopped);
• impaired sense of smell, usually combined with a perversion of taste;
• leukopenia, thrombocytopenia;
• hives;
• rash;
• anaphylaxis;
• Stevens-Johnson syndrome;
• Lyell's syndrome.

Contraindications

• severe liver dysfunction;
• severe renal impairment (KK<30 мл/мин);
• porphyria;
• simultaneous use with astemizole, cisapride, pimozide, terfenadine, ergotamine, dihydroergotamine;
• pregnancy;
• lactation period (breastfeeding);
• children's age up to 3 years (for the dosage form in the form of tablets);
• hypersensitivity to macrolide antibiotics.

Use during pregnancy and lactation

The safety of clarithromycin during pregnancy and lactation has not been studied.

Clarithromycin is known to be excreted in breast milk.

Therefore, Klacid should be used during pregnancy and lactation only in cases where there is no safer alternative, and the risk associated with the disease itself outweighs the possible harm to the mother and fetus.

special instructions

Clarithromycin is excreted mainly by the liver. In this regard, caution should be exercised when prescribing Klacid to patients with impaired liver function.

In the presence of chronic liver diseases, it is necessary to conduct regular monitoring of blood serum enzymes.

Caution should be observed in the treatment of Klacid patients with moderate and severe renal insufficiency.

Cases of toxicity of colchicine in combination with clarithromycin have been described in clinical practice, especially in the elderly. Some of them were observed at patients with a renal failure; Several deaths have been reported in these patients.

The possibility of cross-resistance between clarithromycin and other macrolide drugs, as well as between lincomycin and clindamycin, must be considered.

Be wary appoint against the background of drugs metabolized by the liver.

In the case of co-administration with warfarin or other indirect anticoagulants, it is necessary to control the prothrombin time.

drug interaction

In clinical studies, when theophylline or carbamazepine was combined with clarithromycin, there was a small but statistically significant (p<0.05) повышение уровней теофиллина и карбамазепина в сыворотке крови.

With the simultaneous use of Klacid with inhibitors of HMG-CoA reductase (lovastatin, simvastatin), rhabdomyolysis developed in rare cases.

With the simultaneous use of clarithromycin with cisapride, an increase in the levels of the latter was observed. This can lead to prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsades de pointes. Similar effects have been reported in patients receiving clarithromycin with pimozide.

Macrolides cause a violation of the metabolism of terfenadine, which leads to an increase in its plasma levels and is sometimes associated with the development of arrhythmias, incl. prolongation of the QT interval, ventricular tachycardia, ventricular fibrillation and ventricular tachycardia of the "pirouette" type. In one study in 14 healthy volunteers, the combined use of clarithromycin tablets and terfenadine resulted in a 2- to 3-fold increase in serum levels of the acid metabolite of terfenadine and prolongation of the QT interval, which was not accompanied by any clinical effects.

In clinical practice, cases of ventricular tachycardia of the "pirouette" type have been reported with the combination of clarithromycin with quinidine or disopyramide. During treatment with clarithromycin, serum levels of these drugs should be monitored.

In clinical practice, when clarithromycin was combined with ergotamine or dihydroergotamine, cases of acute toxicity of the latter were recorded, which is characterized by vasospasm, ischemia of the extremities and other tissues, including the central nervous system.

In patients receiving clarithromycin tablets in combination with digoxin, an increase in serum concentrations of the latter was observed. It is advisable to monitor serum levels of digoxin.

Colchicine is a substrate for CYP3A and P-glycoprotein. Clarithromycin and other macrolides are inhibitors of CYP3A and P-glycoprotein. With the simultaneous appointment of colchicine and clarithromycin, inhibition of P-glycoprotein and / or CYP3A can lead to an increase in the action of colchicine. Patients should be carefully monitored for symptoms of toxic effects of colchicine.

Simultaneous oral administration of Klacid tablets with zidovudine in HIV-infected adult patients may lead to a decrease in the equilibrium concentrations of zidovudine. No such interaction has been observed in HIV-infected children receiving clarithromycin suspension with zidovudine or dideoxyinosine.

Analogues of the drug Klacid

Structural analogues for the active substance:

• Arvicin;
• Arvicin retard;
• Binocular;
• Zimbaktar;
• Kispar;
• Clubax;
• Clarkt;
• Clarithromycin;
• Clarithrosin;
• Claricin;
• Claricite;
• Claromin;
• Clasine;
• Klacid SR;
• Clerimed;
• Coater;
• Crixan;
• Seidon-Sanovel;
• SR-Claren;
• Fromilid;
• Fromilid Uno;
• Ecositrin.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

One of the popular antibiotics that is prescribed for a wide variety of diseases in children and adults is Klacid. He is loved by pediatricians, therapists, pulmonologists and dermatovenereologists: in each of these specializations, the drug enjoys well-deserved fame and popularity. However, consumers sometimes do not share the admiration of doctors. The reason lies in the rather high, especially in these difficult times, the cost of antibiotics.

You can read all the reviews of people about the use of the active substance Klacid - clarithromycin on the article page about Clarithromycin. There are reviews directly about the drug Klacid.

Questions are pouring in as if from a cornucopia: where does such a price come from? Why is another drug containing the same active ingredient so much cheaper? Is there really nothing more economical? In fact, these questions are not as simple as it seems at first glance. We will try to clarify the situation in an article on the drug Klacid. And to begin with, let's talk a little about the manufacturing company Klacida, Abbott.

Before continuing reading: If you are looking for an effective method of getting rid of a runny nose, pharyngitis, tonsillitis, bronchitis or colds, then be sure to check out site section Book after reading this article. This information has helped so many people, we hope it will help you too! So, now back to the article.

Briefly about Abbott

One of the largest pharmaceutical companies, Abbott has expanded its activities around the world. Its factories and representative offices are located in many countries and continents. This nuance is associated with consumer confusion about the origin of Klacid. On different packages of the same drug, Germany, France, Belgium and other countries may be indicated as the manufacturer. Confused shoppers sometimes accuse pharmacists of selling "counterfeits" and "falsifications." Let's understand pharmaceutical tricks together.

In fact, Abbott is an American company that operates today in more than 150 countries around the world. It can be safely called a Pfizer-level pharmaceutical giant. Founded in 1888, a small enterprise has become today one of the largest drug manufacturers, whose specialists create new drugs.

Like many other large corporations, Abbott dispersed production around the world - this technique allows you to somewhat reduce costs and reduce the final cost of the drug. That is why Klacid, which we are talking about today, can be released in France, and in Italy, and in many other countries.

On the packaging of Klacid tablets, the location is not indicated by the central office of Abbott, located in Illinois, USA, but by the address of the factory where this series of the drug was created. Therefore, buyers should not be confused by the change in the country of origin.

Klacid as a brand

Klacid is an original drug whose active ingredient is the antibiotic clarithromycin. The term "original" or "brand" in pharmaceuticals means a medicine that was created for the first time, practically from scratch. A striking example of the original drug, familiar to almost every person, is the famous Viagra: it was with her that the era of sildenafil and erection stimulants in general began. Klacid also became the world's first clarithromycin drug. A new antibiotic was born in 1980. Its creators were scientists who worked in a Japanese pharmaceutical company. Looking ahead, let's say that a few years after the drug was launched on the market, Abbott bought the patent from the Japanese and became the owner of a new trademark.

The goal pursued by Japanese scientists was to create a drug based on the macrolide antibiotic erythromycin, which was popular at that time. It was good for its unique spectrum of action and high bactericidal efficiency, but it had several significant drawbacks. Firstly, Erythromycin was rather poorly tolerated - against the background of its use, gastrointestinal side effects often developed, such as nausea, vomiting, stomach pain, and so on. And secondly, Erythromycin was absorbed rather slowly, that is, it was absorbed from the stomach. Because of this, it had to be taken at least four times a day, which is not only not very convenient, but also fraught with additional side effects.

The efforts of Japanese scientists were crowned with success: they were able to create a semi-synthetic drug close to Erythromycin with an ideal efficacy and safety profile. They became Clarithromycin, which, after the sale of the patent to Abbott, became known as Klacid.

Release form: read the instructions for Klacid

Today, Klacid is available in four different dosage forms:

• powder from which a solution for infusion is prepared (intravenous drip infusion);
• powder for making a suspension (sometimes erroneously called a syrup) for children. Note that this form has two dosages: 125 mg and 250 mg in 5 ml of the finished drug. To hide the bitterness inherent in antibacterial drugs, sucrose and fruit flavor were added to the suspension;
• tablets, dose 250 and 500 mg, film-coated. The latter hides the unpleasant, bitter taste of Klacid (characteristic of all antibiotics without exception). The instructions for use indicate that the shell of Klacid is yellow.

In addition, along with standard forms, Abbott also produces long-acting or prolonged-acting tablets - Klacid SR. With the help of special modern production technologies, a slow release of the antibiotic from the tablet mass is achieved, which ensures a longer stay in the blood plasma. Long-acting drugs, including Klacid SR, can be taken half as often as regular tablets.

Klacid for respiratory tract infections

Klacid is prescribed for various infectious diseases caused by pathogens that die under the action of clarithromycin. Like all other macrolides, Klacid is effective against a wide range of opportunistic and pathogenic bacteria, including staphylococci (including aureus), streptococci, pathogens of upper respiratory tract infections (including sinusitis), moraxella and hemophilic bacilli, whooping cough pathogens and many other pathologies.

Due to such a wide spectrum of activity, the drug is successfully used in almost all areas of medicine. The high efficiency of Klacid against a variety of gram-positive microorganisms responsible for damage to the upper and lower respiratory tract determines its use in ENT practice and pulmonology. Klacid is prescribed for the treatment of:

• acute bacterial tonsillitis, better known as tonsillitis;
• otitis media (inflammation of the middle ear);
• acute sinusitis (for example, sinusitis, frontal sinusitis, and so on);
• acute bronchitis, laryngitis, pharyngitis. It is appropriate to note here that in most cases these diseases are caused not by a bacterial, but by a viral infection. Therefore, the use of antibiotics, including Klacid for bronchitis or inflammation of the vocal cords (laryngitis) is the exception rather than the rule;
• pneumonia. By the way, it is worth talking about pneumonia separately.

Atypical pneumonia

Klacid is most appropriate for pneumonia in debilitated patients, for example, the elderly, frequently ill children, or patients with hospital-acquired pneumonia (i.e., developed during a hospital stay for another disease). This is due to the fact that patients with reduced immune defenses are quite likely to develop atypical forms of pneumonia caused not by gram-positive flora (pneumococci, staphylococci or moraxella), but by rarer and much more aggressive pathogens.

For example, pneumonia can be associated with bacteria that manage to get inside the cells. Most antibiotics do not penetrate the cell membrane, and therefore these microorganisms are immune to penicillins or cephalosporins. How long not to take Amoxicillin or not to inject Ceftriaxone with SARS - there will be no effect. At the same time, Klacid in an average dose of 500 mg (as well as other macrolides, for example, Azithromycin) will work quickly and efficiently.

Separately, I would like to note the effectiveness of Klacid in legionnaires' disease, or legionellosis - pneumonia caused by legionella bacteria that colonize in the humid environment of air conditioners. Legionella is completely immune to first-line antibiotics for pneumonia (penicillins, in particular Amoxicillin or its combination with clavulanate). That is why the world's first outbreak of the disease, which occurred at the Legionnaires' Congress, claimed the lives of several dozen people. Legionellosis primarily affects people with weakened immune systems (the categories we mentioned above). If the doctor has reason to suspect that the patient has atypical pneumonia, he prescribes macrolides as the drug of choice, and often the choice falls on Klacid.

Klacid in dermatovenereology

Along with that, Clarithromycin is one of the most popular antibacterial drugs in dermatovenereology. It is effective for most soft tissue and skin infections, including furunculosis, folliculitis, erysipelas (erysipelas associated with staph infection), and cat-scratch skin infection (felinosis). In addition, Klacid tablets is one of the drugs of choice for the treatment of two very "popular" sexually transmitted infections: chlamydia and mycoplasmosis.

By the way, many venereologists, prescribing a course of treatment for these two diseases, intimidate patients with an extremely low effectiveness of treatment. They write out huge prescriptions containing up to a dozen different drugs, recommend massages, baths, poultices and lotions, arguing that only in combination can one cope with the disease. But in fact, everything is not quite so.

Tales about the difficult, full of hardships and difficulties in the treatment of chlamydia and mycoplasmosis are associated with the fact that both chlamydia and mycoplasma are intracellular bacteria that are insensitive to most antibiotics. If you choose the right drug and start therapy with macrolides (for example, Klacid or Sumamed), then there will be no problems if the correct dosages and duration of treatment are observed. Macrolides perfectly penetrate into the cell and destroy bacteria.

Klacid in gastroenterology

And another "narrow" specialization of Klacid is peptic ulcer of the stomach and duodenum. It has been proven that the vast majority of cases of these diseases are associated with infection with the bacterium Helicobacter pylori. She manages to survive in the aggressive hydrochloric acid environment of the stomach and contribute to ulceration of its walls. For many years, until the link between ulcer and infection was discovered, the disease was considered chronic. However, the discovery of Helicobacter finally put an end to the permanent course of peptic ulcer. Today, even severe and multiple ulcerative lesions can be cured in just two weeks, during which the course of antibiotic therapy lasts. First-line drugs are Clarithromycin (Klacid), the penicillin antibiotic Amoxicillin and a drug from the group of proton pump inhibitors that can block the production of hydrochloric acid for a long time (Omeprazole, Pantoprazole, Rabeprazole and others).

Brand and analogue: which is better?

We came to the discussion of one of the most burning questions: what is better, branded, but expensive Klacid, or its cheaper analogue, for example, Klabaks, Clarithromycin-Teva, Fromilid and so on?

It is difficult to give a definite answer. The original drug and the analogue have the same formula, so theoretically they should work the same way. However, the effect of the drug largely depends on the excipients - after all, it is they that determine both the release rate and the features of absorption and excretion of the active substance. It is the original drug, the formula of which has been carefully selected over several years, has the most balanced composition, providing the most favorable distribution indicators, and, consequently, efficiency. This information is also confirmed by clinical studies, showing that the brand and its analogues are never completely identical drugs.

Nevertheless, it is impossible to say that Klacid's analogues are a priori less effective than the original. "So what to do?" the reader will ask. - "Buy an expensive brand or limit yourself to a more economical generic Klacid?" The burden of responsibility for making this decision is best shifted to the shoulders of the doctor. Some experts believe that in case of severe infections, it is not worth saving on medicines and it makes sense to buy only originals that guarantee a 100% result. At the same time, if the disease is not dangerous, you can rely on analogues. In general, it is better to solve this dilemma together with the doctor and purely individually.

How to take Klacid?

And finally, let's figure out how and how many days to take Klacid. The instructions for use for adults and children indicate that Klacid tablets should be administered at 250-500 mg twice a day for 6 days to 2 weeks, and the dose of suspension for a child is calculated depending on weight and is 7.5 mg of Clarithromycin per kilogram of weight 2 times a day. If a prolonged form of the drug is prescribed, the frequency of administration is halved, that is, 500 mg once a day for an adult patient.

Thanks to clarithromycin, the drug has a bacteriological effect. 5 ml of solution contains 250 mg of the active substance.

The composition of the product includes the following excipients:

• carbomer (carbopol 974R) used as a thickener;
• Povidone K90 designed to bind toxins;
• silicon dioxide has an absorbent effect;
• titanium dioxide gives the powder a white color;
• xanthan gum increases the viscosity of the suspension;
• fruit flavor gives the suspension a pleasant smell so that the kids do not refuse to take the remedy;
• potassium sorbate designed to increase the shelf life of the drug.

pharmachologic effect

Klacid belongs to the group of macrolide antibiotics. The active substance of the drug inhibits the activity of pathogenic microorganisms. In large doses, Klacid destroys harmful bacteria.

The therapeutic effect of the antibiotic is due to the fact that clarithromycin interferes with the process of protein formation in the bacterial cell.

The drug has an effect on the following microorganisms:

Release form

The white powder is intended for the preparation of a suspension. When mixed with water, a suspension with a fruity aroma is formed.

There are 2 dosage forms of the drug - 125 mg and 250 mg. The 125 mg suspension is available in a 60 ml vial. For a dosage of 250 mg, a 100 ml plastic container is intended.

Dosage of children's medicine

To prepare a solution, you need to add water to a vial of powder up to a certain mark. Shake the liquid container.

The finished solution retains medicinal properties for 2 weeks. After that, it is recommended to pour the solution. If the course of treatment exceeds 2 weeks, you will have to prepare a new suspension.

Liquid should be stored at room temperature. Shake the bottle vigorously before each dose.

When calculating the dosage of the Klacid suspension for children, it should be taken into account that up to 7.5 mg of clarithromycin should be per 1 kg of the baby's weight. Suspension to a sick child should be given 2 times a day.

The duration of the drug is determined by the doctor, based on the patient's condition. The antibiotic is not recommended for more than 2 weeks.

Indications for appointment

Children's suspension Klacid is prescribed for the treatment of the following diseases:

In the next video - the transfer of Dr. Komarovsky, dedicated to antibiotics. When should they be given, how long should they be taken, and what side effects should be observed:

Side effects

After taking an antibiotic, some children experience allergic reactions. Treatment can lead to disruption of the digestive system.

The solution causes anxiety, fear and insomnia in the baby. Due to a sharp release of adrenaline, the child experiences disorientation in space.

The medicine can cause nausea, vomiting and tinnitus.

Pathogenic microorganisms eventually become resistant to the active ingredient of the drug. Do not take the remedy for more than 2 weeks.

Contraindications

The antibiotic should not be used in case of hypersensitivity to the substances that make up the drug. The dosage for the treatment of children with diseases of the liver and kidneys should be reduced by 2 times.

If you experience headache, dizziness and diarrhea, you must stop taking the suspension.

How it interacts with other substances

An antibiotic can cause harm to the body in combination with the following drugs:

• Astemizol;
• Cisapride;
• Terfenadine;
• Limozid.

The ban is due to the fact that clarithromycin in combination with these drugs leads to a violation of the heart rhythm. The antibiotic should not be used together with alkaloids, as this can cause poisoning.

The drug reduces the therapeutic effect of Rifabutin. When taken concomitantly with Ritonavir, the dosage must be adjusted.

Negative consequences may occur in patients taking Triazol. Patients may experience drowsiness.

Signs of an overdose

Exceeding the dose indicated in the instructions may cause indigestion. In this case, it is necessary to wash the baby's stomach.

special instructions

Prolonged use of an antibiotic can cause the development of superinfection. The patient has a growth of pathogenic microorganisms that are insensitive to the active substance of the drug. During the course of treatment, it is necessary to control the level of enzymes in the blood. If signs of hepatitis appear, treatment with Klacid should be discontinued.

Storage conditions and term and price in the Russian Federation

The powder retains its properties for 3 years. The product is recommended to be stored at temperatures up to 30 degrees.

You can buy a suspension of Klacid for children, containing 125 mg of the active ingredient, at an average price of 370 rubles. To buy a bottle containing 250 mg of clarithromycin, you need to pay about 460 rubles.