Klacid - instructions for use for children and reviews. Brand and analogue: which is better? Release form: read the instructions for Klacid

In this article, you can read the instructions for use medicinal product Klacid. Reviews of site visitors - consumers are presented this medicine, as well as the opinions of specialist doctors on the use of Klacid in their practice. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications were observed and side effects, possibly not declared by the manufacturer in the annotation. Klacid's analogues, if available 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 high efficiency 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 not confirmed clinical research and practical significance 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

Ready suspension should be taken orally regardless of food intake (can be taken 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.

Recommended daily dose suspension of clarithromycin 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, since any other solvent may cause precipitation. Do not use solvents containing preservatives or inorganic salts.

The reconstituted solution of the drug, obtained by the method described above, contains enough 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.

Do not mix the solution with any medicines or solvents, unless their physical or chemical compatibility with clarithromycin IV.

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.

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 non-proprietary 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, with a 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 the gastrointestinal 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 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 is highly effective against a wide range of 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

Infections of the lower respiratory tract (bronchitis, pneumonia, etc.);

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

Infections of the skin and soft tissues (folliculitis, inflammation of the subcutaneous tissue erysipeloid, etc.);

Acute 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, there were no significant differences in the frequency of these adverse reactions between groups of patients who had or did not have 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, oral candidiasis, 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 albumin-globulin ratio1, increased serum alkaline phosphatase4, increased serum lactate dehydrogenase4

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 (in 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

Renal 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 systems.

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 loss, 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 may lead to ergotoxicity), lovastatin, simvastatin (due to increased risk of myopathy, 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 the possible development of severe consequences of the interaction.

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 the prescribing information for the appropriate 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 - the 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 No dose reduction of clarithromycin is required in patients with normal renal function. In patients with renal insufficiency, dose adjustment is necessary: ​​with 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 drugs (CYP3A substrates): alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, methylprednisolone, midazolam, omeprazole, oral anticoagulants (eg warfarin), pimozide , quinidine, rifabutin, sildenafil, tacrolimus, terfenadine, triazolam and vinblastine, 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 for clinical signs of 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.

A bidirectional drug interaction between clarithromycin and atazanovir, itraconazole, saquinavir is also possible.

Verapamil: The development of arterial hypotension, bradyarrhythmia and lactic acidosis has been reported 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, including elevated liver enzymes, and hepatocellular and/or cholestatic hepatitis with or without jaundice have been reported with clarithromycin. This liver dysfunction can be severe and is usually reversible. In some cases, fatal liver failure has been reported, 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.

Mild diarrhea 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.

Skin and soft tissue infections of mild to moderate severity

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 carefully monitored when clarithromycin and oral anticoagulants are used in combination.

HMG-CoA reductase inhibitors.

The simultaneous use of clarithromycin lovastatin and simvastatin is contraindicated, because. statins are extensively metabolized by CYP3A4 and co-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 the nervous system, such as convulsions, dizziness, vertigo, hallucinations, confusion, disorientation, etc.

Overdose

Symptoms from the 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

Vials of 60 or 100 ml made of high-density polyethylene (HDPE), sealed with a polypropylene screw cap, with a gasket made of low-density polyethylene, 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

Macrolides are considered one of the most effective and safe antibacterial drugs for children. They are often prescribed for infections of the respiratory tract by microorganisms and are in demand for otitis media, pneumonia, sinusitis or bronchitis. One of the most popular drugs of this group can be called Klacid. Not everyone knows in what form it is prescribed to children, whether infants are allowed, how to calculate its dose, and what analogues can be replaced if necessary.

Release form

Klacid is produced in three different versions:

• Powder for suspension. It is placed in a 60 or 100 ml bottle marked with a line and presented as almost white granules with a fruity odor. When mixed with water, it forms a white, opaque liquid that smells like fruit. This form is produced in two different dosages, allowing the use of medication for children of different ages. A plastic spoon or syringe with divisions is attached to the bottle to accurately measure the right amount of sweet medicine.
• Tablets. They have a yellow shell and an oval shape convex on both sides. Such tablets are also produced in two dosages and are packed in blisters of 7, 10 or 14 pieces. One pack contains from 7 to 42 tablets.
• Lyophilisate for injections. It is presented as a white powder with a slight specific odor. This tool is placed in hermetically sealed glass bottles, which are sold in 1 piece or in a pack of 121 pieces.

Separately, the drug "Klacid SR" is produced, represented by tablets in a shell with a prolonged effect. They are characterized by an oval shape and yellow color. Such tablets are sold in packs of 5 to 56 pieces.

Compound

The active ingredient in each form of the drug is clarithromycin. Its dosage in 5 ml of suspension can be 125 mg or 250 mg. Tablets may contain 250 mg or 500 mg of such a substance each. The bottle with lyophilisate contains 500 mg of the active ingredient. The dosage in "Klacid SR" is also 500 mg per tablet.

Additionally, the medicine includes:

• sucrose, fruit flavor, xanthan gum, povidone K90, maltodextrin, potassium sorbate and other substances in the suspension powder.
• Talc, hypromellose, microcrystalline cellulose, vanillin, stearic acid, croscarmellose, sorbic acid and other compounds in the composition of tablets.
• sodium hydroxide and lactobionic acid in injectable form.
• Magnesium stearate, anthrium alginate, citric acid, macrogol and other components in the drug "Klacid SR".

Operating principle

"Klacid" affects the ribosomes of bacteria, as a result of which the synthesis of proteins in microbial cells is suppressed. The drug is usually sensitive:

• golden staphylococci;
• pneumococci and some other streptococci;
• listeria;
• hemophilic rods;
• gonococci;
• moraxella catharalis;
• legionella pneumophila;
• mycoplasma pneumonia;
• chlamydia;
• ureaplasma;
• mycobacteria;
• helicobacter pylori.

Clostridia, peptococci, whooping cough bacilli, bacteroids, borrelia, campylobacter and some other microorganisms are destroyed by clarithromycin in laboratory tests. If they are the causative agents of the disease, then Klacid should be used after a sensitivity test to make sure that the medicine will work.

Indications

The drug is recommended to be used only when infected with microorganisms that are sensitive to clarithromycin. When prescribing a medicine for sore throat, whooping cough, scarlet fever and other infectious diseases, it is first desirable to determine whether Klacid will act on their pathogen.

At what age is it allowed to take?

The drug in the form of a suspension is not prescribed to newborns and infants up to 6 months, since the safety of the drug for such small patients has not been established. For children older than 6 months of age, the medicine should be prescribed by a doctor who will evaluate the indications and calculate the required dosage by weight.

The tablet form is not used for babies who have not reached the age of 3, but even for children over three years old, the drug is more often prescribed in suspension, due to the simpler dosing of liquid medicine. The drug "Klacid SR" is used in the treatment of children over 12 years old, if their weight is more than 40 kg.

Injections are not prescribed for children under 18 years of age. They are in demand only for very severe infections or in a situation where it is impossible to take Klacid inside. Such injections are made exclusively intravenously by drip, mixing the lyophilisate with sterile water, and then with glucose or saline. As soon as the patient's condition improves, they immediately switch to a suspension or tablets.

Contraindications

The drug is not used for allergies to clarithromycin or another ingredient of the selected form, as well as for intolerance to any other antibiotic that is part of the macrolide group. In addition, "Klacid" is not prescribed or used under the supervision of a doctor:

• with severe liver disease;
• with renal failure;
• with hypokalemia;
• with porphyria;
• with heart failure;
• with bradycardia or arrhythmias.

The suspension should not be given to patients with isomaltase or sucrase deficiency, or with glucose-galactose malabsorption or fructose intolerance. In addition, this form is not recommended for children with diabetes.

Side effects

Treatment with Klacid can cause:

• allergic rash;
• insomnia;
• headaches;
• strong sweating;
• diarrhea
• nausea;
• pain in the abdomen;
• vomiting;
• taste disorders;
• changes in liver function tests.

Sometimes the drug causes fever, chills, fatigue, discoloration of urine, increased levels of urea or creatinine, leukopenia, liver damage, arrhythmia, nosebleeds, constipation, muscle pain, decreased appetite, convulsions and other symptoms. If they appear in a child, the issue of continuing treatment with Klacid should be discussed with the pediatrician.

When taken for a very long time, bacteria can become insensitive to the drug, which requires the appointment of another antibiotic. Prolonged use of "Klacid" can cause the activation of a fungal infection.

Instructions for use

Suspension

The drug is not produced in finished form, so parents need to prepare it for admission on their own. The powder should be mixed with water immediately before use, since the finished medicine is stored for a certain time.

Having opened the bottle, pour non-carbonated ordinary water inside to the mark, then close the medicine and shake. So, depending on the dosage, 60 ml of a homogeneous white suspension is obtained containing 125 mg of the active ingredient in 5 ml or 100 ml of a suspension containing 250 mg of the active ingredient in 5 ml.

Before each use of such a tool, it must be shaken, and only then typed with a spoon or graduated syringe. The medication is given regardless of the diet. If the child does not like the taste of the suspension, the medicine can be washed down with juice, water or some other drink. For babies, this "Klacid" can be mixed with milk, water or formula.

If the infection in a child is provoked by any microorganism (in addition to mycobacteria), a single dose of the drug is calculated by weight, multiplying 7.5 mg by the body weight of a small patient in kilograms. The resulting amount of antibiotic is given twice a day, and the maximum dosage per day for children is 1 g (500 mg twice a day).

For example, a child's body weight is 20 kg, which means that at one time he needs 7.5x20 = 150 mg of clarithromycin (300 mg per day). If a suspension of 125 mg / 5 ml is used, then 1 ml of such a product contains 25 mg of the active compound, which means that the baby should be given 6 ml of this Klacid. When using a suspension of 250 mg / 5 ml, the child will have to give 3 ml of the drug, since 1 ml of the drug with this dosage contains 50 mg of clarithromycin. The annotation to the medicine also has a table with an approximate single dose for different body weights.

The course of treatment usually lasts 5-10 days and is more accurately determined by the doctor, taking into account both the type of pathogen and the severity of the child's condition. In some cases, a 5-day suspension is enough to fight the infection, and sometimes the pediatrician, after 10 days of use, continues therapy for up to 14 days (or even up to 21 days).

If a child has become infected with mycobacteria, the doctor may increase the dosage to 15 mg per kilogram of the patient's weight. The drug is taken until the elimination of clinical symptoms, often combined with other antibiotics.

If the child weighs 40 kg or more, he is given the Klacid tablet in the dosage prescribed for adult patients. The medicine is prescribed at 250-500 mg (depending on the disease), twice a day. The drug "Klacid SR" due to the longer action is taken only once a day.

Overdose

A high dosage of "Klacid" disrupts the digestive system, provokes headaches, confusion and requires an immediate reaction in the form of gastric lavage and the use of sorbents . If the child's condition worsens, you should call a doctor to prescribe symptomatic therapy.

Interaction with other drugs

Klacid is not advised to be combined with many medicines, including: aminoglycoside antibiotics, Terfenadin, Ergotamine, Carbamazepine, Triazolam, Omeprazole, Colchicine, indirect anticoagulants, Methylprednisolone, Rifampicin , "Verapamil" and many other drugs. Their complete list is noted in the annotation to the drug.

Terms of sale

Any of the forms of "Klacida" can be purchased only after presenting a prescription. The average price of a bottle of powder, from which a suspension with an antibiotic concentration of 125 mg / 5 ml is obtained, is 350-380 rubles. For a package of 10 tablets of 250 mg of clarithromycin, you need to pay about 600 rubles. Approximately the same is worth one bottle of injectable "Klacid".

Storage conditions and shelf life

Storage of the sealed powder for suspension during the entire shelf life of 2 years is recommended at room temperature in a place hidden from a small child. After mixing with water, the drug can be stored at a temperature of +15 to +30 degrees for no longer than 14 days. It is not recommended to keep the medicine in the refrigerator, and the medicine that has not been used for two weeks should be thrown away.

Tablets and vials for injection should be kept in a place protected from sunlight, where the temperature will not exceed 25 degrees Celsius. The shelf life of the tablet form is 5 years, the injection form is 4 years.

The antibiotic Klacid contains an active ingredient, as well as additional components: sodium calcium alginate, sodium alginate, lactose, anhydrous citric acid hydrogen phosphate, stearic acid, povidone KZO, magnesium stearate.

Release form

Klacid 500 mg and 250 mg is produced in the form of tablets, which are coated with a yellow shell. The tablets are oval in shape, the presence of two layers is noted along the cut: a yellow film and a whitish core. A blister made of foil can hold 7, 10 or 14 tablets, 1, 2 or 3 such blisters are packed in a cardboard box.

pharmachologic effect

Active substance clarithromycin belongs to the group of macrolides, semi-synthetic. The antibacterial effect is produced by suppressing the bacterial protein synthesis. The consistency of the tablet is such that the active ingredient is released gradually as the drug passes through the gastrointestinal tract. Clarithromycin active against isolated and standard cultures of bacteria. A high effect is noted when using the agent for the treatment of legionnaires' disease, pneumonia of mycoplasmal etiology. Gram-negative bacteria are not sensitive to clarithromycin .

The active substance acts as an antibacterial agent against group A streptococci , pneumococcus , golden staphylococcus , microorganism pathogens hemophilic infection , listeriosis , pneumonia , pneumochlamydiasis , leprosy , , faces , sporotrichosis.

Those pathogens that do not show sensitivity to and Methicillin , are also resistant to clarithromycin .

There has also been a positive impact clarithromycin in relation to the following microorganism (efficacy and safety has not been confirmed in the course of clinical trials): green streptococcus, peptococcus, group B, C, F, G streptococci; causative agents of pasteurellosis in birds, human toxicoinfections, , borreliosis, enterocolitis.

During the metabolism clarithromycin the body releases active 14-hydroxyclarithromycin, which exhibits microbiological activity. Metabolism occurs in the human liver. If a person took the drug regularly, there was no increase in the activity of its influence.

Pharmacokinetics and pharmacodynamics

Substance clarithromycin binds well to blood proteins. The highest concentration of the drug is determined within 6 hours. The larger the dose of the drug taken by the patient, the longer the period of time it is excreted from the body. The amount of the metabolite (14-hydroxyclarithromycin) does not increase in parallel with an increase in the dose of clarithromycin. The greater the accepted dose of Klacid, the less 14-hydroxyclarithromycin is formed in the body.

The drug is excreted from the body through the kidneys and intestines (respectively, 40% and 30% of the dose). After oral administration, clarithromycin and its metabolite are distributed to tissues and body fluids, tissues typically contain twice as much drug as serum.

Dosage adjustment is not required for liver diseases. With kidney disease, the elimination period clarithromycin from the body increases. Also, the elimination period of the drug increases in the elderly.

Indications for use

The use of the drug Klacid is indicated for the following diseases and conditions:

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

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.

Contraindications

Do not take an antibiotic in the following cases:

• with the body to the means of the macrolide group;
• at porphyria ;
• during pregnancy and breastfeeding ;
• children up to 3 years of age.

Carefully, the remedy is prescribed for violations of the kidneys and liver.

Can't be taken at the same time clarithromycin and such medicines: Dihydroergotamine , pimozide , Erhotamine , BUTstemizol .

Side effects

If Klacid is administered intravenously or taken orally, a number of side effects may occur. If such effects occur after intravenous administration or oral administration of tablets, it is necessary to inform the specialist about this. The following manifestations are possible:

• CNS functions : change in taste, .
• Digestive system : nausea , stomach ache, .
• Local reactions with the introduction of the solution : inflammation at the injection site, phlebitis , pain during palpation.
• Laboratory indicators : increased activity of liver enzymes.

In addition to these side effects, side effects that occur less frequently are possible:

• oral cavity;
• thrombocytopenia , leukopenia ;
• hypoglycemia ;
• mental disorders,;
• , convulsions ;
• myalgia ;
• reversible hearing loss;
• ventricular;
• stomatitis , spicy , ;
• liver dysfunction;
• increased levels of creatinine in the blood.

Instructions for use Klacid (Method and dosage)

Instructions for the use of Klacid for children and adults provide for oral administration, regardless of the meal.

Adult patients are shown taking 250 mg of clarithromycin twice a day. If severe diseases, mycobacterial infections are being treated, the dose may be increased to 500 mg twice a day. In most cases, treatment lasts from 5 to 14 days.

If prescribed for treatment suspension Klacid instructions for use must be followed exactly. The suspension is prescribed for the treatment of children, it can be taken regardless of food intake, it can be taken with milk. To prepare the suspension for use, you need to gradually add water to the vial to the mark, then shake. 5 ml of a 60 ml suspension contains 125 mg of clarithromycin; 5 ml of a 100 ml suspension contains 250 mg of clarithromycin. The suspension can be stored for two weeks at room temperature.

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.

Overdose

When taking very large doses of this drug, patients may show signs of impaired functioning of the digestive system. It is important to remove the remnants of the drug from the gastrointestinal tract as soon as possible, after which symptomatic treatment is carried out.

Interaction

Combination is strictly not allowed. clarithromycin and drugs Astemizol , pimozide , Terfenadine , Cisapride , as in this case, the development of serious side effects is likely. In particular, the manifestation of cardiac arrhythmias, including ventricular fibrillation, ventricular tachycardia, is possible.

Concomitant use of clarithromycin and Ergotamine or probably acute poisoning with ergotamines. In particular, ischemia of the extremities, vascular spasm, etc. may occur. Simultaneous administration of clarithromycin and ergot alkaloids is not allowed.

CYP3A inducers induce the metabolism of clarithromycin. As a result, the concentration of clarithromycin and its effectiveness decreases. If clarithromycin is used concomitantly, the plasma concentration increases Rifabutina and the concentration of clarithromycin decreases.

Preparations Nevirapine , Efavirenz , Rifabutin , Rifapentine able to accelerate the metabolism of clarithromycin, thereby reducing its plasma concentration and increasing the concentration of its metabolite - 14-OH-clarithromycin. As a consequence, therapeutic efficacy may decrease.

Decreased concentration clarithromycin observed when taken together with etravirine .

It is necessary to adjust the dose of drugs when co-administered clarithromycin and ritonavir .

With simultaneous treatment with Klacid and oral hypoglycemic drugs or insulin, severe hypoglycemia may occur. Glucose levels should be constantly monitored.

When taking antibiotics concomitantly with quinidine , disopyramide possible ventricular tachycardia.

With caution, clarithromycin should be taken by those who receive drugs - substrates of the CYP3A isoenzyme, as well as in combination with statins.

Concomitant treatment with clarithromycin and is contraindicated.

It is important to monitor the patient's condition during joint treatment and clarithromycin due to the risk of bleeding.

When taking clarithromycin and , there is a need to reduce the dosage of the latter drugs.

Simultaneous treatment with antibiotics and or carbamazepine leads to an increase in the concentration of these drugs in the bloodstream.

When using clarithromycin and triazolam likely to affect the central nervous system, as a result, drowsiness and confusion develop.

People who have impaired liver or kidney function should not take clarithromycin and colchicine at the same time.

With simultaneous treatment with clarithromycin, the effect of the latter is enhanced. It is necessary to constantly monitor the level of digoxin in the blood serum.

There is a bidirectional effect of drugs while taking clarithromycin and atazanavir , as well as clarithromycin and itraconazole, clarithromycin and saquinavir .

When treated simultaneously with an antibiotic and, diltiazem increases the likelihood of developing arterial hypotension.

Terms of sale

In pharmacies, the antibiotic is sold by prescription.

Storage conditions

It is necessary to protect the antibiotic from the access of children, it should be stored at a temperature not exceeding 30 ° C.

Best before date

The shelf life of the antibiotic is 3 years.

special instructions

In people with liver disease, there may be a change in the levels of serum enzymes, from which tablets should be prescribed carefully.

Caution is given to people taking other drugs that are metabolized by the liver in parallel.

With prolonged treatment with antibiotics, the formation of colonies with a large number of insensitive fungi and bacteria is possible.

In chronic liver diseases, serum enzymes should be regularly monitored.

Possible manifestation pseudomembranous colitis during antibiotic treatment. It is also possible to change the normal intestinal microflora.

Caution should be given to people with severe heart failure, bradycardia, hypomagnesaemia. It is necessary to constantly monitor the ECG, determining the increase in the QT interval.

May increase symptoms in people who take clarithromycin.

The powder for the preparation of a suspension of Klacid contains sucrose, which should be taken into account by people suffering.

In the treatment of clarithromycin, you need to carefully manage transport and perform activities that require a high concentration of attention.

Synonyms

Clarithromycin

Klacid's analogs

Coincidence in the ATX code of the 4th level:

Klacid's analogues are agents that belong to the same group and have an active substance similar to Klacid. These are medicines Clarexide , Binocular , Claricite , Clarithrosin , Clarithromycin , Claromin etc. You can replace the drug only after the approval of the doctor, since each of these drugs has certain features of use and side effects.

The price of analogues can be either higher or lower. Differences Klacid and Klacid SR in that the latter drug is a prolonged-release drug, that is, the active substance is released more slowly.

With alcohol

According to the instructions, Klacid and alcohol are incompatible. If the patient consumes alcohol during treatment with this antibiotic, the risk of side effects increases dramatically, since the toxicity of the drug greatly increases.

Klacid for children

Klacid for children can be used from the age of three. In most cases, children are prescribed Klacid suspension. Reviews for children indicate that this drug is quite effective. At the same time, the price of the suspension is quite high. The dosage for children is as follows: 7.5 mg of the drug per 1 kg of the child's weight twice a day. The largest daily dose is 500 mg.

Children who are already 12 years old are prescribed 250 mg (tablets) twice a day. There is evidence that children tolerate Klacid more easily than other antibiotics. Therefore, the drug is often prescribed for , bronchitis , pneumonia etc. However, we should not forget that side effects still occur.

During pregnancy and lactation

There is no precise information on the safety of using Klacid for treatment. and nursing mothers. Therefore, the use during the period of gestation is not practiced.

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In the case of severe inflammation in a child caused by a bacterial infection, it may be difficult to select an antibacterial drug due to contraindications for admission in childhood. In case of a complicated infection accompanied by high fever, a new generation antibiotic Klacid can be prescribed - instructions for use for children allow taking the drug at the age of 3 years with tonsillitis, pneumonia and other inflammatory diseases of the upper respiratory tract.

Klacid for children

Antibiotic Klacid belongs to the group of semi-synthetic antibacterial drugs intended for the treatment of infectious diseases. Its main active ingredient clarithromycin is active against anaerobic, aerobic, gram-positive bacteria, chlamydia, mycoplasmas and some types of microbacteria. Therefore, the drug is a broad-spectrum antibiotic. According to the instructions for use, it can be prescribed to children older than three years.

Composition and form of release

The main forms of release of Klacid are tablets for oral administration and powder for the preparation of suspensions and infusions for injection. The content of clarithromycin in tablet form is 250 mg and 500 mg, excipients are sodium calcium alginate, sodium alginate anhydrous citric acid hydrogen phosphate, lactose, magnesium stearate, stearic acid, povidone KZO. Tablets are covered with a yellow shell, packed in plastic cells of 7 pieces, two blisters in each package. Granular powder for suspensions is available in dosages of 125 and 250 mg.

How the drug works

Klacid belongs to the semi-synthetic antibiotics of the macrolide group, its active ingredient inhibits protein synthesis of harmful microorganisms, preventing their reproduction. The appointment of clarithromycin is practiced in severe infections caused by group A streptococci, pneumococci, Staphylococcus aureus. The main active component of Klacid is released gradually, as the drug passes through the gastrointestinal tract. With an increase in the dose of the drug, the amount of the metabolite (hydroxyclarithromycin) does not increase.

Indications for use

The antibiotic Klacid is prescribed for children for the treatment of mycobacterial infections, infections of the upper respiratory tract, inflammatory lesions and infections of the skin and soft tissues. According to the instructions for use, indications for taking the drug are the following diseases and conditions:

• pneumonia;
• bronchitis;
• pharyngitis;
• laryngitis;
• tracheitis;
• otitis media;
• sinusitis;
• sinusitis;
• complicated angina;
• erysipelas;
• acne;
• furunculosis;
• folliculitis;
• chlamydia;
• sporotrichosis;
• prevention of infections in HIV-infected patients.

Method of application and dosage

The drug is taken regardless of the meal. The habitual diet of a sick child will not have to be changed, since the process of digestion does not change the absorption of the drug, only slightly slows down its speed. According to the instructions, Klacid in tablet form can be taken with water or milk, the suspension must be thoroughly shaken before each use, shaking the bottle vigorously.

Klacid suspension

Children from three to twelve years old are usually prescribed Klacid suspension. The average dosage is calculated from the proportion of 7.5 mg of clarithromycin per 1 kg of the child's weight. In infections caused by mycobacteria, it can be increased to 15 mg per 1 kg of body weight. The received daily dose is divided into two doses - morning and evening. The duration of treatment depends on the diagnosis and the severity of symptoms, averaging 6-8 days. To prepare the solution, pure water is poured into the bottle with the powder to the level of a special mark, the mixture is shaken properly.

Klacid tablets

Klacid tablets are not prescribed for children under 12 years of age if the child's body weight is less than 40 kg. The daily dosage and duration of treatment depends on the severity of the disease and the individual characteristics of the child's body. The regimen is developed by the attending physician. The instructions for use indicate a dosage of 205-500 mg per day, one tablet of 500 mg - in the morning, or 2 tablets of 250 mg, in the morning and evening for 6-14 days.

drug interaction

When taken in parallel with other drugs, the drug Klacid can cause strong negative reactions from the side of the nervous and cardiovascular systems. Some drugs (Rifabutin, Rifapentine, Colchicine) accelerate the metabolism of clarithromycin, reducing its concentration. Klacid may reduce the concentration of SUZA inhibitors; when used together, dosage adjustment is necessary. Instructions for use contains a list of funds, the combined use of which should be carried out with caution:

• oral anticoagulants (the observed increase in serum concentrations of drugs leads to severe arrhythmias);
• means of the ergotamine group;
• ergot alkaloids;
• oral hypoglycemic agents;
• SURZA inductors.

Side effects

When taking a children's suspension of Klacid, according to the instructions for use, adverse reactions from the central nervous system, the digestive system, and individual allergic reactions in the form of a drug rash are possible. They are expressed in the following symptoms:

• dizziness;
• arrhythmia;
• hypoglycemia;
• tachycardia;
• myalgia;
• taste change;
• hives;
• liver dysfunction.

During antibiotic therapy, children are prescribed a course of probiotics, which normalize the intestinal microflora and strengthen the immune system. Klacid significantly affects the functions of the liver, in chronic diseases of this organ during the course of treatment, it is necessary to monitor the concentration of enzymes in the blood serum. In case of metabolic disorders, expressed in the darkening of urine, abdominal pain or jaundice, the drug should be stopped and consult your doctor.

Contraindications

Instructions for use Klacid limits the use of the drug by children under the age of three years. It is contraindicated to take the drug in case of individual intolerance or high sensitivity to macrolide drugs, as well as in conjunction with the following drugs:

• Dihydroergotamine;
• Astemizol;
• Ergotamine;
• pimozide;
• Cisapride;
• Terfenadine.

Terms of sale and storage

Released by prescription. It is necessary to store the finished suspension at a temperature of 15 to 30º C for no more than two weeks. The shelf life of dry powder and tablets Klacid is two years from the date indicated on the package. Keep away from children.

Klacida analogue for children

In the presence of contraindications or the appearance of negative reactions, the drug Klacid for children can be replaced by one of its analogues. In this case, the dosage and regimen of administration should be adjusted. Medicines with a similar mechanism of action include:

• Klibaks;
• Clarexide;
• Zimbaktar;
• Clarithromycin;
• Claromin;

Price Klacida

You can buy Calcid for children at any pharmacy or online pharmacy by ordering home delivery of the medicine. When making a purchase, a pharmacist may require a medical prescription. The average price range for all forms of the drug is presented in the table below.