Klatsid - instructions for use, analogs, reviews and release forms (tablets 250 mg and 500 mg of CP, powder for the preparation of suspension, injections in ampoules) drugs for the treatment of infections in adults, children and pregnancy

In this article, you can read the instructions for using the drug Clacid. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Clacid in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Clacid in the presence of existing structural analogs. Use to treat infections in adults, children, as well as during pregnancy and lactation.

Clacid - Semisynthetic antibiotic group of macrolides. It has antibacterial action, interacting with the 50S ribosomal subunit of bacteria and suppressing protein synthesis in a microbial cell.

Clarithromycin (active ingredient of Clacid) demonstrated high in vitro activity against standard and isolated cultures of bacteria. It is highly effective against many aerobic and anaerobic Gram-positive and Gram-negative microorganisms. Studies conducted in vitro confirm the high efficacy of Clarithromycin against Legionella pneumophila, Mycoplasma pneumoniae and Helicobacter (Campylobacter) pylori.

Clarithromycin is insensitive to Enterobacteriaceae, Pseudomonas spp., And other non-lactose-degrading gram-negative bacteria.

The production of beta-lactamases does not affect the activity of clarithromycin. Most strains of staphylococcus aureus resistant to methicillin and Oxacillin are resistant to clarithromycin.

Clarithromycin has an in vitro effect on most strains of the following microorganisms (however, the safety and efficacy of using clarithromycin in clinical practice is not supported by clinical studies and the practical significance remains unclear): aerobic Gram-positive microorganisms: Streptococcus agalactiae,streptococci (groups C, F, G), streptococcus group Viridans; 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 admission in adults, the bioavailability of the suspension was equivalent to the bioavailability of tablets (at equal doses) or slightly exceeded. The intake of food somewhat delayed the absorption of Clacid 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 of 14-hydroxyclarithromycin. Clarithromycin and its metabolite are well distributed in tissues and body fluids. Tissue concentrations are usually several times higher than serum concentrations. About 40% of the clarithromycin that enters the body is excreted by the kidneys; through the intestine - about 30%.

Indications

• infection of the lower respiratory tract (bronchitis, pneumonia);
• infection of the upper respiratory tract (pharyngitis, sinusitis);
• otitis media;
• infections of the skin and soft tissues (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 a decrease in the frequency of recurrences of duodenal ulcers;
• prevention of the spread of infection caused by the complex of Mycobacterium avium (MAC), in HIV-infected patients;
• odontogenic infections.

Forms of release

Tablets coated with 250 mg and 500 mg (CP or prolonged form of Clacid).

Powder for the preparation of the suspension for ingestion of 125 mg and 250 mg.

Lyophilizate for the preparation of a solution for infusions (injections in ampoules).

Instructions for use and dosing regimen

Pills

The drug is taken orally regardless of food intake.

Usually adults are prescribed 250 mg twice a day. In more severe cases, the dose is increased to 500 mg twice a day. Usually the duration of treatment is from 5-6 to 14 days.

When mycobacterial infections are prescribed 500 mg 2 times a day.

In case of common infections caused by MAC, in patients with AIDS, treatment should be continued as long as there are clinical and microbiological evidence of its usefulness. Clarithromycin should be administered in combination with other antimicrobial agents.

In infectious diseases caused by mycobacteria, in addition to tuberculosis, the duration of treatment is determined by the doctor.

To prevent infections caused by MAC, the recommended dose of clarithromycin for adults is 500 mg 2 times a day.

In odontogenic infections, the dose of clarithromycin is 250 mg twice a day for 5 days.

For eradication of Helicobacter pylori

Combined treatment with three drugs:

• clarithromycin 500 mg twice a day + lansoprazole 30 mg twice a day + amoxicillin 1000 mg twice a day for 10 days;
• clarithromycin 500 mg twice a day + omeprazole 20 mg per day + amoxicillin 1000 mg twice 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 a day + lansoprazole 60 mg per day for 14 days. To fully heal the ulcer, an additional decrease in the acidity of the gastric juice may be required.

Powder for suspension for oral administration

The ready-made suspension should be taken orally regardless of the meal (it is possible with milk).

To prepare the suspension in the vial with granules, gradually add water to the label, 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 of 100 ml: in 5 ml - 250 mg of clarithromycin.

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

Ampoules

The recommended adult dose is 1 g per day divided into 2 equal doses, each of which is administered iv after dissolution in a suitable solvent by drip for 60 min or more.

There are no data on the dosage of Clacid in ampoules for children.

Intramuscular and bolus administration is prohibited.

Patients with impaired renal function and KK less than 30 ml / min dose of clarithromycin should be halved from the normal recommended dose.

Rules for the preparation of solution

1) Add 10 ml of sterile water for injection into a vial of 500 mg of lyophilizate. It is recommended to use only sterile water for injection, since any other solvent can cause the formation of sediment. Do not use solvents containing preservatives or inorganic salts.

The reconstituted drug solution obtained by the above method contains a sufficient amount of a preservative and has a concentration of 50 mg / ml of clarithromycin. The solution is stable for 48 hours at a temperature of 5 ° C or 24 hours at a temperature of 25 ° C. The reconstituted solution of the drug should be used immediately after its preparation. If the preparation is not used immediately after obtaining its reconstituted solution, it is recommended to store it for no more than 24 hours at a temperature of 2 ° C to 8 ° C in aseptic conditions.

2) Prior to administration, the prepared solution of the preparation (500 mg in 10 ml of water for injection) should be added to at least 250 ml of one of the following solvents for IV administration: 5% glucose solution in lactated Ringer's solution, 5% glucose solution , lactated Ringer's solution, 5% glucose Dextrose solution in 0.3% sodium chloride solution, Normosol-M solution in 5% glucose solution,solution of Normosol-R 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 can not be used immediately, it should be stored under aseptic conditions. The drug solution remains stable for 24 hours at a temperature of 2 ° to 5 ° C. After this period, further preservation and use of the solution of clarithromycin IV is not recommended.

Do not mix the solution with any drugs or solvents unless you have first established their physical or chemical compatibility with clarithromycin IV.

Side effect

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

Contraindications

• severe violations of liver function;
• severe renal dysfunction (CK <30 mL / min);
• porphyria;
• simultaneous application with astemizole, cisapride, pimozide, terfenadine, ergotamine, dihydroergotamine;
• pregnancy;
• lactation period (breastfeeding);
• children's age up to 3 years (for a dosage form in the form of tablets);
• increased sensitivity to antibiotics of macrolides.

Application in pregnancy and lactation

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

It is known that clarithromycin is excreted in breast milk.

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

special instructions

Clarithromycin is excreted mainly by the liver. In this regard, caution should be exercised in appointing Clacida to patients with impaired liver function.

In the presence of chronic liver diseases it is necessary to carry out regular monitoring of serum enzymes.

Caution should be observed when treating Cladida patients with moderate and severe renal insufficiency.

In clinical practice, cases of toxicity of colchicine when combined with clarithromycin are described, especially in the elderly. Some of them were observed in patients with renal insufficiency; reported several deaths in these patients.

It is necessary to consider the possibility of cross-resistance between clarithromycin and other macrolide preparations, as well as Lincomycin and clindamycin.

Caution is prescribed against the background of drugs metabolized by the liver.

In the case of co-administration with Warfarin or other indirect anticoagulants, prothrombin time should be monitored.

Drug Interactions

In clinical studies with the combination of theophylline or Carbamazepine with clarithromycin, a small but statistically significant (p <0.05) increase in the levels of theophylline and carbamazepine in serum was observed.

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

With the simultaneous use of clarithromycin with cisapride, an increase in the levels of the latter was observed. This can lead to an extension of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and "pirouette" type polymorphic ventricular tachycardia. Similar effects were observed in patients receiving clarithromycin with pimozide.

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

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

In clinical practice, with the combination of clarithromycin with ergotamine or dihydroergotamine, cases of acute toxicity of the latter were recorded, characterized by vasospasm, ischemia of limbs and other tissues, including the CNS.

In patients receiving clarithromycin in 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 concomitant administration of colchicine and clarithromycin, inhibition of P-glycoprotein and / or CYP3A can lead to increased colchicine action. Patients should be closely monitored to identify symptoms of colchicine's toxic effects.

Simultaneous oral administration of Clacid in zidovudine tablets in HIV-infected adult patients may lead to a decrease in equilibrium concentrations of zidovudine. Similar interactions were not observed in HIV-infected children who took a suspension of clarithromycin with zidovudine or dideoxyinosine.

Analogues of the drug Clacid

Structural analogs for the active substance:

• Arvitsin;
• Arvitsin retard;
• Binocular;
• Zimbactur;
• Kispar;
• Klabaks;
• Clarcat;
• Clarithromycin;
• Clarithrosine;
• Claricin;
• Claricite;
• Claromin;
• Class;
• The CP clacide;
• Clerimedes;
• Coater;
• Crixan;
• Seidon-Sanovel;
• SR-Clarene;
• Fromromide;
• Fromyloid Uno;
• Ecositrin.

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