Clarbact tabs 500mg #10

Clarbact instruction for use

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Composition

One coated tablet may contain 250 or 500 mg of clarithromycin, microcrystalline cellulose, corn and pregelatinized starch, polyvinylpyrrolidone, purified talc, sodium starch glycollate, colloidal silicon dioxide, stearic acid and magnesium stearate are used as auxiliary substances.
The composition of the shell includes substances such as isopropanol, titanium dioxide, hydroxypropylmethylcellulose, purified talc, methylene chloride, polyethylene glycol 6000, lemon flavor and peppermint powder.

Form of issue

Clarbact 500 mg and 250 mg is available in tablets coated with a white or almost white shell, having a capsular form, as well as dividing risk on one side. The cross section of the nucleus is also white or almost white in color. Packed in tablets in blisters for 4 or 10 tablets, sealed in cardboard packs.

pharmachologic effect

Antimicrobial, bactericidal.

Pharmacodynamics and pharmacokinetics

Clarbact is an antibiotic from the macrolide group, a semisynthetic derivative of erythromycin.

Information about pharmacodynamics

The drug is stable in an acidic environment, has an antibacterial effect on the path of inhibition of protein synthesis, interacting with the ribosomal subunit 50S, has a bacteriostatic effect and bactericidal action.
It is established that the drug is active against a wide range of aerobic and anaerobic gram + and gram-microorganisms. The most famous are:
    Aerobic Gram-positive: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Listeria monocytogenes.
    Aerobic gram-negative: Haemophilus influenzae and Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Bordetella pertussis, Legionella pneumophila, Helicobacter pylori.
    Mycobacterium: Mycobacterium avium, Mycobacterium kansasii, Mycobacterium leprae, Mycobacterium fortuitum, Mycobacterium chelonae, Mycobacterium intracellular.
    Mycoplasma: Mycoplasma pneumoniae, Ureaplasma urealyticum.
    Microorhagenisms: Mycobacterium avium, Chlamydia trachomatis, Mycobacterium leprae.
    Anaerobes: some strains of Bacteroides fragilis, Clostridium perfringens, Peptococcus and Peptostreptococcus species, Propionibacterium acnes.

Information on pharmacokinetics

As a result of oral intake, there is a rapid absorption of clarithromycin, which gives a maximum concentration after 2 hours with bioavailability - 68% (regardless of diet). Further penetration into most tissues occurs, with the exception of the central nervous system. 80% of the drug binds to proteins, it is metabolized in the liver with the formation of a metabolite - 14-hydroxyclarithromycin, which has the same or 1-2 order less antimicrobial effect. 36% of the accepted dose is excreted in the urine, 52% - with calories. The half-life of the accepted dose of 250 mg is about 3-4 hours, 500 mg - about 5-6 hours.

Indications for use

Clarbact is prescribed for bacterial infections caused by sensitive microorganisms:
    infections of the upper airways, including laryngitis, pharyngitis, tonsillitis, sinusitis;
    at infections of the lower parts of the respiratory system, among them: bronchitis and its exacerbation, typical and atypical pneumonia;
    with skin infections and soft tissue lesions, for example, with folliculitis, furunculosis, impetigo, wound infection;
    in the case of otitis media;
    with chlamydia;
    with peptic ulcer of stomach and duodenum for eradication of Helicobacter pylori (as a component of combined therapy);
    at a mycobacteriosis, and, at atypical it is necessary to spend treatment in a combination with Rifabutinum (Rfb) and Etambutolom.

Contraindications

    hypersensitivity to the components of Clarbact, as well as to erythromycin and other macrolides;
    functional disorders of the kidney and / or liver;
    porphyria;
    therapy with cisapride, astemizole, terfenadine, pimozide, ergot alkaloids;
    the period of lactation.
Clarbact appoint with caution
Against the background of treatment with drugs metabolized in the liver.

Side effects

Treatment with clarithromycin can lead to various undesirable reactions from the following systems of the human body:
    Nervous system and senses: dizziness, headache, insomnia, increased anxiety and fear, nightmares, tinnitus, altered sense of taste. In rare cases, disorientation, hallucinations, depersonalization and confusion of consciousness, psychosis were recorded, paresthesia in single cases, loss of hearing.
    GASTROINTESTINAL TRACT: functional disorders of the digestive tract (nausea, vomiting, discomfort, diarrhea, gastralgia), the occurrence of stomatitis, glossitis, cholestatic jaundice, transient increase in liver transaminase activity. In rare cases, pseudomembranous enterocolitis, hepatic insufficiency, hepatitis was detected.
    SSS, hematopoiesis and hemostasis: thrombocytopenia, leukopenia; extremely prolonged cases on the cardiogram of QT interval, ventricular arrhythmia, ventricular paroxysmal tachycardia, flutter or fibrillation of the ventricles.
    Genitourinary system: cases of increased serum creatinine concentration, interstitial nephritis or renal insufficiency are rare.
    Manifestations of allergic reactions: skin itch, rash, Stevens-Johnson syndrome, pseudoallergic reactions.

Clarbact, instructions for use (Method and dosage)

Average daily intake for adults
Tablets are taken orally - 500 mg in two divided doses. The dosage can be increased to 1000 mg in 2 divided doses. The standard course of treatment is from 6 to 14 days.

For children

Dosage: 7.5 mg per 1 kg of body weight, with a maximum daily dose should not exceed 500 mg. The course of treatment is from 7 to 10 days.
In infections caused by Mycobacterium avium
1000 mg for 2 admission during the day, the course of treatment can last from 6 months or more.

Overdose symptoms

Dyspeptic disorders, headaches, confusion.

Method of treatment

Immediate gastric lavage, symptomatic treatment. Conduction of hemodialysis or peritoneal dialysis does not lead to a significant change in serum clarithromycin level.

Interaction

    Simultaneous use with oral hypoglycemic agents or insulin can lead to the development of hypoglycemia.
    C inhibitors of the enzyme HMG-CoA reductase, for example, Lovastatin and Simvastatin reported cases of development of acute necrosis of skeletal muscles.
    With Digoxin, an increase in the plasma concentration of the latter is observed, which, subsequently, without a constant control of the serum Digoxin content in the serum can lead to digitalis intoxication.
    With Triazolam, its clearance of triazolam decreases and the pharmacological effect is increased, accompanied by confusion and development of drowsiness.

Storage conditions

The drug from list B: must be stored in a dry dark place with a temperature of up to 25 ° Celsius.
For safety reasons, the drug should be out of the reach of children.
Shelf life - 2 years.

special instructions

In severe renal failure and creatinine clearance less than 30 ml per minute, it is necessary to appoint clarithromycin in immediate release tablets, the average dose should be reduced by 2 times with the maximum duration of treatment - no more than 2 weeks.
Prolonged or repeated use of the drug and other antibiotics can lead to the development of cross-resistance between antibiotics, as well as superinfection - insensitive bacteria or fungi. In addition, prolonged diarrhea can be a manifestation of pseudomembranous colitis and requires immediate discontinuation of the drug and consultation with a doctor.

In pregnancy and lactation

The action category for the fetus according to the classification of teratogenicity of the FDA is category C. Despite the fact that adequate and qualitatively controlled studies of the safety of the use of the drug have not been conducted, the appointment of Clarbacte to pregnant patients is possible:
    subject to a presumably greater therapeutic effect compared to potential risks to the fetus;
    if alternative therapy is not possible.
Attention! Patients who become pregnant during the treatment with clarithromycin should be warned about possible risks to fetal growth and development.

Reviews of Clarbact

The drug is considered a good effective antibiotic, has proven itself for a long time, doctors prescribe it often enough for infectious diseases of different origin and localization. However, one can also find negative reviews related to adverse reactions of the drug: patients complain of changes in taste, dysbacteriosis, abdominal and headaches.