Кларбакт

Кларбакт – antibiotic drug of group of macroleads.

Form of release and structure

Кларбакт is issued in the form of tablets, coated: kapsulovidny, from almost white till white color, on one party – dividing risk; on a break – a coated kernel of almost white or white color (in blisters on 4 or 10 pieces, on 1 blister in a cardboard pack).

Is a part of 1 tablet:

• Active ingredient: кларитромицин – 250 or 500 mg;
• Auxiliary components: corn starch, microcrystallic cellulose, polyvinylpirrolidone, prezhelatinizirovanny starch, sodium starch glycollate, the purified talc, stearic acid, colloid silicon dioxide, magnesium stearate;
• Cover: isopropanol, titanium dioxide, a gidroksipropilmetiltsellyuloz, polyethyleneglycol 6000, the purified talc, lemon fragrance, methylene dichloride, peppermint powder.

Indications to use

Кларбакт appoint for treatment of the infectious diseases caused by microorganisms, sensitive to effect of active agent:

• Infections of upper and lower parts of respiratory tracts (including pharyngitis, pneumonia, bronchitis, sinusitis);
• Infections of soft tissues and skin (including erysipelatous inflammations, folliculites);
• Otitises;
• The localized infections caused by Mycobacterium chelonae, Mycobacterium kansasii and Mycobacterium fortuitum;
• The Mikobakterialny infections (extended or localized), the caused Mycobacterium avium and Mycobacterium intracellulare.

Also drug is shown for an eradikation of Helicobacter pylori and reduction of frequency of a recurrence of an ulcer of a duodenum.

Contraindications

• The functional disturbances of kidneys and a liver proceeding in a severe form;
• Simultaneous use with ergot alkaloids, and also tsizapridy, astemizoly, Pimozidum, terfenadiny;
• Hypersensitivity to drug components, and also antibiotics from group of macroleads.

Safety of use of a klaritromitsin at pregnancy and during breastfeeding is not established. To pregnant women of Klarbakt appoint only in cases of lack of alternative treatment after ratio assessment advantage/risk. In the period of a lactation drug should be used with care.

Route of administration and dosage

Кларбакт accept inside.

The average adult dose makes 2 times a day on 250 mg. In case of need the single dose can be increased twice. Course duration – from 6 to 14 days.

To children of Klarbakt appoint at the rate of 7,5 mg/kg of body weight a day, but no more than 500 mg. Course duration – from 7 to 10 days.

At treatment of the caused Mycobacterium avium of infections administration of drug 2 times a day on 1000 mg is shown. Course duration – half a year and longer.

At a renal failure (clearance of creatinine it is less than 30 ml in a minute) Klarbakt's dose needs to be lowered twice. The maximum duration of a course at this group of patients – 2 weeks.

Side effects

• Central and peripheral nervous system: perhaps – a tranzitorny headache, alarm, dizziness, fear, fear, nightmares, sleeplessness, a sonitus, disorientation, confusion of consciousness, a hallucination, depersonalization, psychoses; seldom – paresthesias;
• Alimentary system: most often – dyspepsia, nausea, abdominal pains, diarrhea and vomiting; perhaps – pseudomembranous colitis (from moderately severe states to life-threatening forms), increase in activity of enzymes of a liver (has passing character), taste disturbances, stomatitis, a glossitis, candidiasis of a mucous membrane of an oral cavity, language discoloration during use of a klaritromitsin, discoloration of teeth (as a rule, reversible); seldom – the hepatitis proceeding with increase in level of enzymes of a liver in blood, jaundice and a cholestasia (in certain cases these injuries of a liver carried heavy and, as a rule, reversible character); in isolated cases – the liver failure leading to a lethal outcome;
• Urinary system: seldom – a renal failure, intersticial nephrite, increase in content of serumal creatinine;
• Cardiovascular system: seldom – increase in an interval of QT, ventricular arrhythmia (including a ventricular Bouveret's disease, blinking or trembling of ventricles);
• Hemopoietic system: in some cases – a leukopenia, thrombocytopenia;
• Allergic reactions: perhaps – anaphylactic reactions, skin rash, a small tortoiseshell, Stephens-Johnson's syndrome;
• Sense bodys: perhaps – a hearing loss (has reversible character, after drug withdrawal it is recovered), the taste perception changes arising usually together with taste disturbances;
• Others: seldom – a hypoglycemia (in certain cases at a concomitant use with peroral hypoglycemic means or insulin).

Special instructions

Patients with chronic diseases of a liver need to carry out control of activity of liver enzymes regularly.

Кларбакт it is necessary to take with caution along with the medicines which are metabolized in a liver (definition of their concentration in a blood plasma is recommended).

At joint appointment with warfarin or other indirect anticoagulants it is necessary to control a prothrombin time.

In the presence of anamnestic data on heart diseases simultaneous use with tsizapridy, terfenadiny, astemizoly is not recommended.

It is necessary to consider a possibility of cross stability between klaritromitsiny and other antibiotic drugs from group of macroleads, and also clindamycin and lincomycin.

At long or repeated therapy superinfection (growth of mushrooms and bacteria, insensitive to effect of drug) can develop.

Medicinal interaction

At simultaneous use of Klarbakt with some drugs there can be following effects:

• The drugs which are metabolized in a liver with participation of isoenzymes of system _{of P450 cytochrome} (indirect anticoagulants, theophylline, carbamazepine, midazolam, to triazoles, cyclosporine, Disopyramidum, рифабутин, Phenytoinum, digoxin, ловастатин, ergot alkaloids): increase in their concentration in blood;
• Tsizaprid, Pimozidum, астемизол, терфенадин: significant increase in their concentration that can lead to lengthening of an interval of QT and development of cardiac arrhythmias, including fibrillation of ventricles, a ventricular Bouveret's disease, blinking or trembling of ventricles (the combination of drugs is contraindicated);
• GMG-KOA-reduktazy inhibitors (ловастатин, симвастатин): development of an acute necrosis of skeletal muscles (in rare instances);
• Digoxin: increase in its concentration (to avoid digitalis intoxication, it is necessary to exercise constantly control of its content in serum);
• To triazoles: decrease in its clearance that can lead to increase in its pharmacological effects in the form of confusion of consciousness and drowsiness;
• Ergotamine (ergot alkaloids): development of acute ergotaminovy intoxication in the form of a heavy peripheral vasospasm and disturbance of sensitivity;
• Zidovudine (oral administration at HIV-positive adults): reduction of its _Css (stationary concentration in blood) in this connection not less than 4 hours are recommended to observe an interval between administrations of drugs;
• Ritonavir: increase in serumal concentration of a klaritromitsin (correction of concentration of a klaritromitsin at patients with disturbances of kidneys can be required; it is not recommended to apply Klarbakt in a daily dose more than 1000 mg).

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 2 years.