Клабакс

Клабакс – antibacterial drug of a broad spectrum of activity for system use, from group of macroleads.

Form of release and structure

Клабакс release in the following dosage forms:

• Tablets, film coated: oval, biconvex, light yellow color, on one of the parties marking in black color, depending on a dose - "CXT 250" or "CXT 500" (250 mg: on 4 pieces in blisters, on 1 or 3 blisters in a cardboard pack; 500 mg: on 10 pieces in blisters, on 1 blister in a cardboard pack);
• Granules for preparation of suspension for intake: the loose granulated powder, color from white to almost white, forms when mixing with water white or almost white suspension of sweetish taste with a fruit smell (on 42 g (for a dosage of 125 mg / 5 ml) or 70 g (for a dosage of 250 mg / 5 ml) granules in the bottles from polyethylene of high density equipped with the white screw-on cover with control of the first opening, with protection against children and a filling volume tag complete with a measured spoon and the measured syringe with a scale, on 1 set in a cardboard pack).

Structure of 1 tablet:

• Active ingredient: кларитромицин – 250 mg or 500 mg;
• Auxiliary components: povidone, magnesium stearate, cellulose microcrystallic, the talc purified silicon dioxide colloid, sodium of a kroskarmelloz;
• Film cover: hydroxypropyl cellulose, a gidroksipropilmetiltsellyuloza, propylene glycol, titanium dioxide, sorbitan monooleate, a varnish quinolinic yellow, the talc purified vanillin;
• Printing Opacode Black ink (опакод S-1-17823 black): the shellac glazed (esterified) in ethanol ferrous oxide black (E172), isopropyl alcohol, butyl alcohol, ammonia solution, propylene glycol.

Structure of 5 ml of ready suspension:

• Active ingredient – кларитромицин 125 mg or 250 mg;
• Auxiliary components: gipromelloza, sodium of a kroskarmelloz, cellulose microcrystallic, hydroxypropyl cellulose, alginic acid;
• Kishechnorastvorimy covering of granules: methacrylic acid, the talc purified, a macrogoal 1500, silicon dioxide colloid anhydrous, carbomer (карбопол 974P);
• Auxiliary components for suspension: aspartame, sucrose, ksantovy pitch, Natrium benzoicum, sodium citrate, silicon dioxide colloid anhydrous, titanium dioxide (E171), fragrance fruit 051880, fragrance mint (E517), sodium chloride.

Indications to use

• Chronic and acute bronchitis, pneumonia;
• Pharyngitis, sinusitis, average otitis;
• Infections of soft tissues and skin.

In addition for tablets:

• Eradikation Helicobacter pylori at a peptic ulcer of a stomach and duodenum (as a part of complex treatment);
• The infections caused by Mycobacterium intracellulare or Mycobacterium avium;
• Toxoplasmosis, leprosy;
• Urea-and mycoplasmosis, clamidiosis.

Contraindications

• Heavy liver failure, hepatitis (including in the anamnesis);
• Simultaneous use with any of the following drugs: Pimozidum, терфенадин, астемизол, ergotamine, dihydroergotamine, симвастатин, ловастатин, цизаприд;
• I trimester of pregnancy;
• Children's age up to 6 years (for tablets);
• Hypopotassemia, including surdokardialny (cardioclassroom) syndrome (for granules);
• Hypersensitivity to a klaritromitsin, other macroleads and to any of drug components.

In II and III trimesters of pregnancy Klabaks's use is possible only a case of considerable exceeding of estimated advantage for mother over potential risk for a fruit.

If it is necessary to accept drug during a lactation, for this period breastfeeding should be stopped.

Data on safety and efficiency of use of a klaritromitsin at children's age up to 6 months at the moment are not enough.

Route of administration and dosage

Tablets, film coated
Pill should be taken entirely (not to crush, not to chew), washing down with liquid. Meal practically does not influence drug absorption, but can slow down this process slightly.

The recommended dosing mode for children of 12 years and adults: 250 mg 2 times a day, as necessary at heavy infections are allowed increase in a dose to 500 mg 2 times a day, a course of therapy from 5 to 14 days.

At an ulcer of a duodenum of Klabaks accept as a part of an antikhelikobakterny course of therapy 500 mg 2 or 3 times a day within 7-10 days.

At patients with a heavy renal failure it is necessary to carry out dose adjustment depending on the clearance of creatinine (CC). At KK to 30 ml/min.: moderately heavy infections – 250 mg of 1 times a day; heavier – 250 mg 2 times a day.

For treatment of the infections caused by Mycobacterium avium, drug is accepted on 500 mg by 2 times a day.

For children of 6-12 years the daily dose of 15 mg/kg/days divided into 2 receptions, each 12 h within 5-10 days is recommended.

Granules for preparation of suspension for intake
Suspension is intended for oral administration, is preferential at children (in connection with a possibility of careful dosing).

The recommended duration of a course of therapy depends on weight of a condition of the patient and a species of pathogenic microflora, and makes from 5 to 10 days.

The recommended daily dose of Klabaks in suspension in doses of 125 mg / 5 ml and 250 mg / 5 ml for children, at the rate of 7,5 mg/kg twice a day:

• From 1 to 2 years (weight of 8-11 kg): 125 mg / 5мл – 2,5 ml; 250 mg / 5мл – 1,25 ml (62,5 mg);
• From 3 to 6 years (weight of 12-19 kg): 125 mg / 5мл – 5,0 ml; 250 mg / 5мл – 2,5 ml (125 mg);
• From 7 to 9 years (weight of 20-29 kg): 125 mg / 5мл – 7,5 ml; 250 mg / 5мл – 3,75 ml (187,5 mg);
• From 10 to 12 years (weight of 30-40 kg): 125 mg / 5мл – 10 ml; 250 mg / 5мл – 5 ml (250 mg).

Over 500 mg twice a day кларитромицин are allowed to be accepted only at therapy of serious infections.

Children till 1 year and with body weight accept less than 8 kg of Klabaks twice a day in a dose at the rate of 7,5 mg/kg.

The bottle with granules before preparation of suspension should be stirred up accurately until granules do not begin to move freely.

To prepare suspension for intake, it is necessary to add boiled chilled water to a tag on a bottle and to stir up it before receiving homogeneous yellow-white suspension.

Side effects

• Central Nervous System (CNS): confusion of consciousness, dizziness, sensation of fear, nightmares, sleeplessness;
• Alimentary system: abdominal pain, diarrhea, nausea, vomiting, glossitis, stomatitis; seldom – pseudomembranous colitis; in some cases – cholestatic jaundice, increase in activity of enzymes of a liver;
• Allergic reactions: anaphylactic answers, small tortoiseshell; in some cases – Stephens-Johnson's syndrome;
• Another: temporary change of flavoring feelings.

Symptoms of overdose are diarrhea, nausea, vomiting. Treatment of a state: a gastric lavage, the supporting symptomatic therapy.

Special instructions

Antibioticotherapia changes normal intestinal microflora therefore there is a probability of development of the superinfection caused by microorganisms, resistant to a klaritromitsin.

Antibiotics from group of macroleads have cross resistance.

Heavy persistent diarrhea can be a symptom of pseudomembranous colitis.

In case of simultaneous use of a klaritromitsin with theophylline, digoxin, lovastatiny, carbamazepine, simvastatiny, midazolam, Phenytoinum, triazolamy, cyclosporine and alkaloids of an ergot control of concentration of these substances in a blood plasma is necessary.

It is periodically recommended to control a prothrombin time at the patients receiving along with klaritromitsiny warfarin or other peroral anticoagulants.

Medicinal interaction

Mutual influence of the following substances / drugs and a klaritromitsin at simultaneous use:

• Astemizol, цизаприд: кларитромицин, oppressing activity of an isoenzyme of CYP3A4, slows down the speed of their metabolism, increasing thereby an interval of QT and increasing risk of development of ventricular arrhythmia in the pirouette type;
• Atorvastatin: moderately its concentration in a blood plasma increases, increasing risk of development of a myopathy;
• Warfarin: strengthening of its anticoagulating action and, as a result, growth of risk of bleedings is possible;
• Digoxin: possibly essential increase in its concentration in a blood plasma with development of glikozidny intoxication;
• Disopyramidum: there is a probability of increase in its concentration in a blood plasma as a result of inhibition of metabolism of Disopyramidum in a liver under the influence of a klaritromitsin owing to what prolongation of an interval of QT, development of disturbances of a cordial rhythm in the pirouette type, growth of secretion of insulin and a hypopotassemia is possible;
• Zidovudine: a little its bioavailability decreases;
• Itrakonazol, carbamazepine, cyclosporine: their concentration in a blood plasma increases, strengthening of side effects is possible;
• Colchicine: there are data on the life-threatening heavy toxic reactions which are result of its action;
• Lansoprazol: stomatitis, a glossitis, coloring of language in dark color are possible;
• Methylprednisolonum: reduction of its clearance;
• Midazolam: increase in its concentration in a blood plasma, strengthening of effects;
• Omeprazol: considerably its concentration increases and slightly concentration of a klaritromitsin in a blood plasma increases;
• Pimozidum: its concentration in a blood plasma increases, there is a risk of development of heavy cardiotoxic effect;
• Prednisonum: there are reliable data about development of psychosis and acute mania;
• Ritonavir: possibly significant increase in concentration of a klaritromitsin, at the same time considerably decreases concentration of its metabolite – a 14-gidroksiklaritromitsin;
• Rifabutin: its concentration in a blood plasma increases, increasing risk of development of a uveitis; concentration of a klaritromitsin in a blood plasma decreases;
• Rifampicin: in a blood plasma concentration of a klaritromitsin considerably decreases;
• Sertraline: there is a probability of development of a serotoninovy syndrome;
• Theophylline: increase in its concentration in a blood plasma is possible;
• Terfenadin: reduction in the rate of metabolism of a terfenadin and increase in its concentration in a blood plasma is probable (can serve as the reason of increase in an interval of QT and increase in risk of development of ventricular arrhythmia in the pirouette type);
• Tolbutamidum: development of a hypoglycemia is probable;
• Phenytoinum: increase in its concentration in a blood plasma, increase in risk of development of toxic effect is possible;
• Fluoxetine: there are reliable data about development of toxic effects;
• Ergotamine, dihydroergotamine: there are data on strengthening of their side effect.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature not above 25 °C.

Period of validity – 2 years.

Ready suspension should be held in densely closed container, not to freeze, not to store in the refrigerator, not to use longer than 2 weeks.