Фромилид® uno

General characteristics. Structure:

Active ingredient: 500 mg of a klaritromitsin.

Excipients: sodium alginate, sodium calcium alginate, lactoses monohydrate, povidone, polysorbate 80, silicon dioxide colloid anhydrous, magnesium stearate, talc, gipromelloza, dye quinolinic yellow (Е 104), titanium dioxide (E171), propylene glycol.

Antibiotic with a wide range of bacteriostatic and antibacterial action.

Pharmacological properties:

Pharmacodynamics. Klaritromitsin is a semi-synthetic antibiotic from group of macroleads. It inhibits synthesis of protein in a microbic cell, generally has bacteriostatic action; also bactericidal action. Microorganisms sensitive to a kleritromitsin: Mycoplasmapneumoniae, Legionellapneumophila, Chlamydiatrachomatis and S. of pneumoniae, Ureaplasmaurealyticum; gram-positive microorganisms (streptococci and staphylococcus, Listeriamonocytogenes, Corynebacteriumspp.); gram-negative microorganisms (Haemophilusinfluenzaei Hducreyi, Moraxellacatarrhalis, Bordetellapertussis, NeisseriagonorrhoeaevlN. meningitidis, Borreliaburgdorferi, Pasteurellamultocida, Campylobacterspp. and Helicobacterpylori); some anaerobe bacterias (Eubacteriumspp., Peptococcusspp., Propionibacteriumspp., Clostridiumperfringensi Bacteroidesmelaninogenicus); Toxoplasmagondiii all mycobacteria, except for M. tuberculosis.

Pharmacokinetics. Klaritromitsin is well soaked up from digestive tract. Food slows down absorption, but does not influence significantly bioavailability of a klaritromitsin. About 20% of a klaritromitsin are immediately metabolized in 14-hydroxy-klaritromitsin having the expressed activity concerning Haemophilusinfluenzae. Klaritromitsin easily gets into fabrics and liquids of an organism where reaches concentration almost by 10 times exceeding concentration in serum. The elimination half-life after reception of a dose of 250 mg makes from 3 to 4 hours; after reception of a dose of 500 mg - from 5 to 7 hours. From 20 to 30% of a klaritromitsin (40% at suspension reception) are removed in not changed view with urine, other part is removed in the form of metabolites.

Absorption of a klaritromitsin from tablets of the prolonged action - is slowed down, but is equivalent to absorption from tablets of immediate action in equal doses. Time of achievement of the maximum concentration increases. After achievement of the maximum concentration the kinetics of both forms of a klaritromitsin (tablets of immediate action and tablets of the prolonged action) is equivalent. Equilibrium concentration is reached by 3rd day. Bioavailability of tablets with the prolonged action is 30% lower, at reception on an empty stomach therefore patients have to take the prolonged form of a klaritromitsin during food. Drug of the prolonged form is not recommended to patients with a heavy renal failure, clearance of creatinine less than 0,5 ml / page. To these patients it can be appointed кларитромицин, tablets with immediate release.

Indications to use:

Drug is intended for treatment of infections of upper parts of respiratory tracts (tonzillofaringit, acute sinusitis), average otitis, infections of lower parts of respiratory tracts, infections of skin and soft tissues, infections caused by mycobacteria (M. avium complex, M. of kansasii, M. of marinum, M. of leprae), and also for treatment of other infectious and inflammatory diseases caused by microorganisms, sensitive to drug.

Klaritromitsin is shown for an eradikation of H.pylori and decrease in frequency of a recurrence of an ulcer of a duodenum as a part of a combination therapy.

Route of administration and doses:

Tablets should not be broken. They should be swallowed entirely, washing down with a small amount of liquid. Administration of drug is recommended during food.

To adults and children 12 years are aged more senior appoint on  1 tablet of Fromilid uno 500 mg each 24 hours. For treatment of heavy infections a daily dose each 24 hours increase to 2 tablets 500 mg.

The course of treatment usually proceeds within 7-14 days.

Features of use:

 In the presence of chronic diseases of a liver it is necessary to carry out regular control of enzymes of blood serum. With  care  appoint    against the background of  the drugs  which are metabolized  a liver (it is recommended to measure their concentration in blood). In case of joint appointment with warfarin or other indirect anticoagulants it is necessary to control a prothrombin time. It is necessary to pay attention to a possibility of cross stability between klaritromitsiny  and  other   antibiotics   from   group  of macroleads,     and also lincomycin and clindamycin. In case of heavy, persistent diarrhea which can indicate pseudomembranous colitis, it is necessary to interrupt administration of drug and to consult at the attending physician.

Use of drug during the periods of pregnancy and a lactation is possible only in that case when the estimated advantage for mother exceeds potential risk for a fruit. Klaritromitsin is allocated with breast milk therefore in need of purpose of drug in the period of a lactation it is necessary to stop breastfeeding.

Drug does not exert impact on the speed of psychomotor reactions of the patient during the driving or work with mechanisms.

Side effects:

Nausea, vomiting, diarrhea and pain in a stomach belong to side effects. In case of heavy and persistent diarrhea, pseudomembranous colitis which can be noted in certain cases drug should be cancelled. Also stomatitis, a glossitis, a headache, hypersensitivity reactions (urticaria, an anaphylaxis, very seldom Stephens's syndrome - Johnson), passing change of flavoring feelings, disturbances can be noted from the central nervous system at certain patients (dizziness, confusion of consciousness, sensation of fear, sleeplessness, nightmares). At most of patients by-effects of weak intensity. Increase in activity of enzymes of a liver and cholestatic jaundice are very seldom noted. In case of side effects it is necessary to consult at the doctor. At treatment klaritromitsiny, as well as when using other macroleads,  lengthening an interval of QT, ventricular arrhythmia, including a ventricular Bouveret's disease and trembling or ventricular fibrillation was extremely seldom observed.

Interaction with other medicines:

Klaritromitsin is metabolized in a liver where he can inhibit effect of enzymes of a complex of R-450 cytochrome. At simultaneous treatment klaritromitsiny and other drugs which are metabolized by means of this system, concentration of the last can raise and cause by-effects. Therefore терфенадин, цисаприд,      or   астемизол      it is not necessary   to appoint Pimozidum      during   treatment klaritromitsiny because of threat of development of life-threatening arrhythmias.

It is necessary to control periodically a prothrombin time at the patients receiving кларитромицин along with warfarin or other peroral anticoagulants. Co-administration of a klaritromitsin and zidovudine reduces absorption of a zidovudine. Co-administration of a ritonavir and klaritromitsin leads to substantial increase of level of maintenance of a klaritromitsin in serum and to considerable decrease in level of maintenance of its metabolite of a 14-gidroksiklaritromitsin in serum.

Contraindications:

Drug    should not  be accepted  the patient  with  hypersensitivity  to a klaritromitsin or other antibiotics from group of macroleads. As drug is metabolized generally in a liver, it is not necessary to appoint it the patient with a liver failure of heavy degree, hepatitis (in the anamnesis), a porphyria and in 1 trimester of pregnancy. Klaritromitsin it is not necessary to appoint the patient receiving терфенадин, цисаприд, Pimozidum or астемизол.

Overdose:

Development of symptoms from digestive tract (nausea, vomiting, diarrhea) is probable; headache, confusion of consciousness.

At overdose the immediate gastric lavage and a symptomatic treatment is necessary. The hemodialysis and peritoneal dialysis do not lead to considerable change of level of a klaritromitsin in blood serum.

Storage conditions:

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

Issue conditions:

According to the recipe

Packaging:

Tablets, the prolonged action, 500 mg. On 5 or 7 tablets in the blister. Or 1 or 2 blisters (on 7 tablets) place 1 blister (on 5 tablets) in a cardboard pack together with the application instruction.