Bee-sept-Pharmak

General characteristics. Structure:

Active ingredient: co-trimoxazole;

1 tablet contains sulfamethoxazole 400 mg, Trimethoprimum of 80 mg;

excipients: lactose, monohydrate; sodium lauryl sulfate; povidone; silicon dioxide colloid anhydrous; sodium of a kroskarmeloz; magnesium stearate.

Pharmacological properties:

Pharmacodynamics. Би-сепТ-Фармак® - the combined antibacterial drug which contains sulfamethoxazole (sulfonamide with an average duration of action) and Trimethoprimum. Both components of drug affect one chain of biochemical reactions (sulfamethoxazole slows down inclusion of paraaminobenzoic acid in recycling of folic acid, and Trimethoprimum is inhibitor of reductase of dihydrofolic acid) that leads to strengthening of antibacterial action and slower development of bacterial resistance. Би-сепТ-Фармак® in vitro concerning Escherichia coli (including against enteropathogenic strains), indolopositive strains of Proteus spp is active. (R. is also relative vulgaris), Morganella morganii, Moraxella catarrhalis, Klebsiella spp., Proteus mirabilis, Enterobacter spp., Haemophilus ducreyi, Haemophilus influenzae, Brucella spp., Shigella flexneri, Shigella sonnei; Streptococcus pneumonae, Streptococcus spp., Staphylococcus spp., Listeria monocytogenes, Nocardia asteroides. Би-сепТ-Фармак® it is active also in relation to Toxoplasma gondii, Pneumocystis carinii. Drug does not affect viruses and activators of fungus diseases.

Pharmacokinetics. Both components of drug are quickly soaked up in a digestive tract. The maximum concentration in a blood plasma are noted in 2 - 4 hours after use; therapeutic concentration of drug in a blood plasma and fabrics remain for 12 hours. Trimethoprimum contacts proteins of a blood plasma for 70%, and sulfamethoxazole - for 44 - 62%. High concentration of Trimethoprimum is defined in a secret of bronchial glands, a prostate and in bile. Concentration of sulfamethoxazole in liquids of an organism is slightly lower. Both connections in high concentration appear in a phlegm, vulval allocations and in liquid of a middle ear; the volume of distribution of sulfamethoxazole makes 0,36 l/kg, Trimethoprimum – 2 l/kg. Half-life in a blood plasma makes respectively 10 hours for sulfamethoxazole and 8 - 10 hours for Trimethoprimum. For 72 hours also 66,8% of Trimethoprimum are removed with urine of 84,5% of the accepted dose of sulfamethoxazole.

Pharmaceutical characteristics.

Main physical and chemical properties: tablets of white or almost white color, with a flat surface, risky and a facet. It is allowed to put on the one hand tablets a text of "Bs".

Indications to use:

The infections of urinary tract caused by strains of Escherichia coli, Klebsiella spp, sensitive to drug., Enterobacter spp., Morganella morganii, Proteus mirabilis, Proteus vulgaris;

the infections of a digestive tract caused by sensitive strains of Shigella flexneri, Shigella sonnei (bacterial dysentery);

pneumonia (treatment and the prevention) caused by Pneumocystis carinii (bacteriological confirmed);

the exacerbation of chronic bronchitis at adults caused sensitive to the drug Haemophilus influenzae, Streptococcus pneumonіae;

the acute average otitis at children caused sensitive to the drug Haemophilus influenzae, Streptococcus pneumonіae;

toxoplasmosis at adults;

the diarrhea of travelers at adults caused by Escherichia coli.

Route of administration and doses:

Apply inside to adults and children 6 years are more senior. Accept in time or after food, washing down with enough liquid.

Adults and demi are more senior than 12 years.

For treatment of an inflammation of urinary tract, the infections of a digestive tract caused by Shigella of exacerbations of chronic bronchitis the average peroral dose makes 2 tablets 2 times a day.

At an inflammation of urinary tract drug is accepted within 10-14 days, at an exacerbation of chronic bronchitis - 14 days, at the infections of a digestive tract caused by Shigella - 5 days.

At diarrhea of the traveler take 2 pill each 12 hours before disappearance of symptoms.

For treatment of a toxoplasmosis of Bi-sept-Pharmak® appoint the adult on 2-3 таб. 2 rubles/days. Duration of a course of treatment – 2-4 weeks, if necessary are possible to repeat the cycle in 7 days.

For treatment of the pneumonia caused by Pneumocystis carinii and bacteriological confirmed the offered daily dose makes 90-120 mg/kg of body weight, divided into equal single doses which should be accepted each 6 h within 14-21 days.

For prevention of pneumocystic pneumonia (at persons from risk group) take 2 pill of 1 times a day within 7 days.

The daily dose should not exceed 4 tablets (1920 mg).

At patients with clearance of creatinine of 15-30 ml/min. the dose needs to be reduced half. If clearance of creatinine less than 15 ml/min., use of drug are not shown.

Children aged from 6 up to 12 years.

For treatment of an inflammation of urinary tract, the infections of a digestive tract caused by Shigella, acute average otitis - 1 tablet 2 times a day.

At an inflammation of urinary tract and acute average otitis drug is accepted within 10 days, at the infections of a digestive tract caused by Shigella - 5 days.

For treatment of the pneumonia caused by Pneumocystis carinii and bacteriological confirmed the offered daily dose makes 90-120 mg/kg of body weight, divided into equal single doses which should be accepted each 6 h within 14-21 days.

Features of use:

Use during pregnancy or feeding by a breast.

Contraindicated.
Children.

It is not recommended to appoint Bi-sept-Pharmak® to children under 6 years in this dosage form.

Special security measures. If throughout treatment of Bi-sept-Pharmak® there are symptoms which indicate a possibility of complications, in particular rash, a pharyngalgia, the increased body temperature, joint pains, cough, short wind, jaundice, disturbance of an urination, hypostases, a back pain, it is necessary to stop drug use.

At a renal failure it is necessary to carry out dose adjustment of Bi-sept-Pharmak®. Drug should not be used for treatment of β-hemolitic streptococcal tonsillitis.

At patients of advanced age the risk of emergence of heavy undesirable effects of Bi-sept-Pharmak® increases (damage of kidneys or a liver, heavy skin reactions, block). The patients with AIDS accepting Bi-sept-Pharmak® have such symptoms as rash, fervescence, a leukopenia, increase in levels of aminotransferases, a hypopotassemia and a hyponatremia more often. It is necessary to appoint with care drug to patients with heavy abnormal liver functions or kidneys, the deficit of folic acid (for example, to elderly people, persons with alcohol addiction; using anticonvulsant drugs; with a sprue), with heavy allergic reactions, to patients with bronchial asthma, and also patients with reduced activity of enzyme glyukozo-6-fosfatdegidrogenazy.

It is regularly necessary to control function of a liver, kidneys and a blood picture at long use of Bi-sept-Pharmak®.

For the warning of a crystalluria and obstruction of renal tubules to patients it is necessary to increase the liquid use.

During treatment, in connection with risk of development of a photosensitization, it is necessary to avoid insolation.

Ability to influence speed of response at control of motor transport or work with other mechanisms. When developing dizziness patients should abstain from control of motor transport and work with other mechanisms.

Side effects:

Drug is usually well transferred, side reactions arise seldom and are poorly expressed.

From a nervous system: headache, dizziness, ataxy, sudorg; in some cases - aseptic meningitis or meningeal symptomatology; uveitis, hallucinations, neuropathy (peripheral neuritis, paresteziya).

From respiratory system: separate cases of pulmonary infiltrates.

From the alimentary system: nausea, vomiting, diarrhea, stomatitis, increase in activity of "hepatic" transaminases and content of bilirubin, hepatitis, acute pancreatitis (against the background of a serious illness or AIDS), it is rare - a pseudomembranous coloenteritis.

From bodies of a hemopoiesis: leukopenia, neutropenia, thrombocytopenia; very seldom there can be an agranulocytosis, megaloblastny, hemolitic or aplastic anemias, a methemoglobinemia, pancytopenia or purpura.

From an urinary system: in isolated cases the content of nitrogen and concentration of urea, blood creatinine can increase; intersticial nephrite, renal failure; crystalluria. In the presence at the sick hypostases caused by cardiovascular pathology increase in a daily urine is possible.

From a musculoskeletal system: seldom - an arthralgia, a mialgiya, рабдомиолиз.

Allergic reactions: itch, photosensitization, multiformny exudative erythema (including Stephens-Johnson's syndrome), toxic epidermal necrolysis (Lyell's disease) and Shenleyn-Genokh's purpuras, allergic myocarditis, hyperthermia, Quincke's disease. Metabolism: development of a hyperpotassemia in patients with a renal failure, with the broken potassium exchange or in cases of simultaneous use of drugs which provoke a hyperpotassemia is possible; a hypoglycemia or a hyponatremia at a renal failure, liver diseases, a hyponutrient.

Others: development of fungal infections.

Frequency and manifestation of side reactions at patients with AIDS are much higher in comparison with other patients.

Interaction with other medicines:

At patients of advanced age simultaneous use of Bi-sept-Pharmak® with digoxin can increase its concentration, and with some diuretics, in particular tiazida, increases risk of development of thrombocytopenia.

Би-сепТ-Фармак® can strengthen effect of indirect anticoagulants, strengthens hypoglycemic effect of sulfonamides that demands reduction of a dose of these drugs. Би-сепТ-Фармак® slows down metabolism of Phenytoinum owing to what action of Phenytoinum is prolonged. Би-сепТ-Фармак® can strengthen action of a methotrexate, dipheninum, barbiturates, non-steroidal anti-inflammatory drugs; to increase cyclosporine level in a blood plasma, increasing its nephrotoxicity.

At use of Bi-sept-Pharmak® with ascorbic acid the risk of development of a crystalluria increases.

Contraindications:

Hypersensitivity to drug components. Liver and/or renal failure (clearance of creatinine less than 15 ml/min.). Aplastic anemia. B12 – scarce anemia. Megaloblastny foliyevodefitsitny anemia. Agranulocytosis, leukopenia. Deficit glyukozo-6-fosfatdegidrogenazy. A hyperbilirubinemia at children. Bronchial asthma. Diseases of a thyroid gland. Pregnancy and period of feeding by a breast.

Overdose:

At acute overdose of drug lack of appetite, nausea, vomiting, a headache, drowsiness, a loss of consciousness is observed. In case of overdose of drug it is necessary to stop its reception, to wash out a stomach or to cause vomiting, to accept a large amount of liquid, in case of need to carry out a symptomatic treatment. At chronic overdose hemopoiesis function oppression (thrombocytopenia, a leukopenia) is observed. In that case appoint фолинат calcium in a dose 5 - 15 mg/days.

Storage conditions:

Period of validity. 3 years. Not to use drug after the termination of the period of validity specified on packaging. To store in the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 20 tablets in the blister enclosed in a pack.