Biseptol is an antibacterial sulfa drug.
Release form and composition
Make Biseptol tablets containing the active substances:
- Sulfamethoxazole (100 or 400 mg);
- Trimethoprim (20 or 80 mg).
Auxiliary substances of the drug are propylene glycol, methyl parahydroxybenzoate, potato starch, polyvinyl alcohol, talc, magnesium stearate, propyl parahydroxybenzoate.
In blister packs of 20 tablets.
Biseptol is also manufactured as an oral suspension containing 200 mg of sulfamethoxazole and 40 mg of trimethoprim. Suspension aids include sodium carboxymethylcellulose, magnesium aluminum silicate, strawberry flavor, purified water, propylene glycol, citric acid monohydrate, propyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium hydrogen phosphate, sodium saccharinate, maltitol, cremophor RH 40.
In dark glass bottles of 80 ml.
Indications for use
According to the instructions, Biseptol is indicated for the treatment of infectious and inflammatory diseases, such as:
- Otitis, sinusitis;
- Pneumonia, bronchitis, empyema, lung abscess;
- Prostatitis, urethritis, pyelonephritis, salpingitis;
- Pyoderma, furunculosis;
- Cholera, bacterial dysentery, diarrhea, typhoid fever.
According to the instructions, Biseptol is contraindicated in:
- Severe renal failure;
- Established damage to the liver parenchyma;
- Pregnancy and breastfeeding;
- Severe renal dysfunction in the absence of the ability to control the plasma level of the drug;
- Hyperbilirubinemia in children;
- Severe blood diseases (agranulocytosis, anemia caused by a lack of folic acid, megaloblastic, aplastic anemia, and also leukopenia caused by a deficiency of vitamin B12);
- Children under 3 years old (for tablets);
- Children under 2 months (for suspension)
- Hypersensitivity to sulfonamides;
- Hypersensitivity to active or auxiliary components of the drug;
- Deficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis).
In the application of Biseptol should be careful when:
- Bronchial asthma;
- Deficiency of folic acid in the body;
- Pathologies of the thyroid gland.
Dosing and Administration
Biseptol tablets are taken orally after a meal, drinking half a glass of water.
Children aged 3-5 years, the drug is prescribed in a dose of 240 mg 2 times a day. Children from 6 to 12 years old and adults - 480 mg 2 times a day.
In pneumonia, Biseptol is indicated at a dose of 100 mg per kg of body weight per day. The interval between taking the medication should not be less than 6 hours, the maximum duration of therapy is 2 weeks.
Suspension Biseptol is taken orally after a meal, drinking plenty of liquids.
Children from 12 years old and adults are prescribed 960 mg of suspension every 12 hours. In the case of severe infection, the dose may be increased to 1440 mg every 12 hours. The duration of treatment is from 5 to 14 days.
Children at the age of 2-5 months are prescribed 120 mg of the suspension every 12 hours, from 6 months to 5 years - 240 mg each, at the age of 6-12 years - 480 mg In this case, the duration of therapy should not exceed 10 days. If a week after the start of Biseptol is not observed, there is no clinical improvement, you should contact your doctor for alternative therapy.
The use of Biseptol may cause the following side effects:
- Respiratory system: choking, bronchospasm, cough, pulmonary infiltrates;
- Central and peripheral nervous systems: dizziness, headache, tremor, aseptic meningitis, apathy, peripheral neuritis, depression;
- Blood formation system: thrombocytopenia, neutropenia, leukopenia, agranulocytosis, aplastic, hemolytic, megaloblastic anemia, methemoglobinemia, hypothrombinemia, eosinophilia;
- Urinary system: toxic nephropathy, accompanied by anuria and oliguria, polyuria, renal failure, interstitial nephritis, increased urea levels, hematuria, crystalluria, hypercreatininemia;
- Digestive system: nausea and vomiting, abnormal stool, abdominal pain, loss of appetite, cholestasis, stomatitis, glossitis, increased liver enzymes, hepatitis, hepatonecrosis, pancreatitis, pseudomembranous enterocolitis;
- Musculoskeletal system: myalgia, arthralgia;
- Allergies: skin rash, itching, urticaria, photosensitization, erythema multiforme, allergic myocarditis, exfoliative dermatitis, allergic dermatitis, fever, toxic epidermal necrolysis;
- Metabolism: hyperkalemia, hypoglycemia, hyponatremia.
Biseptol should be used with caution in patients with allergic history.
During long courses of therapy, the patient should regularly examine the blood for the likelihood of hemolytic changes. As a rule, these changes quickly pass after the appointment of folic acid, which does not violate the antimicrobial activity of the drug.
When applying Biseptol, prolonged exposure to the sun should be avoided.
In AIDS patients, the risk and severity of side effects of Biseptol increases.
Biseptol should not be prescribed for the treatment of pharyngitis and tonsillitis caused by beta-hemolytic streptococcus group A due to the widespread prevalence of resistance strains.
Medicaments similar in therapeutic action to Biseptol are:
Terms and conditions of storage
According to the instructions, Biseptol should be stored in a cool, dark, out of reach of children. The shelf life of the drug is 5 years from the date of issue.