Biseptol tablets 400 mg/80 mg blister 20 pcs.

Active ingredients: sulfamethoxazole, trimethoprim (co-trimoxazole);

1 tablet of 100 mg / 20 mg contains sulfamethoxazole 100 mg, trimethoprim 20 mg;

1 tablet 400 mg / 80 mg contains sulfamethoxazole 400 mg trimethoprim 80 mg;

Excipients: potato starch, talc, magnesium stearate, polyvinyl alcohol.

• hypersensitivity to trimethoprim and sulfamethoxazole (including sulfonamide derivatives, sulfonylurea antidiabetic agents, as well as thiazide diuretics) and other components of the drug;
• acute hepatitis, liver dysfunction, severe liver failure, including diagnosed liver parenchymal damage, porphyria;
• blood diseases, hematopoiesis disorders, severe hematological disorders, megaloblastic anemia caused by folic acid deficiency, glucose-6-phosphate dehydrogenase deficiency (threat of hemolysis);
• severe renal failure, characterized by creatinine clearance less than 15 ml / minute, if it is not possible to determine the concentration of the drug in the blood plasma (except in cases of hemodialysis);
• the drug is contraindicated in patients undergoing chemotherapy;
• The drug should not be prescribed in combination with dofetilide.

Adults and children over 12 years of age. Usually the initial dose is two tablets 2 times a day (morning and evening). The tablets should be taken after meals, with plenty of liquid. In severe infections, higher daily doses may be prescribed – up to 3 tablets 2 times a day. For maintenance therapy lasting more than 14 days, it is recommended to take one tablet 2 times a day.

Children 6-12 years of age. The recommended daily dose for children is 6 mg of trimethoprim and 30 mg of sulfamethoxazole per kg of body weight. This dose should be divided into two doses.

The recommended daily dose for children aged 6 to 12 years is one tablet 2 times a day.

Duration of treatment: for acute infections, except gonorrhea, treatment should last at least 5 days or 2 more days after the symptoms of the disease disappear. A three-day course of treatment may be sufficient for women with uncomplicated acute cystitis. However, children with this disease are recommended to use the drug for 5-7 days.

Pregnant women

This drug should not be used during pregnancy and breastfeeding.

Children

The drug is used to treat children over 6 years of age.

Drivers

The drug does not cause a decrease in psychophysical activity and the ability to drive vehicles and operate machinery. If side effects from the nervous system develop during treatment (dizziness, headache, convulsions, nervousness, fatigue), which may cause a decrease in the speed of psychomotor reactions, you should avoid driving vehicles and working with complex mechanisms.

It is not known what dose of the drug can be life-threatening. In case of overdose of sulfonamides, there is a lack of appetite, colic-like pain, nausea, vomiting, diarrhea, dizziness, headache, drowsiness, loss of consciousness. Fever, hematuria and crystalluria may occur, in case of chronic overdose, bone marrow suppression and hepatitis may develop. In case of acute overdose of trimethoprim, nausea, vomiting, dizziness, headache, mental depression, confusion, bone marrow suppression may occur.

If symptoms of overdose appear, it is necessary to stop using the drug, induce vomiting, and drink plenty of fluids if diuresis is insufficient and kidney function is normal. Acidification of urine will accelerate the excretion of trimethoprim, but will increase the risk of sulfonamide crystallization in the kidneys. The patient’s blood count, serum electrolytes, and other biochemical parameters should be monitored. If bone marrow damage or symptoms of hepatitis appear, the usual treatment in such cases should be applied. Hemodialysis is ineffective. Peritoneal dialysis is ineffective.

In chronic poisoning, there is suppression of spinal cord function, manifested by thrombocytopenia, leukopenia, or megaloblastic anemia. In this case, leucovorin (5-15 mg per day) should be used.

The most frequent adverse reactions during treatment with the drug are from the digestive tract (nausea, vomiting, lack of appetite) and skin allergic reactions (rash, urticaria).

Zidovudine: in some cases, the simultaneous use of co-trimoxazole and zidovudine increases the risk of hematological disorders caused by Biseptol. If it is necessary to use co-trimoxazole and zidovudine simultaneously, blood parameters should be monitored.

Folinic acid: Supplementation with folic acid has been shown to affect the antimicrobial efficacy of trimethoprim-sulfamethoxazole. This has been observed in the prevention and treatment of pneumonia caused by Pneumocystis jiroveci.

Store at a temperature not exceeding 25°C.

Keep out of reach of children.

Shelf life – 5 years.