Biseptol, 240 mg/5 ml suspension 80 ml

Biseptol is a combined antibacterial drug with a broad spectrum of bactericidal action, whose mechanism is due to the blocking of folate biosynthesis in microbial cells.

Sulfamethoxazole disrupts the synthesis of dihydrofolic acid, and trimethoprim prevents the conversion of dihydrofolic acid to tetrahydrofolic acid.

Active against almost all groups of microorganisms – Gram-negative bacteria: Salmonella spp, Shigella spp., Neisseria spp., Proteus vulgaris, Vibrio cholerae, Yersinia spp., Escherichia coli, Corynebacterium spp.; Gram-positive bacteria: Staphylococcus spp. and others.

The drug is also sensitive Chlamydia spp., Actinomyces spp., Klebsiella spp.

Mycobacteria, viruses, most anaerobic bacteria are resistant to the drug.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
– respiratory tract infections (including bronchitis, pneumonia, lung abscess, pleural empyema);
– otitis, sinusitis;
– meningitis, brain abscess;
– infections of the genitourinary system (including pyelonephritis, urethritis, salpingitis, prostatitis);
– gonorrhea;
– gastrointestinal infections (including typhoid fever, paratyphoid fever, bacterial dysentery, cholera, diarrhea).

Pharmacological effect

Biseptol is a combined antibacterial drug with a wide spectrum of bactericidal action, the mechanism of which is due to blocking the biosynthesis of folates in microbial cells.

Sulfamethoxazole interferes with the synthesis of dihydrofolic acid, and trimethoprim prevents the conversion of dihydrofolic acid to tetrahydrofolic acid.

Active against almost all groups of microorganisms – gram-negative bacteria: Salmonella spp., Shigella spp., Neisseria spp., Proteus vulgaris, Vibrio cholerae, Yersinia spp., Escherichia coli, Corynebacterium spp.; gram-positive bacteria: Staphylococcus spp. and others.

Chlamydia spp., Actinomyces spp., Klebsiella spp. are also sensitive to the drug.

Mycobacteria, viruses, and most anaerobic bacteria are resistant to the drug.

Special instructions

Caution must be exercised when prescribing Biseptol to patients with impaired liver and/or kidney function, a history of allergic reactions, folic acid deficiency, and elderly patients.

The appearance of a skin rash or severe diarrhea is an indication for discontinuation of the drug.

Biseptol is not indicated for the treatment of sore throat caused by streptococcus.

During treatment with Biseptol, adequate fluid intake should be ensured due to the risk of developing crystalluria and urolithiasis.

When determining the level of creatinine using alkaline Jaffe picrinate while taking Biseptol, it should be taken into account that the result may be 10% higher than the true one.

Control of laboratory parameters

With prolonged use of the drug, it is necessary to monitor the peripheral blood picture.

Active ingredient

Co-trimoxazole [Sulfamethoxazole, Trimethoprim]

Composition

5 ml contains:

Active substances:

sulfamethoxazole 200 mg

trimethoprim 40 mg

Excipients:

macrogol glyceryl hydroxystearate,

magnesium aluminum silicate,

carmellose sodium,

citric acid monohydrate,

methylhydroxybenzoate,

propylhydroxybenzoate,

sodium saccharinate,

sodium hydrogen phosphate dodecahydrate,

maltitol,

strawberry flavoring,

propylene glycol,

purified water.

Contraindications

– severe liver dysfunction;
– severe renal dysfunction (creatinine clearance less than 15 ml/min);
– disorders of the hematopoietic system;
– severe diseases of the cardiovascular system;
– deficiency of glucose-6-phosphate dehydrogenase;
– pregnancy;
– children’s age up to 3 months;
– hypersensitivity to the components of the drug.

Side Effects

From the digestive system: rarely – nausea, vomiting, diarrhea; in isolated cases – pseudomembranous colitis, cholestatic hepatitis.

Allergic reactions: in isolated cases – Stevens-Johnson syndrome, Lyell’s syndrome.

From the hematopoietic system: in isolated cases – reversible thrombocytopenia, leukopenia, neutropenia, agranulocytosis, megaloblastic anemia.

From the urinary system: rarely – hematuria, nephritis.

From the side of the central nervous system: in isolated cases – headache, depression, dizziness.

Side effects are usually mild and reversible after discontinuation of the drug.

Interaction

With simultaneous use, trimethoprim enhances the effect of hypoglycemic agents – sulfonylurea derivatives.

When Biseptol is used together with thiazide diuretics, the risk of thrombocytopenia and increased bleeding increases.

Co-trimoxazole enhances the anticoagulant effect of warfarin and the anticonvulsant activity of phenytoin.

When used together, rifampicin reduces the half-life of trimethoprim.

The combined use of Biseptol and cyclosporine after kidney transplantation worsens the patient’s condition.

Overdose

Symptoms: nausea, vomiting, clouding of consciousness.

Treatment: discontinuation of the drug, gastric lavage (no later than 2 hours after taking the drug), drinking plenty of fluids, forced diuresis, taking calcium folinate (5-10 mg/day).

Storage conditions

Store in a dry place, protected from light and out of reach of children.

Manufacturer

Medana Pharma, Poland