Biseptol, 240mg/5ml suspension, 80ml

Composition

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of 5 ml contains:

Active ingredients:

sulfamethoxazole 200 mg

trimethoprim 40 mg

Auxiliary substances:

macrogol glyceryl hydroxystearate,

magnesium aluminosilicate,

sodium carmellose,

citric acid monohydrate,

methyl hydroxybenzoate,

propyl hydroxybenzoate,

sodium saccharinate,

sodium hydrophosphate dodecahydrate,

maltitol,

strawberry flavor,

propylene glycol,

purified water.

Pharmacological action

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

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

It is 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.

Indications

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

Contraindications

– severe disturbances of liver function;– severe renal dysfunction (CC less than 15 ml/min);– violations of the hematopoietic system; severe cardiovascular disease;– 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 some cases – reversible thrombocytopenia, leukopenia, neutropenia, agranulocytosis, megaloblastic anemia.

From the urinary system:  rarely-hematuria, nephritis.

From the central nervous system:  in some cases – headache, depression, dizziness.

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

Interaction

When used concomitantly, trimethoprim enhances the effect of hypoglycemic agents – sulfonylurea derivatives.

When Biseptol is co-administered 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.

How to take, course of use and dosage

The drug is prescribed at a dose of 6 mg of trimethoprim and 30 mg of sulfamethoxazole per 1 kg of body weight/day. Children from 3 to 6 months – 2.5 ml every 12 hours

for children from 7 months to 3 years 2.5-5 ml every 12 cdmam from 4 to 6 years – 5-10 ml every 12 hours

for children between 7 to 12 years – 10 ml every 12 vzroslye and children over 12 years: 20 ml every 12 hours

The duration of therapy is 10-14 days (with shigellosis-5 days). For infections caused by Pneumocystis carinii, the dose is 120 mg / kg of body weight per day; the drug is taken every 6 hours for 14-21 days.

When prescribing the drug to patients with impaired renal function (creatinine clearance 15-30 ml / min) the dose should be halved.

Overdose

Symptoms:  nausea, vomiting, blurred vision.

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

Special instructions

Caution should be exercised when prescribing Biseptol to patients with impaired liver and/or kidney function, with a history of allergic reactions, with 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 strep throat.

Adequate fluid intake should be ensured during Biseptol treatment due to the risk of crystalluria and urolithiasis.

When determining creatinine levels using alkaline Jaffe picrinate while taking Biseptol, it should be borne in mind that the result may be 10% higher than the true one.

Monitoring of laboratory parameters

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

Storage conditions

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

Active ingredient

Co-trimoxazole Sulfamethoxazole, Trimethoprim

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Description

Children older than 2 months, Children as prescribed by a doctor

Indications

Boils, Otitis media, Salmonellosis, Pneumonia, Infectious diseases, Prostatitis, Bronchitis, Urethritis