BISEPTOL SUSPENSION BOTTLE 80ML

Active ingredient and dosage form

Oral suspension white or light cream color with a strawberry smell.
5 ml of suspension contains sulfamethoxazole 200 mg, trimethoprim 40 mg;
Excipients: cremophor RH 40, Magnesium aluminum silicate, sodium carboxymethyl cellulose, citric acid, sodium hydrogen phosphate, methyl hydroxybenzoate, propyl hydroxy benzoate, sodium saccharinate, maltitol, strawberry flavor, propylene glycol, purified water.
in dark glass bottles of 80 ml; in a carton pack 1 bottle (a measure with a scale is attached to the package)

Mechanism of 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 disrupts the synthesis of dihydrofolic acid, and trimethoprim prevents the conversion of dihydrofolic acid to tetrahydrofolic acid.
Active for 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.
To the drug also sensitive Chlamydia spp., Actinomyces spp., Klebsiella spp.
To drug are resistant mycobacteria, viruses, most anaerobic bacteria.

Indications and usage

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, abscess of the brain;
- infections of the genitourinary system (including pyelonephritis, urethritis, salpingitis, prostatitis);
- gonorrhea;
- gastrointestinal infections (including typhoid fever, paratyphoid fever, bacterial dysentery, cholera, diarrhea);

- infections of the skin and soft tissues (including furunculosis, pyoderma).

Contraindications

- severe liver dysfunction;
- pronounced impaired renal function (CC less than 15 ml / min);
- violations 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 drug.

Dosage and administration

Suspension.
The drug is administered 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
children from 7 months to 3 years - 2.5-5 ml every 12 hours
children from 4 to 6 years - 5-10 ml every 12 hours
children from 7 to 12 years - 10 ml every 12 hours
adults and children over 12 years old - 20 ml every 12 hours

The duration of therapy is 10-14 days (with shigellosis - 5 days).
With 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 patients with impaired renal function (CC 15-30 ml / min) should reduce the dose by half.

Adverse reactions

Gastrointestinal: rarely - nausea, vomiting, diarrhea; in rare cases - pseudomembranous colitis, cholestatic hepatitis.
Allergic reactions: in isolated cases - Stevens-Johnson syndrome, Lyell's syndrome.
Hemic and lymphatic: in rare cases, reversible thrombocytopenia, leukopenia, neutropenia, agranulocytosis, megaloblastic anemia.
Urogenital: rarely - hematuria, nephritis.
From the side of the central nervous system: in rare cases - headache, depression, dizziness.
Side effects are usually mild and reversible after discontinuation of the drug.

Pregnancy and breastfeeding

Biseptol is contraindicated for use in pregnancy.
If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

Special notes

Care must be taken 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 diarrhea severe course is an indication for discontinuation of the drug.
Not indicated the appointment of Biseptol for the treatment of angina caused by streptococcus.
During treatment with Biseptolum, adequate fluid intake should be ensured due to the risk of developing crystalluria and urolithiasis.
When determining the level of creatinine using alkaline picrinate Jaffe while taking Biseptol, it should be taken into account that the result can be 10% higher than the true one.
Control of laboratory parameters
With prolonged use of the drug is necessary to monitor the picture of peripheral blood.

Overdosage

Symptoms: nausea, vomiting, clouding of consciousness.
Treatment: drug withdrawal, gastric lavage (no later than 2 hours after taking the drug), abundant drinking, forced diuresis, Calcium folinate intake (5-10 mg / day).

Drug Interactions

With the simultaneous use of trimethoprim enhances the action of hypoglycemic agents - sulfonylurea derivatives.
The combined use of Biseptol with thiazide diuretics increases the risk of thrombocytopenia and increased bleeding.
Co-trimoxazole enhances the anticoagulant effect of Warfarin and the anticonvulsant activity of phenytoin.
When combined, rifampicin reduces the half-life of trimethoprim.
The combined use of Biseptol and cyclosporine after kidney transplantation worsens the patient's condition.

Storage conditions

Store in a dry, dark place and out of reach of children.

Biseptol