Biseptol 480mg / 5ml concentrate for solution for injection No. 10 ampoules


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Biseptolum 480mg / 5ml concentrate for solution for injection №10 ampoules

Release form
Concentrate for solution for infusion

1 ml of concentrate contains sulfamethoxazole 80 mg, trimethoprim 16 mg

10 vials of 5 ml.

pharmachologic effect
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.
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.
The drug is resistant to mycobacteria, viruses, most anaerobic bacteria.

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).

- 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 components of Biseptol.

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

Dosage and administration
Parenteral: i / m for adults and children over 12 years old - 480 mg every 12 hours, children 6–12 years old - 240 mg every 12 hours. In / in drip, adults and children over 12 years old - 960–1920 mg every 12 hours. children 6-12 years old - 480 mg 2 times a day; 6 months-5 years - 240 mg 2 times a day; 6 weeks-5 months - 120 mg 2 times a day. For maximum effectiveness, a constant concentration of trimethoprim in plasma or serum should be maintained at 5 μg / ml or higher.Malaria caused by Plasmodium falciparum, - in / in infusion (1920 mg 2 times a day) for 2 days. Children will need a correspondingly reduced dose. To achieve higher concentrations in the CSF administered in / in the drip (dissolved in 200 ml of solvent) for 1 h, 2 times a day.

Side effects
On the part of the digestive system: rarely - nausea, vomiting, diarrhea; in rare cases - pseudomembranous colitis, cholestatic hepatitis.
Allergic reactions: in isolated cases - Stevens-Johnson syndrome, Lyell's syndrome.
On the part of 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.

special instructions
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.

Drug interaction
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.

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).

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

Shelf life
2 years.

It is a drug. Consultation with a doctor is required.