BISEPTOL AMPOULE 480MG/5ML

Active ingredient and dosage form

Biseptol concentrate for solution for infusion (480 mg / 5 ml):
1 ml of concentrate contains sulfamethoxazole 80 mg, trimethoprim 16 mg;
in 5 ml ampoules; in a box of 10 ampoules.

Mechanism of action

Biseptol - 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 (includingfurunculosis, pyoderma).

Dosage and administration

Pills
Children aged 2 to 5 years the drug is prescribed in 240 mg (2 tablets. 120 mg) 2 times / day;
children aged 6 to 12 years - 480 mg each (4 tab. 120 mg or 1 tab. 480 mg) 2 times / day.
With pneumonia the drug is prescribed at the rate of 100 mg of sulfamethoxazole per 1 kg of body weight / day. The interval between doses of 6 hours, the duration of reception - 14 days.
With gonorrhea The dose of the drug is 2 g (in terms of sulfamethoxazole) 2 times / day with an interval between doses of 12 hours.
Adults and children over 12 years old the drug is prescribed on 960 mg 2 times / day, if necessary, long-term therapy - 480 mg 2 times / day.
Duration of a course of treatment from 5 to 14 days. At severe disease and / or chronic infections may increase the single dose of 30-50%.
With the duration of the course of therapy for more than 5 days and / or increasing the dose of the drug, it is necessary to monitor the picture of peripheral blood; when pathological changes occur, folic acid should be administered at a dose of 5–10 mg / day.
pills are taken after a meal, drinking plenty of liquids.

With severe infections, as well as in the absence of the possibility of oral administration of the drug, used IM or IV drip Biseptol.

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.

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.

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.