Biseptol - instructions for use, analogs, reviews and release form (tablets of 120 mg and 480 mg, suspension or syrup), a drug for the treatment of sore throats, colds and cystitis in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Biseptol. It is comments of visitors - users of the drug, as well as opinions of doctors skilled in the use Biseptol in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Biseptol analogs in the presence of existing structural analogues. The use for the treatment of sore throat, colds, cystitis and other infectious diseases in adults, children,as well as during pregnancy and lactation.

Biseptol - Combined antibacterial drug, contains sulfamethoxazole and trimethoprim.

Sulfamethoxazole, similar in structure to PABA, disrupts the synthesis of dihydrofolic acid in bacterial cells, preventing the incorporation of PABA into its molecule.

Trimethoprim enhances the action of sulfamethoxazole, disrupting the reduction of dihydrofolic acid into a tetrahydrofolic - active form of folic acid, responsible for protein metabolism and division of the microbial cell.

It is a broad-spectrum bactericide.

It is active against gram-positive aerobic bacteria, gram-negative aerobic bacteria, against gram-positive anaerobes, against protozoa: Plasmodium spp., Toxoplasma gondii; pathogenic fungi: Coccidioides immitis, Histoplasma capsulatum, Pneumocystis carinii, Leishmania spp.

The drug is resistant to: Corynebacterium spp., Pseudomonas aeruginosa, Mycobacterium tuberculosis, Treponema spp., Leptospira spp., Viruses.

Inhibits the activity of E. coli, which leads to a decrease in the synthesis of thiamine, riboflavin, nicotinic acid and other B Vitamins in the intestine.

The duration of the therapeutic effect is 7 hours.

Pharmacokinetics

After taking the drug inside the active substances quickly and completely absorbed from the digestive tract. Trimethoprim well penetrates into tissues and biological environments of the body: lungs, kidneys, prostate, bile, saliva, sputum, spinal fluid. The binding of trimethoprim to plasma proteins is 50%; sulfamethoxazole - 66%. The main way of excretion is the kidneys; while trimethoprim is excreted unchanged to 50%; sulfamethoxazole - 15-30% in the active form.

Indications

Treatment of infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

• infections of the respiratory tract (including bronchitis, pneumonia, lung abscess, pleural empyema);
• otitis, sinusitis;
• infections of the genitourinary system (including pyelonephritis, urethritis, salpingitis, prostatitis);
• gonorrhea;
• infections of the digestive tract (including typhoid fever, paratyphoid, bacterial dysentery, cholera, diarrhea);
• infections of the skin and soft tissues (including furunculosis, pyoderma).

Forms of release

Tablets 120 mg and 480 mg.

Suspension or syrup for oral administration.

Concentrate for the preparation of solution for infusions (injections) Biseptol 480.

Instructions for use and dosage

Install individually.The drug is taken after a meal, squeezed with enough liquid.

Children aged 3 to 5 years, the drug is prescribed to 240 mg (2 tablets of 120 mg) 2 times a day; children aged 6 to 12 years - 480 mg (4 tablets of 120 mg or 1 tablet of 480 mg) 2 times a day.

With pneumonia, the drug is prescribed at the rate of 100 mg of sulfamethoxazole per 1 kg of body weight per day. The interval between meals is 6 hours, the duration of the reception is 14 days.

With gonorrhea, the dose of the drug is 2 g (in terms of sulfamethoxazole) 2 times a day with an interval between doses of 12 hours.

Adults and children over 12 years of age the drug is prescribed for 960 mg twice a day, with prolonged therapy - 480 mg 2 times a day.

The duration of the course of treatment is from 5 to 14 days. In severe disease and / or chronic infections, an increase in the single dose by 30-50% is possible.

If the duration of the course of therapy is more than 5 days and / or the dose is increased, it is necessary to control the picture of peripheral blood; at occurrence of pathological changes it is necessary to appoint folic acid in a dose of 5-10 mg a day.

Side effect

• headache
• dizziness
• depression
• apathy
• tremor
• bronchospasm
• suffocation
• cough
• nausea, vomiting
• loss of appetite
• diarrhea
• gastritis
• abdominal pain
• stomatitis
• leukopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anemia, aplastic and hemolytic anemia, eosinophilia
• polyuria
• interstitial nephritis
• impaired renal function
• hematuria
• arthralgia
• myalgia
• pruritus
• photosensitization
• hives
• drug fever
• rash
• multi-form exudative erythema (including Stevens-Johnson syndrome)
• fever
• angioedema
• hyperemia sclera
• hypoglycaemia, hyperkalemia, hyponatremia.

The drug is usually well tolerated.

Contraindications

• established damage to the liver parenchyma;
• severe renal dysfunction in the absence of the possibility of controlling the concentration of the drug in the blood plasma;
• severe renal insufficiency (CC less than 15 ml / min);
• severe blood diseases (aplastic anemia, B12-deficiency anemia, agranulocytosis, leukopenia, megaloblastic anemia, anemia associated with a deficiency of folic acid);
• hyperbilirubinemia in children;
• deficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis);
• pregnancy;
• lactation;
• Children under 3 years old (for this dosage form);
• hypersensitivity to the components of the drug;
• hypersensitivity to sulfonamides.

Application in pregnancy and lactation

Biseptol is contraindicated for use in pregnancy and lactation (breastfeeding).

special instructions

With caution, prescribe the drug in a weighed allergic anamnesis.

With long (more than a month) treatment course, regular blood tests are necessary, since there is a possibility of hematological changes (most often asymptomatic). These changes can be reversible in the appointment of folic acid (3-6 mg per day), which does not significantly interfere with the antimicrobial activity of the drug. Particular caution is needed in the treatment of elderly patients or patients with suspected initial folate deficiency. The purpose of folic acid is also suitable for long-term treatment with a drug in high doses.

For the prevention of crystalluria it is recommended to maintain a sufficient volume of excreted urine. The likelihood of toxic and allergic complications of sulfonamides significantly increases with a decrease in the filtration function of the kidneys.

It is also inappropriate to use food products containing a large number of PABC, green parts of plants (cauliflower, spinach, beans), carrots, tomatoes.

Excessive sunlight and UV irradiation should be avoided.

The risk of side effects is much higher in AIDS patients.

It is not recommended to use the drug for tonsillitis and pharyngitis caused by beta-hemolytic streptococcus group A, because of the widespread resistance of strains.

Trimethoprim may alter the results of the serum level of Methotrexate in the enzyme, but it does not affect the result when choosing a radioimmunoassay.

Drug Interactions

With the simultaneous use of Biseptol with thiazide diuretics, there is a risk of thrombocytopenia and bleeding (the combination is not recommended).

Co-trimoxazole increases the anticoagulant activity of indirect anticoagulants, as well as the effect of hypoglycemic drugs and methotrexate.

Co-trimoxazole reduces the intensity of the hepatic metabolism of phenytoin (increases its T1 / 2 by 39%) and warfarin, enhancing their effect.

With simultaneous use of pyrimethamine in doses exceeding 25 mg / week, increases the risk of megaloblastic anemia.

With the simultaneous use of diuretics (often thiazides) increase the risk of thrombocytopenia.

Benzocaine, procaine, procainamide (as well as other drugs, as a result of the hydrolysis of which PABA is formed) reduce the effectiveness of Biseptol.

Between diuretics (including thiazides, furosemide) and oral hypoglycemic agents (sulfonylurea derivatives) on the one hand, and antibacterial agents of the sulfonamides group, on the other hand, it is possible to develop a cross-allergic reaction.

Phenytoin, barbiturates, PASC intensify manifestations of folic acid deficiency with simultaneous use with Biseptolum.

The derivatives of salicylic acid strengthen the action of Biseptol.

Ascorbic acid, hexamethylenetetramine (as well as other drugs, acidifying urine) increase the risk of developing crystalluria on the background of Biseptol.

Kolestiramin reduces absorption while taking with other drugs, so it should be taken 1 hour after or 4-6 hours before taking co-trimoxazole.

When used simultaneously with drugs that oppress bone marrow hematopoiesis, the risk of myelosuppression increases.

In some cases, Biseptol may increase the concentration of Digoxin in the blood plasma in elderly patients.

Biseptol may reduce the effectiveness of tricyclic antidepressants.

In patients after kidney transplantation, while simultaneous application of Co-trimoxazole and cyclosporine, there is a passing impairment of the function of the transplanted kidney, manifested by an increase in serum creatinine concentrations, which is probably caused by the action of trimethoprim.

Reduces the effectiveness of oral contraception (oppresses the intestinal microflora and reduces the intestinal circulation of the hormonal means).

Analogues of the drug Biseptol

Structural analogs for the active substance:

• Bactrim;
• Bactrim forte;
• Berlocid 240;
• Berlocid 480;
• Bi-Septin;
• Biseptol 480;
• Briefeptol;
• Grosseptol;
• Dvseptol;
• Duo-Septol;
• Co-trimoxazole;
• Co-trimoxazole-Acry;
• Co-trimoxazole-Rivofarm;
• Co-trimoxazole-STI;
• Cotripharm 480;
• Methosulfabol;
• Oriprim;
• Polseptol;
• Septrin;
• Sinersul;
• Sulotrim;
• Sumetrolim;
• Trimezol.

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