Biseptol: indications, dosage for children and adults. Tablets "Biseptol": instructions for use for children Biseptol instructions for use tablets for adults reviews

In this article you can read the instructions for use of the drug Biseptol. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Biseptol in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Biseptol in the presence of existing structural analogues. Use for the treatment of sore throats, colds, cystitis and other infectious diseases in adults, children, as well as during pregnancy and lactation.

Biseptol- a combined antibacterial drug containing sulfamethoxazole and trimethoprim.

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

Trimethoprim enhances the effect of sulfamethoxazole by interfering with the reduction of dihydrofolic acid into tetrahydrofolic acid, the active form of folic acid responsible for protein metabolism and microbial cell division.

It is a broad-spectrum bactericidal drug.

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 following are resistant to the drug: Corynebacterium spp., Pseudomonas aeruginosa, Mycobacterium tuberculosis, Treponema spp., Leptospira spp., viruses.

Inhibits the vital 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 therapeutic action is 7 hours.

Pharmacokinetics

After taking the drug orally, the active substances are quickly and completely absorbed from the gastrointestinal tract. Trimethoprim penetrates well into the tissues and biological environments of the body: lungs, kidneys, prostate, bile, saliva, sputum, cerebrospinal fluid. The binding of trimethoprim to plasma proteins is 50%; sulfamethoxazole - 66%. The main route of elimination is the kidneys; in this case, trimethoprim is excreted unchanged up to 50%; sulfamethoxazole - 15-30% in active form.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

  • respiratory tract infections (including bronchitis, pneumonia, lung abscess, pleural empyema);
  • otitis media, sinusitis;
  • 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).

Release forms

Tablets 120 mg and 480 mg.

Suspension or syrup for oral use.

Concentrate for the preparation of solution for infusion (injection) Biseptol 480.

Instructions for use and dosage

Installed individually. The drug is taken after meals with a sufficient amount of liquid.

For children aged 3 to 5 years, the drug is prescribed 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.

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

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

For adults and children over 12 years of age, the drug is prescribed 960 mg 2 times a day, for long-term therapy - 480 mg 2 times a day.

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

When the course of therapy lasts more than 5 days and/or the dose of the drug is increased, it is necessary to monitor the peripheral blood picture; if pathological changes occur, folic acid should be prescribed at a dose of 5-10 mg per day.

Side effect

  • headache
  • dizziness
  • depression
  • apathy
  • tremor
  • bronchospasm
  • suffocation
  • cough
  • nausea, vomiting
  • loss of appetite
  • diarrhea
  • gastritis
  • stomach pain
  • stomatitis
  • leukopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anemia, aplastic and hemolytic anemia, eosinophilia
  • polyuria
  • interstitial nephritis
  • renal dysfunction
  • hematuria
  • arthralgia
  • myalgia
  • photosensitivity
  • hives
  • drug fever
  • exudative erythema multiforme (including Stevens-Johnson syndrome)
  • increase in body temperature
  • angioedema
  • scleral hyperemia
  • hypoglycemia, hyperkalemia, hyponatremia.

The drug is generally well tolerated.

Contraindications

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

Use during pregnancy and breastfeeding

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

Special instructions

The drug is prescribed with caution in case of a burdened allergy history.

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

During treatment, it is also inadvisable to consume foods containing large amounts of PABA - green parts of plants (cauliflower, spinach, legumes), carrots, tomatoes.

Excessive sun and UV exposure should be avoided.

The risk of side effects is significantly higher in patients with AIDS.

Trimethoprim may change the results of determining serum methotrexate levels using the enzymatic method, but does not affect the result when choosing a radioimmunoassay method.

Drug interactions

When Biseptol is used simultaneously with thiazide diuretics, there is a risk of developing 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 hepatic metabolism of phenytoin (increases its T1/2 by 39%) and warfarin, enhancing their effect.

When used concomitantly, pyrimethamine in doses exceeding 25 mg/week increases the risk of developing megaloblastic anemia.

When used concomitantly, diuretics (usually 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 sulfonamide group, on the other hand, the development of a cross-allergic reaction is possible.

Phenytoin, barbiturates, PAS increase the manifestations of folic acid deficiency when used simultaneously with Biseptol.

Salicylic acid derivatives enhance the effect of Biseptol.

Ascorbic acid, hexamethylenetetramine (as well as other drugs that acidify urine) increase the risk of developing crystalluria during the use of Biseptol.

Cholestyramine reduces absorption when taken concomitantly 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 inhibit bone marrow hematopoiesis, the risk of developing 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, with the simultaneous use of co-trimoxazole and cyclosporine, there is a passing dysfunction of the transplanted kidney, manifested by an increase in serum creatinine concentrations, which is probably caused by the effect of trimethoprim.

Reduces the effectiveness of oral contraception (inhibits intestinal microflora and reduces the enterohepatic circulation of hormonal agents).

Analogues of the drug Biseptol

Structural analogues of the active substance:

  • Bactrim;
  • Bactrim forte;
  • Berlocid 240;
  • Berlocid 480;
  • Bi-Septin;
  • Biseptol 480;
  • Brifeseptol;
  • Groseptol;
  • Dvaseptol;
  • Duo-Septol;
  • Co-trimoxazole;
  • Co-trimoxazole-Acri;
  • Co-trimoxazole-Rivopharm;
  • Co-trimoxazole-STI;
  • Cotripharm 480;
  • Metosulfabol;
  • Oriprim;
  • Polseptol;
  • Septrin;
  • Sinersul;
  • Sulotrim;
  • Sumetrolim;
  • Trimezol.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Biseptol is a combined antibacterial drug used in the treatment of a wide range of diseases.

Pharmacological action of Biseptol

The active components of Biseptol have a pronounced antibacterial effect:

  • Sulfamethoxazole disrupts the synthesis of dihydrofolic acid in bacterial cells;
  • Trimethoprim, enhancing the effect of sulfamethoxazole, disrupts the reduction of dihydrofolic acid into the active form of folic acid, which is responsible for microbial cell division and protein metabolism.

Biseptol, according to the instructions, is a broad-spectrum bactericidal agent and is active against most aerobic bacteria, protozoa and pathogenic fungi.

Viruses, as well as Pseudomonas aeruginosa, Corynebacterium spp., Treponema spp., Mycobacterium tuberculosis, Leptospira spp., show resistance to the drug.

The duration of action of Biseptol is 7 hours.

Release form

Biseptol is available in the form:

  • Round yellowish tablets engraved with “Bs” containing 2 active ingredients – sulfamethoxazole and trimethoprim. 120 and 480 mg, 20 tablets per package;
  • Concentrate for the preparation of solution for infusion (Biseptol 480) in ampoules of 5 ml;
  • Sugar-free oral suspension with strawberry flavor.

Analogues of Biseptol in terms of active components are Bactrim, Bi-Septin, Brifeseptol, Metosulfabol, Dvaseptol, Co-trimoxazole.

Biseptol's analogue by mechanism of action is Sulfatone in the form of tablets and solution for injection.

Indications for use of Biseptol

According to the manufacturer's instructions, Biseptol is prescribed for the treatment of infectious and inflammatory diseases that are caused by microorganisms sensitive to the drug, namely:

  • Infections of the genitourinary system, including urethritis, pyelonephritis, prostatitis, salpingitis;
  • Various respiratory tract infections, including pneumonia, bronchitis, lung abscess, pleural empyema;
  • Gonorrhea;
  • Otitis, sinusitis;
  • Infections of soft tissues and skin, including pyoderma, furunculosis;
  • Infections of the gastrointestinal tract, including typhoid fever, typhus, bacterial cholera, dysentery, diarrhea.

Contraindications for use

The medication Biseptol, according to the instructions, is contraindicated for use in:

  • Severe renal dysfunction;
  • Established damage to the liver parenchyma;
  • Severe blood diseases, including B12 deficiency anemia, aplastic anemia, leukopenia, agranulocytosis, megaloblastic anemia, and anemia associated with folic acid deficiency;
  • Severe renal failure;
  • Glucose-6-phosphate dehydrogenase deficiency;
  • Hyperbilirubinemia in children;
  • Lactation;
  • Pregnancy;
  • Hypersensitivity to the components of the drug and to sulfonamides.

The use of Biseptol tablets is contraindicated in pediatrics under 3 years of age. Biseptol 480 and the medicine in the form of a suspension should not be used in children under 2 months of age.

In addition, Biseptol should be used with caution when:

  • Bronchial asthma;
  • Deficiency of folic acid in the body;
  • Diseases of the thyroid gland.

Directions for use and dosage

According to the instructions, the dosage of Biseptol is determined individually. The medication should be taken before meals.

Children's dosage of Biseptol depends on age. Children 3-5 years old are usually prescribed 2 tablets (120 mg each), children 6-12 years old - twice as much. The frequency of administration is twice a day.

Adults and adolescents over 12 years of age are usually prescribed 2 Biseptol tablets (480 mg) twice a day. The duration of treatment usually varies from 5 to 14 days.

When treating chronic infections, the doctor may increase the standard dosage by 30-50%. For long-term therapy, doses of the medication are usually halved.

Biseptol 480 is administered intravenously. The solution for infusion is prepared immediately before administration. Rapid intravenous injections of Biseptol 480 are not recommended.

The adult dose is 960 mg of Biseptol 480 every 12 hours. The pediatric dose is calculated based on body weight.

In case of an overdose of Biseptol, the following symptoms may develop:

  • Intestinal colic;
  • Lack of appetite;
  • Vomit;
  • Nausea;
  • Headache;
  • Jaundice;
  • Dizziness;
  • Crystalluria;
  • Loss of consciousness;
  • Drowsiness;
  • Hematuria;
  • Fever.

Drug interactions Biseptol

The combined use of Biseptol with thiazide diuretics increases the risk of bleeding and thrombocytopenia.

The effectiveness of Biseptol is reduced by procaine, benzocaine and procainamide.

The risk of developing a cross-allergic reaction increases with simultaneous use of Biseptol with diuretics and oral hypoglycemic agents.

The simultaneous use of the drug with barbiturates, phenytoin and PAS leads to increased manifestations of folic acid deficiency.

Strengthening the effect of Biseptol is possible when combined with salicylic acid derivatives.

The risk of developing crystalluria increases when taking the medication simultaneously with ascorbic acid, hexamethylenetetramine and other drugs that acidify urine.

Biseptol, according to the instructions, can reduce the effectiveness of tricyclic antidepressants.

Side effects of Biseptol

According to the instructions, Biseptol is well tolerated in most cases, however, due to concomitant diseases or in the presence of hypersensitivity to the active components, the following side effects may occur:

  • Tremor, headache, apathy, dizziness, depression, aseptic meningitis, peripheral neuritis (central and peripheral nervous systems);
  • Abdominal pain, nausea, glossitis, vomiting, stomatitis, loss of appetite, diarrhea, gastritis, cholestasis, hepatitis, pancreatitis (digestive system);
  • Dyspnoea, bronchospasm, pulmonary infiltrates, cough (respiratory system);
  • Hyperkalemia, hypoglycemia, hyponatremia (metabolism);
  • Neutropenia, leukopenia, agranulocytosis, thrombocytopenia, eosinophilia, megaloblastic anemia, hypoprothrombinemia, aplastic anemia, methemoglobinemia (hematopoietic system);
  • Myalgia, arthralgia (musculoskeletal system);
  • Interstitial nephritis, renal dysfunction, polyuria, hematuria, crystalluria (urinary system).

The most common allergic reactions that develop when using Biseptol include:

  • Angioedema;
  • Hives;
  • Allergic myocarditis;
  • Drug fever;
  • Photosensitivity;
  • Increased body temperature;
  • Exudative erythema multiforme;
  • Rash;
  • Exfoliative dermatitis;
  • Toxic epidermal necrolysis;
  • Hyperemia of the sclera.

Conditions and shelf life

Biseptol is an antibacterial medicine, the dispensing of which from pharmacies is permitted only for medical prescription. The shelf life of Biseptol tablets and Biseptol 480, subject to the necessary storage conditions, is 5 years, the suspension is 3 years.

Biseptol is a combination drug belonging to the group of sulfonamides. It contains sulfamethoxazole and trimethoprim. The medicine is often prescribed by specialists for the treatment of various diseases caused by pathogenic microflora.

Effect of the drug

The drug is characterized by a wide range of effects against the following microorganisms:

  • Protozoan microorganisms;
  • Gram-positive aerobic bacteria;
  • Aerobic bacteria;
  • Gram-positive anaerobes;
  • Gram-negative aerobic bacteria;
  • Pathogenic fungi.

Biseptol also inhibits E. coli, causing a decrease in the absorption of B vitamins, nicotinic acid, thiamine, riboflavin in the intestine. The duration of the therapeutic effect is about 7 hours.

The instructions attached to the drug Biseptol state that the medication does not affect:

  • Viruses;
  • Corynebacterium spp.;
  • Treponema spp;
  • Pseudomonas aeruginosa;
  • Mycobacterium tuberculosis;
  • Leptospira spp.

Biseptol antibiotic or not

Antibiotics are drugs of natural or semi-synthetic origin that have an antimicrobial effect. As for Biseptol, this drug is completely synthesized and belongs to the sulfonamides. They are commonly called antibacterial chemical drugs.

Antibacterial agents kill bacteria or inhibit their reproduction and growth.

Sulfonamides penetrate into the structure of microbes instead of para-aminobenzoic acid, causing disturbances in the metabolism of their vital functions and the growth of bacteria. While doing this job, sulfonamides are not antibiotics. Medicines represent a different group of antimicrobial medications.

Sulfonamides became the first systemic antimicrobial drugs. They have been used for more than 65 years, thereby creating the risk of a mass of microbial strains becoming addicted to this group of drugs. It was possible to increase the sensitivity of pathogenic microbes by developing combination medications that combine these antimicrobial agents with trimethoprim. These include Co-trimoxazole and other analogues of Biseptol.

It is worth noting that Co-trimoxazole is a drug with a leader in side effects that are life-threatening. Danish medical academics have found that Biseptol has a negative effect on hematopoiesis, provoking a condition in which the bone marrow stops producing leukocytes - granulocytes, that is, it contributes to aplastic anemia.

This phenomenon causes a severe disorder of hematopoiesis, in which patients die within a few months without the necessary qualified assistance. This condition (aplastic anemia) causes complete atrophy of the brain, and in terms of danger it occupies a leading position together with blood oncology.

Composition and release form

The release form of the drug Biseptol may be as follows:

  • Suspensions for oral administration 240 mg/5 ml – 80 ml bottle. 100 ml contains the active substances trimethoprim - 0.8 g, sulfamethoxazole - 4.0 g and auxiliary ingredients. The medicine is dispensed according to a doctor's prescription.
  • Biseptol tablets contain 0.4 mg of sulfamethoxazole and 0.08 g of trimethoprim for adults. The medication used to treat children has the following dosage - 0.2 g trimethoprim and 0.1 g sulfamethoxazole. The package contains 20 tablets.
  • Concentrates for injections of 480 mg (in 1 ml of product - 16 mg of trimethoprim and 80 mg of sulfamethoxazole).



Pharmacokinetics

The mechanism of action of Biseptol is as follows:

  • Trimethoprim and sulfamethoxazole are completely absorbed by the digestive system when taken.
  • Trimethoprim is quickly transported into cells and also instantly penetrates tissue barriers into the kidneys, lungs, bile, prostate gland, saliva, cerebrospinal fluid, and sputum. The substance is excreted through the kidneys in half of the consumed volume unchanged.
  • Sulfamethoxazole is supplied via the kidneys, with about 30% in the active form.

Biseptol: indications for use

The drug is intended for the treatment of infectious diseases caused by pathogenic microorganisms. Biseptol is recommended for:

  • Infectious lesions of the respiratory system (bronchitis or pulmonary abscess, sinusitis, inflammation of the brain and lungs, sinusitis, otitis, flu or cold, sore throat);
  • Infection of the genitourinary system (prostatitis, urethritis, cystitis, salpingitis);
  • Foodborne diseases (shigellosis, cholera and paratyphoid fever);
  • Skin lesions - furunculosis and pyoderma.

For cystitis or prostatitis, the effectiveness of the medicine can be observed when pathologies are provoked by the following pathogenic microorganisms: fungi, cocci, E. coli. In this case, recovery will take place quickly and effectively.

Biseptol is used to treat acute and chronic forms of these diseases.

The dosage for the treatment course is selected individually by the attending physician. Self-therapy is fraught with the risk of severe complications. Inflammatory processes in the prostate gland, leading to various diseases, are provoked by pathogenic microbes, so you need to know which treatment regimen to use in each specific situation.

Biseptol for pathologies of an infectious nature of origin of the genitourinary system is prescribed to stop the further transition of the pathological reaction into a chronic form.

In severe cases of the disease, antibacterial agents with a broad spectrum of action are added to the antiviral drug. Therapy is carried out for three weeks, after which the patient is recommended to take a month's break. Then treatment should be resumed.

Before using Biseptol, the patient should undergo laboratory testing for pathogenic flora. Based on the test results, the doctor selects the required group of medications.

AIDS is an incurable disease that kills hundreds of thousands of people around the world

Scientists are constantly developing new drug formulas to help alleviate the condition of patients. The antiviral drug Biseptol can be used to treat HIV-infected children.

Long-term studies have shown that this drug helps reduce the death rate of children by almost 50%. Today, in many African countries, where the disease is most common in children, Biseptol is prescribed to them. This is due to its high efficiency and availability.

Contraindications

Biseptol must not be used:

  • Patients with hypersensitivity to incoming components;
  • Pregnant women;
  • During lactation;
  • Children under 6 years of age for intramuscular administration;
  • Up to 3 months of age;
  • For Pneumocystis pneumonia;
  • In case of hyperbilirubinemia in children;
  • For bronchial asthma;
  • If severe kidney failure is diagnosed;
  • With folic acid deficiency;
  • When a dysfunction of the thyroid gland is detected;
  • For pathologies of the hematopoietic system.

Biseptol can have side effects on the body from:


The drug can provoke an allergic reaction and manifest itself in the form of itching, rash, drug fever, urticaria, fever, exfoliative dermatitis, scleral hyperemia, allergic myocarditis, angioedema.

Annotation on dosage and methods of administration

Tablets for internal use are recommended for adult patients and children over 12 years of age, 960 mg at a time. However, the medicine can be used at 480 mg per day twice. In advanced forms of the disease, the drug may be prescribed to take 480 mg three times a day.

For children 1–2 years old, Biseptol tablets are prescribed in a dosage of 120 mg in the morning and evening; for children 2–6 years old, the dosage can be increased to 240 mg.

The suspension should be taken after a meal with a sufficient volume of liquid (960 mg) every 12 hours. In severe cases, the dosage of the suspension can also be increased to 1440 mg, which must be taken every 12 hours.

Biseptol in syrup form is intended for children. Up to 2 years it is recommended 120 mg, 2–6 years 240 mg, in the older category of people the dosage is 240–480 mg. You need to take the medicine twice a day. The duration of treatment depends on the degree of neglect of the inflammatory process and can range from several days to several months.

The drug can be used to prevent recurrences of chronic infections and urinary tract pathologies. In this case, the recommended dosage is 480 mg once before bedtime. The duration of the therapeutic course is 3–12 months.

When treating acute cystitis in adolescents and children, a regimen of 480 mg is used twice a day for three days. Biseptol for intravenous injections for adults and adolescents, 960–1920 mg every 12 hours, for children - according to age and existing standards.

In case of severe infection, intravenous or intramuscular administration of the drug is used. The drug concentrate cannot be administered with other solutions. Children over 12 years of age, as well as adult patients, are prescribed injections of 10 ml twice a day. For children under 5 years of age, the dosage of the drug is reduced by four times, and for schoolchildren - by half. In severe situations, a half dose increase is allowed for any age group. The medicine must be administered for at least 5 days (when the characteristic manifestations of the disease disappear, and then another couple of days).

Overdose

Failure to follow your doctor's recommendations for the correct use of the drug can result in negative consequences. The substance co-trimoxazole can be life-threatening. If you have unpleasant symptoms, you must stop taking this drug and perform gastric lavage, and it is recommended to do this procedure no later than 2 hours after using the drug. Drinking plenty of fluids and artificial vomiting will help improve your condition after poisoning.

In case of chronic poisoning with Biseptol, there may be a risk of leukopenia. Thrombocytopenia and megaloblastic anemia may occur. Leucovorin, recommended for use in a dosage of 5–15 mg per day, helps relieve unpleasant discomfort.

The condition after poisoning should be kept under control.

If any deviations occur, you should immediately contact your doctor and notify him of the problems.

Special instructions

If rashes or diarrhea appear on the skin in the acute stage, you should immediately stop taking Biseptol. It is forbidden to take the medicine for streptococcal sore throat.

Patients are advised to drink plenty of fluids during treatment with these drugs.

During long-term drug therapy, it is necessary to monitor the parameters of the circulatory system.

It is not advisable to include green vegetables, as well as tomatoes and carrots in your diet. You should not be in direct sunlight for a long time. Biseptol is not recommended for use in respiratory tract pathologies. Trimethoprim contributes to changes in the serum concentration of methotrexate.

Biseptol during pregnancy

It is recommended to use the drug for pregnant women only if there is a clear positive result. In the third trimester of pregnancy, its use is contraindicated, since it can cause Botkin's disease in the child. It is advisable to take Biseptol only in liquid form.

During the therapeutic course, pregnant women due to a deficiency of folic acid in their body are prescribed this substance at a dose of 5 mg per day. For nursing mothers with any pathologies, taking this medicine is strictly prohibited.

Alcohol compatibility

Biseptol, like many other drugs, cannot be combined with alcohol and protein contained in food. If you drink alcohol and this drug at the same time, you may experience limb cramps. In such cases, an increase in pressure and body temperature is recorded, and a suffocating cough is noted.

Biseptol with alcohol can cause an allergic reaction. It may continue to occur each time you use this drug, regardless of whether alcohol was consumed or not. The most unpleasant moment in the tandem of alcohol and drugs is cerebral ischemia, which can cause death.

Analogues

Biseptol is produced by various pharmacological companies under the following names:

  • Bel-septol;
  • Bactiseptol;
  • Babytrim;
  • Bi-sept;
  • Raseptol;
  • Bicotrim;
  • Triseptol.



Its popular analogues in the form of suspensions and tablets for children have become products made in Poland. A good substitute for this medication is the drug produced by the French company Senexi Bactrim.

The drug Co-Trimoxazole in dosages of 240 mg and 480 is produced by Pharmstandard. This medicine is an inexpensive analogue of Biseptol. There are other manufacturers producing the drug under this name. What they all have in common is affordability. In pharmacies you can also buy more expensive analogues - Bi-septin from Holland, Septrin from the English company Glaxo.

Drug price

The price range for Biseptol in domestic pharmacies is as follows:

  • In tablets 120 mg – 31 rubles. (20 pcs.);
  • In tablets 480 mg – 67 rubles. (20 pcs.);
  • In ampoules of 5 ml - 340 rubles. (10 pcs.);
  • Suspension 240 mg – 120 rub.

“Biseptol” has been known for decades. In Soviet times, it was the most popular drug for almost any infectious disease, it is available for both adults and children, its price is not high, and the drug is effective. It was gradually replaced by new drugs with a greater spectrum of action and effectiveness. But today “Biseptol” does not lose its relevance, and reviews from doctors confirm this.

Composition and principle of action

When is Biseptol used and how much should you take it? One Biseptol 120 mg tablet contains 100 mg of sulfamethoxazole, 20 mg of trimethoprim and additional components. Accordingly, a dose of 240 mg or 480 mg contains two and three times more active substances. The combined effect of the drug components is aimed at inhibiting the formation of folic acid in the bacterial cell. The substances are selected in such a way that they enhance each other’s effects. This adds to the effectiveness of the drug.

Its action occurs as follows:

  • sulfamethoxazole- has a structure similar to para-aminobenzoic acid, due to which it interferes with the formation of folic acid;
  • trimethoprim - slows down the transition of vitamin B9 precursors to the active form.

Thanks to this, minimal concentrations of folic acid are created, which is essential for the growth and development of bacteria. "Biseptol" in high concentration causes the death of pathogens sensitive to it and, thus, eliminates the infection.

The activity of the drug applies to the following microorganisms:

  • coli;
  • streptococci;
  • staphylococci;
  • pneumococci;
  • typhoid and dysentery bacteria;
  • gonococci;
  • salmonella;
  • hemophilus influenzae;
  • Klebsiella;
  • enterococcus;
  • chlamydia;
  • toxoplasma;
  • Leishmania.

The product has no effect on Pseudomonas aeruginosa and tubercle bacilli, Leptospira, spirochetes and viruses.

When to use

Modern doctors prescribe Biseptol for pathologies caused by pathogenic microbes susceptible to the effects of sulfamethoxazole. The method of application is indicated in the table.

Organs or organ systemsPathology
Upper respiratory tract- Chronic and acute bronchitis;
- inflammatory lesion of the pleura;
- pneumonia;
- abscesses;
- inflammatory complications of bronchiectasis;
- laryngitis
ENT organs- Otitis;
- sinusitis (for example, sinusitis, sinusitis);
- inflammation of the tonsils (tonsillitis);
- infectious process in the mucous membrane of the larynx and pharynx
Genitourinary organs- Inflammation of the uterine appendages;
- prostatitis;
- urethritis;
- cystitis;
- epididymitis;
- chronic pyelonephritis;
- gonorrhea
Digestive system- Diarrhea of ​​bacterial etiology, including food poisoning;
- inflammation of the bile ducts
Leather- Acne;
- purulent lesions of hair follicles and soft tissues
Severe infectious and inflammatory diseases with high fever- Meningitis;
- sepsis;
- purulent bone marrow lesions;
- severe infections after injuries

"Biseptol" is effective against toxoplasmosis and malaria. Biseptol is prescribed for children in case of contraindications to antibiotics or an allergic reaction to commonly used drugs. High effectiveness of treatment is achieved for sore throat, cough with bronchitis, as well as sinusitis, inflammation of the lungs, middle ear, intestinal infections, furunculosis, and enlarged lymph nodes. It should be used only as prescribed by a doctor.

Contraindications

After administration, Biseptol quickly penetrates the systemic bloodstream and reaches its maximum concentrations within three to five hours. Metabolized in the liver. High concentrations of the drug are created in the kidneys, as it is mainly excreted in the urine. Contraindications for use are as follows:

  • hypersensitivity to the components of the drug;
  • complex forms of heart failure;
  • liver pathologies with damage or death of its cells;
  • renal failure;
  • anemia caused by a lack of folic acid;
  • pathology of blood and bone marrow;
  • bronchial asthma;
  • hay fever;
  • atopic (allergic) dermatitis.

Biseptol should not be taken if the patient has previously had an immunological decrease in platelet levels caused by taking the drug.

The components of the drug help reduce the content of folic acid and can lead to its deficiency. In addition, the use of the drug in the third trimester of pregnancy may contribute to the occurrence of kernicterus in the fetus. Therefore, Biseptol is strictly contraindicated during pregnancy and breastfeeding, and it should not be used by children under three months.

In cases of using Biseptol in pregnant women, an additional intake of 5 g of folic acid daily is necessary. Elderly people should use this drug with great caution. The same applies to patients with thyroid pathologies.

Instructions for use of "Biseptol"

The dosage of Biseptol and the duration of use are prescribed by the doctor individually in each specific case. You can take it in a convenient form; dosage regimens do not differ in the amount of active substance.

"Biseptol" is available in tablets of 120 (for children) and 480 mg, in the form of syrup and suspension in ampoules for oral administration. Schemes for using various forms of the drug are described in the tables.

Table - How to take Biseptol correctly depending on age

Tablets or suspension should be taken after meals with clean still water. The course of treatment lasts up to 14 days. If therapy continues for more than five days, it is recommended to monitor blood counts. In case of abnormal fluctuations, up to 10 mg of folic acid per day is additionally prescribed.

Depending on the type and severity of the infectious process, the standard dosage of Biseptol may vary, as can be seen from the table.

Table - Separate regimens for taking Biseptol

In severe forms of the infectious-inflammatory process, the doctor may double the dose.

Side effects and overdose

The instructions indicate good tolerability of the drug and minimal risk of side effects. But we can still highlight the following:

  • nausea, vomiting and diarrhea;
  • headache, dizziness;
  • tendency to depression;
  • inflammation of peripheral nerves;
  • bronchial spasms, asthma attacks and cough;
  • obstructed bile flow;
  • acute inflammation of the large intestine;
  • decreased neutrophil levels (agranulocytosis);
  • decrease in the number of leukocytes and platelets in the blood;
  • deficiency of vitamin B12 and folic acid;
  • severe form of allergic dermatitis;
  • the appearance of blood in the urine, crystalluria.

People with HIV infection are more likely to experience side effects.

An overdose of the drug worsens headaches, nausea, vomiting, abdominal pain, and changes in red blood counts. Treatment is symptomatic and includes gastric lavage and, if necessary, administration of drugs to restore folic acid levels. For example, based on calcium folinate.

Special instructions

When taking Biseptol, there is a risk of salt crystals appearing in the urine and the formation of kidney stones, therefore, to prevent such side effects throughout treatment, it is necessary to drink enough fluid and monitor blood tests.

Concomitant use of the drug with diuretics increases the risk of hypokalemia (low potassium in the blood) and bleeding. During the treatment period, it is recommended to completely abstain from alcohol so as not to provoke toxic hepatitis. With long-term therapy, it is necessary to take tests to monitor the functional state of the kidneys, liver and monitor hematological parameters.

Analogues

The following drugs are analogues of the active ingredients:

  • "Bactrim";
  • "Septrin";
  • "Sumetrolim";
  • "Berlocid";
  • "Zeplin";
  • "Co-trimoxazole."

Biseptol 480: instructions for use and reviews

Latin name: Biseptol 480

ATX code: J01EE01

Active ingredient: co-trimoxazole (sulfamethoxazole + trimethoprim)

Manufacturer: JSC "Warsaw Pharmaceutical Plant Polfa" (Poland)

Updating the description and photo: 22.10.2018

Biseptol 480 is an antimicrobial combined sulfonamide drug.

Release form and composition

The dosage form of Biseptol 480 is a concentrate for the preparation of a solution for infusion: a transparent, colorless or light yellow liquid with a characteristic odor of ethanol (5 ml in ampoules, in a cardboard box of 2 contour packages or 10 ampoules without packaging).

Composition of concentrate per 1 ml/1 ampoule:

  • active ingredients: sulfamethoxazole – 80/400 mg; trimethoprim – 16/80 mg;
  • excipients: sodium hydroxide, sodium metabisulfite, propylene glycol, benzyl alcohol, ethanol, water for injection.

Pharmacological properties

Pharmacodynamics

Biseptol 480 is a combined antibacterial drug. Active components in its composition: sulfamethoxazole - an effective antimicrobial substance of medium duration of action, inhibiting the synthesis of folic acid by competitive antagonism with para-aminobenzoic acid; trimethoprim is a bacteriostatic antibiotic that inhibits bacterial dihydrofolic acid reductase. Their combination gives a synergistic antibacterial effect, and therefore the effectiveness of such a complex is much higher in comparison with the effect of other drugs.

Biseptol 480 is a broad-spectrum antibiotic; shows its activity against the following microorganisms: Streptococcus (Streptococcus pneumoniae), Neisseria gonorrhoeae (enterotoxogenic strains inclusive), Neisseria meningitidis, Staphylococcus, Klebsiella, Escherichia coli, Haemophilus influenzae, Enterobacter, Proteus spp., Proteus mirabilis, Salmonella spp. (Salmonella typhi and Salmonella paratyphi inclusive), Vibrio cholerae, Bacillus anthracis, Listeria spp., Nocardia asteroides, Bordetella pertussis, Enterococcus faecalis, Pasteurella spp., Brucella spp., Mycobacterium spp. (Mycobacterium leprae inclusive), Enterobacter spp., Citrobacter, Legionella pneumonia, Providencia, certain species of Pseudomonas (excluding P. aeruginosa), Serratia marcescens, Morganella spp., Yersinia spp., Chlamydia spp. (Chlamydia trachomatis and Chlamydia psittaci inclusive), Actinomyces israelii, Shigella, Toxoplasma gondii, Plasmodium spp., Pneumocystis carinii, Histoplasma capsulatum, Coccidioides immitis, Leishmania spp.

Microorganisms exhibiting resistance to Biseptol 480: Corynebacterium spp., Mycobacterium tuberculosis, Pseudomonas aeruginosa, Leptospira spp., Troponema spp. and viruses.

The drug inactivates the vital activity of E. coli, leads to a decrease in the intestinal synthesis of riboflavin, thiamine, nicotinic acid, and other B vitamins. The duration of the therapeutic effect is 7 hours.

Pharmacokinetics

Biseptol 480 penetrates quickly into body tissues and biological fluids and is well distributed in them. The drug penetrates the blood-brain barrier (BBB), the histohematic barrier, and is excreted in breast milk. Its concentration in urine and lungs significantly exceeds plasma concentration. In vaginal secretions, bronchial secretions, bones, saliva, tissues and secretions of the prostate gland, breast milk, middle ear fluid, bile, cerebrospinal fluid, aqueous humor of the eye, interstitial fluid, sulfamethoxazole and trimethoprim accumulate to a lesser extent. Both active components are distributed differently: sulfamethoxazole - only in the extracellular space, and trimethoprim - both outside and inside cells. 66% of sulfamethoxazole and 45% of trimethoprim are bound to plasma proteins.

Both drugs undergo metabolism in the liver. Sulfamethoxazole is metabolized to a greater extent, forming acetylated derivatives - metabolites that do not have antimicrobial activity.

Biseptol 480 is excreted by the kidneys both by glomerular filtration and by active tubular secretion. Up to 80% of the drug is excreted within 72 hours in the form of metabolites; 20% of sulfamethoxazole and 50% of trimethoprim are excreted unchanged. In urine, the concentration of active substances is higher than in blood plasma. The drug is excreted through the intestines in small quantities. The half-life (T1/2) for sulfamethoxazole is 9–11 hours, for trimethoprim – 10–12 hours. In children, this figure is significantly less and depends on the age of the child: in the first year of life it is 7–8 hours, from 1 year to 10 years – 5–6 hours. T1/2 increases in elderly patients with impaired renal function.

Indications for use

  • gastrointestinal infections: paratyphoid fever, typhoid fever, cholera, salmonella carriage, dysentery, cholangitis, cholecystitis, gastroenteritis caused by enterotoxic strains of Escherichia coli;
  • infections of the reproductive and urinary systems in acute and chronic course: pyelitis, pyelonephritis, urethritis, cystitis, epididymitis, prostatitis, chancroid, gonorrhea, granuloma inguinale, lymphogranuloma venereum;
  • infectious lesions of the ENT organs: tonsillitis, otitis media, laryngitis, sinusitis, scarlet fever;
  • infections of the upper and lower respiratory tract: acute and chronic bronchitis, lobar pneumonia, bronchiectasis, Pneumocystis pneumonia, bronchopneumonia, lung abscess, pleural empyema;
  • infections of the skin and soft tissues: pyoderma, acne, furunculosis, wound infections and abscess, infection after surgical interventions;
  • other infectious diseases: sepsis, toxoplasmosis, acute brucellosis, osteoarticular infections, osteomyelitis, malaria (Plasmodium falciparum), South American blastomycosis, whooping cough (as part of complex treatment).

Contraindications

Absolute contraindications:

  • liver failure;
  • renal failure with creatinine clearance (CC) less than 15 ml/min;
  • megaloblastic anemia due to deficiency of vitamin B 9 (folic acid), aplastic anemia, agranulocytosis, B 12 deficiency anemia, leukopenia;
  • deficiency of glucose-6-phosphate dehydrogenase;
  • hyperbilirubinemia in children;
  • intramuscular administration of the drug to children under 6 years of age;
  • neonatal period and age up to 2 months;
  • period of pregnancy and lactation;
  • individual hypersensitivity to sulfonamide drugs, trimethoprim and (or) other components of Biseptol 480.

The drug is used with caution in cases of vitamin B9 deficiency, bronchial asthma, liver/kidney dysfunction, and thyroid diseases.

Instructions for use of Biseptol 480: method and dosage

A solution prepared from Biseptol 480 concentrate must be administered intravenously (IV) by drip. The drug should not be used as a quick intravenous injection.

To dilute the Biseptol 480 concentrate, the following infusion solutions can be used: 5 and 10% dextrose solutions; 0.9% NaCl solution; 0.45% NaCl solution with 2.5% dextrose solution; Ringer's solution.

  • children under 12 years of age: the daily dose is determined at the rate of 36 mg per kg of body weight and is divided into 2 administrations in equal quantities;
  • children over 12 years of age and adult patients: 960 mg (10 ml or 2 ampoules) 1 time per 12 hours; if necessary, it is possible to increase the single dose to 1440 mg (15 ml or 3 ampoules), 2-3 times a day.
  • 5 ml (1 ampoule) of the drug – 125 ml of infusion solution;
  • 10 ml (2 ampoules) of the drug – 250 ml of infusion solution;
  • 15 ml (3 ampoules) of the drug - 500 ml of infusion solution.

The prepared solution of Biseptol 480 should not be mixed with infusion solutions other than those listed above, or other medications.

For patients with renal failure with CC from 15 to 30 ml/min, the dose of the drug is reduced by 1/2 of the average therapeutic dose.

Side effects

When used according to indications in compliance with the dosage regimen, Biseptol 480 is usually well tolerated by patients, but the following side effects are possible:

  • central nervous system: headaches, dizziness; in some cases - apathy, depression, tremor, aseptic meningitis, peripheral neuritis;
  • Gastrointestinal tract: vomiting, nausea, diarrhea, anorexia, abdominal pain, gastritis, glossitis, stomatitis, increased activity of liver enzymes, cholestasis, hepatitis, pseudomembranous enterocolitis, liver necrosis;
  • respiratory system: bronchospasm, infiltration of lung tissue;
  • hematopoietic organs: rarely – leukopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anemia, hypoprothrombinemia;
  • urinary system: renal dysfunction, interstitial nephritis, polyuria, hematuria, crystalluria, hypocreatininemia, increased urea levels, toxic nephropathy with decreased diuresis to oliguria and anuria;
  • musculoskeletal system: myalgia, arthralgia;
  • hypersensitivity reactions: rash, itching, polymorphic erythema, exfoliative dermatitis, photosensitivity, allergic myocarditis, hyperthermia, redness of the sclera, Quincke's edema;
  • reactions at the injection site: pain, thrombophlebitis;
  • other: hypoglycemia.

Overdose

Symptoms of an overdose of Biseptol 480 are intestinal colic, nausea, vomiting, headache, dizziness, depression, fainting, drowsiness, confusion, fever, blurred vision, crystalluria, hematuria; Due to prolonged overdose, leukopenia, thrombocytopenia, jaundice, and megaloblastic anemia are possible.

To treat the condition it is necessary:

  • flush the patient's stomach;
  • ensure the intake of drugs that cause acidification of urine to enhance the excretion of trimethoprim;
  • increase fluid intake;
  • to eliminate the effect of trimethoprim on the bone marrow, administer calcium folinate intramuscularly at a dose of 5–15 mg/day;
  • to stimulate erythropoiesis when trimethoprim inhibits the hematopoietic functions of the bone marrow, administer folic acid preparations intramuscularly at a dose of 3–6 mg/day, for a course of 5–7 days;
  • if necessary, perform hemodialysis.

Special instructions

When using Biseptol 480 in patients with acquired immunodeficiency syndrome (AIDS) using co-trimoxazole for the treatment of Pneumocystis pneumonia, undesirable effects such as hyperthermia, skin rashes, and leukopenia are more often observed.

It is advisable to determine the plasma concentration of sulfamethoxazole every 2–3 days immediately before the next infusion; if its value is > 150 mcg/ml, then therapy should be interrupted until the plasma value drops to 120 mcg/ml.

Long-term treatment must be carried out under systematic monitoring of the functional state of the liver and kidneys, as well as peripheral blood parameters.

In order to prevent crystalluria in patients, it is necessary to maintain the volume of urine excreted in sufficient quantities.

Due to the deterioration of the filtration function of the kidneys, the likelihood of allergic and toxic complications when using sulfonamides increases significantly.

During treatment, it is not advisable to eat foods containing para-aminobenzoic acid (PABA) in large quantities - tomatoes, carrots and green parts of vegetables (cauliflower, spinach, legumes).

Due to the likely increase in photosensitivity when using Biseptol 480, excessive solar and artificial ultraviolet irradiation should be avoided.

Impact on the ability to drive vehicles and complex mechanisms

The drug has no effect on the ability to perform types of work that require high concentration of attention and speed of psychomotor reactions.

Use during pregnancy and lactation

According to the instructions, Biseptol 480 is contraindicated for pregnant and lactating women.

Use in childhood

Biseptol 480 is contraindicated for premature babies, newborns and infants up to the 2nd month of life.

For impaired renal function

  • renal failure with CC< 15 мл/мин – противопоказано применение Бисептола 480;
  • renal failure with CC 15–30 ml/min – it is recommended to use 1/2 of the average therapeutic dose.

For liver dysfunction

The use of co-trimoxazole is contraindicated in liver failure.

Use in old age

Elderly patients receiving treatment with Biseptol 480 are recommended to additionally administer folic acid at a dose of 3–6 mg/day; This combination does not significantly affect the antimicrobial activity of the drug. Particular care is required in the treatment of elderly patients with suspected underlying folate deficiency.

Drug interactions

Biseptol 480 concentrate is pharmaceutically compatible with the following solutions: 5 and 10% dextrose (glucose) solutions; 0.9% NaCl solution; 0.45% NaCl solution with 2.5% dextrose (glucose) solution; Ringer's solution.

Possible drug interactions of Biseptol 480 with other substances/drugs:

  • phenytoin, oral hypoglycemic agents, warfarin derivatives: their effect is enhanced, prothrombin time and bleeding duration are prolonged;
  • diuretics (including thiazide diuretics): the risk of thrombocytopenia increases in elderly patients;
  • cyclosporine: its concentration in the blood decreases;
  • medications and solutions containing bicarbonates: simultaneous intravenous administration with co-trimoxazole is prohibited;
  • indirect coagulants: their anticoagulant activity increases;
  • hypoglycemic agents and methotrexate: their effectiveness increases;
  • rifampicin: reduces T1/2 of trimethoprim;
  • phenytoin and warfarin: the intensity of hepatic metabolism decreases and their effect increases; T1/2 of phenytoin is prolonged by 39%;
  • pyrimethamine (in doses > 25 mg per week): increases the likelihood of developing megaloblastic anemia;
  • diuretics (mainly thiazide): increase the risk of thrombocytopenia;
  • procaine, procainamide, benzocaine, other drugs, as a result of the hydrolysis of which PABA is formed: reduce the effectiveness of co-trimoxazole;
  • Barbiturates, phenytoin, para-aminosalicylic acid (PAS): increase the manifestations of folic acid deficiency;
  • hexamethylenetetramine, ascorbic acid, other medicinal substances that acidify urine: increase the likelihood of developing crystalluria;
  • salicylates: enhance the effectiveness of the drug;
  • cholestyramine: inhibits the absorption of co-trimoxazole, so it must be taken 1 hour after or 4-6 hours before using Biseptol 480;
  • oral contraceptives: their reliability decreases due to inhibition of intestinal microflora and a decrease in the enterohepatic circulation of hormonal compounds.

Between diuretics (furosemide, thiazides, etc.) and hypoglycemic drugs for oral use (sulfonylurea derivatives) on the one hand and sulfonamides on the other, a cross-allergic reaction may develop.

Analogues

Analogues of Biseptol 480 are Co-trimoxazole, Bactrim, Brifeseptol, Bi-Septin, Dvaseptol, Metosulfabol, etc.

Terms and conditions of storage

Store in a dry place at a temperature not exceeding 30 °C. Keep away from children.

Shelf life – 5 years.