Biseptol for intestinal infections. “Biseptol”: how effective is “grandmother’s” medicine for “all diseases”

At the end of the 20th century, Biseptol became such a common drug that it was used with or without a prescription for any reason, seeing it as a panacea for many ills. Today, the popularity of the medicine has begun to wane. Few people are interested in what biseptol is and what it helps with. However, this far from harmless remedy still remains in people’s minds as a cheap way to combat certain diseases. How justified is “unauthorized” treatment with Biseptol?

In the minds of Russian people, the most dangerous drugs in terms of side effects are antibiotics. In this regard, the question arises: is biseptol an antibiotic or not? Can I take it without a prescription?

The medicine belongs to the group of antiseptics, i.e. antibacterial drugs. The active ingredients in it are:

sulfamethoxazole (suppresses the reproduction and growth of bacteria);
trimethoprim (increases the effect of sulfamethoxazole).

Biseptol cannot be classified as an antibiotic, since the latter are substances of natural origin, and the components of Biseptol were created in the laboratory.

Although the drug has nothing to do with antibiotics and belongs to the group of sulfonamides, you should not think that it is absolutely safe. With improper therapy, microorganisms become accustomed to the components of this product. Frequent use makes Biseptol ineffective, and the disease enters the chronic stage.

The medicine is available in several forms:

in tablets of 480 and 120 mg (the latter option is for children);
in the form of a suspension or syrup (1 teaspoon of suspension (5 ml) contains 240 mg of active substance; it must be shaken before use);
in the form of ampoules of 480 mg for injection in a hospital setting.

When is Biseptol indicated?

The spectrum of influence of this representative of sulfonamides is quite wide:

gram-positive and gram-negative bacteria;
toxoplasma;
streptococci and staphylococci;
protozoan microorganisms;
toxoplasma;
coli;
pathogenic fungi.

In this regard, the range of diseases for which a doctor can prescribe Biseptol will also be wide:

respiratory diseases: tonsillitis, pharyngitis, tonsillitis, bronchitis, sinusitis, tracheitis and others;
infectious diseases urinary tract;
gastrointestinal diseases (typhoid fever, paratyphoid fever, diarrhea and others).

The desire of many people to use Biseptol to treat colds and ARVI is not always advisable, since these diseases are caused by viruses that are not sensitive to antibacterial drugs.

But for sore throat or bacterial complications after viral diseases of the ENT and respiratory organs, the use of the drug is completely justified. In these and other cases, the question arises of how to take Biseptol and what the dosages will be.

For children from 2 months to 5 years, a suspension is used - 240 mg 2 times a day. If the child can take tablets, then 2 tablets 2 times a day with a dosage of 120 mg are recommended.

Children over 6 years old can be given tablets with a dosage of 480 mg 2 times a day. For adolescents over 12 years of age and adults, the recommended dose is 960 mg 2 times a day. Treatment should last for at least 5 days and no more than 2 weeks. If you complete therapy before the time specified by the doctor, there is a risk of the most resistant microorganisms surviving and the disease becoming chronic.

It is quite natural to prescribe biseptol for cystitis. Most cases of this disease are caused by E. coli. However, you should not try any painful sensations in the area genitourinary system cure with this medicine. Most often, fluoroquinolone drugs are prescribed for cystitis. Unjustified use of Biseptol for cystitis can lead to the survival of some microorganisms, as a result of which the disease becomes chronic.

Biseptol should only be given to children under the supervision of a doctor. Most parents do not even have a clear idea of what Biseptol is and what it helps with. If you treat babies with it uncontrollably, you can only do harm. The earliest age when children can be given biseptol is from 6 weeks.

When taking medication, you must remember the following rules:

The medicine must be taken strictly every 12 hours;
take the drug after meals;
maintain the minimum course of treatment - 5 days.

Contraindications

with liver and kidney diseases;
disorders of the hematopoietic system;
during pregnancy and lactation;
with individual intolerance to the components of the drug.

Side effects

Side effects of Biseptol include:

rash, urticaria, dermatological diseases;
diarrhea, nausea, stomatitis, loss of appetite;
intestinal dysbiosis;
candidiasis, thrush.

These side effects are common. If they occur, you must immediately stop taking the drug.

In recent studies, other adverse reactions have been noted, but they occur once in several thousand people, for example, disruption of the hematopoietic system.

Analogs

Most often in pharmacies you can find biseptol produced by Polish pharmacists. However, there are also less expensive foreign and Russian analogues:

Senexy Bactrim (France);
Co-trimoxazole (Russia);
Bi-septin (Holland);
Septrin (England).

Which biseptol analogues to choose depends on the doctor’s recommendations and the patient’s financial capabilities. Dutch products are characterized by excellent quality, but the Russian drug is much cheaper.

Biseptol is by no means a harmless remedy, and you should not use it without consulting a doctor, even though it is not an antibiotic. Negligent treatment can lead to the fact that the medicine does not help, but only harms. You need to be especially careful with children: the side effects of Biseptol and incorrectly selected therapy sometimes provoke consequences that are difficult to correct.

Biseptol is the most popular “branded” antibacterial drug from the Polish pharmaceutical plant Polfa, designed to combat mild and moderate infections of the respiratory, genitourinary and digestive tract. This is a combination drug that contains two active ingredients: sulfamethoxazole and trimethoprim. Sulfamethoxazole, similar in structure to para-aminobenzoic acid (PABA) and captured by the microbe instead, prevents the synthesis of dihydrofolic acid in microbial cells, preventing PABA from being incorporated into its molecule. Trimethoprim, in turn, potentiates the effect of sulfamethoxazole, disrupting the formation of the active form of folic acid - tetrahydrofolic acid, which is responsible for protein metabolism and bacterial cell division. Thus, the combination of sulfamethoxazole and trimethoprim (known as co-trimoxazole) causes a double blocking effect on the metabolism of infectious agents.

Biseptol has a bactericidal effect, i.e. it completely and irreversibly reduces the microbial population. Its activity is manifested against the following disruptors of the normal balance of intestinal microflora: Staphylococcus spp., Streptococcus spp. (including pneumoniae species), Neisseria spp. (including meningitidis and gonorrhoeae species, Escherichia coli, Salmonella spp. (including typhi and paratyphi species), Haemophilus influenzae (including ampicillin-resistant strains), Bacillus anthracis, Vibrio cholerae, Nocardia asteroides, Listeria spp.

Enterococcus faecalis, Bordetella pertussis, Proteus spp., Klebsiella spp., Francisella tularensis, Pasteurella spp., Mycobacterium spp. (including Mycobacterium leprae), Citrobacter, Brucella spp., Enterobacter spp., Providencia, Legionella pneumophila, certain species of Pseudomonas, Yersinia spp., Serratia marcescens, Morganella spp., Shigella spp., Chlamydia spp., (including trachomatis and psittaci species), Toxoplasma gondii, pathogenic fungi, Leishmania spp., Actinomyces israelii, Histoplasma capsulatum, Coccidioides immitis. Biseptol does not act on Pseudomonas aeruginosa, Corynebacterium spp., Mycobacterium tuberculosis, Leptospira spp., Treponema spp., as well as viruses. As an indirect negative effect of this drug on the body, one can mention the inhibition of the vital activity of Escherichia coli, which leads to the suppression of the synthesis of B vitamins, but the same can be said about other antibacterial drugs with an identical spectrum of action.

Biseptol is available in the form of a suspension for oral use and in tablets. The duration of its therapeutic effect is 7 hours. The dosage regimen and duration of antibacterial therapy are determined by the attending physician. Long-term (more than 1 month) use of the drug requires mandatory monitoring of blood counts, because a number of reversible hematological changes are possible

Pharmacology

Co-trimoxazole is a combined antimicrobial drug consisting of sulfamethoxazole and trimethoprim in a ratio of 5:1.

Sulfamethoxazole, similar in structure to para-aminobenzoic acid (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.

Both components thus disrupt the formation of folic acid, which is necessary for the synthesis of purine compounds by microorganisms, and then nucleic acids (RNA and DNA). This disrupts the formation of proteins and leads to the death of bacteria. In vitro it is a broad-spectrum bactericidal agent, but sensitivity may vary by geographic location.

Typically susceptible pathogens (minimum inhibitory concentration (MIC) less than 80 mg/l for sulfamethoxazole): Moraxella (Branhamella) catarrhalis, Haemophilus influenzae (beta-lactamase-forming and beta-lactamase-non-forming strains), Haemophilus parainfluenzae, Escherichia coli (including enterotoxogenic strains), Citrobacter spp. (including Citrobacter freundii), Klebsiella spp. (including Klebsiella pneumoniae, Klebsiella oxytoca), Enterobacter cloaceae, Enterobacter aerogenes, Hafnia alvei, Serratia spp. (including Serratia marcescens, Serratia liquefaciens), Proteus mirabilis, Proteus vulgaris, Morganella morganii. Shigella spp. (including Shigella flexneri. Shigella sonnet). Yersinia spp. (including Yersinia enterocolitica), Vibrio cholerae, Edwardsiella tarda, Alcaligenes faecalis, Burkholderia (Pseudomonas) cepacia, Burkholderia (Pseudomonas) pseudomallei.

Also, Brucella spp.. Listeria monocytogenes, Nocardia asteroides, Pneumocystis carinii, Cyclospora cayetanensis may be sensitive.

Partially sensitive pathogens (MIC 80-160 mg/l for sulfamethoxazole): coagulase-negative strains of Staphylococcus spp. (including methicillin-sensitive and methicillin-resistant strains of Staphylococcus aureus). Streptococcus pneumoniae (penicillin-sensitive and penicillin-resistant strains), Haemophilus ducreyi, Providencia spp. (including Providencia rettgeri), Salmonella typhi. Salmonella enteritidis, Slenotrdphomonas maltophilia (formerly called Xanthomonas maltophilia), Acinetobacter Iwoffii, Acinetobacter baumanii, Aeromonas hydrophila.

Resistant pathogens (MIC more than 160 mg/l for sulfamethoxazole): Mycoplasma spp., Mycobacterium tuberculosis, Treponema pallidum, Pseudomonas aeruginosa.

If the drug is prescribed empirically, it is necessary to take into account the local characteristics of drug resistance of possible pathogens of a particular infectious disease. For infections that may be caused by partially susceptible microorganisms, it is recommended to conduct a sensitivity test to exclude pathogen resistance.

Pharmacokinetics

When taken orally, absorption is rapid and almost complete - 90%. After a single dose of 160 mg of trimethoprim + 800 mg of sulfamethoxazole, the C max of trimethoprim is 1.5-3 mcg/ml, and of sulfamethoxazole is 40-80 mcg/ml. Cmax in blood plasma is reached within 1-4 hours; The therapeutic level of concentration is maintained for 7 hours after a single dose. With repeated doses with an interval of 12 hours, the minimum equilibrium concentrations are stabilized within the range of 1.3-2.8 mcg/ml for trimethoprim and 32-63 mcg/ml for sulfamethoxazole. C ss of the drug is achieved within 2-3 days.

Well distributed in the body. V d of trimethoprim is about 130 l, sulfamethoxazole is about 20 l. Penetrates through the blood-brain barrier, placental barrier and into breast milk. In the lungs and urine it creates concentrations exceeding the content in plasma. Trimethoprim penetrates slightly better than sulfamethoxazole into non-inflamed prostate tissue, seminal fluid, vaginal secretions, saliva, healthy and inflamed lung tissue, bile, while both components of the drug penetrate equally into the cerebrospinal fluid and aqueous humor of the eye. Large amounts of trimethoprim and slightly smaller amounts of sulfamethoxazole are released from the bloodstream into the interstitial and other extravasal body fluids, with concentrations of trimethoprim and sulfamethoxazole exceeding the MIC for most pathogenic microorganisms. Plasma protein binding is 66% for sulfamethoxazole and 45% for trimethoprim. Metabolized in the liver. Some metabolites have antimicrobial activity. Sulfamethoxazole is metabolized primarily by N4-acetylation and, to a lesser extent, by conjugation with glucuronic acid. Excreted by the kidneys in the form of metabolites (80% within 72 hours) and unchanged (20% sulfamethoxazole, 50% trimethoprim); Not significant amount- through the intestines. Both substances, as well as their metabolites, are excreted by the kidneys, both by glomerular filtration and tubular secretion, as a result of which the concentrations of both active substances in the urine are significantly higher than in the blood.

T1/2 of sulfamethoxazole - 9-11 hours, trimethoprim - 10-12 hours, in children - significantly less and depends on age: up to 1 year - 7-8 hours, 1-10 years - 5-6 hours.

In elderly patients and/or patients with impaired renal function (creatinine clearance (CC) 15-20 ml/min), T1/2 increases, which requires dose adjustment.

Release form

Suspension for oral administration is white or light cream in color, with a strawberry odor.

Excipients: macrogol glyceryl hydroxystearate, magnesium aluminum silicate, carmellose sodium, citric acid monohydrate, methylhydroxybenzoate, propylhydroxybenzoate, sodium saccharinate, sodium hydrogen phosphate dodecahydrate, maltitol, strawberry flavoring, propylene glycol, purified water.

80 ml - dark glass bottles (1) - cardboard packs.

Dosage

Orally, after eating with a sufficient amount of liquid.

Adults and children over 12 years of age: 960 mg every 12 hours; for severe infections - 1440 mg every 12 hours; for urinary tract infection - 10-14 days, for exacerbation of chronic bronchitis - 14 days, for traveler's diarrhea and shigellosis - 5 days. The minimum dose and dose for long-term treatment (more than 14 days) is 480 mg every 12 hours.

Children: from 2 months (or 6 weeks at birth from mothers with HIV infection) to 5 months - 120 mg, from 6 months to 5 years - 240 mg, from 6 to 12 years - 480 mg every 12 hours, which approximately corresponds to a dose of 36 mg/kg per day.

The course of treatment for urinary tract infections and acute otitis media is 10 days, for shigellosis - 5 days. For severe infections, doses for children can be increased by 50%.

For acute infections, the minimum duration of treatment is 5 days; after the symptoms disappear, therapy is continued for 2 days. If after 7 days of therapy there is no clinical improvement, the patient’s condition should be re-evaluated for possible treatment adjustment.

Soft chancre - 960 mg every 12 hours; If after 7 days healing of the skin element does not occur, therapy can be extended for another 7 days. However, the lack of effect may indicate resistance of the pathogen.

For women with acute uncomplicated urinary tract infections, a single dose of 1920-2880 mg is recommended, if possible in the evening after meals or before bed.

For pneumonia caused by Pneumocystis carinii - 30 mg/kg 4 times a day with an interval of 6 hours for 14-21 days.

For the prevention of pneumonia caused by Pneumocystis carinii, adults and children over 12 years of age - 960 mg/day. For children under 12 years of age - 450 mg/m2 every 12 hours, for 3 consecutive days every week. The total daily dose should not exceed 1920 mg. In this case, you can use the following instructions: per 0.26 m2 of body surface - 120 mg, respectively, per 0.53 m2 - 240 mg, per 1.06 m2 - 480 mg.

For other bacterial infections, the dose is selected individually depending on age, body weight, kidney function and severity of the disease, for example, for nocardiosis in adults - 2880-3840 mg/day for at least 3 months (sometimes up to 18 months). The course of treatment for acute brucellosis is 3-4 weeks, for typhoid fever and paratyphoid fever - 1-3 months.

Overdose

Symptoms: nausea, vomiting, intestinal colic, dizziness, headache, drowsiness, depression, fainting, confusion, fever, hematuria, crystalluria; with prolonged overdose - thrombocytopenia, leukopenia, megaloblastic anemia, jaundice.

Treatment: gastric lavage, forced diuresis, acidification of urine increases the excretion of trimethoprim, IM - 5-15 mg/day of calcium folinate (eliminates the effect of trimethoprim on the bone marrow), if necessary, hemodialysis.

Interaction

Increases the anticoagulant activity of indirect anticoagulants (anticoagulant dose adjustment), as well as the effect of hypoglycemic medicines and methotrexate (competes for protein binding and renal transport of methotrexate, increasing the concentration of free methotrexate).

Reduces the intensity of hepatic metabolism of phenytoin (extends its T1/2 by 39%), increasing its effect and toxic effect.

With simultaneous use of co-trimoxazole with pyrimethamine in doses exceeding 25 mg/week, the risk of developing megaloblastic anemia increases.

Diuretics (usually thiazides and in elderly patients) increase the risk of thrombocytopenia.

May increase serum digoxin concentrations, especially in elderly patients; monitoring of serum digoxin concentrations is necessary.

The effectiveness of tricyclic antidepressants when taken in combination with co-trimoxazole may be reduced.

Patients receiving co-trimoxazole and cyclosporine after kidney transplantation may experience a reversible deterioration in renal function, manifested by an increase in creatinine levels.

Medicines that inhibit bone marrow hematopoiesis increase the risk of myelosuppression.

When co-trimoxazole is used together with indomethacin, the concentration of sulfamethoxazole in the blood may increase.

One case of toxic delirium has been described after simultaneous administration of co-trimoxazole and amantadine.

When used simultaneously with ACE inhibitors, especially in elderly patients, hyperkalemia may develop.

Trimethoprim, by inhibiting the renal transport system, increases the AUC of dofetilide by 103% and the Cmax of dofetilide by 93%. With increasing concentrations, dofetilide may cause ventricular arrhythmias with prolongation of the QT interval, including torsade de pointes (TdP). The simultaneous administration of dofetilide and trimethoprim is contraindicated.

Side effects

From the nervous system: headache, dizziness, aseptic meningitis, peripheral neuritis, convulsions, ataxia, tinnitus, depression, hallucinations, apathy, nervousness.

From the respiratory system: pulmonary infiltrates: eosinophilic infiltrate, allergic alveolitis (cough, shortness of breath).

From the digestive system: nausea, vomiting, loss of appetite, diarrhea, gastritis, abdominal pain, glossitis, stomatitis, cholestasis, increased activity of liver transaminases, hepatitis (including cholestatic), hepatonecrosis, “vanishing bile duct” syndrome ( ductopenia), hyperbilirubinemia, pseudomembranous colitis, acute pancreatitis.

From the hematopoietic organs: leukopenia, neutropenia, thrombocytopenia, hypoprothrombinemia, agranulocytosis, anemia (megaloblastic, hemolytic/autoimmune or aplastic), methemoglobinemia, eosinophilia.

From the urinary system: interstitial nephritis, impaired renal function, hematuria, increased blood urea, hypercreatininemia, toxic nephropathy with oliguria and anuria, crystalluria.

From the musculoskeletal system: arthralgia, myalgia, rhabdomyolysis (mainly in patients with AIDS).

Allergic reactions: fever, angioedema, itching, photosensitivity, skin rash, urticaria, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, allergic myocarditis, conjunctival hyperemia , sclera, anaphylactic/anaphylactoid reactions, serum sickness, hemorrhagic vasculitis (Henoch-Schönlein purpura), periarteritis nodosa, lupus-like syndrome.

Other: hyperkalemia (mainly in AIDS patients during treatment of Pneumocystis pneumonia), hyponatremia, hypoglycemia, weakness, fatigue, insomnia, candidiasis.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

respiratory tract infections: chronic bronchitis (exacerbation), Pneumocystis pneumonia (treatment and prevention) in adults and children;
ENT infections: otitis media (in children);
genitourinary infections: urinary tract infections, chancroid;
gastrointestinal infections: typhoid fever, paratyphoid fever, shigellosis (caused by sensitive strains of Shigella flexneri and Shigella sonnei);
traveler's diarrhea caused by enterotoxic strains of Escherichia coli, cholera (in addition to fluid and electrolyte replacement);
other bacterial infections (possibly combined with antibiotics): nocardiosis, brucellosis (acute), actinomycosis, osteomyelitis (acute and chronic), South American blastomycosis, toxoplasmosis (as part of complex therapy).

Contraindications

liver and/or renal failure (creatinine clearance less than 15 ml/min);
aplastic anemia, B 12 deficiency anemia, agranulocytosis, leukopenia;
deficiency of glucose-6-phosphate dehydrogenase;
simultaneous use with dofetilide;
lactation period;
children up to 2 months or up to 6 weeks at birth from a mother with HIV infection;
hypersensitivity to sulfonamides, trimethoprim and/or other components of the drug.

With caution: dysfunction of the thyroid gland, history of severe allergic reactions, bronchial asthma, folic acid deficiency, porphyria, pregnancy.

Features of application

Use during pregnancy and breastfeeding

During pregnancy, the drug should be prescribed only if the expected benefit from its use outweighs the possible risk to the fetus, since both trimethoprim and sulfamethoxazole cross the placental barrier and thus can affect folic acid metabolism.

In late pregnancy, the use of the drug should be avoided due to the possible risk of developing kernicterus in newborns.

Due to the fact that trimethoprim and sulfamethoxazole pass into breast milk, the use of co-trimaxazole during lactation is contraindicated.

Pregnant women receiving the drug are recommended to take 5 mg of folic acid per day.

Use for liver dysfunction

Contraindicated:

liver failure.

Use for renal impairment

Contraindicated:

renal failure (creatinine clearance less than 15 ml/min).

Use in children

Contraindicated:

children up to 2 months or up to 6 weeks at birth from a mother with HIV infection.

Special instructions

Co-trimoxazole should be prescribed only in cases where the advantage of such combination therapy over other antibacterial monotherapy drugs outweighs the possible risk.

Because the sensitivity of bacteria to antibacterial drugs in vitro varies across different geographic areas and over time, local patterns of bacterial susceptibility should be taken into account when selecting a drug.

With long 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/day), which does not significantly impair the antimicrobial activity of the drug.

Particular caution should be exercised when treating elderly patients or patients with suspected underlying folate deficiency.

The administration of folic acid is also advisable for long-term treatment in high doses.

If there is a significant decrease in the number of any blood cells, the drug should be discontinued.

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

For long-term courses (especially in cases of renal failure), it is necessary to regularly conduct a general urine test and monitor kidney function.

The likelihood of toxic and allergic complications of sulfonamides increases significantly with a decrease in the filtration function of the kidneys. At the first appearance of skin rash or any other severe adverse reaction, the drug should be discontinued.

If cough or shortness of breath suddenly appears or worsens, the patient should be re-examined and discontinuation of drug treatment should be considered.

Excessive sunlight and ultraviolet radiation should be avoided.

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

Cases of pancytopenia have been described in patients taking co-trimoxazole.

Trimethoprim has low affinity for human dehydrofolate reductase, but may increase the toxicity of methotrexate, especially in the presence of other risk factors such as old age, hypoalbuminemia, renal impairment, bone marrow suppression. Such adverse reactions are more likely if methotrexate is prescribed in large doses. To prevent myelosuppression, it is recommended to prescribe folic acid or calcium folinate to such patients.

Trimethoprim disrupts phenylalanine metabolism, but this does not affect patients with phenylketonuria provided they follow an appropriate diet.

Patients whose metabolism is characterized by “slow acetylation” are more

The duration of treatment should be as short as possible, especially in elderly and senile patients.

Co-trimoxazole and, in particular, trimethoprim, which is part of it, can affect the results of determining the concentration of methotrexate in serum, carried out by the competitive protein binding method using bacterial dihydrofolate reductase as a ligand. However, when methotrexate is determined by the radioimmune method, interference does not occur.

Trimethoprim and sulfamethoxazole can affect the results of the Jaffe test (determination of creatinine by reaction with picric acid in an alkaline medium), and in the normal range the results are overestimated by approximately 10%.

Impact on the ability to drive vehicles and operate machinery

Considering the possibility of developing significant side effects, during the treatment period it is necessary to be careful when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Biseptol is a potent combined antibacterial agent. The drug actively destroys coccal flora, including gram-positive and gram-negative pathogens. Let's look at how to take Biseptol correctly for adults and children, what diseases it helps with, and in which cases it is better to postpone its use.

Biseptol - composition, dosage forms

The bactericidal agent Biseptol contains two active ingredients - sulfamethoxazole and trimethoprim. The concentration of these substances in one therapeutic dose depends on the form of release of the drug.

Biseptol is produced in three pharmaceutical forms:

Tablets are round, flat-shaped tablets with a smooth surface, with “-Bs” engraved on one side. The amount of sulfamethoxazole varies from 100 to 400 ml, and trimethoprim from 20 to 80 ml. The composition additionally includes starch, alcohol, talc, propylene glycol.
The suspension is a cream-colored syrup for children with a light strawberry flavor. The product is recommended for children from 2 months to 12 years weighing no more than 80 kg. Biseptol is contraindicated for premature babies.
Concentrate for infusion is a colorless liquid in ampoules that requires preliminary dilution before intravenous administration. The substance is diluted immediately before the dropper. The contents of the ampoule are intensively mixed with the solution for infusion.

Biseptol is active against streptococci, pneumococci, staphylococci, chlamydia, E. coli, and meningococci. The drug is not effective against tuberculosis, leptospirosis and viral diseases. The medicinal effect of the drug is due to its ability to stop the synthesis of folic acid, without which the coccal flora is not able to reproduce.

Biseptol - indications and contraindications

Biseptol is prescribed for infectious diseases caused by microbes sensitive to the drug:

Bronchitis (all forms).
Pneumonia (except viral).
Bronchiectasis.
Angina.
Urethritis.
Otitis.
Pyelonephritis.
Sinusitis.
Cystitis.
Pharyngitis.
Prostatitis.
Brucellosis.
Typhoid fever.
Toxoplasmosis.
Cholera.
Bacterial diarrhea.
Osteomyelitis.

Biseptol is not used in the following cases:

Intolerance to the components of the drug.
Liver damage (hepatitis, porphyria, liver failure).
Blood diseases.
Kidney failure.
Taking a course of chemotherapy.

Dosage and duration of treatment with Biseptol in adults and children

The regimen for taking Biseptol depends on age, body weight and dosage form.

Pills. For the age category “12+”, it is recommended to take 2 tablets at a dose of 400 mg/80 ml or 8 tablets 100 ml/20 ml twice a day. In case of severe inflammatory process the daily dose is increased to 3 or 12 tablets twice a day. The course of treatment is 14 days. For children from 6 to 12 years old, the daily dose is calculated taking into account body weight - 30 ml of sulfamethoxazole per kg.

Suspension. The dose for a child is measured using a measuring cup according to age and taken every 12 hours:

From 2 to 5 months. - 2.5 mg.
From 6 months up to 5 years - 5 mg.
From 6 to 12 years - 10 mg.

The duration of antibacterial therapy depends on the type of disease and is 5-14 days.

Biseptol - possible complications after treatment

Side effects are rarely recorded and, as a rule, are allergic in nature or manifest themselves in the form of digestive disorders. In addition, the following complications may rarely occur:

Changes in the blood formula and disorders of the lymphatic system (anemia, leukopenia).
Allergic processes (rash, bronchospasm, drug-induced fever, urticaria, swelling).
Violations metabolic processes(hyperkalemia, hypercalcemia, sodium deficiency, anorexia).
Mental disorders (psychosis, insomnia, anxiety, fatigue).
Problems with the nervous system (tinnitus, seizures, dizziness, migraine).
Digestive disorders (diarrhea, gastritis).

The use of Biseptol should be monitored by a doctor, since an incorrectly selected dosage can provoke the disease to become chronic or cause a number of serious complications.

Biseptol is a combination drug from the sulfonamide group. It contains sulfamethoxazole and trimethoprim. Biseptol is a drug with a wide spectrum of action. This is a bactericidal drug (it causes the death of microbial cells), but it is not an antibiotic. The effect of the drug is due to the fact that it blocks the synthesis of folic acid, without which the microbial cell cannot divide. Sulfamethoxazole and trimethoprim complement and enhance each other in this mechanism.

Biseptol is active against the following pathogens: staphylococci, streptococci, pneumococci, dysentery bacillus, typhoid bacilli, Proteus, Escherichia coli, salmonella, pneumocystis, plasmodium, leishmaniasis pathogen, meningococci, Vibrio cholerae, actinomycetes, Klebsiella, chlamydia, diphtheria pathogen, okki and some species mushrooms

The drug is ineffective against Pseudomonas aeruginosa, the causative agent of leptospirosis, the causative agent of tuberculosis, spirochetes and viruses.
Biseptol also has an effect on microorganisms that are resistant to other sulfonamide drugs.

Biseptol is quickly and well absorbed from the stomach and reaches maximum concentration in the blood 1-3 hours after administration. The therapeutic concentration of the drug is maintained for up to 7 hours.

The drug penetrates well into biological fluids and tissues of the body: bile, saliva, cerebrospinal fluid, sputum, prostate gland, kidneys, lungs. It is excreted from the body mainly in urine.

Release forms

Biseptol is available in the form of tablets, suspension and concentrate for injection:

Tablets 120 mg (100 mg sulfamethoxazole and 20 mg trimethoprim);
Tablets 480 mg (400 mg sulfamethoxazole and 80 mg trimethoprim);
Tablets "Bactrim forte" 960 mg (800 mg sulfamethoxazole and 160 mg trimethoprim);
Syrup (or suspension) - for oral administration 100 ml (in 1 ml - 40 mg of sulfamethoxazole and 8 mg of trimethoprim);
Concentrate for the preparation of solution for injection 480 mg (in 1 ml of concentrate - 80 mg of sulfamethoxazole and 16 mg of trimethoprim).

The drug should be stored in a dry place and at a temperature not exceeding +25 o C.

Instructions for use of Biseptol

Indications for use

Biseptol is used to treat infections caused by microorganisms sensitive to this drug:

diseases of the respiratory tract (bronchitis in acute and chronic form; pneumonia; pleural empyema - purulent inflammation of the membranes of the lungs; abscess or abscess of the lung; bronchiectasis - expansion of the lumen of the bronchi due to disease);
ENT pathology (otitis, or inflammation of the ear; sinusitis, or inflammation of the paranasal sinuses);
intestinal infections (dysentery, paratyphoid A and B, cholera, typhoid fever);
infections of the genitourinary organs (urethritis - inflammation of the urethra; prostatitis - inflammation of the prostate gland; pyelonephritis - inflammation of the renal pelvis and kidney tissue itself; salpingitis - inflammation of the uterine appendages);
gonorrhea (venereal disease);
infections of soft tissues and skin (pyoderma, or pustular skin lesions; acne; boil, or boil);
meningitis (inflammation of the meninges) and abscess (abscess) of the brain;
septicemia (a form of blood poisoning);
infectious diseases: brucellosis, malaria, toxoplasmosis, borreliosis, scarlet fever;
wound infections and osteomyelitis;
prevention and treatment of Pneumocystis pneumonia in HIV-infected patients.

Contraindications

Biseptol is not used for treatment in the following cases:

with severe cardiovascular insufficiency;
for diseases of the hematopoietic organs;
with severe renal failure;
mothers when breastfeeding;
with deficiency of glucose-6-phosphate dehydrogenase (hereditary disease);
children under 3 months of age and premature babies;
with elevated bilirubin levels in children;
in case of hypersensitivity to the components included in the drug or to other sulfonamide drugs.

Biseptol can be used with caution if the patient has previously had allergies to other drugs; for bronchial asthma; patients with folic acid deficiency; for diseases of the thyroid gland; in early childhood and in old age.

Treatment with Biseptol should be carried out under medical supervision and blood tests should be carefully monitored.

Side effects

Biseptol is usually well tolerated. But, like any medicine, it can have side effects:

From the digestive system: in rare cases - diarrhea, abdominal pain, loss of appetite, nausea, vomiting; in isolated cases - colitis (inflammation of the intestines); reactive inflammation of the liver with stagnation of bile - cholestatic hepatitis; glossitis - inflammation of the tongue; stomatitis – inflammation of the oral mucosa; pancreatitis – inflammation of the pancreas.
From the nervous system in some cases: dizziness, headache, depression, slight trembling of the fingers.
On the part of the kidneys in rare cases: increased volume of urine, inflammation of the kidneys (nephritis), bleeding in the urine.
From the respiratory system: bronchospasm, cough, suffocation or feeling of lack of air.
On the part of the hematopoietic organs in isolated cases: a decrease in the number of leukocytes in the blood, a decrease in the number of neutrophils (a type of leukocytes that protect the body from infections), a decrease in platelets (blood platelets involved in blood clotting), folate deficiency anemia.
From the skin: skin rashes in the form of urticaria; itching; in isolated cases - Lyell's syndrome and Stevens-Johnson syndrome (the most severe types of allergic manifestations on the skin and mucous membranes with necrosis and rejection); Quincke's edema (local or diffuse swelling of the subcutaneous tissue and mucous membranes); increased sensitivity to ultraviolet rays.
Isolated cases of chills and fever have been reported after taking Biseptol (drug fever).
Pain in joints and muscles.
Thrombophlebitis (at the injection site).
Reduced potassium, sodium and blood sugar levels.

Side effects are usually mild and disappear after discontinuation of the medication.

With long-term use (more than 5 days) and when using higher dosages, as well as when changes occur in the blood test during treatment, you should take folic acid 5-10 mg per day.

Drug interactions
Biseptol should not be taken simultaneously with Aspirin, Butadion, Naproxen.

Biseptol enhances the effect of drugs that reduce blood clotting, for example, Warfarin.

Biseptol enhances the effect of some antidiabetic drugs (Gliquidone, Glibenclamide, Glipizide, Chlorpropamide, Gliclazide).

Biseptol increases the activity of the antitumor drug Methotrexate and the anticonvulsant drug Phenytoin.

Biseptol is not recommended to be prescribed simultaneously with thiazide diuretics (Chlorothiazide, Diuril, Naturetin, Metolazone, Diukardin, Furosemide, etc.) - this increases bleeding.

Biseptol in combination with diuretics, as well as with the antidiabetic drugs listed above, can cause a cross-allergic reaction.

Hexamethylenetetramine, ascorbic acid and other drugs that acidify urine increase the risk of the formation of “sand” in the urine when used simultaneously with Biseptol.

Biseptol may increase the concentration of digoxin in the blood in elderly patients.

The simultaneous use of Biseptol and Pyrimethamine (an antimalarial drug) increases the risk of anemia.

Benzocaine, Procaine (drugs for local anesthesia) reduce the effectiveness of Biseptol.

Biseptol dosage
The dose of the drug and duration of administration are prescribed by the doctor individually, depending on the severity of the condition and concomitant diseases.

Adult patients are usually prescribed 960 mg 2 times a day (2 tablets of 480 mg or 1 tablet of forte 2 times) every 12 hours for 5-14 days.

If long-term treatment is necessary, 480 mg is prescribed 2 times a day (1 tablet 480 mg 2 times).

Biseptol suspension is prescribed to adults, 20 ml every 12 hours.

In case of severe disease (sometimes with a chronic disease), the dose can be increased to 50%.

Both with a duration of treatment of more than 5 days, and with an increase in the dose of Biseptol, it is necessary to monitor a general blood test.

But microbes adapt to drugs that are frequently used, and over time they lose sensitivity to these drugs; the medications stop working. This happened with Biseptol. Therefore, the attitude towards the prescription of Biseptol for cystitis is very restrained at the present time.

The correct tactics for treating cystitis is to select medications according to their sensitivity. For this purpose, urine culture is prescribed for microflora and its sensitivity to drugs. The doctor will receive the result 3-4 days after the test and will select the correct treatment.

In some cases, the doctor initially prescribes Biseptol, and after receiving the result of the sensitivity of the flora to drugs, if necessary, changes the treatment. Sometimes Biseptol is prescribed due to intolerance to antibiotics or other medications. Biseptol is prescribed in the usual dosage (2 tablets 2 times a day) for 5-10 days.

Analogs and synonyms of Biseptol

It is necessary to distinguish between drug analogues and drug synonyms.

Analogues are medicines that contain different active ingredients and have different names, but are used in the treatment of the same diseases, because have the same effect. Analogs may differ in potency, tolerability of the drug, contraindications, and side effects.

Analogues of Biseptol are antibiotics of different groups, because they also have an antimicrobial effect. Depending on the sensitivity of the pathogen and the spectrum of action, antibiotics are used to treat the same diseases as Biseptol.

Other sulfonamide drugs are analogues of Biseptol:

Asacol (active ingredient: mesalazine);
Dermazin (active ingredient: sulfadiazine);
Inhalipt (active ingredients: streptocide, sodium sulfathiazole);
Ingaflu (active ingredient: streptocide) and other sulfonamide drugs.

Synonymous drugs are drugs with the same active ingredients, but have different names, because are produced by different companies. These are generic drugs. They may differ in dosage forms, but have the same pharmacological properties.

Synonymous drugs for Biseptol: Bactrim, Bacterial, Bactramin, Abatsin, Andoprim, Baktifer, Abactrim, Bactramel, Hemitrin, Bactrizol, Ectapprim, Berlocid, Bactitsel, Doctonil, Ekspectrin, Gantrin, Falprin, Methomide, Infectrim, Primazole, Microcetim, Oradin, Potesept, Oribakt, Resprim, Sumetrolim, Septotsid, Uroxen, Bactecode, Trixazole, Trimexazole, Blackson, Vanadil, Aposulfatrin, Bactreduct, Groseptol, Cotrimol, Cotribene, Eriprim, Primotren, Sulfatrim, Rancotrim, Expazol, Novotrimed, Oriprim, Cotrimaxol, Cotrimaxazole, Sinersul, Sulotrim, Trimosul.

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 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 mortality 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 the form of syrup 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 case of 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.

Analogs

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.