Disease-causing bacteria are present in the surrounding space of a person, and therefore in his body. Immune cells do not allow pathogenic microflora to develop, but when immunity is weakened or other factors, microbes begin to actively multiply in the body, causing various diseases.

Among the pathogens are bacteria, viruses, fungi. Since these are different biological objects, then treatment should be prescribed in accordance with the pathogen. The doctor prescribes the medicine that will be effective in the fight against this or that microbe. One of the most commonly prescribed antibacterial drugs is Biseptol. What Biseptol helps from and how to take it, we will consider in the article.

For the treatment of various inflammatory diseases, two types of drugs are prescribed: antibacterial and antimicrobial. The former contain substances that kill bacterial cells, while the latter inhibit protein synthesis in the enemy cell and stop its vital activity.

The active ingredients of Biseptol do not have components present in the natural environment, and therefore the drug does not belong to the group of antibiotics. In other words, the drug is completely synthetic.

Composition of the medicine:

• sulfamethoxazole - the main active ingredient, stops the growth and development of bacteria;
• trimetroprin - has an auxiliary effect, prevents the restoration and reproduction of pathogenic microflora.

Co-trimosol is synonymous with sulfonamides. It is found in Trimethoprim, an antibiotic widely used to treat diseases of the urinary system.

Pharmachologic effect:

The bacteriostatic property of the drug is achieved by blocking biosynthesis with active substances folic acid in bacteria cells. Folic acid is involved in metabolic processes in which the protein of the microbe is synthesized with the help of nucleic acids. Violation of biochemical reactions in the cell leads to a stop of reproduction and to its death from the inside.

Biseptol actively affects the following microorganisms:

• gram-positive and gram-negative bacteria;
• protozoa;
• staphylococci;
• toxoplasma;
• streptococci;
• mushrooms;
• Escherichia coli.

The pathogenic microflora that causes syphilis and tuberculosis is resistant to sulfonamides.

Indications for use

Biseptol is indicated for the treatment of infectious diseases caused by microorganisms sensitive to the active substances of the component. Asking the question: "What helps Biseptol?" it should be understood that you cannot self-medicate. It is only the doctor who can correctly determine whether the drug will be effective or not after examining the patient.

• The medicine helps with inflammatory diseases of the respiratory system: rhinitis, bronchitis, pharyngitis, pneumonia, laryngitis and others.
• Bispetol is often prescribed for infectious lesions of the genitourinary system: prostatitis, inflammation of the uterine appendages, pathological processes in the kidneys, bladder, urethra.
• The drug is effective for treating the digestive system: inflammation of the pancreas (pancreatitis), inflammatory processes in the small and large intestine (enterocolitis), gastritis.
• Biseptol is prescribed for pathologies of the ENT organs, accompanied by infection: inflammation of the maxillary sinuses (sinusitis), inflammatory processes occurring in the inner and outer ear (otitis media), purulent inflammation in the tonsils.

Therapeutic effect on prostatitis

Biseptolum for prostatitis is one of the most powerful medicines to fight the disease. It is prescribed if the pathology prostate has an infectious nature. The active ingredients of the drug penetrate deep into the tissues of the prostate, stopping the development of pathogenic bacteria. A decrease in the number and activity of bacteria reduces pain, prostate edema, eliminates other symptoms.

note

Treat prostatitis with Biseptol only on the recommendation of a doctor. Self-medication can be useless or even harmful. After the examination, the specialist will calculate the dosage that will be optimal.

It is necessary to take the drug for inflammation in the prostate for at least two weeks. The doctor prescribes the maximum dosage for the first few days, which is then reduced. After 2-3 days, the patient feels relief from the condition, but it is important not to interrupt the course of treatment, since bacteria can develop resistance to the drug. This, in turn, can lead to chronic prostatitis that is difficult to treat.

Some patients believe that since Biseptol is not an antibiotic, then it can be taken uncontrollably, but this is not the case. The drug has serious side effects, and an increased dose of the drug will not cure prostatitis faster. It is necessary to follow the treatment regimen for inflammation of the prostate and follow all the doctor's recommendations.

Therapeutic effect on other pathologies

Biseptol is prescribed for many inflammatory diseases of the respiratory system and ENT organs. And, at times, people believe that it can be taken for acute respiratory infections, but in this case, the drug is useless, since these diseases are caused by viruses. But angina, tonsillitis, sinusitis and other diseases complicated by bacterial microflora, Biseptol heals perfectly.

In the case of diseases of the genitourinary sphere and intestines - the same situation. In order to understand whether Biseptol is needed, the cause of the painful conditions should be determined. If it is bacteria, then the use of the medication is justified.

Care should be taken with Biseptol treatment when it comes to children. Even if in the past the doctor prescribed a drug for the treatment of, for example, sore throats, then in case of a second illness, in no case should the child be given the medicine on his own.

Otherwise, the bacteria will become resistant, and sore throat will appear again and again.

The therapeutic effect of sulfonamides on different organs is manifested in the same way, since the principle of action on bacterial cells is the same. But the doctor determines the dosage and course of treatment individually.

Before you start taking the drug, you must exclude contraindications. Biseptol is not used in the following cases:

• anemia ( low level folic acid);
• hypersensitivity to active substances;
• pregnancy and lactation;
• severe renal dysfunction;
• childhood hyperbilirubinemia;
• damage to the liver parenchyma;
• at risk of developing hemolysis.

When taking the drug, care must be taken to persons suffering from bronchial asthma and pathologies in the thyroid gland.

The drug can negatively affect various body systems: nervous, respiratory, digestive, musculoskeletal, hematopoietic system.

Taking the drug may be accompanied by the following side effects:

• dizziness and headache;
• depression, apathy and peripheral neuritis;
• abdominal pain, nausea, diarrhea, vomiting;
• hives, rash, erythema;
• cough, choking, bronchospasm;
• anemia, neutropenia, agranulocytosis, thrombocytopenia;
• an increase in the concentration of urea, impaired renal function;
• myalgia, arthralgia.

How to take Biseptol for children and adults

For ease of use, Biseptol is available in different dosage forms.

1. Tablet form available in two dosages:
   • 120 mg - for children;
   • 480 mg - for adults.
2. Suspension for children with strawberry scent in a bottle of 80 ml. 1 dose - 5 ml contains 240 mg of active substances.
3. Concentrate for solution preparation for the purpose of carrying out infusions. 1 ampoule contains 480 mg of active substances.

How to take Biseptol and in what dosage forms depends on the disease and the patient's age.

Treatment in adolescents and adults:

The minimum dose for treatment over 14 days is 480 mg every 12 hours. The standard dosage is 960 mg twice a day, with severe infections the dose is increased to 1440 mg every 12 hours.

• Treatment for infections respiratory tract and ENT organs is ten days.
• Treatment of inflammatory diseases of the genitourinary system is from fourteen to twenty-one days.
• Diseases of the gastrointestinal intestinal tract they are treated for at least five days.
• Therapy infectious diseases genitals (chancre) spend from seven to fourteen days.
• For the treatment of acute urinary tract infections in women, "shock" therapy is carried out, in which a single dose is up to 2880 mg.
• Pneumonia is treated at 960 mg twice a day. The individual dosage is calculated as 30 mg / kg.
• Nocardiosis is treated at a dosage of 2880 mg for at least three months, acute brucellosis - four weeks, typhoid fever - three months.

How to drink Biseptol tablets and suspensions?

How to drink Biseptol in tablets is detailed in the instructions for use for the drug.

The tablets are drunk every 12 hours, so the medication should be taken in the morning and in the evening. You need to take the drug only after meals, the pill is washed down with plenty of clean water.

Do not drink the medicine on an empty stomach, otherwise it can cause side effects.

Treatment in children

Up to five years, the drug is prescribed in a standard dosage of 240 mg in the morning and evening. Six to twelve years old - 480 mg twice a day. The duration of treatment is seven days.

For children from two months of age to six months, at birth from a mother infected with HIV, the dosage is 120 mg.

For children, Biseptol is most often prescribed for treatment intestinal infections, tonsillitis, otitis media, laryngitis and other infectious diseases of the respiratory tract.

The syrup is used from the age of two months, and the 120 mg tablets - from the age of two.

With an individual dosage, the suspension is calculated based on 36 mg of the drug per 1 kg of body weight.

How to drink Biseptol in suspension?

The medicine should be given to the child after a meal, it is advisable to observe the time interval between taking the suspension, which is 12 hours. The medicine is drawn with a special measuring syringe through the neck of the bottle. Before collecting the suspension, the bottle must be shaken well to shake the liquid. There are special divisions on the syringe that determine the dosage.

Suspension Biseptol has a pleasant berry taste, so children drink it easily. If the child wants to drink the medicine, then you can give him pure water.

It is important to give the child the medicine exactly in the dose prescribed by the doctor; in no case should you be independent in this matter.

The minimum dosage is calculated as follows:

• up to six months - 2.5 ml each morning and evening;
• up to three years of age - 2.5-5 ml twice a day;
• up to six years of age - 5-10 ml every 12 hours;
• up to twelve years old - 10 ml after 12 hours.

Prices:

• Tablets 120 mg 20 pieces - 30 rubles;
• Tablets 480 mg 28 pieces - 90 rubles;
• Suspension 240 mg / 80 ml - 120 rubles.

How do Erespal and Biseptol work together?

Biseptol does not work well with various drugs and alcohol. In case of inflammatory diseases of an infectious nature, it is prescribed first of all, if the medicine does not help, then the doctor adjusts the treatment.

Erespal is prescribed for the treatment of infectious diseases of the upper respiratory tract. The drugs have different pharmachologic effect on the body, therefore, the attending physician will best answer the question of combining Erespal and Biseptol.

Biseptol is a combination drug wide range actions. Belongs to the group of sulfonamides.

Release form and composition

Biseptol is available in the following dosage forms:

• Tablets 120 mg. One tablet of Biseptol 120 contains 100 mg of sulfamethoxazole and 20 mg of trimethoprim. The auxiliary components of the drug include magnesium stearate, talc, polyvinyl alcohol, potato starch, propylene glycol, aseptin P and aseptin M. Tablets are packed in contour blisters of 20 pieces, one blister in a cardboard box;
• Tablets 480 mg. One tablet of Biseptol 480 contains 400 mg of sulfamethoxazole and 80 mg of trimethoprim. The auxiliary components of the drug include magnesium stearate, talc, polyvinyl alcohol, potato starch, propylene glycol, aseptin P and aseptin M. Tablets are packed in contour blisters of 20 pieces, one blister in a cardboard box;
• Suspension for oral administration. It is white or light cream in color with a strawberry scent. 5 ml of Biseptol suspension contains 200 mg of sulfamethoxazole, 40 mg of trimethoprim and auxiliary components: magnesium-aluminum silicate, sodium hydrogen phosphate, Cremophor RH 40, sodium salt carboxymethyl cellulose, methyl hydroxybenzoate, sodium saccharinate, citric acid, propyl hydroxybenzoate, maltitol, propylene glycol, strawberry aroma and purified water. The drug is packed in 80 ml bottles in dark glass, one bottle in a cardboard box;
• Concentrate for the preparation of solution for infusion in ampoules of 5 ml. 1 ml of the concentrate contains 80 mg of sulfamethoxazole and 16 mg of trimethoprim. 10 ampoules in a cardboard box.

Indications for use

According to the instructions, Biseptol is used to treat diseases of an infectious and inflammatory nature, which are caused by microorganisms that are sensitive to the drug. Among them:

• Sinusitis;
• Otitis;
• Pneumonia, bronchitis, pleural empyema and lung abscess;
• Urethritis, prostatitis, pyelonephritis, salpingitis, gonorrhea;
• Diarrhea, cholera, paratyphoid fever, typhoid fever, bacterial dysentery;
• Pyoderma and furunculosis.

Contraindications

Contraindications to the use of Biseptol are:

• Severe renal failure;
• An established defect in the liver parenchyma;
• Severe blood diseases (leukopenia, agranulocytosis, B 12 deficiency anemia, megaloblastic anemia, aplastic anemia and anemia caused by vitamin B 9 deficiency);
• Severe renal dysfunction (if it is not possible to control the concentration of Biseptol in the blood plasma);
• Deficiency of the enzyme glucose-6-phosphate dehydrogenase (due to the risk of hemolysis);
• Hyperbilirubinemia in children;
• The period of pregnancy and breastfeeding;
• Children under the age of 3 (for dosage form in the form of tablets);
• Hypersensitivity to drug components and / or sulfonamides.

Caution is required for the use of Biseptol in patients with bronchial asthma, diseases thyroid gland and folate deficiency.

Method of administration and dosage

The tablets are taken orally after meals. According to the instructions, Biseptol is prescribed in the following dosage:

• Children 2-5 years old - 240 mg twice a day;
• Children 6-12 years old - 480 mg twice a day;
• Adults and children over 12 years old - 960 mg twice a day (with long-term course treatment - 480 mg twice a day).

The duration of therapy is 5-14 days. For chronic infections and / or severe course diseases can be increased single dose by 30-50%.

With a course of treatment for more than 5 days and / or an increase in the dosage of Biseptol, it is necessary to control the parameters of peripheral blood. In case of pathological changes, folic acid should be prescribed at a dose of 5-10 mg per day.

Suspension Biseptol, according to the instructions, is prescribed at the rate of 30 mg of sulfamethoxazole and 6 mg of trimethoprim per 1 kg of body weight per day:

• Children 3-6 months old - 2.5 ml twice a day;
• Children 7-36 months - 2.5-5 ml twice a day;
• Children 4-6 years old - 5-10 ml twice a day;
• Children 7-12 years old - 10 ml twice a day;
• Adults and children over 12 years old - 20 ml twice a day.

The duration of the course of treatment is 10-14 days (5 days with shigellosis). For infections caused by the pathogen Pneumocystis carinii, the dosage is 120 mg / kg per day; Biseptol is taken every 6 hours for 2-3 weeks.

If there is no possibility of taking the drug inside, as well as in case of severe infections, intravenous drip or intramuscular administration of Biseptol is used.

Side effects

The negative side effects when using Biseptol include:

• Nausea and vomiting, loose stools, cholestatic hepatitis and pseudomembranous colitis;
• Reversible neutropenia, leukopenia, thrombocytopenia, megaloblastic anemia, and agranulocytosis;
• Lyell and Stevens-Johnson syndrome;
• Nephritis and hematuria;
• Dizziness, depression and headache.

As a rule, all side reactions are mild and disappear after drug withdrawal.

special instructions

If, when using Biseptol, a skin rash appears or severe diarrhea occurs, the drug should be canceled.

Due to the risk of developing urolithiasis and crystalluria, adequate fluid intake should be ensured for the entire period of treatment.

With angina caused by streptococcus, the appointment of Biseptol is not indicated.

Analogs

The structural analogs of Biseptol include a number of drugs: Abacin, Abaktrim, Bactifer, Bacterial, Bactrim, Bactrizol, Bacticel, Berlocid, Bactekod, Blexon, Groseptol, Vanadil, Infektrim, Doktonil, Microcetim, Metomid, Novotrimed, Cotrimax, Cotribazole Oribakt, Potespet, Primazol, Primedit, Sulotrim, Sinersul, Sulfatrim, Trimosul, Trixazol, Resprim, Rankotrim, Uroxen, Eriprim, Falprin, etc.

Terms and conditions of storage

According to the instructions, Biseptol should be stored at a temperature not exceeding 25 ° C out of the reach of children. The shelf life of the drug is 5 years.

Biseptol is a drug (tablets) that corresponds to the group of antimicrobial drugs for systemic use. Important features of the medicinal product from the instructions for use:

• Sold by prescription only
• During pregnancy: contraindicated
• When breastfeeding: contraindicated
• In childhood: with caution
• For violations of liver function: contraindicated
• In case of impaired renal function: with caution

Package

Biseptol is a combined antibacterial drug.

Release form and composition

Forms of release of Biseptol:

• tablets of 120 and 480 mg: flat, round, yellowish (in blisters of 20 pcs., 1 blister in a cardboard box);
• oral suspension: light cream, with the smell of strawberries (in dark glass bottles of 80 ml, 1 bottle in a cardboard box).

1 tablet contains:

• sulfamethoxazole - 100 mg or 400 mg;
• trimethoprim - 20 mg or 80 mg.

5 ml of suspension contains:

• sulfamethoxazole - 200 mg;
• trimethoprim - 40 mg.

Pharmacological properties

Pharmacodynamics

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

Sulfamethoxazole is structurally similar to PABA (para-aminobenzoic acid), in bacterial cells it disrupts the synthesis of dihydrofolic acid, which prevents the incorporation of PABA into its molecule.

Trimethoprim enhances the action of sulfamethoxazole, which occurs due to a violation of the reduction of dihydrofolic acid to tetrahydrofolic acid, which is an active form of folic acid, which is responsible for microbial cell division and protein metabolism.

With the combined action of the components, the process of formation of folic acid is disrupted, which is required for the synthesis of purine compounds by microorganisms, and then nucleic acids - DNA and RNA (deoxyribonucleic and ribonucleic acids). This leads to a violation of the formation of proteins and the death of bacteria.

Biseptol is a broad-spectrum bactericidal agent, but its sensitivity may depend on geographic location.

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

Also, sensitivity to Biseptol can be manifested by Listeria monocytogenes, Cyclospora cayetanensis, Nocardia asteroides, Pneumocystis carinii, Brucella spp.

Partially sensitive pathogens (MIC for sulfamethoxazole - 80–160 mg / l): coagulase-negative strains of Staphylococcus spp. (including methicillin-susceptible and methicillin-resistant strains of Staphylococcus aureus), Streptococcus pneumoniae (penicillin-resistant and penicillin-susceptible strains), Aeromonas hydrophila, Acinetobacter baumannii, Acinetobacter lwoffii, Haemophilus, Provyphilus (including Providencia rettgeri), Salmonella enteritidis, Salmonella typhi, Stenotrophomonas maltophilia (Xanthomonas maltophilia).

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

When empirically prescribing Biseptol, local characteristics of resistance to its effects of possible causative agents of a specific infectious disease should be taken into account. In the treatment of infections that can be caused by partially sensitive microorganisms, a sensitivity test is recommended to exclude the resistance of the pathogen.

Pharmacokinetics

Absorption of Biseptol when taken orally is fast and almost in full (90%).

After a single use of 160 mg of trimethoprim + 800 mg of sulfamethoxazole C max (maximum concentration of the substance) of trimethoprim and sulfamethoxazole is 1.5-3 μg / ml and 40-80 μg / ml, respectively. The time to reach C max in blood plasma is from 1 to 4 hours. After a single dose, the therapeutic level of concentration is maintained for 7 hours. With repeated use with an interval of 12 hours, the minimum C ss (equilibrium concentrations) are stabilized in the range of 1.3–2.8 μg / ml and 32–63 μg / ml for trimethoprim and sulfamethoxazole, respectively. C ss is achieved in 2-3 days.

Co-trimoxazole is well distributed in the body. The V d (volume of distribution) of trimethoprim and sulfamethoxazole is approximately 130 L and 20 L, respectively.

Penetrates through the blood-brain and placental barriers, as well as into breast milk. In urine and lungs, it creates concentrations that are higher than plasma concentrations.

Trimethoprim slightly better than sulfamethoxazole penetrates into non-inflamed prostate tissue, vaginal secretions, bile, seminal fluid, saliva, inflamed and healthy lung tissue. Into the watery moisture of the eye and cerebrospinal fluid both active ingredients penetrate equally well.

Trimethoprim (large amounts) and sulfamethoxazole (slightly smaller amounts) enter the interstitial and other extravasal body fluids from the bloodstream. The concentration of active substances is higher than the MIC for most pathogenic microorganisms.

Plasma protein binding: sulfamethoxazole - 66%, trimethoprim - 45%.

Metabolism takes place in the liver. Sulfamethoxazole is metabolized mainly by N4-acetylation, to a lesser extent by conjugation with glucuronic acid. Some metabolites have antimicrobial activity.

It is excreted mainly in the form of metabolites (within 72 hours - 80%) and as an unchanged substance (sulfamethoxazole - 20%, trimethoprim - 50%). A small part of the dose is excreted through the intestines.

Both substances and their metabolites are excreted by the kidneys (both by glomerular filtration and tubular secretion). As a result, the concentration of both active components in the urine significantly exceeds the concentration in the blood.

T 1/2 (half-life): sulfamethoxazole - 9-11 hours, trimethoprim - 10-12 hours. In children, this indicator is much lower and depends on age: under 1 year old - from 7 to 8 hours, 1-10 years old - from 5 to 6 hours.

In elderly patients and / or patients with impaired renal function (with creatinine clearance 15–20 ml / min) T 1/2 increases (dose adjustment is necessary).

Indications for use

According to the instructions, Biseptol is prescribed for the treatment of infections:

• genitourinary system: pyelonephritis, urethritis, salpingitis, prostatitis;
• respiratory tract: bronchitis, pneumonia, lung abscess, pleural empyema, otitis media, sinusitis;
• skin and soft tissue: pyoderma, furunculosis;
• gastrointestinal tract: dysentery, cholera, typhoid fever, paratyphoid fever, diarrhea.

Contraindications

Absolute:

• severe blood diseases, including megaloblastic anemia, aplastic anemia, B 12 deficiency anemia, leukopenia, agranulocytosis, anemia associated with folic acid deficiency;
• deficiency of glucose-6-phosphate dehydrogenase (associated with the risk of hemolysis);
• severe renal failure (with creatinine clearance less than 15 ml / min);
• diagnosed damage to the liver parenchyma (tablets);
• severe impairment of renal function in cases of inability to control the plasma concentration of the drug in the blood (tablets);
• hyperbilirubinemia in pediatric patients (tablets);
• liver failure (suspension);
• combined use with dofetilide (suspension);
• up to 8 weeks of age, or up to 6 weeks at birth from a mother with HIV infection (suspension), or up to 3 years (tablets);
• lactation period;
• pregnancy (pills);
• individual intolerance to the components of the drug and sulfonamides.

Relative (Biseptol is prescribed under medical supervision):

• thyroid disease;
• bronchial asthma;
• folic acid deficiency;
• porphyria (suspension);
• burdened history of severe allergic reactions (suspension);
• pregnancy (suspension).

Instructions for the use of Biseptol: method and dosage

The regimen for taking the drug is determined by the doctor individually. Both dosage forms should be taken before meals.

Suspension and tablets Biseptol for children over 12 years of age and adults are usually prescribed 960 mg 2 times a day, with prolonged therapy, a single dosage is reduced by 2 times. The duration of therapy is determined by the disease and ranges from 5 to 14 days.

Biseptol dosage regimen for children:

• tablets: from 6 to 12 years old - 4 tablets of 120 mg each or 1 tablet of 480 mg each; from 3 to 5 years old - 2 tablets of 120 mg;
• suspension: from 6 to 12 years - 480 mg each, from 6 months to 5 years - 240 mg each, from 2 to 5 months - 120 mg each.

The frequency of taking Biseptol is 2 times a day, observing the 12-hour interval between doses.

In the treatment of pneumonia, the dose is calculated based on body weight - 100 mg / kg / day. The interval between doses should not exceed 6 hours, the duration of therapy is 2 weeks.

In the treatment of gonorrhea, Biseptol is taken twice a day, 2000 mg (in terms of sulfamethoxazole) with an interval of 12 hours.

The standard dosage of Biseptol can be increased by 30-50% during treatment chronic diseases, and a lower dosage is usually used in cases of long-term treatment.

Side effects

The use of Biseptol can lead to disruption from various body systems:

• respiratory system: eosinophilic infiltrate, allergic alveolitis;
• nervous system: nervousness, headache, hallucinations, aseptic meningitis, dizziness, peripheral neuritis, ataxia, convulsions, depression, tinnitus, apathy;
• hematopoietic organs: anemia, neutropenia, leukopenia, eosinophilia, thrombocytopenia, hypoprothrombinemia, agranulocytosis, methemoglobinemia;
• digestive system: acute pancreatitis, stomatitis, hyperbilirubinemia, hepatonecrosis, gastritis, nausea, decreased appetite, vomiting, diarrhea, abdominal pain, glossitis, cholestasis, increased activity of hepatic transaminases, hepatitis;
• musculoskeletal system: myalgia, arthralgia, rhabdomyolysis;
• urinary system: impaired renal function, interstitial nephritis, hematuria, hypercreatininemia, crystalluria.

Also, while taking Biseptol, various allergic reactions, usually manifested in the form of fever, angioedema, pruritus, photosensitivity, skin rash, urticaria, exudative erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, conjunctival hyperemia, serum sickness, periarteritis nodosa, lupus-like syndrome.

Among others side effects during the use of Biseptol were noted: insomnia, hypoglycemia, hyperkalemia, fatigue, weakness, candidiasis.

Overdose

The main symptoms are:

• sulfamethoxazole: vomiting, nausea, intestinal colic, lack of appetite, headache, dizziness, loss of consciousness, drowsiness; it is also possible to develop fever, hematuria, crystalluria. Later symptoms include jaundice and depression bone marrow;
• trimethoprim (acute poisoning): depression, vomiting, nausea, headache, dizziness, bone marrow suppression, consciousness disorder.

What dose of co-trimoxazole can be life-threatening is not known.

Chronic co-trimoxazole poisoning (with long-term use in high doses) can lead to inhibition of bone marrow function, manifested by thrombocytopenia, megaloblastic anemia or leukopenia.

Therapy: abolition of Biseptol and carrying out measures aimed at removing it from the gastrointestinal tract (no later than two hours after taking the drug, wash the stomach or induce vomiting), drink plenty of fluids in cases where diuresis is insufficient and renal function is not impaired ... Also shown is the introduction of calcium folinate (intramuscularly, 5-15 mg per day). The excretion of trimethoprim is accelerated by the acidic environment of urine, but in this case, the likelihood of crystallization of sulfonamide in the kidneys increases.

special instructions

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

With prolonged courses of treatment (longer than 1 month), due to the high likelihood of hematological changes, it is necessary to regularly conduct blood tests.

The treatment of elderly patients and patients with suspected baseline folate deficiency requires special care.

The appointment of folic acid is advisable with long-term administration of Biseptol in high doses.

Influence on the ability to drive vehicles and complex mechanisms

When running by motor vehicles during the period of therapy, the likelihood of developing such adverse reactions like feeling tired, headache, nervousness, tremors.

Application during pregnancy and lactation

During pregnancy, Biseptol tablets are contraindicated, the suspension can be used after assessing the balance of benefits with risks. In late pregnancy, it is recommended to avoid taking the drug, which is associated with the likelihood of kernicterus in newborns. Biseptol can affect the metabolism of folic acid, therefore, while using the drug, pregnant women are prescribed 5 mg of folic acid per day.

During lactation: therapy is contraindicated.

Childhood use

Contraindications to Biseptol for children:

• suspension: up to 8 weeks, or up to 6 weeks at birth from a mother with HIV infection;
• tablets: up to 3 years.

With impaired renal function

Biseptol therapy is contraindicated for severe renal impairment (with creatinine clearance less than 15 ml / min).

When prescribing Biseptol in the form of tablets, patients with creatinine clearance of 15-30 ml / min should use half the standard dose.

For violations of liver function

Contraindication:

• tablets: diagnosed damage to the liver parenchyma;
• suspension: liver failure.

Use in the elderly

For elderly and senile patients, Biseptol should be prescribed as short a course as possible.

Drug interactions

• phenytoin: the intensity of the hepatic metabolism of phenytoin decreases, due to which its effect and toxic effect intensify;
• diuretics (most often thiazides and in elderly patients): the risk of thrombocytopenia increases;
• drugs that inhibit bone marrow hematopoiesis: the risk of myelosuppression increases;
• ACE (angiotensin-converting enzyme) inhibitors: hyperkalemia may develop (the risk is especially high in elderly patients);
• indirect anticoagulants: anticoagulant activity increases (correction of doses of anticoagulants is required);
• digoxin: its serum concentration may increase, and therefore it is required to monitor serum digoxin concentrations (the risk is especially high in elderly patients);
• dofetilide: the C max of dofetilide increases by 93%, AUC - by 103%, such an increase in the concentration of dofetilide can cause ventricular arrhythmias with prolongation of the QT interval, including arrhythmias like feasts (this combination is contraindicated).

Analogs

Biseptol analogs are:

• by active ingredients: Co-trimoxazole, Bi-Septin, Briefseptol, Dvaseptol, Metosulfabol, Bactrim;
• by therapeutic action: Sulfaton.

Terms and conditions of storage

Shelf life up to 25 ° C:

• tablets - 5 years;
• suspension - 3 years.

Dosage Form: & nbsptablets Compound: Biseptol® 120 mg: one tablet contains:

active ingredients: sulfamethoxazole - 100.0 mg, trimethoprim - 20.0 mg;

Excipients: potato starch - 42.25 mg, talc - 3.75 mg, magnesium stearate - 1.25 mg, polyvinyl alcohol - 0.75 mg, methyl parahydroxybenzoate - 0.15 mg, propyl parahydroxybenzoate - 0.10 mg, propylene glycol - 1.75 mg.

Biseptol® 480 mg: one tabletcontains:

active ingredients: sulfamethoxazole - 400.0 mg, trimethoprim - 80.0 mg;

Excipients: potato starch - 169.0 mg, talc - 15.00 mg, magnesium stearate - 5.00 mg, polyvinyl alcohol - 3.00 mg, methyl parahydroxybenzoate - 0.60 mg, propyl parahydroxybenzoate -0.40 mg, propylene glycol - 7.00 mg.

Description: Flat, round tablets, white with a yellowish sheen, beveled, engraved, Bs " for tablets 120 mg and engraved, Bs " and a scoring line for 480 mg tablets. Pharmacotherapeutic group:Antimicrobial combined remedy ATX: & nbsp

J.01.E.E.01 Co-trimoxazole [sulfamethoxazole in combination with trimethoprim]

Pharmacodynamics:

Combined antimicrobial drug consisting of sulfamethoxazole and trimethoprim. Sulfamethoxazole, which is structurally similar to PABA, disrupts the synthesis of dihydrofolic acid in bacterial cells, preventing the incorporation of PABA into its molecule. Trimethoprim enhances the effect of sulfamethoxazole, disrupting the reduction of dihydrofolic acid to tetrahydrofolic acid, the active form of folic acid, which is responsible for protein metabolism and microbial cell division.

It is a broad-spectrum bactericidal agent, active againstagainst the following microorganisms: Streptococcus spp. (hemolytic strains moresensitive to penicillin), Staphylococcus spp., Streptococcus pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, Escherichia coli (including enterotoxogenic strains), Salmonella spp. (including Salmonella typhi and Salmonella paratyphi); Vibrio cholerae, Bacillus anthracis, Haemophilus influenzae (including ampicillin-resistant strains), Listeria spp., Nocardia asteroides, Bordetella pertussis, Enterococcus faecalis, Klebsiella spp., Proteus spp., Pasteurella spp., Francisella tularensis, Brucella spp., Mycobacterium spp. (including Mycobacterium leprae), Citrobacter, Enterobacter spp., Legionella pneumophila, Providencia, some Pseudomonas species (except Pseudomonas aeruginosa), Serratia marcescens, Shigella spp., Yersinia spp., Morganella spp., Pneumocystis carinii, Chlamydia spp.(incl. Chlamydia trachomatis. Chlamydia psittaci); the simplest: Plasmodium spp., Toxoplasma gondii,natogenic mushrooms,Actinomyces israelii, Coccidioides immitis, Histoplasma capsulatum, Leishmania spp.

Resistant to the drug: Corynebacterium spp., Pseudomonas aeruginosa, Mycobacterium tuberculossis, Treponema spp., Leptospira spp., viruses.

Inhibits the vital activity of E. coli, which leads to a decrease in the synthesis of thymine, riboflavin, nicotinic acid and other B vitamins in the intestine. Duration therapeutic effect is 7 hours.

Pharmacokinetics:

When taken orally, both components of the drug are completely absorbed from the gastrointestinal tract. Maximum concentration active ingredients the drug is observed after 1-4 hours.

Trimethoprim is distinguished by good penetration into cells and through tissue barriers - into the lungs, kidneys, prostate, saliva, phlegm, cerebrospinal fluid. The binding of trimethoprim to proteins is 50%, its half-life is normal from 8.6 to 17 hours.

The main route of excretion of trimethoprim is through the kidneys, 50% unchanged.

Sulfamethoxazole: its binding to plasma proteins 66%, half-life from 9 to 11 hours is normal. The main way of elimination is the kidneys, and, moreover, from 15 to 30% in the active form.

Indications: The drug is used to treat infections: respiratory tract (bronchitis, pneumonia, lung abscess, pleural empyema, otitis media, sinusitis), genitourinary system (pyelonephritis, urethritis, salpingitis, prostatitis), including gonorrheal nature, gastrointestinal (dysentery, cholera, typhoid fever, paratyphoid fever, diarrhea), skin and soft tissues (pyoderma, furunculosis, etc.). Contraindications:

Hypersensitivity to co-trimoxazole, trimethoprim, sulfonamides or any component of the drug, pregnancy, lactation, childhood up to 3 years (for this dosage form), an established diagnosis of damage to the liver parenchyma, severe renal failure if it is not possible to determine the concentration of the drug in the blood plasma (use is not recommended with creatinine clearance below 15 ml / min), severe hematological diseases (aplastic anemia. -12-deficiency anemia, agranulocytosis, leukopenia, megaloblastic anemia, hyperbilirubinemia in children associated with folic acid deficiency), glucose-6-phosphate dehydrogenase deficiency (the likelihood of hemolysis).

Carefully:

The drug should be used with caution in patients with folic acid deficiency, bronchial asthma and thyroid diseases.

Method of administration and dosage:

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

The dose is assigned individually.

Children from 3 to 5 years old: 2 tablets (120 mg) 2 times a day.

Children from 6 to 12 years old: 4 tablets (120 mg) or 1 tablet (480 mg) 2 times a day.

With pneumonia - 100 mg / kg / day (based on sulfamethoxazole), the interval between doses is 6 hours, the course of treatment is 14 days.

With gonorrhea - 2 g of sulfamethoxazole 2 times a day with an interval of 12 hours.

Adults and children over 12 years old: 960 mg 2 times a day, with long-term therapy 480 mg 2 times a day.

With sides of the hematopoietic organs: leukopenia, neutropenia, thrombocytopenia,

Allergic reactions: itching, photosensitivity, urticaria, drug fever, rash, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrosis (Lyell's syndrome), exfoliative dermatitis, allergic myocarditis, fever, angioedema, hyperemia of the sclera.

The duration of the course of treatment is from 5 to 14 days. In severe cases and / or chronic form infectious diseases, an increase in a single dose by 30 50%.

If the course of treatment is extended for more than 5 days and / or the dose is increased, it is necessary to carry out hematological control; in case of a change in the blood picture, it is necessary to prescribe folic acid at a dose of 5-10 mg per day.

Dosage in patients with renal failure: in patients with creatinine clearance 15-30 ml / min. half the standard dose should be used; if creatinine clearance is less than 15 ml / min. co-trimoxazole is not recommended.

Side effects:

The drug is usually well tolerated.

From the side nervous system: headache, dizziness; in some cases - aseptic meningitis, depression, apathy, tremor, peripheral neuritis.

From the respiratory system: bronchospasm, choking, cough, pulmonary infiltrates.

From the digestive system: nausea, vomiting, decreased appetite, diarrhea, gastritis, abdominal pain, glossitis, stomatitis, cholestasis, increased activity of hepatic transaminases, hepatitis, sometimes with cholestatic jaundice, hepatonecrosis, pseudomembranous enterocolitis, pancreatitis.

With sides of the hematopoietic organs: leukopenia, neutropenia, thrombocytopenia,

agranulocytosis, megaloblastic anemia, aplastic and hemolytic anemia, eosinophilia, hypoprothrombinemia, methemoglobinemia.

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

From the musculoskeletal system: arthralgia, myalgia.

Allergic reactions: itching, photosensitivity, urticaria, drug fever, rash, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrosis (Lyell's syndrome), exfoliative dermatitis, allergic myocarditis, fever, angioedema, scleral hyperemia.

Others: hypoglycemia, hyperkalemia, hyponatremia.

Overdose:

It is not known what dose of co-trimoxazole can be life-threatening. In case of an overdose of sulfonamide, the following are noted: lack of appetite, intestinal colic, nausea, vomiting, dizziness, headache, drowsiness, loss of consciousness. Fever, hematuria, crystalluria may also occur. Bone marrow depression and jaundice may develop later. After acute poisoning with trimethoprim, nausea, vomiting, dizziness, headache, depression, impaired consciousness, and bone marrow suppression may occur. Treatment is based on discontinuing the drug and removing it from the gastrointestinal tract (gastric lavage - no later than 2 hours after taking the drug or vomiting should be induced), drinking plenty of fluids if diuresis is insufficient and kidney function is preserved. Introduce calcium folinate (5-10 mg / day). The acidic environment of the urine accelerates the elimination of trimethoprim, but may also increase the risk of sulfonamide crystallization in the kidneys. The blood picture, the composition of plasma electrolytes and other biochemical parameters should be monitored.

Hemodialysis is moderately effective and peritoneal dialysis is ineffective.active. Chronic poisoning: the use of high doses of co-trimoxazole for an extended period can lead to depression of bone marrow function, manifested by thrombocytopenia, leukopenia or megaloblastic anemia.

Interaction:

The drug is not recommended to be taken simultaneously with thiazide diuretics due to the risk of thrombocytopenia (bleeding). Co-trimoxazole increases anticoagulant activity indirect anticoagulants, as well as the action of hypoglycemic drugs and methotrexate. Reduces the intensity of hepatic metabolism of phenytoin (lengthens its T1 / 2 by 39%) and warfarin, increasing their effect.

Rifampicin reduces the T1 / 2 of trimetaprim.

Pyrimethamine in doses exceeding 25 mg / week increases the risk of megaloblastic anemia.

Diuretics (usually thiazides) increase the risk of thrombocytopenia.

Reduce the effect, (and other drugs, as a result of hydrolysis of which PABA is formed).

Between diuretics (thiazides, etc.) and oral hypoglycemic drugs (sulfonylurea derivatives), on the one hand, and antimicrobial sulfonamides, on the other, a cross-allergic reaction may develop. , barbiturates, PASK increase the manifestations of folic acid deficiency. Derivatives salicylic acid enhance the effect.

Ascorbic acid, hexamethylenetetramine (and other drugs that acidify urine) increase the risk of crystalluria.

Cholestyramine reduces absorption, so it should be taken 1 hour after or 4-6 hours before taking co-trimoxazole.

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

May increase plasma digoxin concentration in some elderly patients. May reduce the effectiveness of tricyclic antidepressants. In patients after kidney transplantation, taking co-trimoxazole and, there is a passing dysfunction of the transplanted kidney, manifested by an increase in serum creatinine concentration, which is probably caused by the action of trimethoprim. Reduces the reliability of oral contraception (inhibits the intestinal microflora and reduces the intestinal-hepatic circulation of hormonal compounds).

Special instructions:

The drug is prescribed with caution in case of folic acid deficiency in the body,bronchial asthma, burdened by an allergic history.

With long (over a month) courses of treatment, regular tests are requiredblood, since there is a likelihood of hematological changes (most often asymptomatic). These changes can be reversible with the appointment of folic acid (3-6 mg / day), which does not significantly violate the antimicrobial activity of the drug. Special care should be taken when treating the elderlypatients or patients with suspected baseline folate deficiency. Appointmentfolic acid is also advisable for long-term treatment in high doses.

For the prevention of crystalluria, it is recommended to maintain a sufficient volume of excreted urine. The likelihood of toxic and allergic complications of sulfonamides significantly increases with a decrease in filtration function kidneys. Inappropriate also against the background of treatmentto eat foods containing large amounts of PABA - green parts of plants (cauliflower, spinach, legumes), carrots, tomatoes.

Excessive sun and UV radiation should be avoided.

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

Influence on the results of laboratory tests:

Trimethoprim can alter the results of serum methotrexate measurements by the enzymatic method, but does not affect the results when the radioimmunoassay method is selected.

Co-trimoxazole can increase the results of the Jaffe reaction with picric acid for the quantitative determination of creatinine by 10%.

The product contains parahydroxybenzoates, which can cause allergic reactions, and propylene glycol, which can cause symptoms similar to those of alcohol intake.

Impact on the ability to drive vehicles Wed and fur .:The drug, as a rule, does not affect the psychophysical abilities and the ability to serve moving mechanisms, as well as to control vehicle while driving.

But if undesirable symptoms such as headache, tremors, nervousness, feeling of fatigue appear, you should be extremely careful when driving and servicing cars.

Release form / dosage:Tablets of 120 mg and 480 mg. Package: For a dosage of 120 mg: 20 tablets in a blister made of PVC / A1 foil. 1 blister in a cardboard box with instructions for use.

For a dosage of 480 mg:

20 tablets in a blister made of PVC / A1 foil. 1 blister in a cardboard box with instructions for use. 14 tablets in a blister made of PVC / A1 foil. 2 blisters in a cardboard box with instructions for use.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Best before date:

Shelf life is 5 years.

Do not use the drug with an expired date. Conditions for dispensing from pharmacies: On prescription Registration number: P N013420 / 01 Registration date: 12.12.2007 / 25.06.2014 Expiration date: Indefinite Marketing Authorization Holder:Pabyanitsk pharmaceutical plant Polfa, JSC Poland Manufacturer: & nbsp Representative office: & nbsp Adamed RASHA LLC Russia Date of information update: & nbsp 13.02.2017 Illustrated instructions

Tablets - 1 tab .:

• Active ingredients: sulfamethoxazole 400 mg, trimethoprim 80 mg.
• Excipients: potato starch - 169 mg, talc - 15 mg, magnesium stearate - 5 mg, polyvinyl alcohol - 3 mg, methyl parahydroxybenzoate - 0.6 mg, propyl parahydroxybenzoate - 0.4 mg, propylene glycol - 7 mg.

14 pcs. - blisters (2) - cardboard packs.

Description of the dosage form

Tablets, white with a yellowish sheen, round, flat, scored and engraved "Bs".

pharmachologic effect

Combined antibacterial drug containing sulfamethoxazole and trimethoprim.

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

Trimethoprim enhances the effect of sulfamethoxazole, disrupting the reduction of dihydrofolic acid to tetrahydrofolic acid, the active form of folic acid, which is responsible for protein metabolism and microbial cell division.

It is a broad-spectrum bactericidal drug.

Active against gram-positive aerobic bacteria: Streptococcus spp., Including Streptococcus pneumoniae (hemolytic strains are more sensitive to penicillin), Staphylococcus spp., Bacillus anthracis, Listeria spp., Nocardium asteroides, Enterococcus faecalis spp. (including Mycobacterium leprae, excluding Mycobacterium tuberculosis); gram-negative aerobic bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Escherichia coli (including enterotoxogenic strains), Salmonella spp. (including Salmonella typhi and Salmonella paratyphi); Vibrio cholerae, Haemophilus influenzae (including ampicillin-resistant strains), Bordetella pertussis, Klebsiella spp., Proteus spp., Pasteurella spp., Francisella tularensis, Brucella spp., Citrobacter spp., Enterobacter spp., Some species except Pseudomonas aeruginosa), Serratia marcescens, Shigella spp., Yersinia spp., Morganella spp., as well as for Chlamydia spp. (including Chlamydia trachomatis, Chlamydia psittaci); in relation to gram-positive anaerobes: Actinomyces israelii; for protozoa: Plasmodium spp., Toxoplasma gondii; pathogenic fungi: Coccidioides immitis, Histoplasma capsulatum, Pneumocystis carinii, Leishmania spp.

Resistant to the drug: Corynebacterium spp., Pseudomonas aeruginosa, Mycobacterium tuberculosis, Treponema spp., Leptospira spp., Viruses.

It inhibits the vital activity of Escherichia coli, which leads to a decrease in the synthesis of thiamine, riboflavin, niacin and other B vitamins in the intestine.

The duration of the therapeutic action is 7 hours.

Pharmacokinetics

Suction

After taking the drug inside, the active substances are completely absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved within 1-4 hours after oral administration.

Distribution

Trimethoprim penetrates well into tissues and biological environments of the body: lungs, kidneys, prostate, bile, saliva, phlegm, cerebrospinal fluid. The plasma protein binding of trimethoprim is 50%; sulfamethoxazole - 66%.

Withdrawal

T1 / 2 trimethoprim - 8.6-17 hours, sulfamethoxazole - 9-11 hours. The main route of excretion is the kidneys; while trimethoprim is excreted unchanged up to 50%; sulfamethoxazole - 15-30% in active form.

Clinical pharmacology

Antibacterial sulfa drug.

Indications for use of Biseptol

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 tract infections (including typhoid fever, paratyphoid fever, bacterial dysentery, cholera, diarrhea);
• infections of the skin and soft tissues (including furunculosis, pyoderma).

Contraindications to the use of Biseptol

• 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 (CC less than 15 ml / min);
• severe blood diseases (aplastic anemia, B12-deficiency anemia, agranulocytosis, leukopenia, megaloblastic anemia, folic acid deficiency anemia);
• 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.

The drug is prescribed with caution in case of folic acid deficiency in the body, bronchial asthma, thyroid diseases.

Biseptol Use during pregnancy and children

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

Application in children

Contraindication: children under 3 years of age (for this dosage form).

Biseptol Side effects

The drug is generally well tolerated.

From the nervous system: headache, dizziness; in some cases - aseptic meningitis, depression, apathy, tremor, peripheral neuritis.

From the respiratory system: bronchospasm, choking, cough, pulmonary infiltrates.

From the digestive system: nausea, vomiting, decreased appetite, diarrhea, gastritis, abdominal pain, glossitis, stomatitis, cholestasis, increased activity of hepatic transaminases, hepatitis, sometimes with cholestatic jaundice, hepatonecrosis, pseudomembranous enterocolitis, pancreatitis.

From the hematopoietic system: leukopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anemia, aplastic and hemolytic anemia, eosinophilia, hypoprothrombinemia, methemoglobinemia.

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

From the side musculoskeletal system: arthralgia, myalgia.

Allergic reactions: itching, photosensitivity, urticaria, drug fever, rash, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, allergic myocarditis, fever from angioedema, hyperemia of the sclera.

From the side of metabolism: hypoglycemia, hyperkalemia, hyponatremia.

Drug interactions

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

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

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

Rifampicin reduces the T1 / 2 of trimethoprim.

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

With the simultaneous use of diuretics (usually thiazide), the risk of thrombocytopenia increases.

Benzocaine, procaine, procainamide (as well as other drugs, as a result of 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, a cross-allergic reaction may develop.

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

Salicylic acid derivatives enhance the effect of Biseptol.

Ascorbic acid, hexamethylenetetramine (like other drugs that acidify urine) increase the risk of developing crystalluria while using Biseptol.

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

With simultaneous use with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.

Biseptol® can increase the concentration of digoxin in the blood plasma in some elderly patients.

Biseptol® may decrease 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 action of trimethoprim.

Biseptol® reduces the effectiveness of oral contraception (inhibits the intestinal microflora and reduces the intestinal-hepatic circulation of hormonal agents).

Dosage Biseptol

The drug is taken orally after meals with a sufficient amount of liquid. The dose is set individually.

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

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

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

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

The duration of the course of treatment is from 5 to 14 days. In severe cases of the disease and / or in chronic infections, a single dose may be increased by 30-50%.

If the duration of the course of therapy is more than 5 days and / or an increase in the dose of the drug, it is necessary to control the picture of peripheral blood; when pathological changes appear, folic acid should be prescribed at a dose of 5-10 mg / day.

If a dose is missed, the drug should be taken as soon as possible. If the time for the next dose is approaching, the previous dose should be skipped. Do not take a double dose to compensate for the missed dose.

In patients with renal insufficiency with a CC of 15-30 ml / min, the standard dose of the drug should be reduced by 50%, with a CC of less than 15 ml / min, it is not recommended to use the drug.

Overdose

Symptoms: in case of an overdose of sulfonamide - lack of appetite, intestinal colic, nausea, vomiting, dizziness, headache, drowsiness, loss of consciousness, fever, hematuria, crystalluria are also possible. Bone marrow depression and jaundice may develop later.

After acute poisoning with trimethoprim, nausea, vomiting, dizziness, headache, depression, disturbance of consciousness, depression of bone marrow function are possible.

It is not known what dose of co-trimoxazole can be life-threatening.

Chronic poisoning: the use of co-trimoxazole in high doses for an extended period can lead to depression of bone marrow function, manifested by thrombocytopenia, leukopenia or megaloblastic anemia.

Treatment: discontinuation of the drug and taking measures aimed at removing it from the gastrointestinal tract (gastric lavage no later than 2 hours after taking the drug or induce vomiting), drinking plenty of fluids if diuresis is insufficient and kidney function is preserved. Introduce calcium folinate (5-10 mg / day). The acidic environment of the urine accelerates the elimination of trimethoprim, but may also increase the risk of sulfonamide crystallization in the kidneys.

The blood picture, the composition of plasma electrolytes and other biochemical parameters should be monitored. Hemodialysis is moderately effective and peritoneal dialysis is ineffective.

Precautionary measures

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

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

It is also inappropriate during treatment to consume foods containing a large amount 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 AIDS patients.

Trimethoprim can change the results of the determination of the concentration of methotrexate in serum, carried out by the enzymatic method, but does not affect the result when choosing a radioimmunoassay method.

Co-trimoxazole can increase the results of the Jaffe reaction with picric acid for the quantitative determination of creatinine by 10%.

The drug contains parahydroxybenzoates, which can cause allergic reactions, and propylene glycol, which can cause symptoms similar to those of alcohol intake.

Special precautions for destruction of unused medicinal product

Should not be thrown away medications into drains or household waste containers. Ask your pharmacist how to dispose of unused medicine. These activities will help protect the environment.

Influence on the ability to drive vehicles and use mechanisms

The drug, as a rule, does not affect the psychophysical abilities and the ability to maintain mechanisms and drive a vehicle. However, if undesirable symptoms such as headache, tremors, nervousness, feeling of fatigue appear, care should be taken when driving or servicing machinery.