Active substanceCo-trimoxazole [Sulfamethoxazole + Trimethoprim]Co-trimoxazole [Sulfamethoxazole + Trimethoprim]
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  • Dosage form: & nbsppills
    Composition: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, methylparahydroxybenzoate - 0,15 mg, propyl parahydroxybenzoate - 0.10 mg, propylene glycol - 1.75 mg.
    Biseptol® 480 mg: one tablet contains:
    active ingredients: sulfamethoxazole- 400.0 mg, trimethoprim - 80.0 mg;
    Excipients: potato starch 169.0 mg, talcum 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 of white with a yellowish shade of color, with a facet, with an engraving ,, Bs " for tablets 120 mg and with engraving ,, Bs " and risk for tablets 480 mg.
    Pharmacotherapeutic group:Antimicrobial combination
    ATX: & nbsp

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

    Pharmacodynamics:

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

    It is a broad-spectrum bactericidal drug that is active infollowing microorganisms: Streptococcus spp. (haemolytic strains more sensitive 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. (incl. Mycobacterium leprae), Citrobacter, Enterobacter spp., Legionella pneumophila, Providencia, some species Pseudomonas (Besides Pseudomonas aeruginosa), Serratia marcescens, Shigella spp., Yersinia spp.,Morganella spp., Pneumocystis carinii, Chlamydia spp. (incl. Chlamydia trachomatis. Chlamydia psittaci); protozoa: Plasmodium spp., Toxoplasma gondii, natogenic fungi, 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 vitamins of group B in the intestine. The duration of the therapeutic effect is 7 hours.

    Pharmacokinetics:

    When ingestion, both components of the drug are completely absorbed from the gastrointestinal tract. The maximum concentration of the active components of the drug is observed after 1-4 hours.

    Trimethoprim differs by good penetration into cells and through tissue barriers - into the lungs, kidneys, prostate, bile, saliva, sputum, liquor.The binding of trimethoprim to proteins is 50%, the half-life of it is normal from 8.6 to 17 hours.

    The main way to excrete trimethoprim is through the kidneys, 50% unchanged.

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

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

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

    Carefully:

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

    Dosing and Administration:

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

    Dose is administered individually.

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

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

    When pneumonia - 100 mg / kg / day (of sulfamethoxazole calculation), the interval between receptions - 6 hours treatment - 14 days.

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

    Adults and children over 12 years: 960 mg 2 times a day, with prolonged therapy of 480 mg 2 times a day.Usually the drug is well tolerated.

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

    On the part of the respiratory system: bronchospasm, suffocation, cough, pulmonary infiltrates.

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

    Co the sides of the hematopoiesis: leukopenia, neutropenia, thrombocytopenia,

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

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

    From the musculoskeletal system: arthralgia, myalgia.

    Allergic reactions include itching, photosensitivity, urticaria, drug fever, rash, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrosis (Lyell's syndrome), exfoliative dermatitis, allergic myocarditis, fever, angioneurotic edema, hyperemia sclera.

    Other: hypoglycemia, hyperkalemia, hyponatremia.

    Duration of treatment from 5 to 14 days. In severe and / or chronic forms of infectious diseases, an increase in the single dose per 30-50%.

    In case of prolongation of the course of treatment for more than 5 days and / or increasing the dose, hematological control should be performed; in case of a change in the blood picture, folic acid should be prescribed at 5-10 mg per day.

    Dosage in patients with renal insufficiency: in patients with creatinine clearance 15-30 ml / min. use half the standard dose; if the creatinine clearance is less than 15 ml / min. it is not recommended to use co-trimoxazole.

    Side effects:

    Usually the drug is well tolerated.

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

    On the part of the respiratory system: bronchospasm, suffocation, cough, pulmonary infiltrates.

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

    Co sides of hemopoiesis: leukopenia, neutropenia, thrombocytopenia,

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

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

    From the musculoskeletal system: arthralgia, myalgia.

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

    Other: hypoglycemia, hyperkalemia, hyponatremia.

    Overdose:

    It is not known what dose of co-trimoxazole can be life-threatening. In case of an overdose with sulfonamide, there are: lack of appetite, intestinal colic, nausea, vomiting, dizziness, headache, drowsiness, loss of consciousness.There may also come a fever, hematuria, crystalluria. Later, bone marrow and jaundice may develop. After acute poisoning with trimethoprim, nausea, vomiting, dizziness, headache, depression, frustration of consciousness, suppression of bone marrow function may occur. Treatment is based on the withdrawal of the drug and its removal from the gastrointestinal tract (gastric lavage - no later than 2 hours after taking the drug or should be called vomiting), a plentiful drink if the diuresis is insufficient and the kidney function is preserved. Enter calcium folinate (5-10 mg / day). The acidic urine accelerates the excretion of trimethoprim, but may also increase the risk of crystallization of the sulfonamide in the kidneys. It is necessary to control the blood picture, the composition of electrolytes in plasma and other biochemical parameters.

    Hemodialysis is moderately effective, and peritoneal dialysis is not effectivektiven. Chronic Poisoning: The use of high doses of co-trimoxazole for a prolonged 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 because of the risk of thrombocytopenia (bleeding). Co-trimoxazole increases the anticoagulant activity of indirect anticoagulants, as well as the effect of hypoglycemic drugs and methotrexate. Reduces the intensity of hepatic metabolism of phenytoin (prolongs its T1/2 by 39%) and warfarin, enhancing their effect.

    Rifampicin reduces T1 / 2 trimetaprim.

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

    Diuretics (often thiazides) increase the risk of thrombocytopenia.

    Reduce the effect benzocaine, procaine, procainamide (and other drugs, as a result of the hydrolysis of which a PABC is formed).

    Between diuretics (thiazides, furosemide and others) and oral hypoglycemic drugs (sulfonylurea derivatives), on the one hand, and antimicrobial sulfonamides, on the other, it is possible to develop a cross-allergic reaction. Phenytoin, barbiturates, PASC increase manifestations of folic acid deficiency. The derivatives of salicylic acid intensify the action.

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

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

    Drugs that depress bone marrow hematopoies, increase the risk of myelosuppression.

    It can increase the concentration of digoxin in the plasma in some elderly patients. Can reduce the effectiveness of tricyclic antidepressants. In patients after kidney transplantation, taking co-trimoxazole and ciclosporin, there is a passing violation of the function of the transplanted kidney, manifested by an increase in the 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:

    With caution appoint a drug with a deficiency of folic acid in the body, The bronchial asthma, weighed down by an allergic anamnesis.

    With long (more than a month) treatment courses, regular tests blood, because there is a possibility of hematological changes (most often asymptomatic).These changes can be reversible in the appointment of folic acid (3-6 mg / day), which does not significantly violate the antimicrobial activity of the drug. Special caution should be shown in the treatment of the elderly patients or patients with a suspected initial lack of folate. Appointment Folic acid is also suitable 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 the filtration function kidney. It is also inadvisable against a background of curingTo eat foods that contain large quantities of PABC - green parts of plants (cauliflower, spinach, legumes), carrots, tomatoes.

    Avoid excessive sunlight and UV radiation.

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

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

    Influence on the results of laboratory studies:

    Trimethoprim may alter the results of determining the level of methotrexate in the serum, carried out by the enzymatic method, but does not affect the result when choosing a radioimmunoassay method.

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

    The product contains parahydroxybenzoates, which can cause allergic reactions, as well as propylene glycol, which can cause symptoms similar to those when taking alcohol.

    Effect on the ability to drive transp. cf. and fur:The drug, as a rule, does not affect psychophysical abilities and the ability to service moving mechanisms, as well as to control the transport means in driving time.
    But if there are such undesirable symptoms as headache, tremor, nervousness, a sense of fatigue, you should be extremely careful while driving a vehicle and servicing the machines.
    Form release / dosage:
    Tablets of 120 mg and 480 mg.
    Packaging:For the dosage of 120 mg:
    For 20 tablets in a blister of PVC / A1 foil. For 1 blister in a cardboard box with instructions for use.
    For a dosage of 480 mg:
    For 20 tablets in a blister of PVC / A1 foil. For 1 blister in a cardboard box with instructions for use. For 14 tablets in a blister of PVC / A1 foil. For 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.

    Shelf life:

    Shelf life 5 years.

    Do not use the drug with expired shelf life.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013420 / 01
    Date of registration:12.12.2007 / 25.06.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:Pabianicki Pharmaceutical Plant Polfa, JSCPabianicki Pharmaceutical Plant Polfa, JSC Poland
    Manufacturer: & nbsp
    Representation: & nbspAdamed RASHA LLCAdamed RASHA LLCRussia
    Information update date: & nbsp13.02.2017
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