Expiration date: 10/2026

Composition and form of issue:

Oral suspension, 100 ml contains:

sulfamethoxazole 4000 mg

trimethoprim 800 mg

in bottles of dark glass 80 ml in a pack of cardboard 1 bottle (to the package included a scale).

Description of dosage form:

Suspension of white or light cream color with strawberry smell.

Pharmacological action:

The bactericidal effect is due to the violation of the process of formation of folic acid, necessary for the synthesis of purine compounds by microorganisms, and then nucleic acids: blockade of the synthesis of dihydrofolic acid (sulfametoxazole) and its transformation into tetrahydrofolic acid (trimethoprim).

Pharmacokinetics:

In oral administration, both components are absorbed from the gastrointestinal tract (90%). Cmax achieved through 1-4 h, and persists for 12 h are Well distributed in the body, penetrates through GEB, placenta, in breast milk. In the lungs, the urine, creating a concentration of excess plasma. To a lesser extent, they accumulate in the bronchial secret, vaginal secretions, secret and prostate tissue, cerebrospinal fluid, bile, bones, saliva, watery eye moisture, breast milk, interstitial fluid. Binding to proteins-66% (sulfametoxazole), 45% (trimethoprim). Metabolized in the liver to form inactive metabolites (mostly sulfametoxazole). Excreted by the kidneys in the form of metabolites (80% for 72 hours) and unchanged (sulfamethoxazole — 20%, trimethoprim — 50%), a small amount — through the intestine. T1/2 sulfametoxazole — 9-11 h, trimethoprim — 10-12 h (in patients with impaired renal function and elderly T1 / 2 lengthens).

Description of pharmacological action:

Active against almost all groups of microorganisms: Staphylococcus aureus, Staphylococcus saprophyticus, Streptococcus pneumoniae, Streptococcus agalactiae, Streptococcus viridans, and Pneumocystis carinii, Salmonella spp., (including Salmonella typhi, Salmonella paratyphi), Shigella spp., Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Enterobacter spp., Serratia spp., Escherichia coli, Haemophilus influenzae, Morganella morganii, Yersinia spp., Brucella spp., Neisseria meningitidis, Neisseria gonorrhoeae, Vibrio cholerae, Bacillus anthracis, Listeria spp., Nocardia asteroids, Bordetella pertussis, Enterococcus faecalis, Pasteurella spp., Francisella tularensis, Mycobacterium spp. (including Mycobacterium leprae), Citrobacter, Legionella pneumophila, Providencia, some species of Pseudomonas (except Pseudomonas aeruginosa), Chlamydia spp. (including Chlamydia trachomatis, Chlamydia psittaci), protozoa: Plasmodium spp., Toxoplasma gondii, pathogenic fungi-Actinomyces israelii, Coccidioides immitis, Histoplasma capsulatum, Leishmania spp.

Inhibits the life of the E. coli, which leads to a decrease in the synthesis of thiamine, Riboflavin, nicotinic acid and other b vitamins in the intestine.

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

Indications:

Respiratory tract infections (acute and chronic bronchitis, bronchiectasis, lobar pneumonia, bronchopneumonia, Pneumocystis pneumonia, empyema, lung abscess), infections of ENT organs (otitis media, sinusitis, laryngitis, tonsillitis, pharyngitis, tonsillitis), scarlet fever, infections of the urinary tract (pyelonephritis, pyelitis, epididymitis, cystitis, urethritis, salpingitis, prostatitis, gonorrhea in men and women, chancroid, lymphogranuloma venereum, inguinal granuloma), infections of the gastrointestinal tract (dysentery, cholera, typhoid, salmonellonoyestvo, paratyphoid fever, cholecystitis, cholangitis, gastroenteritis, caused by enterotoxic strains of E. coli), skin and soft tissue infections (acne, furunculosis, pyoderma, abscess, wound infections), osteomyelitis (acute and chronic), brucellosis (acute), sepsis, peritonitis, meningitis, brain abscess, osteoarticular infections, South American blastomycosis, malaria, pertussis (as part of complex therapy).

Contraindications:

Hypersensitivity to the components of the drug, glucose deficiency?6-phosphate dehydrogenase, hepatic and/or renal insufficiency (creatinine Cl less than 15 ml/min), aplastic anemia, B12-deficiency anemia, agranulocytosis, leukopenia, hyperbilirubinemia (in children), pregnancy, breastfeeding, childhood (up to 3 months).

Use during pregnancy and breast-feeding:

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effect:

From the nervous system and sensory organs: headache, depression, apathy, dizziness, tremor, aseptic meningitis, peripheral neuritis.

From the cardiovascular system and blood (hematopoiesis, hemostasis): thrombocytopenia, neutropenia, rarely - agranulocytosis, megaloblastic anemia.

Respiratory system: bronchospasm, pulmonary infiltrates

From the digestive tract: anorexia, gastritis, abdominal pain, glossitis, stomatitis, cholestasis, increased activity of hepatic transaminases, rarely — hepatitis, pseudomembranous colitis.

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

From the musculoskeletal system: arthralgia, myalgia.

Allergic reactions: itching, photosensibilization, rash, fever, redness of the sclera, in some cases, polymorphonuclear bullous erythema Stevens-Johnson, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, allergic myocarditis, angioedema.

Drug interaction:

While taking with thiazide diuretics increases the risk of thrombocytopenia. Increases the effect of indirect anticoagulants, hypoglycemic agents, methotrexate, phenytoin (reduces the intensity of their hepatic metabolism). Reduces the reliability of oral contraception (inhibits intestinal microflora and reduces intestinal-hepatic circulation of hormonal compounds). Pyrimethamine (more than 25 mg/week) increases the likelihood of megaloblastic anemia.

Benzocaine, procaine, procainamide reduce the effect (as a result of their hydrolysis PABK is formed). Between diuretics (thiazide) 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 enhance the manifestation of folic acid deficiency. Derivatives of salicylic acid enhance the action. Ascorbic acid, hexamethylentetramine (and other drugs, acidifying urine ) increase the risk of crystalluria. Colestyramine reduces absorption (should be taken 1 h after or 4-6 h before taking co-trimoxazole). Rifampicin reduces T1/2 of trimethoprim. The combined use of co-trimoxazole and cyclosporine after kidney surgery worsens the condition of patients.

Dosage and administration:

Inside, during or immediately after a meal with plenty of liquid, every 12 hours (2 times a day). Children 3-6 months for 2, 5 ml, 7 months — 3 years, 2, 5-5 ml, 4-6 years: 5-10 ml 7-12 years: 10 ml. Adults and children over 12 years: 20 ml. Duration of treatment — 5-14 days. In severe and / or chronic form of infectious diseases may increase the single dose by 30-50%.

Overdose:

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

Treatment: withdrawal of the drug, gastric lavage (within 2 hours from the time of taking an excessive dose), acidification of urine (to increase the excretion of trimethoprim), abundant drinking, b/m — 5-15 mg/day of calcium folinate (eliminates the effect of trimethoprim on the bone marrow), forced diuresis, if necessary — hemodialysis.

Precautionary measures:

In long-term courses of treatment, regular blood tests are necessary (since there is a possibility of hematological reactions), the appointment of folic acid.

With caution to appoint bronchial asthma, folic acid deficiency, thyroid disease. When prescribing the drug to patients with liver or kidney failure (if the Cl creatinine is 15-30 ml/min, it is recommended to take half the usual dose), the elderly, with a deficit of folates and allergic reactions in the history of caution (the appearance of skin rash or severe diarrhea — the basis for the abolition of the drug). For the prevention of crystalluria should maintain a sufficient amount of urine. During treatment, it is recommended to drink plenty.

It is not recommended for use in tonsillitis, pharyngitis caused by beta-hemolytic Streptococcus group A (due to the widespread resistance of strains).

Excessive sun and ultraviolet radiation should be avoided during treatment.

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

Special instruction:

During treatment it is not advisable to use food products containing PABK — green parts of plants (cauliflower, spinach, legumes), carrots, tomatoes.

Reduces the accuracy of the determination of creatinine using the Jaffe alkaline pectinata (increased creatinine ~ 10%).

Before use, shake the contents of the bottle until a homogeneous suspension.

The drug does not contain sugar.