Sumetrolim ® ® tablets are used in the treatment of infections caused by pathogenic microorganisms sensitive to the drug, in cases where the benefit of such treatment outweighs the possible risk (it is necessary to decide whether it is possible to use only one antibacterial agent):
ENT organs and respiratory tract: acute and chronic bronchitis, bronchiectasis, pneumonia (including those caused by Pneumocystis carinii), pharyngitis, tonsillitis (in infections caused by β-hemolytic streptococcus group A, the eradication rate is not entirely sufficient), sinusitis, otitis media; kidney and urinary tract infections: acute and chronic cystitis, pyelonephritis, urethritis, prostatitis, soft chancre; digestive tract infections: typhoid fever and paratyphoid fever, shigellosis (caused by sensitive strains of Shigella flexneri and Shigella sonnei, if antibacterial therapy is indicated), traveler's diarrhea caused by enterotoxic strains of Escherichia coli, cholera (in addition to fluid and electrolyte replacement); other bacterial infections: acute and chronic osteomyelitis, brucellosis, nocardiosis, actinomycosis, toxoplasmosis, American blastomycosis.
Composition
One tablet contains (active ingredients):
sulfamethoxazole - 400 mg; trimethoprim - 80 mg.
Excipients: potato starch, talc, gelatin, sodium starch glycolate (type A), magnesium stearate, glycerin (85%), stearic acid.
Contraindication
hypersensitivity to trimethoprim and sulfamethoxazole (including sulfonamide derivatives, sulfonylurea antidiabetic agents, and thiazide diuretics) and any other components of the drug; acute hepatitis, impaired liver function, severe liver failure, including diagnosed liver parenchymal damage, porphyria; blood diseases, impaired hematopoiesis, megaloblastic anemia caused by folic acid deficiency, glucose-6-phosphate dehydrogenase deficiency, severe hematological disorders; severe renal failure, characterized by creatinine clearance less than 15 ml / minute, if it is not possible to determine the concentration of the drug in the blood plasma (except in cases of hemodialysis); immune thrombocytopenia caused by the use of trimethoprim and / or sulfamethoxazole; patients undergoing chemotherapy; cannot be prescribed in combination with dofetilide.
Method of application
Adults and children over 12 years old
The initial dose is two tablets 2 times a day (morning and evening) after meals, washed down with plenty of liquid. In severe infections, higher daily doses may be prescribed - up to 3 tablets 2 times a day. For maintenance therapy lasting more than 14 days, it is recommended to take one tablet 2 times a day.
Children aged 6 to 12 years
The recommended daily dose for children is 6 mg of trimethoprim and 30 mg of sulfamethoxazole per 1 kg of body weight. This dose should be divided into 2 doses. The recommended daily dose for children aged 6 to 12 years is one tablet 2 times a day.
Duration of treatment for acute infections, except for gonorrhea, treatment should last at least 5 days, or 2 more days after the symptoms of the disease disappear. A three-day course of treatment may be sufficient for women with uncomplicated acute cystitis. However, children with this disease are recommended to use the drug for 5-7 days. In acute brucellosis, the duration of treatment should be at least 4 weeks, and in nocardiosis - even longer (6-8 tablets for 3 months).
For the prevention and treatment of toxoplasmosis: The dosing regimen for Pneumocystis carinii can be used.
For uncomplicated gonorrhea, a one-day course of treatment is possible - 5 tablets 2 times a day (morning and evening) or a two-day course of treatment - 4 tablets 2 times a day.
For the treatment of pneumonia caused by Pneumocystis carinii, the recommended daily dose is 20 mg of trimethoprim and 100 mg of sulfamethoxazole per 1 kg of body weight (15-16 tablets). This dose should be divided into 2 or more doses, and the treatment should be continued for 14-21 days.
For the prevention of pneumonia caused by Pneumocystis carinii, the recommended dose is two tablets once a day or two tablets every other day, or two tablets twice a day during periods of increased risk of infection.
For prophylaxis in children, the usual therapeutic dose, calculated on the basis of the child's age and body weight, is administered once a day, or 3 times a week for 3 consecutive days. This dose corresponds to approximately 150 mg / m 2 of trimethoprim and 750 mg / m 2 of sulfamethoxazole. The maximum daily doses of trimethoprim and sulfamethoxazole are 320 mg and 1600 mg, respectively.
Application features
Pregnant women
The drug is not used during pregnancy or breastfeeding.
Drivers
The drug does not affect the speed of reaction when driving or working with mechanisms. If side effects from the nervous system develop during treatment, you should avoid driving or working with complex mechanisms.
Overdose
Symptoms of acute overdose: nausea, vomiting, diarrhea, colic, headache, vertigo, dizziness, drowsiness, loss of consciousness, confusion, fever, thinking disorders and visual disorders, jaundice, blood disorders, in severe cases - crystalluria, hematuria and anuria.
Symptoms of chronic overdose: inhibition of hematopoiesis (thrombocytopenia, leukopenia, megaloblastic anemia), as well as other pathological changes in the blood picture due to folic acid deficiency.
Treatment (depending on symptoms). Induction of vomiting, gastric lavage and forced diuresis are recommended (alkalization of urine promotes the excretion of sulfamethoxazole). Alkalization of urine may promote the excretion of sulfamethoxazole, but this reduces the excretion of trimethoprim. The drug is not removed from the body by peritoneal dialysis, but it is partially removed by hemodialysis. Hypersensitivity reactions can be eliminated by steroid drugs. It is necessary to monitor the blood picture and electrolyte levels. In case of pronounced pathological changes in the blood picture or jaundice, specific treatment is prescribed. To eliminate the effect of trimethoprim on hematopoiesis, potassium folate can be prescribed in a dose of 3-6 mg for 5-7 days.
In case of bone marrow suppression caused by prolonged use of the drug "Sumetrolim ® ®" in high doses, it is possible to use leucovorin in doses of 5-15 mg per day until normalization of hematopoiesis.
Side effects
Gastrointestinal tract: nausea, vomiting, lack of appetite, abdominal pain, diarrhea, anorexia, gingivitis, gastritis often occur.
Skin and subcutaneous tissue disorders: allergic rashes, urticaria, itching often appear.
From the nervous system: headache, dizziness, increased fatigue, insomnia.
Blood disorders: thrombocytopenia, neutropenia and leukopenia; granulocytopenia, immunohemolytic anemia, polycythemia.
Musculoskeletal system: pain in the joints and/or muscles.
From the hepatobiliary system: increased levels of aminotransferases, hepatitis (sometimes with cholestatic jaundice), bile duct stenosis syndrome, liver necrosis, severe hepatitis.
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 5 years.
