Država: Armenija
Jezik: angleščina
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sulfamethoxazole, trimethoprim
F. Hoffmann-La Roche Ltd.
J01EE01
sulfamethoxazole, trimethoprim
800mg+ 160mg
tablets
(10/1x10/), in blister
Prescription
Registered
2016-02-22
Patients receiving sulfonylurea derivatives (e.g. glibenclamide, gliclazide, glipizide, chlorpropamide and tolbutamide) or repaglinide, rosiglitazone or pioglitazone should be monitored regularly for hypoglycemia. Sulfonamides, including sulfamethoxazole, can displace methotrexate from plasma protein binding sites and impair its renal transport, thus increasing the concentration of free methotrexate and potentially enhancing its effect and hematological side effects. Coadministration of Bactrim and methotrexate is not recommended. Co-trimoxazole may influence the required dose of oral antidiabetic agents. Like other antibiotics, Bactrim can reduce the efficacy of oral contraceptives. Female patients should therefore be advised to take additional contraceptive measures during Bactrim treatment. OBSERVED INTERACTIONS An increased incidence of thrombocytopenia with purpura has been observed in elderly patients concurrently receiving certain diuretics, primarily thiazides. Platelets should therefore be monitored regularly in patients using diuretics. Coadministration with co-trimoxazole may increase systemic exposure to drugs metabolised primarily by CYP2C9, e.g. coumarins (warfarin, acenocoumarol, phenprocoumon), phenytoin and sulfonylurea derivatives (glibenclamide, gliclazide, glipizide, chlorpropamide and tolbutamide). Coagulation should be monitored in patients treated with coumarins. Reversible deterioration of renal function has been observed in patients treated with co-trimoxazole and ciclosporin following renal transplantation. Cases of pancytopenia have been reported in patients given the combination of trimethoprim and methotrexate (see _Warnings and precautions_ ). Trimethoprim has a low affinity for human dihydrofolate reductase, but may increase the side effects of methotrexate, especially in the presence of risk factors such as old age, hypoalbuminemia, impaired renal function and decreased bone marrow reserve, and in patients receiving high doses of methotrexate. At-risk patients should be treated wit Preberite celoten dokument
January 2018 Summary of Product Characteristics Ro 06-2580 Bactrim oral January 2018 1 BACTRIM ® Sulfamethoxazole + trimethoprim COMPOSITION _Active substances_: Trimethoprim (TM) and sulfamethoxazole (SMZ). The combination of the two active substances TM and SMZ has established itself under the name co-trimoxazole. _Excipients_:_ _ _Bactrim tablets_: Excipients for tablets. _Bactrim Forte tablets_:_ _ Excipients for tablets. _Bactrim syrup for children_:_ _ Flavouring agents: ethyl vanillin, vanillin and others; preservatives: E216, E218; excipients for suspension. PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT _Bactrim tablets_:_ _ White scored tablets, 80 mg TM and 400 mg SMZ. _Bactrim Forte tablets_:_ _ Beige-white scored tablets, 160 mg TM and 800 mg SMZ. _Bactrim syrup for children_:_ _ Oral suspension, 40 mg TM and 200 mg SMZ/5 ml. INDICATIONS AND POTENTIAL USES Infections due to co-trimoxazole-sensitive organisms, such as: Upper and lower respiratory tract and ear infections: acute exacerbations of chronic bronchitis, bronchiectasis, pneumonia (including _ Pneumocystis jirovecii_ pneumonia), sinusitis, otitis media. Urogenital infections: acute and chronic cystitis, pyelonephritis, urethritis, prostatitis. Gastrointestinal infections including typhoid and paratyphoid fever (including treatment of chronic carriers) and cholera (as an adjunct to fluid and electrolyte replacement). January 2018 Summary of Product Characteristics Ro 06-2580 Bactrim oral January 2018 2 Other bacterial infections due to sensitive organisms: acute brucellosis, nocardiosis, mycetoma (except when caused by true fungi), South American blastomycosis _(Paracoccidioides brasiliensis)_. In osteomyelitis as a last-line drug (e.g. when vancomycin is contraindicated), for multiresistant organisms shown to be sensitive to co-trimoxazole. Official recommendations on the appropriate use of antibiotics should be followed, especially usage recommendations to prevent the increase in antibiotic resistance. DOSAGE AND ADMINISTRATI Preberite celoten dokument