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Bactrimel

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Indications:

Treatment of enteritis; treatment of Pneumocystis carinii pneumonia; treatment of severe or complicated UTIs caused by susceptible strains of bacteria. -Treatment of acute otitis media and acute exacerbations of chronic bronchitis; treatment of traveler’s diarrhea; treatment and prophylaxis of P. carinii pneumonia; Shigella enteritis; UTIs caused by susceptible strains of bacteria. -Treatment of cholera, salmonella-type infections, and nocardiosis; prevention of recurrent UTIs in women; prophylaxis of bacterial infections in susceptible patients; treatment of acute and chronic bacterial prostatitis; treatment of skin and soft-tissue infections caused by Staphylococcus aureus .

Contraindications:

Hypersensitivity to trimethoprim or sulfonamides. Megaloblastic anemia. Severe hepatic failure. Pregnancy and breastfeeding. Premature and infants less than two months of age or. glucose 6-phosphate dehydrogenase deficiency (G6PD) deficiency.

Adverse reactions:

CNS Apathy, aseptic meningitis, ataxia, convulsions, depression, fatigue, hallucinations, headache, insomnia, nervousness, peripheral neuritis, vertigo, weakness. EENT Tinnitus. Endocrine Diuresis, hypoglycemia. Hematologic Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, hypoprothrombinemia, leukopenia, megaloblastic anemia, methemoglobinemia, neutropenia, thrombocytopenia. Hypersensitivity Allergic myocarditis, anaphylaxis, angioedema, chills, conjunctival and scleral injection, drug fever, erythema multiforme, exfoliative dermatitis, generalized allergic reactions, generalized skin eruptions, Henoch-Schoenlein purpura, periarteritis nodosa, photosensitivity, pruritus, rash, serum sickness–like syndrome, Stevens-Johnson syndrome, systemic lupus erythematosus, toxic epidermal necrolysis, urticaria. GI Abdominal pain, anorexia, diarrhea, elevation of serum transaminase and bilirubin, emesis, glossitis, hepatitis (including cholestatic jaundice and hepatic necrosis), nausea, pancreatitis, pseudomembranous enterocolitis, stomatitis, vomiting. Genitourinary BUN and serum creatinine elevation, crystalluria and nephrotoxicity in association with cyclosporine, interstitial nephritis, renal failure, toxic nephrosis with oliguria and anuria. Metabolic Hyperkalemia. Musculoskeletal Arthralgia, myalgia, rhabdomyolysis. Respiratory Cough, pulmonary infiltrates, shortness of breath.

Interactions:

ACE inhibitors Hyperkalemia, possibly with cardiac arrhythmias or cardiac arrest, may occur during coadministration. Amantadine A case of toxic delirium has been reported after coadministration with sulfamethoxazole/trimethoprim. Antiarrhythmic agents (eg, amiodarone, bretylium, disopyramide, dofetilide, procainamide, quinidine, sotalol), arsenic trioxide, chlorpromazine, cisapride, dolasetron, droperidol, mefloquine, mesoridazine, moxifloxacin, pentamidine, pimozide, tacrolimus, thioridazine, ziprasidone An additive effect of trimethoprim/sulfamethoxazole with other drugs that prolong the QT interval cannot be excluded. Cyclosporine May cause decreased therapeutic effect of cyclosporine and increased risk of nephrotoxicity. Digoxin Increased digoxin levels may occur. Diuretics (eg, thiazides) An increased incidence of thrombocytopenia with purpura has been reported during coadministration. Indomethacin Sulfamethoxazole blood levels may be increased. Methenamine Methenamine is contraindicated for use with sulfonamides because of the potential of formation of insoluble precipitates in the urine. Methotrexate May displace methotrexate from protein-binding sites, thus increasing free methotrexate levels. Phenytoin Trimethoprim may inhibit metabolism of phenytoin or other hydantoins. Procainamide Trimethoprim may inhibit renal elimination of procainamide and its metabolites. Sulfones (eg, dapsone) The plasma concentration of both drugs may be increased. Sulfonylureas May increase hypoglycemic response to sulfonylureas because of displacement from protein-binding sites or inhibition of hepatic metabolism. Tricyclic antidepressants Efficacy may be decreased. Vaccines, live The effectiveness of live vaccines may be decreased. Warfarin May cause prolonged PT. Laboratory Test Interactions Can interfere with serum methotrexate assay as determined by competitive binding protein technique when bacterial dihydrofolate reductase is used as binding protein. May interfere with Jaffe alkaline picrate reaction assay for creatinine, resulting in overestimations

Warnings:

Monitor Monitor CBC frequently during treatment; obtain urinalysis with microscopic examination and renal function tests. Pregnancy Category C . Do not use at term because of risk of neonatal kernicterus. Lactation Undetermined. Not recommended during breast-feeding because sulfonamides are excreted in breast milk and may cause kernicterus. Premature infants and infants with hyperbilirubinemia or G-6-PD deficiency are also at risk for adverse reactions. Children Not recommended for infants younger than 2 mo of age. Elderly Increased risk of severe adverse reactions in elderly patients. Hypersensitivity Sulfonamide-associated deaths, although rare, have occurred from hypersensitivity of respiratory tract, Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Both components can interfere with hematopoiesis. IV use at high doses for extended periods of time may cause bone marrow depression. Renal Function Use with caution. Dosage adjustment may be required. Hepatic Function Use with caution. Dosage adjustment may be required. Special Risk Patients Use with caution in patients with possible folate deficiency (eg, patients who are elderly or chronic alcoholic, patients undergoing anticonvulsant therapy, patients with malabsorption syndromes or malnutrition), porphyria, G-6–PD deficiency, thyroid dysfunction, or severe allergy or bronchial asthma, or patients who have sulfite sensitivity. Clostridium difficile –associated diarrhea Has been reported and may range in severity from mild diarrhea to fatal colitis. Ulceration Take tablets with water or food to prevent lodging in esophagus and subsequent ulceration. Hypoglycemia Cases of hypoglycemia in nondiabetic patients are seen rarely, usually occurring after a few days of therapy. Patients with renal dysfunction, liver disease, malnutrition, or those receiving high doses are particularly at risk. Benzyl alcohol Injection solution may contain benzyl alcohol. In newborn infants, benzyl alcohol has been associated with an increased incidence of neurological and other complications, which are sometimes fatal. Sodium metabisulfite Injection solution may contain sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms. Patients with AIDS Incidence of adverse reactions, especially rash, fever, elevated aminotransferase values, and leukopenia, is greatly increased. Streptococcal pharyngitis Do not use for streptococcal pharyngitis. Sulfonamides Sulfonamides are chemically similar to some diuretics (acetazolamide and the thiazides), goitrogens, and oral hypoglycemic agents. Goiter production, diuresis, and hypoglycemia occur rarely in patients receiving sulfonamides. Cross-sensitivity may occur.

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