Prescription Drugs

CLINICAL PHARMACOLOGYACTIONS TAO (troleandomycin) is an antibiotic shown to be active in vitro against the following gram-positive organisms: Streptococcus pyogenes Diplococcus pneumoniae Susceptibility plate testing: If the Kirby-Bauer method of disc sensitivity is used, a 15 mcg. oleandomycin disc should give a zone of over 18 mm when tested against a troleandomycin sensitive bacterial strain.

DESCRIPTION TAO (troleandomycin) is a synthetically derived acetylated ester of oleandomycin, an antibiotic elaborated by a species of Streptomyces antibioticus. It is a white crystalline compound, insoluble in water, but readily soluble and stable in the presence of gastric juice. The compound has a molecular weight of 814 and corresponds to the empirical formula C 41 H 67 NO 15 . Inert ingredients in the formulation are: hard gelatin capsules (which may contain inert ingredients); lactose; magnesium stearate; sodium lauryl sulfate; starch.

INDICATIONS Diplococcus pneumoniae Pneumococcal pneumonia due to susceptible strains. Streptococcus pyogenes Group A beta-hemolytic streptococcal infections of the upper respiratory tract. Injectable benzathine penicillin G is considered by the American Heart Association to be the drug of choice in the treatment and prevention of streptococcal pharyngitis and in long term prophylaxis of rheumatic fever. Troleandomycin is generally effective in the eradication of streptococci from the nasopharynx. However, substantial data establishing the efficacy of TAO (troleandomycin) in the subsequent prevention of rheumatic fever are not available at present. DOSAGE AND ADMINISTRATION Clinical judgment based on the type of infection and its severity should determine dosage within the below listed ranges. Adults: 250 to 500 mg 4 times a day Children: 125 to 250 mg (3-5 mg/lb or 6.6 to 11 mg/kg) every 6 hours When used in streptococcal infection, therapy should be continued for ten days. HOW SUPPLIED TAO (troleandomycin) is supplied as: Capsules 250 mg: Each capsule contains troleandomycin equivalent to 250 mg of oleandomycin; bottles of 100 (NDC 0049-1590-66).

PATIENT INFORMATIONINFORMATION FOR PATIENTS No Information Provided

OVERDOSE No Information Provided CONTRAINDICATIONS Troleandomycin is contraindicated in patients with known hypersensitivity to this antibiotic.

SIDE EFFECTS The most frequent side effects of troleandomycin preparations are gastrointestinal, such as abdominal cramping and discomfort, and are dose related. Nausea, vomiting, and diarrhea occur infrequently with usual oral doses. During prolonged or repeated therapy, there is a possibility of overgrowth of nonsusceptible bacteria or fungi. If such infections occur, the drug should be discontinued and appropriate therapy instituted. Mild allergic reactions such as urticaria and other skin rashes have occurred. Serious allergic reactions, including anaphylaxis, have been reported. DRUG INTERACTIONS No Information Provided

WARNINGS Usage in Pregnancy: Safety for use in pregnancy has not been established. The administration of troleandomycin has been associated with an allergic type of cholestatic hepatitis. Some patients receiving troleandomycin for more than two weeks or in repeated courses have shown jaundice accompanied by right upper quadrant pain, fever, nausea, vomiting, eosinophilia, and leukocytosis. These changes have been reversible on discontinuance of the drug. Liver function tests should be monitored in patients on such dosage, and the drug discontinued if abnormalities develop. Reports in the literature have suggested that the concurrent use of ergotamine-containing drugs and troleandomycin may induce ischemic reactions. Therefore, the concurrent use of ergotamine-containing drugs and troleandomycin should be avoided. Troleandomycin should be administered with caution to patients concurrently receiving estrogen containing oral contraceptives. Studies in chronic asthmatic patients have suggested that the concurrent use of theophylline and troleandomycin may result in elevated serum concentrations of theophylline. Therefore, it is recommended that patients receiving such concurrent therapy be observed for signs of theophylline toxicity, and that therapy be appropriately modified if such signs develop. PRECAUTIONS Troleandomycin is principally excreted by the liver. Caution should be exercised in administering the antibiotic to patients with impaired hepatic function.