Prescription Drugs

CLINICAL PHARMACOLOGY Action The in vitro and in vivo antibacterial action of paromomycin closely parallels that of neomycin. It is poorly absorbed after oral administration, with almost 100% of the drug recoverable in the stool.

Humatin (paromomycin sulfate) Capsule DESCRIPTION Humatin is a broad spectrum antibiotic produced by Streptomyces rimosus var. paromomycinus . It is a white, amorphous, stable, water-soluble product supplied as capsules containing the equivalent of 250 mg paromomycin. The capsule contains D&C yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin, NF; and titanium dioxide, USP.

INDICATIONS Humatin is indicated for intestinal amebiasis - acute and chronic (NOTE - It is not effective in extraintestinal amebiasis); management of hepatic coma - as adjunctive therapy. DOSAGE AND ADMINISTRATION Intestinal Amebiasis Adults and Pediatric Patients: Usual dose - 25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days. Management of Hepatic Coma Adults: Usual dose - 4 g daily in divided doses, given at regular intervals for five to six days. HOW SUPPLIED Humatin Capsules, each containing paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows NDC 61570-529-10: Bottles of 100 Store at controlled room temperature 15° - 30°C (59° - 86°F). Protect from moisture. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI 48202. Revised: Nov 2001

PATIENT INFORMATION No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.

OVERDOSE No information provided. CONTRAINDICATIONS Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.

SIDE EFFECTS Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily. DRUG INTERACTIONS No information provided.

WARNINGS Included as part of the PRECAUTIONS section. PRECAUTIONS The use of this antibiotic, as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patient is essential. If new infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken. The drug should be used with caution in individuals with ulcerative lesions of the bowel to avoid renal toxicity through inadvertent absorption. Pediatric Use See DOSAGE AND ADMINISTRATION section.