Humatin

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

Humatin is indicated for intestinal amebiasis - acute and chronic (NOTE - It is not effective in extraintestinal amebiasis); management of hepatic coma - as adjunctive therapy.

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.

Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.

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.

SIDE EFFECTS

Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily.

DRUG INTERACTIONS

No information provided.

Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily.

No information provided.