Humatin

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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.

Undesirable effects

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

Therapeutic 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.

Date of revision of the text

Nov 2001

Name of the medicinal product

Humatin

Qualitative and quantitative composition

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

Special warnings and precautions for use

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.

Dosage (Posology) and method of 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.

Interaction with other medicinal products and other forms of interaction

SIDE EFFECTS

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

DRUG INTERACTIONS

No information provided.