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HUMATIN Label and HUMATIN General Information

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humatin (Paromomycin Sulfate)  capsule 
[Monarch Pharmaceuticals, Inc.]

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.

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.

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.

Contraindications

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

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.

Adverse Reactions

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

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.

Rx only.

Prescribing Information as of November 2001.

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI 48202

Humatin (Paromomycin Sulfate)

PRODUCT INFO Product Code 61570-529 Dosage Form CAPSULE Route Of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Paromomycin Sulfate (Paromomycin) Active 250 MILLIGRAM  In 1 CAPSULE D&C yellow No. 10 Inactive   FD&C blue No. 1 Inactive   FD&C red No. 3 Inactive   FD&C yellow No. 6 Inactive   gelatin Inactive   titanium dioxide Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color YELLOW Score 1 Shape CAPSULE Symbol false Imprint Code Coating false Size 19mm

PACKAGING # NDC Package Description Multilevel Packaging 1 61570-529-10 100 CAPSULE In 1 BOTTLE None

Revised: 03/2007