Humatin
Generic Name: paromomycin sulfate
Dosage Form: Capsules
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
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Revised: 03/2007
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