HUMATIN Capsule (2021)

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1. Description

Paromomycin sulfate is a broad spectrum antibiotic produced by Streptomyces riomosus var. paromomycinus. It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate is designated ...

2. Clinical Pharmacology

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 ...

3. Indications and Usage

Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy. To reduce the development ...

4. Contraindications

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

6.1. General

Prescribing HUMATIN Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the ...

6.2. Information for Patients

Patients should be counseled that antibacterial drugs including HUMATIN Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When HUMATIN ...

6.10. Pediatric Use

See DOSAGE AND ADMINISTRATION section.

7. Adverse Reactions

Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily. To report SUSPECTED ADVERSE REACTIONS, Waylis Therapeutics LLC at 844-200-7910 or FDA at 1-800-FDA-1088. www.fda.gov/medwatch. ...

10. 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: ...

11. How Supplied

HUMATIN Capsules each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows: NDC 80725-250-01: Bottles of 100 The capsule is Dark Blue Opaque/White Opaque, imprinted with ...

12. Storage and Handling

Store at 20°-25°C (68°-77°F) [See USP controlled Room Temperature]. Protect from moisture. Preserve in tight containers as defined in the USP.