Paromomycin Sulfate

Patient Information

No information provided. Please refer to the PRECAUTIONS section.

Description

Paromomycin sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) is a broad spectrum antibiotic produced by Streptomyces riomosus var. paromomycinus. It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) is designated chemically as O-2,6-Diamino-2,6-dideoxy-β-L-idopyranosyl-(1→3)-O-β-D-ribofuranosyl-(1→5)-O-[2-amino-2-deoxy-α-D-glucopyranosyl-(1→4)]-2-deoxystrepta-mine sulfate (salt). The molecular formula is C₂₃H₄₅N₅O₁₄ • xH₂SO₄, with a molecular weight of 615.64 (base). Its structural formula is:

Each capsule, for oral administration, contains paromomycin sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) equivalent to 250 mg paromomycin. Each capsule also contains the following inactive ingredients: FD&C Green #3; FD&C Yellow #5 (tartrazine); gelatin, NF; and titanium dioxide, USP.

Indications

Paromomycin sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) is indicated for intestinal amebiasis—acute and chronic (NOTE—It is not effective in extraintestinal amebiasis); management of hepatic coma—as adjunctive therapy.

Dosage And Admintisration

Intestinal amebiasis: Adults and Children: 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

Paromomycin Sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) Capsules, each contain paromomycin sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) equivalent to 250 mg paromomycin. The capsule is green/yellow, imprinted “175” in black ink on the cap and body.

NDC 57664-175-08: Bottles of 100

Store at controlled room temperature 15°-30°C (59°-86°F).

Protect from moisture.

Caution—Federal law prohibits dispensing without prescription.

3/97. Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202. FDA revision date: n/a

Side Effects

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

Drug Interactions

No information provided.

WarningS

No information provided.

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.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Overdose

No information provided.

Contraindications

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

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.