|Dosage Form||Package Information||Links|
|CAPSULE||100 CAPSULE in 1 BOTTLE (57664-175-08)||Label Information|
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 chemically as O-2,6-Diamino-2,6-dideoxy-Î²-L-idopyranosyl-(1â†’3)-O-Î²-D- ribofuranosyl-(1â†’5)-O-[2-amino-2-deoxy-Î±-D-glucopyranosyl-(1â†’4)]-2-deoxystreptamine 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 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.
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.
Paromomycin Sulfate Capsules, each contain paromomycin sulfate 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° to 30°C (59° to 86°F).
Protect from moisture.
Cautionâ€”Federal law prohibits dispensing without prescription.
ALKALOIDA Chemical Company Zrt.
Kabay János u. 29.
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
paromomycin sulfate capsule
|Labeler - Sun Pharmaceutical Industries, Inc. (146974886)|
|Sun Pharmaceutical Industries, Inc.||146974886||MANUFACTURE(57664-175) , PACK(57664-175)|