paromomycin (as paromomycin sulfate) 250 MG Oral Capsule
Paromomycin sulfate is a broad spectrum antibiotic produced by Streptomyces riomosus var.
It is a white, amorphous, stable, water-soluble product.
Paromomycin sulfate 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-deoxystreptamine sulfate (salt).
The molecular formula is C 23 H 45 N 5 O 14 • x H 2 SO 4 , 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.
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.
Caution —Federal law prohibits dispensing without prescription.
Manufactured by: ALKALOIDA Chemical Company Zrt.
4440 Tiszavasvári Kabay János u.
Hungary Distributed by: Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512 Revised: 04/2015
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.
DOSAGE AND ADMINISTRATION
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.