PAROMOMYCIN SULFATE- paromomycin sulfate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PAROMOMYCIN SULFATE (UNII: 845NU6GJPS) (PAROMOMYCIN - UNII:61JJC8N5ZK)

Available from:

Sun Pharmaceutical Industries, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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. 29. Hungary Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Revised: 04/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PAROMOMYCIN SULFATE- PAROMOMYCIN SULFATE CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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PAROMOMYCIN SULFATE CAPSULES, USP
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 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
H N O • _x_H SO , 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.
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 in the stool.
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.
CONTRAINDICATIONS
23
45
5
14
2
4
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.
This product contains FD&C Yellow No. 5 (tartrazine) which may ca