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:

Central Texas Community Health Centers

INN (International Name):

PAROMOMYCIN SULFATE

Composition:

PAROMOMYCIN 250 mg

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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Paromomycin Sulfate Capsules and other antibacterial drugs, Paromomycin Sulfate Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of 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, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows: NDC 23155-038-01: Bottles of 100 The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body. STORAGE 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) MF # 0241-02 Issued: 10/13

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PAROMOMYCIN SULFATE - PAROMOMYCIN SULFATE CAPSULE
CENTRAL TEXAS COMMUNITY HEALTH CENTERS
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PAROMOMYCIN SULFATE
CAPSULES, USP
RX ONLY
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 _0_-2, 6-Diamino-2, 6-dideoxy-β
-L-idopyranosyl-(1→3)-_0_-β -D-ribofuranosyl-
(1→5)-_0_-[2-amino-2-deoxy-α
-D-glucopyranosyl-(1→4)]-2-deoxystreptamine sulfate (salt). The
molecular formula is C
H N O •xH 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
Blue # 1, D&C Red # 28, FD&C
Red # 40, gelatin and titanium dioxide. The imprinting ink for the 250
mg capsule contains D&C yellow
#10, FD&C blue # 1, FD&C blue # 2, FD&C red # 40, iron oxide black,
pharmaceutical shellac glaze,
and propylene glycol.
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.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Paromomycin
Sulfate Capsules and other antibacterial drugs, Paromomycin Sulfate
Capsules should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by susceptible bacteria.
23
45
5
14
2
4
When culture and susceptibility information are available, they should
be considered in selecting or
modifying antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility
patterns may co