HUMATIN- 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:

Waylis Therapeutics LLC

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 HUMATIN™ Capsules and other antibacterial drugs, HUMATIN™ 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:

HUMATIN™ Capsules each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows: NDC 80725-250-01: 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HUMATIN- PAROMOMYCIN SULFATE CAPSULE
WAYLIS THERAPEUTICS LLC
----------
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
HUMATIN™ Capsules, and other antibacterial drugs, HUMATIN™
Capsules should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
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
23
45
5
14
2
4
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
HUMATIN™ Capsules and other antibacterial drugs, HUMATIN™ 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 susceptibi