HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

Keltman Pharmaceuticals Inc.

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone. Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in analgesia can be abused and are subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disea

Product summary:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 325 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 110” on obverse and bisected on the reverse. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied by Keltman Pharmaceuticals Inc. as follows: Storage:   Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. A Schedule CIII Narcotic.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN - HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
KELTMAN PHARMACEUTICALS INC.
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
Rx only
DESCRIPTION
Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied in
tablet form for oral
administration.
Hydrocodone bitartrate is an opioid analgesic and antitussive and
occurs as fine, white crystals or as a
crystalline powder. It is affected by light. The chemical name is:
4,5α-epoxy-3-methoxy-17-
methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the
following structural formula:
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a non-
opiate, non-salicylate analgesic and antipyretic. It has the following
structural formula:
Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains:
Hydrocodone Bitartrate, USP ......................... 10 mg
Acetaminophen, USP .................................... 325 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide, magnesium
stearate and microcrystalline cellulose.
Meets USP Dissolution Test 1.
CLINICAL PHARMACOLOGY
Hydrocodone is a semisynthetic narcotic analgesic and antitussive with
multiple actions qualitatively
similar to those of codeine. Most of these involve the central nervous
system and smooth muscle. The
precise mechanism of action of hydrocodone and other opiates is not
known, although it is believed to
relate to the existence of opiate receptors in the central nervous
system. In addition to analgesia,
narcotics may produce drowsiness, changes in mood and mental clouding.
The analgesic action of acetaminophen involves peripheral influences,
but the specific mechanism is as
yet undetermined. Antipyretic activity is mediated through
hypothalamic heat regulating centers.
Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of
acetaminophen have negligible
effects on the cardiovascular or respiratory systems; however, toxic
doses may cau