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:

McKesson Packaging Services Business Unit of McKesson Corporation

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate and acetaminophen tablets 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. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Controlled Substance – Hydrocodone bitartrate and acetaminophen tablets are classified as a Schedule III controlled substance. Abuse and Dependence – Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant prop

Product summary:

Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg are supplied as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M357 on one side and bisected on the other side. The tablets are supplied in: Boxes of 10x10 UD 100 NDC 63739-455-10 Boxes of 25x30 UD 750 NDC 63739-455-01 Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/325 mg are supplied as an unscored oval-shaped white tablet debossed with M366 on one side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M358 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/650 mg are supplied as a capsule-shaped white tablet debossed with M359 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/750 mg are supplied as a capsule-shaped white tablet debossed with M360 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/325 mg are supplied as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M363 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/650 mg are supplied as a capsule-shaped blue tablet debossed with M361 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/660 mg are supplied as a capsule-shaped white tablet debossed with M362 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/750 mg are supplied as a capsule-shaped white tablet debossed with M364 on one side and bisected on the other side. Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure. Storage – Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. A Schedule III Narcotic. Manufactured By: Mallinckrodt Inc., Hazelwood, MO 63042 USA. Distributed By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027 IS-455-M72-01-A1 September 2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN
5/500MG TABLETS USP
CIII
RX ONLY
DESCRIPTION
Hydrocodone Bitartrate and Acetaminophen Tablets 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:
TABLET
HYDROCODONE BITARTRATE USP
ACETAMINOPHEN USP
5 mg/325 mg
5 mg
325 mg
5 mg/500 mg
5 mg
500 mg
7.5 mg/325 mg
7.5 mg
325 mg
7.5 mg/500 mg
7.5 mg
500 mg
7.5 mg/650 mg
7.5 mg
650 mg
7.5 mg/750 mg
7.5 mg
750 mg
10 mg/325 mg
10 mg
325 mg
10 mg/500 mg
10 mg
500 mg
10 mg/650 mg
10 mg
650 mg
10 mg/660 mg
10 mg
660 mg
10 mg/750 mg
10 mg
750 mg
In addition, each tablet contains the following inactive ingredients:
crospovidone, magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized starch, silicon
dioxide, and stearic acid.
The 10 mg/650 mg tablet also contains FD & C Blue No. 1 Aluminum Lake
12%.
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 clou