LORTAB 5/325 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)

Available from:

RxPak Division of McKesson Corp.

INN (International Name):

hydrocodone bitartrate

Composition:

hydrocodone bitartrate 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LORTAB 5/325- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
LORTAB 7.5/325- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
LORTAB 10/325- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
RXPAK DIVISION OF MCKESSON CORP.
----------
LORTAB®
HYDROCODONE BITARTRATE CII
AND ACETAMINOPHEN TABLETS, USP
RX ONLY
WARNING
HEPATOTOXICITY
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER
FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF
THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF
ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND
OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.
DESCRIPTION
LORTAB is 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:
C
H NO ·C H O ·2 ½H O M.W. = 494.49
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:
C H NO M.W. = 151.16
Each LORTAB for oral administration are available in the following
strengths:
18
21
3
4
6
6
2
8
9
2
Each LORTAB for oral administration are available in the following
strengths:
PRODUCT STRENGTH
HYDROCODONE BITARTRATE
ACETAMINOPHEN
5 mg/325 mg
5 mg
325 mg
7.5 mg/325 mg
7.5 mg
325 mg
10 mg/325 mg
10 mg
325 mg
In addition each tablet contains the following inactive ingredients:
croscarmellose sodium, magnesium
stearate, microcrystalline cellulose, silicon dioxide, and stearic
acid.
Meets USP Dissolution Test 2.
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 oth