HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)

Disponível em:

Trigen Laboratories, LLC

DCI (Denominação Comum Internacional):

HYDROCODONE BITARTRATE

Composição:

HYDROCODONE BITARTRATE 2.5 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
TRIGEN LABORATORIES, LLC
----------
HYDROCODONE
BITARTRATE
AND ACETAMINOPHEN
TABLETS, USP
2.5 MG/325 MG
CII
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
Hydrocodone bitartrate and acetaminophen 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:
4,5a-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 · 2½ H O MW = 494.490
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:
18
21
3
4
6
6
2
C H NO MW = 151.16
Each tablet contains the following active ingredients:
Hydrocodone Bitartrate
2.5 mg WARNING: May be habit- forming.
Acetaminophen
325 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
crospovidone, magnesium stearate, microcrystalline cellulose,
povidone, pregelatinized starch 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 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, chan