HYDROCODONE BITARTATE AND ACETAMINOPHEN- hydrocodone bitartate and acetaminophen tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Major Pharmaceuticals

INN (Medzinárodný Name):

HYDROCODONE BITARTRATE

Zloženie:

HYDROCODONE BITARTRATE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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. Hydrocodone Bitartrate and Acetaminophen Tablets are classified as a Schedule II controlled substance. 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 proportions only after several weeks of continued nar

Prehľad produktov:

Hydrocodone Bitartrate and Acetaminophen Tablets USP, contain hydrocodone bitartrate 5 mg and acetaminophen 325 mg. They are supplied as white with orange specks, capsule-shaped, bisected tablets, debossed WATSON on one side and 3202 on the other side, in unit dose box of 100. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container with a child-resistant closure. A Schedule CII Narcotic. Manufactured by: Mikart, Inc. Atlanta, GA 30318 Manufactured for: Watson Pharma, Inc. Parsippany, NJ 07054 USA Distributed by: MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150  USA Rev. 08/2014 Code 667D00

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

HYDROCODONE BITARTATE AND ACETAMINOPHEN- HYDROCODONE BITARTATE AND
ACETAMINOPHEN TABLET
MAJOR PHARMACEUTICALS
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
TABLETS USP 5 MG/325 MG
C-II
RX ONLY
REV. 08/2014
BOXED 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
4,5α-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 tablet contains:
Hydrocodone Bitartrate...... 5 mg
Acetaminophen.................. 325 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, crospovidone, microcrystalline cellulose,
povidone, pregelatinized starch,
stearic acid and sugar spheres which are composed of starch derived
from corn, sucrose, and FD&C
Yellow #6. 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