HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Apotheca Inc.

INN (Mezinárodní Name):

HYDROCODONE BITARTRATE

Složení:

HYDROCODONE BITARTRATE 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Hydrocodone Bitartrate and Acetaminophen Tablets USP, contain Hydrocodone Bitartrate 5mg and Acetaminophen 325mg. NDC 12634-264-00 Bottles of 10 NDC 12634-264-40 Bottles of 40 NDC 12634-264-50 Bottles of 50 NDC 12634-264-57 Blister Pack of 20 NDC 12634-264-59 Blister Pack of 30 NDC 12634-264-61 Blister pack of 10 NDC 12634-264-64 Blister Pack of 4 NDC 12634-264-65 Blister Pack of 5 NDC 12634-264-66 Blister Pack of 6 NDC 12634-264-71 Bottles of 30 NDC 12634-264-80 Bottles of 20 NDC 12634-264-82 Bottles of 12 NDC 12634-264-85 Bottles of 15 NDC 12634-264-91 Blister Pack of 1 NDC 12634-264-92 Bottles of 2 NDC 12634-264-94 Bottles of 4 NDC 12634-264-95 Bottles of 5 NDC 12634-264-96 Bottles of 6 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 Repackaged and Distributed by: Apotheca Inc. Phoenix, AZ 85006 USA Rev. 01/2014

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
APOTHECA INC.
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
TABLETS USP 5 MG/325 MG
C-II
RX ONLY
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 and mental clouding