HYDROCODONE BITARTRATE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

DIRECT RX

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Hydrocodone bitartrate and acetaminophen tablets, USP 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, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone. Misuse, Abuse, and Diversion of Opioids Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in analgesia can be abused and are subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and crav

Produktu pārskats:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, contain hydrocodone bitartrate 5 mg and acetaminophen 325 mg. They are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 109” on obverse and bisected on the reverse. They are available as follows: Bottles of 100:             NDC 53746-109-01 Bottles of 500:             NDC 53746-109-05 Bottles of 1000:           NDC 53746-109-10 Storage:  Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. A Schedule CIII Narcotic. Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Rev. 12-2013

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

HYDROCODONE BITARTRATE- HYDROCODONE BITARTRATE TABLET
DIRECT RX
----------
HYDROCODONE BITARTRATE
BOXED WARNING SECTION
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 SECTION
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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:
Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains:
Hydrocodone Bitartrate, USP ........................... 5 mg
Acetaminophen, USP .................................... 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 1.
CLINICAL PHARMACOLOGY SECTION
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.
The analgesic action of acetaminophen involves peripheral influences,
but the specific
mechanism is as yet undetermined. Antipyretic activity is mediated
through
hypothalamic heat regulating centers. Acetaminophen inhibits
prostaglandin synthetase.
Therapeutic d