HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Solco Healthcare US, LLC

INN (Internationale Bezeichnung):

HYDROCODONE BITARTRATE

Zusammensetzung:

HYDROCODONE BITARTRATE 7.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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. Controlled Substance Hydrocodone bitartrate and acetaminophen tablets is classified as a Schedule II controlled substance. Abuse and Dependence 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

Produktbesonderheiten:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg are supplied as yellow-orange, capsule-shaped tablets containing 7.5 mg hydrocodone bitartrate (WARNING: May be habit-forming ) and 325 mg acetaminophen. Tablets are debossed "116" score on one side and “MIA” on the other side, and are supplied in bottles of 100 tablets (NDC 43547-373-10). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
SOLCO HEALTHCARE US, LLC
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP, FOR ORAL USE
SOLCO HEALTHCARE US, LLC
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 4,000 milligrams per day, and often
involve more than one
acetaminophen-containing product.
DESCRIPTION
Hydrocodone Bitartrate* and Acetaminophen Tablets are supplied in
tablet form for oral administration.
*WARNING: May be habit-forming. (See PRECAUTIONS, Information for
Patients/Caregivers, and
DRUG ABUSE AND DEPENDENCE).
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 ...... 7.5 mg
WARNING: May be habit-forming.
Acetaminophen ................. 325 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
crospovidone, magnesium stearate (powder), microcrystalline cellulose,
povidone, pregelatinized
starch, stearic acid, D&C Yellow #10 Lake, and FD&C Yellow #6 Aluminum
Lake.
This product complies with 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 beli