HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

EPM Packaging Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dose should not exceed 8 tablets. HOW SUPPLIED 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 CII Narcotic. DEA Order Form Required. Mfg Addres s Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Rev. 08-2015-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
EPM PACKAGING INC
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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.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
5 mg/325 mg
CS-II
Rx only
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:
4,5a-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
nonopiate,
non-salicylate analgesic and antipyretic. 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.
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 ac