HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Dispensing Solutions, Inc.

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 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 craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, bu

leaflet_short:

are supplied as white with bright pink specks, capsule-shaped, scored tablets, debossed "3591" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 100, 500 and 1000. are supplied as white with orange specks, capsule­-shaped, scored tablets, debossed “3604” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 10, 30, 60, 90, 100, 120, 180, 500 and 1000. are supplied as white, capsule-shaped, scored tablets, debossed "3592" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 20, 30, 50, 60, 90, 100, 120, 180, 240, 500 and 1000. are supplied as light orange, oval-­shaped, scored tablets, debossed “3605” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 10, 90, 100, 120, 500 and 1000. are supplied as white with green specks, capsule-shaped, scored tablets, debossed "3594" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 30, 60, 90, 100, 120, 180, 240, 500 and 1000. are supplied as white, modified capsule-shaped, scored tablets, debossed "3595" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 100, 500 and 1000. are supplied as white capsule-shaped, scored tablets, debossed "3596" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 60, 90, 100, 120, 500 and 1000. are supplied as light yellow, modified capsule-shaped, scored tablets, debossed "3601" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 60, 90, 100, 120, 150, 180, 240, 500 and 1000. are supplied as pink, capsule-shaped tablets, debossed "3600" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 30, 60, 90, 100, 120, 150, 180, 500 and 1000. are supplied as light blue, capsule-shaped, scored tablets, debossed "3597" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 30, 60, 90, 100, 120, 180, 500 and 1000. are supplied as white oval-shaped, scored tablets, debossed "3598" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 100, 500 and 1000. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. A Schedule CIII Narcotic.

authorization_status:

Abbreviated New Drug Application

SPC

HYDROCODONE BITARTRATE AND ACETAMINOPHEN - HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
DISPENSING SOLUTIONS, INC.
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
CIII
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:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 2.5 MG/500 MG
Each tablet contains:
Hydrocodone Bitartrate ............. 2.5 mg
Acetaminophen ......................... 500 mg
In addition each tablet contains the following inactive ingredients:
colloidal silicon dioxide, corn starch,
croscarmellose sodium, FD&C Red #3, magnesium stearate,
microcrystalline cellulose, povidone,
pregelatinized starch, stearic acid, and sucrose. May also contain
crospovidone. Meets USP
Dissolution Test 1.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/325 MG
Each tablet contains:
Hydrocodone Bitartrate ................. 5 mg
Acetaminophen ............................. 325 mg
In addition, each tablet contains the following inactive ingredients:
croscarmellose sodium, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone,
pregelatinized starch, sodium
lauryl sulfate, stearic acid and sugar s