HYDROCODONE BITARTATE AND ACETAMINOPHEN- hydrocodone bitartrate, acetaminophen tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Aidarex Pharmaceuticals LLC

INN (Medzinárodný Name):

HYDROCODONE BITARTRATE

Zloženie:

HYDROCODONE BITARTRATE 2.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5mg/325mg are supplied as white, capsule shaped, debossed "2.5/325" on one side and "KLE" on the other side. Store at 20 degrees C to 25  degrees C (68 degrees F to 77  degrees F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. A Schedule CIII Narcotic Rx Only Manufactured by: MIKART, INC. Atlanta, GA 30318 Manufactured for: KLE 2, Inc. Culver City, CA 90232 Repackaged By: Aidarex Pharmaceuticals, LLC. Coronoa, CA 92880

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

HYDROCODONE BITARTATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE,
ACETAMINOPHEN TABLET
AIDAREX PHARMACEUTICALS LLC
----------
HYDROCODONE BITARTRATE
AND ACETAMINOPHEN
TABLETS USP
2.5 MG/325 MG
RX ONLY
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:
C
H NO •C H O •2½H O
M.W. = 494.49
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:
C H NO
M.W. = 151.16
Each tablet contains:
18
21
3
4
6
6
2
8
9
2
Hydrocodone Bitartrate...... 2.5 mg
Acetaminophen.................. 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 2.
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.
The analgesic