THERACODOPHEN-325- hydrocodone bitartrate, acetaminophen, .gamma.-aminobutyric acid kit

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Physician Therapeutics LLC

Designació comuna internacional (DCI):

HYDROCODONE BITARTRATE

Composición:

HYDROCODONE BITARTRATE 10 mg

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain. CONTRAINDICATIONS Hydrocodone bitartrate and acetaminophen tablets, USP 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. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of hydrocodone bitartrate and acetaminophen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, re

Resumen del producto:

HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg / 325 mg are available as white to off white, scored, oblong biconvex tablets, debossed “IP 110” on obverse and bisected on the reverse. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied as follows: Bottles of 100:   NDC 53746-110-01 Bottles of 500:   NDC 53746-110-05 Bottles of 1000: NDC 53746-110-10 Storage:   Store at 25°C (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. Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 12-2009 How Supplied Theramine is supplied in purple and white, size 0 capsules in bottles of 60 or 90 capsules. Physician Supervision Theramine is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision. U.S. patent pending. Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225 Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved NDC: 68405-1008-02 NDC: 68405-1008-03

Estat d'Autorització:

unapproved drug other

Fitxa tècnica

THERACODOPHEN-325 - HYDROCODONE BITARTRATE, ACETAMINOPHEN,
.GAMMA.-AMINOBUTYRIC ACID
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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THERACODOPHEN-325
DESCRIPTION
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-6one 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 Hydrocodone Bitartrate and Acetaminophen Tablets, USP contains:
Hydrocodone Bitartrate, USP. . . . . . . . . 10 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
Hydrocodone is a semisynthetic opioid 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,
opioids 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.
Acetaminophe