TREZIX- acetaminophen, caffeine, dihydrocodeine bitartrate capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), DIHYDROCODEINE BITARTRATE (UNII: 8LXS95BSA9) (DIHYDROCODEINE - UNII:N9I9HDB855)

Disponibbli minn:

Proficient Rx LP

INN (Isem Internazzjonali):

ACETAMINOPHEN

Kompożizzjoni:

ACETAMINOPHEN 320.5 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain. Dihydrocodeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus. This combination product is subject to the provisions of the Controlled Substance Act and has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Like other opioid analgesics, dihydrocodeine may produce subjected effects

Sommarju tal-prodott:

TREZIX™ capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 30(NDC #63187-705-30), 60(NDC #63187-705-60), 90(NDC #63187-705-90), 100 (NDC #63187-705-00) and 120 capsules (NDC #63187-705-72) Capsules are imprinted “TREZIX” on the red cap in white ink. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture. Rx Only Manufactured for: WraSer Pharmaceuticals LLC Ridgeland, MS 39157 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 13001 Rev. May 2014 Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

TREZIX- ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE
PROFICIENT RX LP
----------
TREZIX™ CAPSULES
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
320.5 MG / 30 MG / 16 MG
RX ONLY CIII
WARNING: DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO
MORPHINE
Respiratory depression and death have occurred in children who
received codeine
following tonsillectomy and/or adenoidectomy and had evidence of being
ultra-rapid
metabolizers of codeine due to a CYP2D6 polymorphism.
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:
TREZIX™ capsules are supplied in capsule form for oral
administration.
Each red capsule contains:
Acetaminophen...........................................320.5 mg
Caffeine ..........................................................30
mg
Dihydrocodeine bitartrate ...............................16 mg
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:
Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder
or white glistening
needles, is a central nervous system stimulant. It has the following
structural formula:
Dihydrocodeine Bitartrate (4,5 _-epoxy-3-methoxy-17-methylmorphinan-6
_-ol (+)-
tartrate), an odorless, fine white powder is an opioid analgesic. It
has the following
structural formula:
In addition, each capsule contains the following inactive ingredients:
crospovidone,
magnesium stearate, povidone, pregelatinized starch, stearic acid. The
capsule is
composed of FD&C Red #40, and gelatin. Imprinting ink is composed of
ammonium
hydroxide, isopropyl alcohol, n-butyl alcohol, pharmaceutical glaze
(modified) in SD-45,
propylene glycol,