TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Tilgjengelig fra:

AvKARE

INN (International Name):

TRAMADOL HYDROCHLORIDE

Sammensetning:

TRAMADOL HYDROCHLORIDE 37.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain. Tramadol hydrochloride and acetaminophen tablets, USP should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, USP, acetaminophen, USP, any other component of this product or opioids. Tramadol hydrochloride and acetaminophen tablets, USP are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride and acetaminophen tablets, USP may worsen central nervous system and respiratory depression in these patients. Abuse Tramadol has mu-opioid agonist activity. Tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, p

Produkt oppsummering:

Tramadol hydrochloride and acetaminophen tablets, USP, 37.5 mg/325 mg, are beige colored, film-coated, biconvex capsule shaped tablets with “AN 617” debossed on one side and plain on the other side. They are available as follows: Bottles of 90 count: NDC 42291-832-90 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 container as defined in the USP. Rx only

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
AVKARE
----------
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP
HEPATOTOXICITY
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS CONTAIN TRAMADOL
HYDROCHLORIDE AND
ACETAMINOPHEN.
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACTIVE 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
4,000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE
ACETAMINOPHEN-CONTAINING PRODUCT
(SEE WARNINGS)
DESCRIPTION
Tramadol hydrochloride and acetaminophen tablets, USP combine two
analgesics, tramadol, USP 37.5
mg and acetaminophen, USP 325 mg.
The chemical name for tramadol hydrochloride, USP is (±)
_cis_-2-[(dimethylamino)methyl]-1-(3-
methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
The molecular weight of tramadol hydrochloride, USP is 299.84.
Tramadol hydrochloride, USP is a
white, bitter, crystalline and odorless powder.
The chemical name for acetaminophen, USP is _N_-acetyl-
_p_-aminophenol. Its structural formula is:
The molecular weight of acetaminophen, USP is 151.17. Acetaminophen,
USP is an analgesic and
antipyretic agent which occurs as a white, odorless, crystalline
powder, possessing a slightly bitter
taste.
Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg
tramadol hydrochloride, USP
and 325 mg acetaminophen, USP and are beige in color. Inactive
ingredients in the tablets are carnauba
wax, crospovidone, iron oxide black, iron oxide red, iron oxide
yellow, microcrystalline cellulose,
pregelatinized starch, polyethylene glycol, polyvinyl alcohol,
povidone, sodium starch glycolate,
stearic acid, talc and titanium dioxide.
Dissolution Method: Test 2
CLINICAL PHARMACOLOGY
The following information is based on studies of tramadol alone or
acetaminophen alone, except where
otherwise noted:
_PHARMACODYNAMICS_
Tramadol hydrochloride and acetaminophen tablets contain tramadol