TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated

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:

STAT Rx USA LLC

INN (International Name):

TRAMADOL HYDROCHLORIDE

Sammensetning:

TRAMADOL HYDROCHLORIDE 37.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tramadol hydrochloride and acetaminophen tablet is indicated for the short-term (five days or less) management of acute pain. Tramadol hydrochloride and acetaminophen tablet should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product or opioids. Tramadol hydrochloride and acetaminophen tablet is 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 tablet may worsen central nervous system and respiratory depression in these patients. Tramadol has mu-opioid agonist activity. Tramadol Hydrochloride and Acetaminophen Tablet, a tramadol-containing product, can be abused and may be subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors infl

Produkt oppsummering:

Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg are available in the following form: light yellow colored, film coated, capsule shaped, biconvex tablets, debossed with “537” on one side and plain on the other side. Available as follows: Bottle of 30                      NDC 42549-569-30 Bottle of 60                      NDC 42549-569-60 Bottle of 90                      NDC 42549-569-90 Bottle of 112                    NDC 42549-569-02 Bottle of 120                    NDC 42549-569-12 Dispense in a tight container. Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature] Manufactured by: Sun Pharmaceutical Industries, Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202 C.S. No. 5401T32 Iss: 06/10

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET, FILM COATED
STAT RX USA LLC
----------
RX ONLY
DESCRIPTION
Tramadol hydrochloride and acetaminophen tablet for oral
administration (37.5 mg tramadol
hydrochloride/325 mg acetaminophen tablets) combines two analgesics,
tramadol and acetaminophen.
The chemical name for tramadol hydrochloride is
(±)_cis_-2-[(dimethylamino) methyl]-1-(3-
methoxyphenyl) cyclo-hexanol hydrochloride. Its structural formula is:
The molecular formula of tramadol hydrochloride is C
H NO .HC1. The molecular weight of
tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white,
bitter, crystalline and odorless
powder.
The chemical name for acetaminophen is _N-acetyl_-_p_-aminophenol. Its
structural formula is:
The molecular formula of acetaminophen is C H NO . The molecular
weight of acetaminophen is
151.17.
Acetaminophen is an analgesic and antipyretic agent which occurs as a
white, odorless, crystalline
16
13
2
8
9
2
powder, possessing a slightly bitter taste.
Tramadol hydrochloride and acetaminophen tablets contain 37.5 mg
tramadol hydrochloride and 325 mg
acetaminophen and are light yellow in color. Inactive ingredients in
the tablet are microcrystalline
cellulose, pregelatinized starch, sodium starch glycolate, corn
starch, magnesium stearate, opadry
yellow and povidone. In addition, opadry yellow contains:
hydroxypropyl methyl cellulose, titanium
dioxide, macrogol, talc, and iron oxide yellow.
CLINICAL PHARMACOLOGY
The following information is based on studies of tramadol alone or
acetaminophen alone, except where
otherwise noted:
PHARMACODYNAMICS
_Tramadol_
Tramadol is a centrally acting synthetic opioid analgesic. Although
its mode of action is not completely
understood, from animal tests, at least two complementary mechanisms
appear applicable: binding of
parent and M1 metabolite to μ-opioid receptors and weak inhibition of
reuptake of norepinephrine and
serotonin.
Opioid activity is due to both low affinity binding of the parent
co