TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

TRAMADOL HYDROCHLORIDE

Compoziție:

TRAMADOL HYDROCHLORIDE 37.5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated for the short-term (five days or less) management of acute pain. Tramadol hydrochloride and acetaminophen tablets 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 tablets 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 may worsen central nervous system and respiratory depression in these patients. Tramadol may induce psychic and physical dependence of the morphine-type (µ-opioid). (See WARNINGS. ) Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with a prior history

Rezumat produs:

Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other are available as follows: Dispense in a tight container. Store at 25o C (77o F); excursions permitted to 15º to 30o C (59º to 86o F). Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, NY 10977 Revised: 11/09 OS946-01-1-03 Repackaging and Relabeling by: Physicians Total Care, Inc. Tulsa, OK     74146

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg,
combines two analgesics, tramadol
and acetaminophen.
The chemical name for tramadol hydrochloride is
(±)_cis_-2-[(dimethylamino)methyl]-1-(3-
methoxyphenyl) cyclohexanol hydrochloride. Its structural formaula is:
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 weight of acetaminophen is 151.17. Acetaminophen is an
analgesic and antipyretic agent
which occurs as a white, odorless, crystalline powder, possessing a
slightly bitter taste.
Tramadol hydrochloride and acetaminophen tablets contain 37.5 mg
tramadol hydrochloride and 325 mg
acetaminophen and are orange in color. Tramadol hydrochloride and
acetaminophen tablets are intended
for oral administration. Inactive ingredients in the tablet are
crospovidone, magnesium stearate,
microcrystalline cellulose, OPADRY II Orange, povidone, pregelatinized
starch, purified water, and
stearic acid. OPADRY II Orange contains: FD&C red #40; FD&C yellow #6;
hypromellose 2910
3cP, 6cP, and 50cP; polydextrose; polyethylene glycol; titanium
dioxide; triacetate; and triacetin.
CLINICAL PHARMACOLOGY
The following information is based on studies of tramadol alone or
acetaminophen alone, except where
otherwise noted:
PharmacodynamicsTramadol
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
compound and higher affinity binding of
the O-demethylated metabolit