TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Rebel Distributors Corp

INN (mednarodno ime):

TRAMADOL HYDROCHLORIDE

Sestava:

TRAMADOL HYDROCHLORIDE 37.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Tramadol hydrochloride and acetaminophen tablets 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 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 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, psychosocial, and environmental factors influenc

Povzetek izdelek:

Tramadol hydrochloride and acetaminophen tablets are beige colored, film-coated, biconvex capsule shaped tablets with “AN 617” debossed on one side and plain on the other side and are available as follows: Bottles of 12: NDC 42254-051-12 Bottles of 30: NDC 42254-051-30 Bottles of 60: NDC 42254-051-60 Bottles of 90: NDC 42254-051-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Rx only Manufactured by: Amneal Pharmaceuticals Paterson, New Jersey 07504 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42164 Rev. 09-2009 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
REBEL DISTRIBUTORS CORP
----------
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS
RX ONLY
DESCRIPTION
Tramadol hydrochloride and acetaminophen tablets combine two
analgesics, tramadol 37.5 mg and
acetaminophen 325 mg.
The chemical name for tramadol hydrochloride is
(±)_cis_-2-[(dimethylamino)methyl]-1-(3-
methoxyphenyl) cyclohexanol hydrochloride. Its structural formula 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 151.16. 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 beige in color. Inactive ingredients in the
tablet are carnauba wax, crospovidone,
microcrystalline cellulose, Opadry
beige, pregelatinized starch, povidone, sodium starch glycolate
and stearic acid. Opadry Beige contains: iron oxide black, iron oxide
red, iron oxide yellow,
polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
The following information is based on studies of tramadol alone or
acetaminophen alone, except where
otherwise noted:
_PHARMACODYNAMICS_
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 metabolite M1 to µ-opioid receptors. In animal
models, M1 is up to 6 times more
potent th