TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 37.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 30:                                      NDC 63187-084-30 Bottles of 60:                                      NDC 63187-084-60 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 Manufactured by:                                                                   Amneal Pharmaceuticals Co. (I) Pvt. Ltd.  Ahmedabad, INDIA 382220 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 09-2013 Repackaged by: Proficient Rx LP Westlake Village, CA 91362

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
PROFICIENT RX LP
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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP
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
hydrochloride and acetaminophen.
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 hi