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:

Keltman Pharmaceuticals Inc.

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, 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 of opioid

Product summary:

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 . They are supplied by Keltman Pharmaceuticals Inc. 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 This Product was Repackaged By Sandhills Repackaging For: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, MS 39232 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
KELTMAN PHARMACEUTICALS INC.
----------
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 37.5 MG/325 MG
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 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 151.17. 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:
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
com