TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

STAT Rx USA LLC

INN (Διεθνής Όνομα):

TRAMADOL HYDROCHLORIDE

Σύνθεση:

TRAMADOL HYDROCHLORIDE 37.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain. Tramadol HCl 37.5 mg/Acetaminophen 325 mg should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product, or opioids. Tramadol HCl 37.5 mg/Acetaminophen 325 mg 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 HCl 37.5 mg/Acetaminophen 325 mg may worsen central nervous system and respiratory depression in these patients. Tramadol has mu-opioid agonist activity. Tramadol HCl 37.5 mg/Acetaminophen 325 mg 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 influencing its developm

Περίληψη προϊόντος:

Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets are light yellow, coated, capsule-shaped tablets imprinted "O-M" on one side and "650" on the other and are available as follows: Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F).

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET, COATED
STAT RX USA LLC
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TRAMADOL HYDROCHLORIDE 37.5 MG/ACETAMINOPHEN 325 MG
TABLETS
FULL PRESCRIBING INFORMATION
HEPATOTOXICITY
TRAMADOL HYDROCHLORIDE 37.5 MG/ACETAMINOPHEN 325 MG TABLETS CONTAINS
TRAMADOL HCL
AND ACETAMINOPHEN. ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF
ACUTE LIVER FAILURE, AT
TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF
LIVER INJURY ARE ASSOCIATED
WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4,000 MILLIGRAMS
PER DAY, AND OFTEN
INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT (SEE WARNINGS).
DESCRIPTION
Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg 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 151.17. Acetaminophen is an
analgesic and antipyretic agent
which occurs as a white, odorless, crystalline powder, possessing a
slightly bitter taste.
Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain
37.5 mg tramadol
hydrochloride and 325 mg acetaminophen and are light yellow in color.
Inactive ingredients in the tablet
are powdered cellulose, pregelatinized corn starch, sodium starch
glycolate, corn starch, magnesium
stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium
dioxide, iron oxide, and carnauba
wax.
CLINICAL PHARMACOLOGY
The following information is based on studies of tramadol alone or
acetaminophen alone, except where
otherwise noted:
PHARMACODYNAMICS
Tramadol HCl 37.5 mg/Acetaminophen 325 mg tablets contain tramadol and
acetaminophen. Tramadol is
a centrally actin