Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
STAT Rx USA LLC
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE 37.5 mg
ORAL
PRESCRIPTION DRUG
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
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).
New Drug Application
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, COATED STAT RX USA LLC ---------- 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 Läs hela dokumentet