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Drug Catalog - Product Detail

TRAMADOL HCL TAB 50MG 1000CT

NDC Mfr Size Str Form
69543-0136-11 VIRTUS PHARMACEUTICALS 1000 50MG TABLET
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Description
DESCRIPTION Tramadol hydrochloride tablets, USP, is a centrally acting analgesic. 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 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide. Chemical Structure
How Supplied
HOW SUPPLIED Tramadol hydrochloride tablets, USP, 50 mg, are available as white, oval, film-coated tablets debossed with" 101 " on one side and " OUYI " on the other side. Bottles of 100 tablets: NDC 69543-136-10 Bottles of 500 tablets: NDC 69543-136-50 Bottles of 1000 tablets: NDC 69543-136-11 Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 –30°C (59 – 86°F) [see USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults.
Dosage and Administration
DOSAGE AND ADMINISTRATION Adults (17 years of age and over) For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride tablets can be improved by initiating therapy with a titration regimen: The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, tramadol hydrochloride tablets 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day. For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, tramadol hydrochloride 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day. Individualization of Dose Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability. In all patients with creatinine clearance less than 30 mL/min , it is recommended that the dosing interval of tramadol hydrochloride be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis. The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours. In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.