red dose in a 4-hour dialysis period.
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 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 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per 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 tablets 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 tablets 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.
HOW SUPPLIED
Tramadol Hydrochloride Tablets, 50 mg are available as white, round, film coated tablets, debossed with 466 on one side and WATSON on the other. Each tablet contains 50 mg of tramadol hydrochloride. They are supplied in bottles of 100, 500 and 1000 tablets.
Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]
Dispense in a tight container as defined in the USP.
Watson Laboratories, Inc.
Corona, CA 92880 USA
30354-3
Rev: August 2004
INGREDIENTS AND APPEARANCE
TRAMADOL HCL
tramadol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0466
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tramadol hydrochloride (UNII: 9N7R477WCK) (Tramadol - UNII:39J1LGJ30J) 50 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium ()
hypromellose ()
lactose monohydrate ()
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose ()
polysorbate ()
polyethylene glycol ()
pregelatinized starch ()
titanium dioxide (UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 466;WATSON
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