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ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
DOSAGE AND ADMINISTRATION
ULTRAM ER should not be used in patients with:
- creatinine clearance less than 30 mL/min,
- severe hepatic impairment (Child-Pugh Class C) (See PRECAUTIONS, Use in Renal and Hepatic Disease.)
ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and Drug Abuse And Addiction).
Adults (18 years of age and over)
Patients Not Currently on Tramadol Immediate-Release Products
For patients not currently treated with tramadol immediate-release (IR) products, ULTRAM ER should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. ULTRAM ER should not be administered at a dose exceeding 300 mg per day.
Patients Currently on Tramadol Immediate-Release Products
For patients maintained on tramadol IR products, calculate the 24-hour tramadol IR dose and initiate a total daily dose of ULTRAM ER rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with ULTRAM ER, some patients maintained on tramadol IR products may not be able to convert to ULTRAM ER. ULTRAM ER should not be administered at a dose exceeding 300 mg per day. The concomitant use of ULTRAM ER with other tramadol products is not recommended (see WARNINGS).
Individualization Of Dose
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of ULTRAM ER have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.
In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, 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. ULTRAM ER should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
ULTRAM ER (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms:
100 mg: Round, convex, white to off-white tablets imprinted with “100” over “ER” on one side in black ink
Bottle of 30 tablets – NDC 50458-653-30
200 mg: Round, convex, white to off-white tablets imprinted with “200” over “ER” on one side in black ink
Bottle of 30 tablets – NDC 50458-655-30
300 mg: Round, convex, white to off-white tablets imprinted with “300” over “ER” on one side in black ink
Bottle of 30 tablets – NDC 50458-657-30
Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F).
Manufactured by: Valeant Pharmaceuticals International, Inc., Steinbach, MB, R5G 1Z7, Canada. Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560. Revised: July 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/30/2015
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