"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
ULTRACET® is indicated for the short-term (five days or less) management of acute pain.
DOSAGE AND ADMINISTRATION
For the short-term (five days or less) management of acute pain, the recommended dose of ULTRACET® is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day.
Individualization of Dose
In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of ULTRACET® be increased not to exceed 2 tablets every 12 hours. Dose selection for an elderly patient should be cautious, in view of the potential for greater sensitivity to adverse events.
ULTRACET® (tramadol hydrochloride/acetaminophen) Tablets with tramadol 37.5 mg and acetaminophen 325 mg are light yellow, coated, capsule-shaped tablets imprinted “O-M” on one side and “650” on the other and are available as follows:
|100's:||NDC 50458-650-60||Bottles of 100 tablets|
|HUD 100's:||NDC 50458-650-10||Packages of 100 unit doses in blister packs, 10 cards of 10 tablets each|
Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 -86°F).
Manufactured by: Janssen Ortho, LLC Gurabo, Puerto Rico 00778. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560. Revised October 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/4/2013
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