"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
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 2013
Last reviewed on RxList: 11/4/2013
This monograph has been modified to include the generic and brand name in many instances.
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