"A US Food and Drug Administration (FDA) advisory panel voted 15 to 5 Tuesday, recommending that the combination of an analgesic with antacids is not "a rational combination for over-the-counter (OTC) use for the relief of minor aches and pains as"...
DOSAGE AND ADMINISTRATION
CAUTION: Roxanol™ (Morphine Sulfate 20 mg/mL) is a HIGHLY CONCENTRATED solution of Morphine Sulfate for Oral Administration.Error in dosage or confusion between milligrams (mg) of morphine and milliliters (mL) of solution may cause significant over-dosage. Dosing instructions should be clearly pre-scribed in milligrams (mg) of morphine and milliliters (mL) of solution. VERIFY CORRECT DOSE AND VOLUME BEFORE ADMINISTRATION TO PATIENT.
Usual Adult Oral Dose
10 to 30 mg every 4 hours or as directed by physician. Dosage is a patient dependent variable, therefore increased dosage may be required to achieve adequate analgesia.
For control of severe, chronic pain in patients with certain terminal diseases, this drug should be administered on a regularly scheduled basis, every 4 hours, at the lowest dosage level that will achieve adequate analgesia.
Morphine Dosage Reduction
During the first two to three days of effective pain relief, the patient may sleep for many hours. This can be misinterpreted as the effect of excessive analgesic dosing rather than the first sign of relief in a pain exhausted patient. The dose, therefore, should be maintained for at least three days before reduction, if respiratory activity and other vitals signs are adequate.
Following successful relief of severe pain, periodic attempts to reduce the narcotic dose should be made. Smaller doses or complete discontinuation of the narcotic analgesic may become feasible due to a physiologic change or the improved mental state of the patient.
Morphine Sulfate (Immediate Release)
Oral Solution (Concentrate)
20 mg per mL
NDC 66479-560-03: Bottles of 30 mL with calibrated dropper.
NDC 66479-560-12: Bottles of 120 mL with calibrated dropper.
NDC 66479-560-24: Bottles of 240 mL with calibrated spoon.
Store at 25°C (77°F);excursions are permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]
DEA Order Form Required.
ROXANOL (morphine sulfate) is a trademark of Xanodyne Pharmaceuticals, Inc.
© 2005 Xanodyne Pharmaceuticals, Inc., Manufactured by: Boehringer Ingelheim Roxane, Inc. Columbus, OH 43216
Marketed by: Xanodyne Pharmaceuticals, Inc. Newport, KY 41071. Rev.10-2005. FDA rev date:
Last reviewed on RxList: 8/22/2007
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