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Roxicodone

Indications & Dosage
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INDICATIONS

For the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION

The usual adult oral dose is 10 to 30 mg every 4 hours as needed for pain or as directed by physician. The dose must be individually adjusted according to severity of pain, patient response and patient size. More severe pain may require 30 mg or more every 4 hours. If the pain increases in severity, analgesia is not adequate or tolerance occurs, a gradual increase in dosage may be required.

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.

HOW SUPPLIED

5 mg white scored tablets (Identified 54 582).

NDC 66479-580-25: Unit dose, 25 tablets per card, (reverse numbered), 4 cards per shipper.
NDC 66479-580-10: Bottles of 100 tablets.

5 mg per 5 mL Oral Solution

NDC 66479-583-05: Unit dose patient cup filled to deliver 5 mL (5 mg Oxycodone Hydrochloride), ten 5 mL patient cups per shelf pack, four shelf packs per shipper.
NDC 66479-583-50: Bottles of 500 mL.

20 mg per mL Liquid Concentrate

NDC 66479-584-03: Bottles of 30 mL with calibrated dropper [graduations of 0.25 mL (5 mg), 0.5 mL (10 mg), 0.75 mL (15mg), and 1 mL (20 mg) on the dropper].

Store at 25°C (77°F);excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]

DEA Order Form Required.
ROXICODONE is a registered trademark of Xanodyne Pharmaceuticals, Inc. Marketed by: Xanodyne® Pharmaceuticals, Inc. Newport, KY 41071. Rev.02-2006. FDA rev date: 8/31/2000

Brand Name: Roxicodone
Generic Name: Oxycodone

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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