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Endocet

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Endocet

Endocet

INDICATIONS

ENDOCET (oxycodone and acetaminophen tablets) is indicated for the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. ENDOCET (oxycodone and acetaminophen tablets) tablets are given orally.

Endocet (oxycodone and acetaminophen tablets) 5 mg/325 mg; Endocet (oxycodone and acetaminophen tablets) 7.5 mg/500 mg; Endocet (oxycodone and acetaminophen tablets) 10 mg/650 mg

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Endocet (oxycodone and acetaminophen tablets) 7.5 mg/325 mg; Endocet (oxycodone and acetaminophen tablets) 10 mg/325 mg

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Strength Maximal Daily Dose
Endocet 5 mg/325 mg 12 Tablets
Endocet 7.5 mg/325 mg 8 Tablets
Endocet 7.5 mg/500 mg 8 Tablets
Endocet 10 mg/325 mg 6 Tablets
Endocet 10 mg/650 mg 6 Tablets

Cessation of Therapy

In patients treated with ENDOCET (oxycodone and acetaminophen tablets) tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

HOW SUPPLIED

ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:

5 mg/325 mg

White, round, tablet, with one face scored and the other inscribed "Endo" and "602".

Bottles of 100                                  NDC 60951-602-70
Bottles of 500                                  NDC 60951-602-85

Unit dose package of 100 tablets NDC 60951-602-75

7.5 mg/325 mg

Peach oval-shaped, tablet debossed with "E700" on one side and "7.5/325" on the other.

Bottles of 100                                  NDC 60951-700-70

7.5 mg/500 mg

Peach, capsule-shaped, tablet debossed with "E796" on one side and "7.5" on the other.

Bottles of 100                                  NDC 60951-796-70

10 mg/325 mg

Yellow, capsule-shaped, tablet debossed with "E712" on one side and "10/325" on the other.

Bottles of 100                                  NDC 60951-712-70

10 mg/650 mg

Yellow, oval, tablet debossed with "E797" on one side and "10" on the other.

Bottles of 100                                  NDC 60951-797-70

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

DEA Order Form Required.

Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317. February, 2007. FDA rev date: n/a

Last reviewed on RxList: 3/27/2008
This monograph has been modified to include the generic and brand name in many instances.

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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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