May 29, 2016
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Zorvolex

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Zorvolex

Indications
Dosage
How Supplied

INDICATIONS

ZORVOLEX is indicated for

DOSAGE AND ADMINISTRATION

General Dosing Instructions

Carefully consider the potential benefits and risks of ZORVOLEX and other treatment options before deciding to use ZORVOLEX. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

The effectiveness of ZORVOLEX when taken with food has not been studied in clinical studies. Taking ZORVOLEX with food may cause a reduction in effectiveness compared to taking ZORVOLEX on an empty stomach [see CLINICAL PHARMACOLOGY].

Acute Pain

For management of mild to moderate acute pain, the dosage is 18 mg or 35 mg orally three times daily.

Osteoarthritis Pain

For management of osteoarthritis pain, the dosage is 35 mg orally three times daily.

Dosage Adjustments In Patients With Hepatic Impairment

Patients with hepatic disease may require reduced doses of ZORVOLEX compared to patients with normal hepatic function [see CLINICAL PHARMACOLOGY]. As with other diclofenac products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.

Non-Interchangeability With Other Formulations Of Diclofenac

ZORVOLEX capsules are not interchangeable with other formulations of oral diclofenac even if the milligram strength is the same. ZORVOLEX capsules contain diclofenac free acid whereas other diclofenac products contain a salt of diclofenac, i.e., diclofenac potassium or sodium. A 35 mg dose of ZORVOLEX is approximately equal to 37.6 mg of sodium diclofenac or 39.5 mg of potassium diclofenac. Therefore, do not substitute similar dosing strengths of other diclofenac products without taking this into consideration.

HOW SUPPLIED

Dosage Forms And Strengths

ZORVOLEX (diclofenac) capsules: 18 mg - blue body and light green cap (imprinted IP-203 on the body and 18 mg on the cap in white ink).

ZORVOLEX (diclofenac) capsules: 35 mg - blue body and green cap (imprinted IP-204 on the body and 35 mg on the cap in white ink).

Storage And Handling

ZORVOLEX (diclofenac) capsules are supplied as:

  • 18 mg - blue body and light green cap (imprinted IP-203 on the body and 18 mg on the cap in white ink)

NDC (42211-203-23), Bottles of 30 capsules
NDC (42211-203-29), Bottles of 90 capsules

  • 35 mg - blue body and green cap (imprinted IP-204 on the body and 35 mg on the cap in white ink)

NDC (42211-204-23), Bottles of 30 capsules
NDC
(42211-204-29), Bottles of 90 capsules

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.

Manufactured (under license from iCeutica Pty Ltd) for and Distributed by: Iroko Pharmaceuticals, LLC, One Kew Place, 150 Rouse Boulevard, Philadelphia, PA 19112. Revised: May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/23/2016

Indications
Dosage
How Supplied

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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