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Zorvolex

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Zorvolex

INDICATIONS

ZORVOLEX is indicated for treatment of mild to moderate acute pain in adults.

DOSAGE AND ADMINISTRATION

Initial Dosing

For treatment of mild to moderate acute pain, the dosage is 18 mg or 35 mg three times daily. 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]. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

Non-Interchangeability with Other Formulations of Diclofenac

ZORVOLEX (diclofenac) capsules do not result in an equivalent systemic exposure to diclofenac as other formulations of oral diclofenac. Other formulations contain a salt of diclofenac, i.e. diclofenac potassium or sodium, while ZORVOLEX contains the free acid. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX.

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, treatment should be started at the lowest dose. Start treatment with a dose of ZORVOLEX 18 mg three times a day and if efficacy is not achieved, discontinue use.

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, NDC (42211-203-23), Bottles of 30 capsules
18 mg, NDC (42211-203-29), Bottles of 90 capsules
35 mg, NDC (42211-204-23), Bottles of 30 capsules
35 mg, NDC (42211-204-29), Bottles of 90 capsules

Storage

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-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. Issued: October 2013

Last reviewed on RxList: 10/31/2013
This monograph has been modified to include the generic and brand name in many instances.

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