"The US Food and Drug Administration (FDA) has approved diclofenac sodium injection (Dyloject, Hospira Inc), a proprietary nonsteroidal anti-inflammatory drug (NSAID) for the treatment of mild to moderate pain, and for the management of mod"...
DOSAGE AND ADMINISTRATION
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].
For management of mild to moderate acute pain, the dosage is 18 mg or 35 mg orally three times daily.
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.
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
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
NDC (42211-204-29), Bottles of 90 capsules
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. Revised: Aug 2014
Last reviewed on RxList: 9/4/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Zorvolex Information
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.
Chronic Pain/Back Pain
Find tips and advances in treatment.