Zorvolex
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ZORVOLEX is indicated for management of mild to moderate acute pain.
ZORVOLEX is indicated for management of osteoarthritis pain.
History
There is currently no drug history available for this drug.
Other Information
ZORVOLEX (diclofenac) capsules contain the active ingredient diclofenac which is a benzeneacetic acid based nonsteroidal anti-inflammatory drug (NSAID). ZORVOLEX is available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name of diclofenac is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following structural formula.
The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink.
Sources
Zorvolex Manufacturers
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Iroko Pharmaceuticals Llc
![Zorvolex (Diclofenac) Capsule [Iroko Pharmaceuticals Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zorvolex | Iroko Pharmaceuticals Llc
2.1 Initial DosingThe 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 (12.3)]. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.1, 5.2)].
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.
2.2 Dosage Adjustments in Patients with Hepatic ImpairmentPatients with hepatic disease may require reduced doses of ZORVOLEX compared to patients with normal hepatic function [see Clinical Pharmacology (12.3)]. As with other diclofenac products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.
2.3 Non-Interchangeability with Other Formulations of DiclofenacZORVOLEX 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.
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