Diclopr Gel

Generic name: diclofenac, methyl salicylate, menthol
Dosage form: gel, cream kit

Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.

DicloPR : Diclofenac 1% 100g /Amplify Relief MM 118g
19&Pacific Dover, DE 19904
NDC:71437-3425-01

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICALGEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL.

DICLOFENAC SODIUM topical gel, 1%, for topical use only
Initial U.S. Approval: 1988

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning.

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardialinfarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
(5.1)

• Diclofenac sodium topical gel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach orintestines, which can be
ifatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of pepticdisease and/or GI bleeding are at greater risk for serious GI events. (5.2)

-----------------RECENT MAJOR CHANGES-----------------
Boxed Warning 05/2016
Warnings and Precautions, Cardiovascular
Thrombotic Events (5.1) 05/2016
Warnings and Precautions, Heart Failure
and Edema (5.5) 05/2016

------------------INDICATIONS AND USAGE------------------ Diclofenac sodium topical gel, 1% is a non-steroidal anti- inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (1)
• Diclofenac sodium topical gel, 1% was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)

--------------DOSAGE AND ADMINISTRATION-------------
• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. (2.1)
• Lower extremities: Apply the gel (4 g) to the affected area
4 times daily. Do not apply more than 16 g daily to any one affected joint of the lower extremities. (2.2)
• Upper extremities: Apply the gel (2 g) to the affected area
4 times daily. Do not apply more than 8 g daily to any one affected joint of the upper extremities. (2.3)
• Total dose should not exceed 32 g per day, over all affected joints. (2.3) Diclofenac sodium topical gel should

be measured onto the enclosed dosing card to the appropriate 2 g or 4 g designation. (2)