Indications
Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
- Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium topical gel 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 was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)
Contraindications
The use of diclofenac sodium topical gel is contraindicated in patients with a known hypersensitivity to diclofenac. Diclofenac sodium topical gel should not be administered in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.1)].
Diclofenac sodium topical gel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)] .
- Known hypersensitivity to diclofenac, aspirin, or other NSAIDs. ( 4 , 5.2 )
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ( 4 )
- Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. ( 4 )
Warnings and precautions
- Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. The lowest possible dose of diclofenac sodium topical gel should be used in patients with known CV disease or risk factors for CV disease. ( 5.1 )
- NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation. Diclofenac sodium topical gel should be prescribed with caution in those with a prior history of ulcer disease or gastrointestinal bleeding. ( 5.2 )
- Elevation of one or more liver tests may occur during therapy with diclofenac. Diclofenac sodium topical gel should be discontinued immediately if abnormal liver tests persist or worsen. ( 5.3 )
- Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Diclofenac sodium topical gel should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors. ( 5.6 )
At a glance
- Brand name
- Voltaren Arthritis Pain
- Active substance
- diclofenac sodium
- Route
- Topical
- Dosage form
- Gel
- Applicant
- Haleon US Holdings
- Status
- Over the counter
- FDA approval
- 17 Oct 2007
- Application
- NDA022122-001



