DS Prep Pak - Kit
(diclofenac sodium topical gel with Gloves and Wipes), 1%, for topical use only
These highlights do not include all the information needed to use DS Prep PAK safely and effectively. See full prescribing information for VOLTAREN ® GEL.
Initial U.S. Approval: 1988
These highlights do not include all the information needed to use VOLTAREN ® GEL safely and effectively. See full prescribing information for VOLTAREN ® GEL.
VOLTAREN ® GEL (diclofenac sodium topical gel), 1%, for topical use only.
Initial U.S. Approval: 1988
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Cardiovascular Risk
Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. ( 5.1).
VOLTAREN® GEL is contraindicated for the treatment of peri -operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk ( 4, 5.1)
Non-steroidal anti-inflammatory drugs (NSAIDs), including VOLTAREN® GEL, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients are at greater risk for serious gastrointestinal events. ( 5.2)
INDICATIONS AND USAGE
VOLTAREN ® 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. (1)
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VOLTAREN ® GEL has not been eva luated for use on the spine, hip, or shoulder. (14.1)
DOSAGE AND ADMINISTRATION
Total dose should not exceed 32 g per day, over all affected joints. ( 2.3) VOLTAREN ® GEL should be measured onto the enclosed dosing card to the appropriate 2 g or 4 g designation. ( 2)
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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)
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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)
DOSAGE FORMS AND STRENGTHS
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Known hypersensitivity to diclofenac, aspirin, or other NSAIDs. ( 4, 5.2)
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History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ( 4)
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Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. ( 4)
WARNINGS AND PRECAUTIONS
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Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. The lowest possible dose of VOLTAREN ® GEL should be used in patients with known CV disease or risk factors for CV disease. ( 5.1)
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NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation. VOLTAREN ® GEL should be prescribed with caution in those with a prior history of ulcer disease or gastrointestinal bleeding. ( 5.2)
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Elevation of one or more liver tests may occur during therapy with diclofenac. VOLTAREN ® GEL should be discontinued immediately if abnormal liver tests persist or worsen. ( 5.3)
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Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. VOLTAREN ® 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)
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Hypertension can occur with NSAID treatment. Blood pressure should be monitored closely during treatment with VOLTAREN ® GEL. ( 5.4)
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Fluid retention and edema have been observed in some patients taking NSAIDs. VOLTAREN ® GEL should be used with caution in patients with fluid retention or heart failure. ( 5.5)
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Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to VOLTAREN ® GEL and should be discontinued immediately if an anaphylactoid reaction occurs. ( 5.7)
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NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. VOLTAREN ® GEL should be discontinued if rash or other signs of local skin reaction occur. ( 5.8)
ADVERSE REACTIONS
Most common adverse reactions (incidence >2% of patients treated with VOLTAREN ® GEL and greater than placebo) are application site reactions, including dermatitis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-398-5876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
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Concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects including increased GI bleeding. ( 7.1)
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Concomitant use of anticoagulants and diclofenac have a risk of serious GI bleeding higher than users of either drug alone. ( 7.2)
See 17 for Medication Guide.
Revised: 10/2015
