"Jan. 12, 2011 -- A new study weighs in on the debate over the relative safety of nonsteroidal anti-inflammatory medications (NSAIDs), commonly used to treat joint and muscle aches and pain.
The study, published online in the BMJ,"...
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
[See the Patient Instructions for Use]
The dosing card can be found attached to the inside of the carton.
The proper amount of VOLTAREN® GEL should be measured using the dosing card supplied in the drug product carton. The dosing card is made of clear polypropylene. The dosing card should be used for each application of drug product. The gel should be applied within the rectangular area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The 2 g line is 2.25 inches long. The 4 g line is 4.5 inches long. The dosing card containing VOLTAREN® GEL can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. If treatment site is the hands, patients should wait at least one (1) hour to wash their hands.
Lower Extremities, Including The Feet, Ankles, Or Knees
Apply the gel (4 g) to the affected foot, ankle, or knee 4 times daily. VOLTAREN® GEL should be gently massaged into the skin ensuring application to the entire affected foot, or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
Upper Extremities Including The Hands, Wrists, Or Elbows
Apply the gel (2 g) to the affected hand, wrist, or elbow 4 times daily. VOLTAREN® GEL should be gently massaged into the skin ensuring application to the entire affected hand, wrist, or elbow. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.
Total dose should not exceed 32 g per day, over all affected joints.
- Avoid showering/bathing for at least 1 hour after the application. Inform patient to wash his/her hands after use, unless the hands are the treated joint. If VOLTAREN® GEL is applied to the hand(s) for treatment; inform patient not to wash the treated hand(s) for at least 1 hour after the application.
- Do not apply VOLTAREN® GEL to open wounds.
- Avoid contact of VOLTAREN® GEL with eyes and mucous membranes.
- Do not apply external heat and/or occlusive dressings to treated joints.
- Avoid exposure of the treated joint(s) to natural or artificial sunlight.
- Avoid concomitant use of VOLTAREN® GEL on the treated skin site with other topical products, including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications
- Concomitant use of VOLTAREN® GEL with oral non-steroidal anti-inflammatory drugs(NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects. Do not use combination therapy with VOLTAREN® GEL and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.
- Avoid wearing of clothing or gloves for at least 10 minutes after applying VOLTAREN® GEL.
Dosage Form And Strength
VOLTAREN® GEL (diclofenac sodium topical gel), 1%
Storage And Handling
VOLTAREN® GEL (diclofenac sodium topical gel, 1%) is available in tubes containing 100 grams of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%).
100 grams tube
3 Pack (3 Tubes containing 100 g each) ..NDC 63481-684-03
5 Pack (5 Tubes containing 100 g each) ..NDC 63481-684-05
Store at room temperature 20°C to 25°C (68°F to 77°F)[See USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your VOLTAREN® GEL.
Marketed by: Endo Pharmaceuticals Inc., Malvern, PA 19355. Manufactured by:Novartis Pharma Produktions GmbH, Wehr, Germany forSandoz Inc., Princeton, NJ 08540. Revised: May 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/7/2016
Additional Voltaren Gel 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.
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