A summary of the pharmacokinetic parameters is presented in Systemic exposure (area under the concentration-time curve) and maximum plasma concentrations of diclofenac are significantly lower with Voltaren Gel than with comparable oral treatment of diclofenac sodium.Systemic exposure with recommended use of Voltaren Gel (4 x 4 g per day applied to 1 knee) is on average 17 times lower than with oral treatment.

which it was not prescribed.

It is not known if Voltaren Gel is safe and effective if used on your spine, hips, or shoulders.This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.

The maker is charging $12.99 for a tube with 1.76 oz. You can ask your pharmacist or health care (NSAIDs)NSAIDs are used to treat pain and redness, swelling, and Do not use combination therapy with Voltaren Gel and an oral NSAID unless the benefit outweighs the risk.The following adverse reactions are discussed in greater detail in other sections of the labeling:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.During clinical development, 913 patients were exposed to Voltaren Gel in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities. The Voltaren ® Arthritis Pain Gel formulation is an emulgel, a non-greasy formulation that combines a gel and cream for topical application. Diclofenac sodium is a white to slightly yellow crystalline powder.

In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (greater than 8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients. help relieve arthritis pain in some of your joints.

VOLTAREN® GEL may be used Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.No information is available from controlled clinical studies regarding the use of Voltaren Gel in patients with advanced renal disease. Squeeze Voltaren Gel onto the dosing card evenly up to the 4 g line (a 4.5 inch length of gel), making sure the gel covers the 4 g area of the dosing card (see Figure G). The clinical significance of this interaction is not known.

The renal effects of VOLTAREN GEL may hasten the progression of renal dysfunction in patients with preexisting renal disease.Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma [see Seek emergency help if an anaphylactic reaction occurs.A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative Diclofenac may cause premature closure of the fetal Anemia has occurred in NSAID-treated patients. This may be due to NSAIDs, including VOLTAREN GEL, may increase the risk of bleeding events. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver Physicians should measure transaminases at baseline and periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. Prostaglandins sensitize The pharmacokinetics of VOLTAREN GEL were assessed in healthy volunteers following repeated applications during 7 days of VOLTAREN GEL to 1 knee (4 x 4 g per day) or to 2 knees and 2 hands (4 x 12 g per day) versus the recommended oral dose of diclofenac sodium for the treatment of osteoarthritis (3 x 50 mg per day). However, severe hepatic reactions can occur at any time during treatment with diclofenac.If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc. No clinically relevant differences of systemic absorption and of tolerability were found between applications of Voltaren Gel (4 x 4 g per day on 1 knee) with and under the conditions tested. You may report side effects to FDA at 1-800-FDA1088.Medicines are sometimes prescribed for purposes other In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. The lowest GoodRx price for the most common version of generic Voltaren Gel is around $14.11, 74% … Concomitant use may result in skin reactions or change the absorption of VOLTAREN GEL.Instruct patients to minimize or avoid exposure of treated areas to natural or artificial sunlight [see Carcinogenicity studies in mice and rats administered diclofenac sodium as a dietary constituent for 2 years at doses up to 2 mg/kg/day (approximately 0.5 and 1 times, respectively, the maximum recommended human topical dose of VOLTAREN GEL based on bioavailability and body surface area (In a photococarcinogenicity study conducted in hairless mice, topical application of a diclofenac sodium gel product at doses up to 0.035% diclofenac sodium (a 29-fold lower diclofenac sodium concentration than present in VOLTAREN GEL) resulted in an earlier median time of onset of tumors.Diclofenac was not mutagenic or clastogenic in a battery of genotoxicity tests that included the bacterial reverse mutation assay, in vitro mouse Diclofenac did not affect male or female fertility in rats at doses up to 4 mg/kg/day (approximately 2 times than the maximum human topical dose of VOLTAREN GEL based on bioavailability and BSA comparison).Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestationUse of NSAIDs, including VOLTAREN GEL, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.