Pain as assessed by the patients at Week 12 using the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Pain Subindex was lower in the diclofenac sodium topical gel group than the placebo group.Study 2 evaluated the efficacy of diclofenac sodium topical gel for the treatment of osteoarthritis in subjects with osteoarthritis of the hand in an 8-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group study. No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity to the effect of NSAIDs in some older individuals cannot be ruled out.Diclofenac, as with any NSAID, is known to be substantially excreted by the kidney, and the risk of toxic reactions to diclofenac sodium topical gel may be greater in patients with impaired renal function. Pharmacokinetic Parameters and Comparison of diclofenac sodium topical gel to Oral Diclofenac Sodium Tablets After Repeated AdministrationTable 4. In this particular study, based on an overall number of 10 cases of liver injury associated with diclofenac, the adjusted odds ratio increased further with female gender, doses of 150 mg or more, and duration of use for more than 90 days.Physicians should measure transaminases at baseline and periodically in patients receiving longterm therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. Application site reactions, including application site dermatitis, were the most frequent reason for treatment discontinuation.In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies. Before you use diclofenac sodium topical gel for the first time, your healthcare provider or pharmacist should show you how to correctly measure your dose using the dosing card.Do not use more than a total of 32 grams of diclofenac sodium topical gel each day. If you are a consumer or patient please visit Diclofenac Sodium Topical Gel is contraindicated in patients with previous serious skin reactions to NSAIDs [Diclofenac may cause premature closure of the fetal ductus arteriosus.
(Basis: treatment with diclofenac sodium topical gel of 1 knee, 4 times a day versus 50 mg, 3 times a day of oral diclofenac tablets.) Avoid use of NSAIDs, including Diclofenac Sodium Topical Gel, in pregnant women starting at 30 weeks of gestation (third trimester) [Anemia has occurred in NSAID-treated patients.
The increase in CV thrombotic risk has been observed most consistently at higher doses.To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. Diclofenac sodium is a benzeneacetic acid derivative. Additionally, 583 patients were exposed to diclofenac sodium topical gel in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee. In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.Reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose (MRHD) of diclofenac sodium topical gel based on bioavailability and body surface area (BSA) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 5 and 10 times the MRHD based on bioavailability and BSA comparison).
The dosing card is re-usable. The 4 g line is 4.5 inches long.The dosing card containing Diclofenac Sodium Topical Gel can be used to apply the gel. Select one or more newsletters to continue. ), discontinue Diclofenac Sodium Topical Gel immediately, and perform a clinical evaluation of the patient.To minimize the potential risk for an adverse liver related event in patients treated with Diclofenac Sodium Topical Gel, use the lowest effective dose for the shortest duration possible. Do not give NSAIDs to other people, even if they have the same symptoms that you have. Pain in the target hand as assessed by the patients at Weeks 4 and 6 on a visual analog scale from 0 to 100 was lower in the diclofenac sodium topical gel group than the placebo group.Diclofenac Sodium Topical Gel, 1% is an opaque white gel and 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%).Store at room temperature 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].Keep from freezing. 13.Poe TE, Scott RB, Keith JF Jr. Interaction of indomethacin with furosemide. These events can occur at any time during use and without warning symptoms.