Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of Voltaren Gel at the first appearance of skin rash or any other sign of hypersensitivity. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.During the first and second trimesters of pregnancy, diclofenac should not be given unless clearly necessary. Diclofenac is a widely used analgesic so that exposure during pregnancy may frequently occur. Do not throw the dosing card away. This observational cohort study used the German Embryotox pharmacovigilance database to assess the risk of major birth defects and spontaneous abortion after first trimester exposure to diclofenac. Skin tests in a previously treated patient population indicated a 2.18% probability of sensitisation to diclofenac, triggering allergic contact dermatitis (type IV). If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects Of the total number of subjects treated with Voltaren Gel in clinical studies, 498 were 65 years of age and over. However, even short-term NSAID therapy is not without risk.Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. These serious events may occur without warning. The dosing card containing Voltaren Gel can be used to apply the gel. taken, how much, and when it happened. Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial.In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with Voltaren Gel, and 3% for patients in the placebo group. Additionally, 583 patients were exposed to Voltaren Gel in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee. Human and animal studies indicate that diclofenac crosses the placenta. Diclofenac-containing gel has been shown to clear AK lesions with maximum therapeutic effect seen 30 days after cessation of medicinal product therapy.Mean absorption of diclofenac through the skin ranges from <1% to 12% with large interindividual variability. The 4 g line is 4.5 inches long. It allows continued monitoring of the benefit/risk balance of the medicinal product. Of these, 513 patients received Voltaren Gel for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations.In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. At the end (during the third trimester) of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate to the following risks: Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.In clinical trials, of oral diclofenac-containing products, meaningful elevations (i.e. Specific data on diclofenac are rare. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. Repeat these … Unable to load your delegates due to an error Foetal death and growth retardation occurred at materno-toxic doses. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). 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. Follow all instructions closely. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone Concomitant use of Voltaren Gel and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding Voltaren Gel is not a substitute for low dose aspirin for cardiovascular protection.NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).