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Indications and usage:
Voltaren Gel (Diclofenac) is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Voltaren Gel was not evaluated for use on joints of the spine, hip, or shoulder.
Voltaren tablets are indicated:
Dosage and administration:
Dosage forms and strengths:
Symptoms following acute NSAIDs and Diclofenac overdoses are usually limited tolethargy, drowsiness, nausea, vomiting, and epigastric pain, which aregenerally reversible with supportive care. Gastrointestinal bleeding canoccur. Hypertension, acute renal failure, respiratory depression andcoma may occur, but are rare. Anaphylactoid reactions have beenreported with therapeutic ingestion of NSAIDs, and may occur followingan overdose.
Patients should be managed by symptomatic and supportive care fol-lowing a NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodial-ysis, or hemoperfusion may not be useful due to high protein binding.
Warnings and precautions:
Side effects, adverse reactions:
Most common adverse reactions (incidence > 2% of patients treated with Voltaren Gel and greater than placebo) are application site reactions, including dermatitis.
In patients taking Voltaren (Diclofenac Sodium) enteric-coated tablets, or other NSAIDs, the most frequently reported adverse experiencesoccurring in approximately 1%-10% of patients are:Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liverenzymes, headaches, increased bleeding time, pruritus, rashes and tin-nitus.
To report suspected adverse reactions of Diclofenac pills or gel, contact Novartis pharmaceutical company or your local FDA.
Use in specific populations:
Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.
NSAIDs are associated with reversible infertility. Consider withdrawal of Voltaren (Diclofenac) in women who have difficulties conceiving.