A-fenac Gel-30gr.

Class: Analgesic/NSAID Action Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis. Indications Treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis. Potassium salt is approved for management of pain and primary dysmenorrhea, when prompt pain relief is needed. Ophthalmic: Treatment of postoperative inflammation after cataract removal. Topical: Treatment of actinic keratosis. Unlabeled use(s): Treatment of biliary colic, dysmenorrhea, enuresis, glomerular disease, gout, migraine headache, renal colic. Contraindications Sensitivity to aspirin or any NSAID; soft contact lenses (ophthalmic); benzyl alcohol, polyethylene glycol monomethyl ether 350, and hyaluronate sodium (topical). Route/Dosage Osteoarthritis PO 100 to 150 mg/day in divided doses. Rheumatoid Arthritis PO 100 to 200 mg/day in divided doses. Ankylosing Spondylitis PO 100 to 125 mg/day in divided doses; may give additional 25 mg at bedtime. Analgesia and Primary Dysmenorrhea (Potassium Salt Only) PO 50 mg tid; may give initial dose of 100 mg if needed. Ophthalmic 1 drop of 0.1% solution in affected eye qid. Actinic Keratosis ADULT: Topical Apply gel to lesions bid. Interactions Cyclosporine: May increase nephrotoxicity. Digoxin: May increase digoxin serum concentrations. Diuretics: May inhibit diuretic and antihypertensive effects. Lithium: May decrease lithium clearance. Methotrexate: May increase methotrexate levels. Warfarin: May increase risk of gastric erosion and bleeding. Lab Test Interferences May prolong bleeding time. Adverse Reactions CV: Edema; water retention; hypertension; CHF. CNS: Headache; vertigo; drowsiness; dizziness. DERM: Rash; urticaria; fasciitis; photosensitivity; contact dermatitis, exfoliation (topical). EENT: Transient stinging and burning (ophthalmic); tinnitus. GI: Diarrhea; vomiting; abdominal pain; dyspepsia; peptic ulcer; GI bleeding. GU: Acute renal failure; nephrotic syndrome. HEMA: Fall in hemoglobin; bruising; prolonged bleeding time; thrombocytopenia purpura; anemia. RESP: Breathing difficulties in aspirin-sensitive individuals. OTHER: Hypersensitivity reactions. Ophthalmic use may cause bleeding tendencies and other effects associated with systemic use, caused by absorption. Precautions Pregnancy: Category B. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Increased risk of adverse reactions. GI effects: Serious GI toxicity (eg, bleeding, ulceration, perforation) can occur at any time, with or without warning symptoms. Renal effects: Acute renal insufficiency; interstitial nephritis; hyperkalemia; hyponatremia; and renal papillary necrosis may occur. PATIENT CARE CONSIDERATIONS Administration/Storage Administer after meals or with food to minimize gastric irritation. Do not administer antacids within 2 hr of giving enteric-coated diclofenac because antacids may destroy enteric coating. Assessment/Interventions Obtain patient history, including drug history and any known allergies. Assess arthritic pain and limitations of movement before and after administration (pain location and intensity). If given for eye inflammation after surgery, assess for changes. Notify health care provider of any signs of GI bleeding. Monitor and document I&O. Monitor for GI problems and guaiac stool. Review baseline CBC, BUN, and creatinine. If photosensitivity occurs, provide protective measures (eg, sunscreens, clothing) until tolerance is developed. If BP rises to hypertensive range, notify health care provider. Monitor transminases and other hepatic enzymes. Make a determination from lab results within 4 wk of initiating therapy and at intervals thereafter. Discontinue diclofenac immediately if clinical signs and symptoms consistent with liver disease develop, if systemic manifestations occur (eg, eosinophilia, rash), and if abnormal liver tests are detected or worsen.