Simflamfas

Diclofenac (oral powd/tab: K; topical gel: diethylamine)

Oral powd & tab: Treatment of signs & symptoms of RA, OA & acute & chronic ankylosing spondylitis. Relief of pain & primary dysmenorrhea. Short-term treatment of acute migraine attack, post-op pain, & inflammation post-tooth extraction & post-orthopaedic surgery. Topical gel: Traumatic inflammation of tendon, ligament, muscle & joint due to strain, sprain, & bruise. Localised soft tissue rheumatism eg, tendovaginitis, bursitis, arm-shoulder syndrome, & periarthropathy. Localized rheumatic disease eg, OA in peripheral joint & vertebral column.

Oral powd/tab Adult Initially 100-150 mg daily. Mild case 50-100 mg daily in 3 divided doses. Max dose: Pain, OA 150 mg daily. RA 225 mg daily. Ankylosing spondylitis 125 mg daily. Migraine Initially 50 mg, may be increased by 50 mg. If needed, the increment dose of 50 mg may be taken at 4-6 hrly interval. Max daily dose: Not >200 mg daily. Adolescent ≥14 yr 50-100 mg daily in 1-2 divided doses. Max daily dose: Not >150 mg daily. Gel Adult Apply on the affected skin 3-4 times daily & rub gently.

FC tab: Should be taken with food: Swallow whole, do not divide/chew. Powd for oral soln: May be taken with or without food.

Hypersensitivity. 3rd trimester of pregnancy. Oral powd: Patients w/ gastric or peptic ulcer, bleeding or perforation. History of asthma, urticaria, or anaphylaxis or allergic type reactions after using aspirin or other NSAIDs. Periop pain treatment. Patients w/ liver, kidney, or heart failure. Gel: Patients in whom ASA & other NSAIDs induced asthma, urticaria, or rhinitis.

Oral powd: Patients w/ CV or any risk factor of CV disease, HTN, fluid retention, heart, liver or kidney disorders, a history of GI ulcer or bleeding. Concomitant use w/ corticosteroid or oral anticoagulant. Prolonged NSAID use, smoking, alcohol consumption, poor health status. Patients receiving ACE inhibitor. Patients w/ phenylketonuria. 3rd trimester of pregnancy. Elderly. Gel: Extensive & prolonged use may cause systemic side effects. Contains propylene glycol which may cause mild local irritation. Pregnancy & lactation.

Oral powd: Headache, dizziness, somnolence, paresthesia, memory disturbances, seizure, anxiety, tremor, aseptic meningitis, taste disturbances, thrombocytopenia, leucopenia, anemia, agranulocytosis, hypersensitivity, systemic anaphylactic, disorientation, depression, insomnia, nightmare, irritability, psychotic disorders, visual disturbances, vertigo, palpitation, CHF, MI, chest pain, HTN, vasculitis, asthma, pneumonitis, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia, epigastric pain, GI bleeding or ulcer, colitis, hepatitis, jaundice, liver dysfunction, skin rash, urticaria, acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, kidney papillary necrosis, edema. Gel: Pustular rash, hypersensitivity, angioneurotic edema, asthma, dermatitis (including contact dermatitis), rash, eczema, erythema, itching, bullous dermatitis, photosensitivity reactions.

Oral powd: Lithium, digoxin, diuretics, antihypertensive agents, anticoagulants, antiplatelets, SSRIs, oral antidiabetic drugs, MTX, cyclosporins, quinolone antibiotics, warfarin, potent CYP2C9 inhibitors (eg, sulfinpyrazone, voriconazole), phenytoin.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

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