Safrosyn S

Naproxen Na

Relief of mild to moderate pain eg, postpartum & post-op pain, pain following IUD insertion & due to orthopedic surgery. Primary dysmenorrhea, mild to moderately severe, acute or chronic musculoskeletal & soft tissue inflammation & acute gout. Migraine headache prophylaxis.

Analgesia, dysmenorrhea, acute musculoskeletal conditions & pain states Initially 550 mg followed by 275 mg every 6-8 hr. Acute gout Initially 825 mg followed by 275 mg every 8 hr. Menorrhalgia 825-1,375 daily in 2 doses on 1st day of menstruation. Total daily dose: Not to exceed 1,100 mg. Acute migraine headache 825 mg at 1st symptom of impending attack, additional 275-550 mg may be taken not before ½ hr after initial dose throughout the day. Migraine headache prophylaxis 550 mg bd. Total daily dose: Not to exceed 1,375 mg.

May be taken with or without food.

Hypersensitivity to naproxen, aspirin or other NSAIDs. Active or previous history of recurrent peptic ulcer/haemorrhage; upper GI bleeding or perforation related to previous NSAIDs therapy. Severe cardiac, hepatic or renal failure. Last trimester of pregnancy. Childn <2 yr.

Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; if skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur. History of bronchial asthma or allergic disease; angioedema, rhinitis, nasal polyps; cardiac impairment, HTN, heart failure; inflammatory bowel disease eg, ulcerative colitis, Crohn's disease; PUD eg, alcoholism, smoking. GI bleeding, ulceration or perforation; SLE, mixed connective tissue disorders; coagulations disorders; established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease. Assess renal function prior to & during therapy. Closely monitor BP during & at regular intervals of therapy. Patients on controlled Na diet. Long-term & high-dose use. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Avoid combination w/ other NSAIDs. Concomitant use w/ diuretics, ACE inhibitors, ARBs; anticoagulants, drugs interfering w/ haemostasis; steroids; corticosteroids, SSRIs, antiplatelets. May affect ability to drive & use machines. Not recommended in patients w/ baseline creatinine <30 mL/min, dialysis. Renal or hepatic impairment. May impair fertility. Not recommended in women of childbearing potential, during labour, delivery & lactation. Not to be used during 1st 2 trimesters of pregnancy. Not recommended in childn <16 yr. Elderly or debilitated patients.

Heartburn, nausea, vomiting, constipation, diarrhoea, flatulence, dyspepsia, abdominal discomfort, epigastric distress; hypersensitivity reactions; hyperkalaemia; insomnia, dream abnormalities, depression, confusion, hallucinations; convulsions, dizziness, headache, lightheadedness, drowsiness, paraesthesia, retrobulbar optic neuritis, inability to concentrate, cognitive dysfunction, aseptic meningitis; visual disturbances, corneal opacity, papillitis, papilloedema; tinnitus, hearing disturbances; oedema, palpitations, HTN, cardiac failure, CHF; vasculitis; dyspnoea, asthma, eosinophilic pneumonitis, pulmonary oedema; nephropathy, nephrotoxicity; abnormal LFTs, fatal hepatitis, jaundice; granulocytopenia, thrombocytopenia, neutropenia, agranulocytosis, eosinophilia, leucopenia, aplastic & haemolytic anaemia; skin eruption & rashes eg, fixed drug eruption, itching (pruritus), urticaria, ecchymoses, purpura, sweating; myalgia, muscle weakness; female infertility; oedema, thirst, pyrexia, fatigue, malaise; raised serum creatinine.

Increased plasma conc w/ probenecid. Decreased MTX, lithium elimination. Reduced antihypertensive effect of β-blockers, ACE inhibitors, ARBs. Increased risk of renal failure w/ cyclosporin. Increased risk of nephrotoxicity w/ diuretics, tacrolimus. Exacerbated cardiac failure, reduce GFR & increased plasma cardiac glycoside levels. Reduced effect of mifepristone. Increased risk of GI bleeding or ulceration w/ corticosteroids. Enhanced effects of anticoagulants. Increased risk of convulsions associated w/ quinolones. Increased risk of GI bleeding w/ antiplatelets, SSRIs. Concomitant use w/ other albumin-bound drugs eg, coumarin-type anticoagulants, sulfonylureas, hydantoins, other NSAIDs, aspirin; glimepiride, glipizide.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

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