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Page 1 of 11 Description of Naproxen: Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body. Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively: Naproxen (R=-COOH) C14H14O3 mol wt 230.26 naproxen sodium (R=-COONa) C14H13NaO3 mol wt 252.23 Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROSYN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. Brand Name & Manufacturer Name of Naproxen: Brand Name ANAFLEX Contains Dosage Form Naproxen sodium 250mg & Tablet Manufacturer ACI Ltd. Price(Tk.) 250mg x 50s Page 2 of 11 500mg/tablet pack: 250.00 MRP; 500mg x 30s pack: 270.00 MRP ANAFLEX Gel Naproxen 10% w/w gel preparation Gel ACI Ltd. 15gm pack: 62.00 MRP ANAFLEX SR Naproxen sodium 500mg/tablet Tablet (sustained release) ACI Ltd. 500mg x 20s pack: 280.00 IP ARNEX Naproxen sodium 500mg/tablet Tablet 500mg x 30s Silva Pharmaceuticals pack: 180.00 MRP Ltd. BPXEN Naproxen sodium 250mg & Tablet 500mg/tablet 250mg x 50s pack: 200.00 Bristol Pharma MRP; 500mg x Ltd. 50s pack: 375.00 MRP COSNAP Naproxen sodium 250mg/tablet Cosmo Pharma 250mg x 50s pack: 150.00 Laboratories MRP Ltd. Tablet Drug International Ltd. DIPROXEN Naproxen sodium 250mg & Tablet 500mg/tablet DIPROXEN CR-500 Naproxen sodium 500mg/tablet Tablet Drug (controlled International release) Ltd. DIPROXEN Gel Naproxen 10% w/w gel preparation Gel Drug International Ltd. 250mg x 100s pack: 420.00 MRP; 500mg x 50s pack: 350.00 MRP 500mg x 30s pack: 300.00 MRP 15gm pack: 60.00 MRP Naproxen sodium 250mg & Tablet 500mg/tablet 250mg x 50s pack: 200.00 SOMATEC Pharmaceuticals MRP; 500mg x 50s pack: 350.00 Ltd. MRP NAID Naproxen sodium 250mg & Tablet 500mg/tablet 250mg x 50s pack: 200.00 Pacific Pharmaceuticals MRP; 500mg x 50s pack: 376.00 Ltd. MRP NAPASIN Naproxen sodium Skylab FRITT Tablet 50s pack: 210.00 Page 3 of 11 250mg/tablet NAPEC Pharmaceuticals MRP Ltd. Naproxen sodium 250mg & Tablet 500mg/tablet Unimed & Unihealth Manufacturers Ltd. 250mg x 30s pack: 120.00 MRP; 500mg x 30s pack: 240.00 MRP 250mg x 50s pack: 200.00 MRP; 500mg x 30s pack: 210.00 MRP NAPIUM Naproxen sodium 250mg & Tablet 500mg/tablet Kumudini Pharma Ltd. NAPIX-500 Naproxen sodium 500mg/tablet 500mg x 30s Modern Pharmaceuticals pack: 140.00 MRP Ltd. Brand Name NAPREN NAPRO NAPRO-A Contains Naproxen sodium 250mg/tablet Tablet Dosage Form Tablet Naproxen sodium 250mg & Tablet 500mg/tablet Naproxen sodium 250mg & Tablet 500mg/tablet NAPROBEN Naproxen sodium 500mg/tablet 500 Tablet Manufacturer Price(Tk.) Alco Pharma Ltd. 50s pack: 150.00 MRP Aristopharma Ltd. 250mg x 50s pack: 210.00 MRP; 500mg x 30s pack: 210.00 MRP Acme Laboratories Ltd. 250mg x 100s pack: 400.00 MRP; 500mg x 30s pack: 210.00 MRP Benham 500mg x 30s Pharmaceutical pack: 180.00 IP Ltd. NAPROCID Naproxen sodium 250mg & Tablet 500mg/tablet 250mg x 30s pack: 120.05 Gaco MRP; 500mg x Pharmaceuticals 30s pack: 210.00 MRP NAPROSON Naproxen sodium 275mg/tablet Jayson 50s pack: 202.00 Pharmaceuticals IP Ltd. Tablet NAPROSYN Naproxen sodium 250mg & Tablet Roche 250mg x 50s Page 4 of 11 500mg/tablet pack: 331.50 Bangladesh Pharmaceuticals MRP; 500mg x 50s pack: 629.50 Ltd. MRP NAPROX Naproxen sodium 250mg & Tablet 500mg/tablet 250mg x 50s pack: 250.00 Eskayef MRP; 500mg x Bangladesh Ltd. 50s pack: 400.00 MRP NAPROX Naproxen sodium 125mg/5ml: suspension Suspension 50ml bot: 30.00 Eskayef Bangladesh Ltd. MRP NAPROX Naproxen 10% w/w gel preparation Gel 15gm pack: Eskayef Bangladesh Ltd. 60.00 MRP NAPROXEN Naproxen sodium 500mg/tablet Tablet Amico Laboratories Limited NAPROXIN NAPRYN NAPSOD Naproxen sodium 250mg & Tablet 500mg/tablet 250mg x 30s pack: 127.20 Ambee Pharmaceuticals MRP; 500mg x 30s pack: 206.70 Ltd. MRP Naproxen sodium 250mg & Tablet 500mg/tablet 250mg x 50s pack: 275.00 Health Care Pharmaceuticals MRP; 500mg x 30s pack: 270.00 Ltd. MRP Naproxen sodium 275mg & Tablet 550mg/tablet Unimed & Unihealth Manufacturers Ltd. NAPTODIN- Naproxen sodium 500mg/tablet 500 Brand Name 500mg x 30s pack: 210.00 MRP Contains Tablet Dosage Form 275mg x 30s pack: 120.00 MRP; 550mg x 30s pack: 240.00 MRP 500mg x 50s Desh Pharmaceuticals pack: 350.00 MRP (Pvt.) Ltd. Manufacturer Price(Tk.) SONAP Naproxen sodium 250mg & Tablet 500mg/tablet 500mg x 30s Square Pharmaceuticals pack: 150.00 MRP Ltd. SUXEN Naproxen 10% w/w gel preparation 15gm pack: Supreme Pharmaceutical 60.00 MRP Gel Page 5 of 11 Incepta 15gm pack: Pharmaceuticals 62.00 MRP Ltd. TICOFLEX Naproxen sodium 250mg & Tablet 500mg/tablet TICOFLEX Naproxen sodium 125mg/5ml: suspension TICOFLEX Naproxen 10% w/w gel preparation Gel Incepta 50ml bot: 35.00 Pharmaceuticals MRP Ltd. TICOFLEX SR Naproxen sodium 500mg/tablet Tablet (sustained release) 250mg x 50s pack: 200.00 Incepta Pharmaceuticals MRP; 500mg x 50s pack: 350.00 Ltd. MRP TOFA Naproxen sodium 250mg & Tablet 500mg/tablet Kemiko 15gm pack: Pharmaceuticals 60.00 MRP Ltd. Naproxen sodium 250mg & Tablet 500mg/tablet 250mg x 50s pack: 200.00 Renata Limited MRP; 500mg x 50s pack: 350.00 MRP Naproxen sodium 500mg/tablet 250mg x 50s pack: 200.00 Apex Pharmaceuticals MRP; 500mg x 30s pack: 240.00 Ltd MRP XENAPRO XPRO Clinical Information: Naproxen Indications: 1. 2. 3. 4. 5. 6. 7. 8. 9. ankylosing spondylitis arthralgia bone pain bursitis dental pain dysmenorrhea fever gouty arthritis headache Incepta 30s pack: 240.00 Suspension Pharmaceuticals MRP Ltd. Tablet Page 6 of 11 10. heterotopic ossification 11. juvenile rheumatoid arthritis (JRA) 12. migraine 13. migraine prophylaxis 14. mild pain 15. moderate pain 16. myalgia 17. osteoarthritis 18. rheumatoid arthritis 19. tendinitis Side Effetcs of Neproxen: 1. Common heartburn, nausea, or stomach/abdominal pain 2. Less common 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. dizziness drowsiness vomiting diarrhea headache tiredness (fatigue) loss of appetite constipation bloating or swelling, especially of the legs and feet* peptic (stomach) ulcers* bleeding from the stomach or intestines* nervousness anxiety depression 3. Rare 1. 2. 3. 4. 5. decreased hearing vision changes* double vision* hepatitis (liver inflammation)* liver damage, which may cause yellow skin or eyes (jaundice)* Page 7 of 11 6. 7. 8. 9. 10. 11. 12. 13. 14. rash and itching* high blood pressure* low white blood cell count with increased risk of infection low platelet count with increased risk of bleeding low red blood cell count (anemia) which can cause tiredness and other symptoms kidney damage (usually gets better after medicine is stopped) kidney failure allergic reaction with trouble breathing, raised itchy welts on the skin, or swelling of the face, mouth, or throat* heart attack or stroke* Contraindication of Naproxen: Naproxen delayed-release tablets are contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium. Naproxen delayed-release tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Naproxen delayed-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery Precaution of Naproxen: 1. Before taking naproxen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. 2. Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, severe loss of body water (dehydration), stroke, throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers). Page 8 of 11 3. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. 4. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. 5. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. 6. Some naproxen products contain salt (sodium). Tell your doctor if you are on a saltrestricted diet. 7. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 8. Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding. 9. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor before using this medication. 10. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. Dosage of Naproxen: Usual Adult Dose for Ankylosing Spondylitis Initial: 250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day. The initial dose for naproxen sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day. Page 9 of 11 Maintenance: May be increased to a daily maximum of 1500 mg (naproxen) or 1650 mg (naproxen sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of naproxen sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods. Usual Adult Dose for Rheumatoid Arthritis Initial: 250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day. The initial dose for naproxen sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day. Maintenance: May be increased to a daily maximum of 1500 mg (naproxen) or 1650 mg (naproxen sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of naproxen sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods. Usual Adult Dose for Acute Gout 750 mg (naproxen) or 825 mg (naproxen sodium) orally one time, followed by 250 mg (naproxen) or 275 mg (naproxen sodium) every 8 hours until the gouty attack has resolved, usually 2 to 3 days. The recommended dose of naproxen sodium controlled-release is two to three 500 mg tablets (1000 to 1500 mg) orally on the first day, followed by two 500 mg tablets (1000 mg) orally daily until the attack has subsided. Usual Adult Dose for Bursitis 550 mg naproxen sodium orally once, followed by 550 mg naproxen sodium every 12 hours, or 275 mg (naproxen sodium)/250 mg (naproxen) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg naproxen sodium or 1000 mg naproxen. The recommended initial dose of naproxen sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 Page 10 of 11 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg). Usual Adult Dose for Tendonitis 550 mg naproxen sodium orally once, followed by 550 mg naproxen sodium every 12 hours, or 275 mg (naproxen sodium)/250 mg (naproxen) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg naproxen sodium or 1000 mg naproxen. The recommended initial dose of naproxen sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg). Usual Adult Dose for Dysmenorrhea 550 mg naproxen sodium orally once, followed by 550 mg naproxen sodium every 12 hours, or 275 mg (naproxen sodium)/250 mg (naproxen) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg naproxen sodium or 1000 mg naproxen. Over-the-counter preparation: naproxen sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period. The recommended initial dose of naproxen sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg). Usual Adult Dose for Pain 550 mg naproxen sodium orally once, followed by 550 mg naproxen sodium every 12 hours, or 275 mg (naproxen sodium)/250 mg (naproxen) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg naproxen sodium or 1000 mg naproxen. Over-the-counter preparation: naproxen sodium 220 mg orally every 8 hours as needed. Do not Page 11 of 11 exceed 2 caplets in any 8- to 12-hour period. The recommended initial dose of naproxen sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg). Usual Geriatric Dose for Pain Over-the-counter preparation - 220 mg (naproxen sodium) orally every 12 hours or 250 mg (naproxen) orally every 8 hours as needed. Usual Pediatric Dose for Fever Dosage guidelines are based on naproxen: Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours. Usual Pediatric Dose for Pain Dosage guidelines are based on naproxen: Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours. Usual Pediatric Dose for Juvenile Rheumatoid Arthritis Dosage guidelines are based on naproxen: Greater than or equal to 2 years: 5 mg/kg orally twice a day. Maximum dose: 1000 mg/day.