Axen Tablets / Film-coated
Naproxen
250mg
Julphar (Gulf Pharmaceutical Industries)
| Pack size | 20's (10's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | JULPHAR DRUG STORE |
| Retail Price | 15.50 AED |
Available as:
Indications
Axen Tablets / Film-coated is used for:
Rheumatoid arthritis, Ankylosing spondylitis, Post-operative pain, Dysmenorrhea, Acute gout, Acute migraine attacks, Renal colic, Mild to moderate pain, Tendonitis, Osteoarthritis (degenerative arthritis), Acute musculoskeletal disorders, Bursitis
Adult Dose
Adults
Oral:
Pain
500 mg PO initially, then 250 mg PO q6-8hr or
500 mg PO q12hr PRN; not to exceed 1250 mg/day naproxen base on day 1; subsequent daily doses should not exceed 1000 mg naproxen base
Extended release: 750-1000 mg PO qDay; may temporarily increase to 1500 mg/day if tolerated well and clinically indicated
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis
500-1000 mg/day PO divided q12hr; may increase to 1500 mg/day if tolerated well for limited time
Extended release: 750-1000 mg PO qDay; may temporarily increase to 1500 mg/day if tolerated well and clinically indicated
Dysmenorrhea
500 mg PO initially, then 250 mg PO q6-8hr or 500 mg PO q12hr (long-acting formula); not to exceed 1250 mg/day on first day; subsequent doses should not exceed 1000 mg/day naproxen base
Gout, Acute
750 mg PO initially, followed by 250 mg q8hr until attack subsides
Extended release: 1000-1500 mg qDay, followed by 1000 mg qDay until attack subsides
Child Dose
Pain
>12 years
500 mg PO initially, then 250 mg PO q6-8hr or 500 mg PO q12hr PRN; not to exceed 1250 mg/day naproxen base on day 1; subsequent daily doses should not exceed 1000 mg naproxen base
Extended release: 750-1000 mg PO qDay; may temporarily increase to 1500 mg/day if tolerated well and clinically indicated
Juvenile Idiopathic Arthritis
>2 years: 10 mg/kg/day oral suspension PO divided q12hr; not to exceed 15 mg/kg/day
Renal Dose
Renal impairment: CrCl <30 mL/min: Use not recommended
Severe: Contraindicated.
Administration
Should be taken with food.
Contra Indications
Hypersensitivity. Aspirin or NSAID allergy. Perioperative pain in the setting of CABG surgery. Pregnancy (3rd trimester).
Precautions
Patient w/ known CV disease or risk factors for CV disease, history of GI bleeding or peptic ulceration, fluid retention or heart failure. Hepatic and renal impairment. Elderly. Pregnancy and lactation. Patient Counselling May impair ability to drive and operate machinery. Monitoring Parameters BP should be monitored closely during initiation and throughout therapy. Perform periodically renal function, CBC and chemistry profile in patients receiving long-term therapy.
Lactation: Drug excreted in breast milk; effect on infant unknown; not recommended
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive; NSAIDs inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth
Lactation
The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Interactions
May enhance methotrexate toxicity. Reduced BP response to ACE inhibitors or angiotensin II receptor antagonists. Increased risk of serious GI events (e.g. ulcer) w/ aspirin. Increased risk of GI bleeding w/ warfarin. May reduce the natriuretic effects of furosemide or thiazide diuretics. May increase serum lithium concentrations and reduce renal lithium clearance.
Delayed absorption w/ antacids, colestyramine or sucralfate. May interfere w/ the antihypertensive effects of beta-blockers (e.g. propranolol). May increase serum levels w/ probenecid.
Adverse Effects
Side effects of Naproxen :
1-10%
Abdominal pain (3-9%), Constipation (3-9%), Dizziness (3-9%), Drowsiness (3-9%), Headache (3-9%), Heartburn (3-9%), Nausea (3-9%), Edema (3-9%), GI bleeding (1-4%), GI perforation (1-4%), Lightneadedness (<3%), GI ulcers (1-4%), Fluid retention (3-9%), Diarrhea (1-3%), Stomatitis (<3%), Diverticulitis (1-3%), Dyspnea (3-9%), Hearing disturbances (<3%)
<1%
Meaningful (3 × upper limit of normal) elevation of serum alanine aminotransferase or aspartate aminotransferase
Mechanism of Action
Naproxen, a propionic acid derivative, is a prototypical NSAID. It reversibly inhibits the cyclooxygenase-1 and -2 (COX-1 and -2) enzymes, thus resulting in reduced synthesis of prostaglandin precursors. It can inhibit platelet aggregation, has anti-inflammatory, analgesic and antipyretic actions.
Note
Axen 250mg Tablets / Film-coated manufactured by Julphar (Gulf Pharmaceutical Industries). Its generic name is Naproxen. Axen is availble in United Arab Emirates.
Farmaco UAE drug index information on Axen Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.