Naproxen	(nay-PROX-ehn)FDA MEDWATCH ALERT
Trade Name(s):	EC Naprosyn   ·Tablets, delayed-release 375 mg   ·Tablets, delayed-release 500 mg   Naprosyn   ·Tablets 250 mg   ·Tablets 375 mg   ·Tablets 500?mg   ·Suspension 125 mg/5 mL Naproxen Sodium   Aleve   ·Tablets 200 mg (220 mg naproxen sodium)   Anaprox   ·Tablets 250 mg (275 mg naproxen sodium)   Anaprox DS   ·Tablets 500?mg (550 mg naproxen sodium)   Naprelan   ·Tablets, controlled-release 375 mg (412.5 mg naproxen sodium)   ·Tablets, controlled-release 500 mg (550 mg naproxen sodium) Apo-Naproxen Apo-Naproxen EC Apo-Naproxen SR Gen-Naproxen EC Novo-Naprox Novo-Naprox EC Nu-Naprox Apo-Napro-Na Apo-Napro-Na DS Novo-Naprox Sodium Novo-Naprox SR Novo-Naprox Sodium DS Indicates Canadian Trade Name.
Class:	NSAID
Action:	Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis. Absorption: Naproxen is completely absorbed from the GI tract. Tablet T max is 2 to 4 h (immediate-release); suspension T max is 1 to 4 ? h; fasted patients' T max is 4 to 6 h (delayed-release); bioavailability is 95%; steady state is reached in 4 to 5 days.
	Distribution: Vd is 0.16 L/kg and protein binding is 99% albumin-bound.
	Excretion: Naproxen is eliminated in urine (95%), primarily as naproxen less than 1%, 6-0-desmethylnaproxen less than 1%, or their conjugates (66% to 92%). Naproxen t ½ is 12 to 17 h; Cl is 0.13 ? mL/min/kg; t ½ of metabolites and conjugates is less than 12 h.
	Special Populations: Renal Function Impairment - Metabolites and conjugates may accumulate.
Indications:
	Rx Management of mild to moderate pain, symptoms of rheumatoid or osteoarthritis, bursitis, tendonitis, ankylosing spondylitis, primary dysmenorrhea, acute gout. Naproxen (not naproxen sodium) also indicated for treatment of juvenile rheumatoid arthritis. Delayed-release naproxen is not recommended for initial treatment of acute pain because absorption is delayed compared to other naproxen formulations.
	OTC Temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, minor arthritis pain, pain of menstrual cramps, and reduction of fever.
Indications:	Unlabeled use(s): Sunburn, migraine, PMS.
Contraindications:	Allergy to aspirin, iodides or any NSAID; patients in whom aspirin or other NSAIDs induce symptoms of asthma, rhinitis or nasal polyps.
Interactions:
	Anticoagulants May increase effect of anticoagulants because of decreased plasma protein binding. May increase risk of gastric erosion and bleeding.
	Lithium May decrease lithium Cl.
	Methotrexate May increase methotrexate levels.
Lab Test Interferences:	May falsely increase urinary 17-ketosteroid values; may interfere with urinary assays for 5-hydroxy-indoleacetic acid.
Adverse Reactions:
	cardiovascular: Edema; weight gain; CHF; alterations in BP; vasodilation; palpitations; tachycardia; chest pain; bradycardia.
	cns: Headache; dizziness; drowsiness; vertigo; lightheadedness; mental depression; nervousness; irritability; fatigue; malaise; insomnia; sleep disorders; dream abnormalities; aseptic meningitis.
	dermatologic: Rash; urticaria; purpura; skin eruptions.
	eent: Visual changes; tinnitus; rhinitis; pharyngitis, stomatitis.
	gi: Constipation; heartburn; abdominal pain; peptic ulceration and bleeding; nausea; dyspepsia; diarrhea; vomiting; anorexia; colitis; flatulence.
	gu: Glomerulonephritis; interstitial nephritis; nephrotic syndrome; acute renal insufficiency and renal failure; dysuria; hyperkalemia; hyponatremia; renal papillary necrosis.
	hepatic: Increased LFT results.
	hematologic: Increased bleeding time; leukopenia; thrombocytopenia; granulocytopenia; eosinophilia; ecchymosis.
	respiratory: Bronchospasm; laryngeal edema; dyspnea; shortness of breath.
Precautions:
	Pregnancy: Category B .
	Lactation: Excreted in breast milk.
	Children: Safety and efficacy in children younger than 2 yr of age not established (Rx); do not give to children younger than 12 yr of age except under the advice and supervision of a health care provider (OTC).
	Elderly: Increased risk of adverse reactions.
	Renal function impairment: Assess function before and during therapy in patients with renal function impairment because NSAID metabolites are eliminated renally.
	Hepatic function impairment: May need to reduce dose in patients with hepatic failure.
	CV disease Drug may worsen CHF and may decrease hypertension control.
	Concomitant therapy Do not use naproxen sodium and naproxen concomitantly; both drugs circulate as naproxen anion.
	GI effects Serious GI toxicity (eg, bleeding, ulceration, perforation) can occur at any time, with or without warning symptoms.
Overdosage:	Signs & symptoms Drowsiness, nausea, heartburn, vomiting, indigestion, seizures.
Patient/Family Education:	Tell patient to take with milk, meals or antacids; follow with ½ to 1 glass of water to reduce GI upset. Advise patient to shake oral suspension before measuring. Explain that it may take 2 to 4 wk with naproxen and 1 to 2 days with naproxen sodium for anti-inflammatory effects to occur. Peak analgesic effect may occur in 1 to 2 h. Caution patient that use with aspirin, alcohol, steroids, and other GI irritants may cause increased GI upset. Instruct patient to report the following symptoms to health care provider: visual problems, abdominal pain, symptoms of gastric bleeding. Caution patient to avoid intake of alcoholic beverages and smoking. Advise patient to use caution while driving or performing other activities that require coordinated motor movements and mental alertness.