NAPROXEN

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). NAPROXEN TABLETS ARE INDICATED: FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF JUVENILE ARTHRITIS NAPROXEN TABLETS ARE ALSO INDICATED: FOR RELIEF OF THE SIGNS AND SYMPTOMS OF TENDONITIS FOR RELIEF OF THE SIGNS AND SYMPTOMS OF BURSITIS FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ACUTE GOUT FOR THE MANAGEMENT OF PAIN FOR THE MANAGEMENT OF PRIMARY DYSMENORRHEA

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). AFTER OBSERVING THE RESPONSE TO INITIAL THERAPY WITH NAPROXEN TABLETS, THE DOSE AND FREQUENCY SHOULD BE ADJUSTED TO SUIT AN INDIVIDUAL PATIENT'S NEEDS. DIFFERENT DOSE STRENGTHS AND FORMULATIONS (I.E., TABLETS, SUSPENSION) OF THE DRUG ARE NOT NECESSARILY BIOEQUIVALENT. THIS DIFFERENCE SHOULD BE TAKEN INTO CONSIDERATION WHEN CHANGING FORMULATION. ALTHOUGH NAPROXEN TABLETS, NAPROXEN SUSPENSION, NAPROXEN DELAYED-RELEASED TABLETS, AND NAPROXEN SODIUM TABLETS ALL CIRCULATE IN THE PLASMA AS NAPROXEN, THEY HAVE PHARMACOKINETIC DIFFERENCES THAT MAY AFFECT ONSET OF ACTION. ONSET OF PAIN RELIEF CAN BEGIN WITHIN 1 HOUR IN PATIENTS TAKING NAPROXEN. THE RECOMMENDED STRATEGY FOR INITIATING THERAPY IS TO CHOOSE A FORMULATION AND A STARTING DOSE LIKELY TO BE EFFECTIVE FOR THE PATIENT AND THEN ADJUST THE DOSAGE BASED ON OBSERVATION OF BENEFIT AND/OR ADVERSE EVENTS. A LOWER DOSE SHOULD BE CONSIDERED IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT OR IN ELDERLY PATIENTS (SEE WARNINGS; HEPATOTOXICITY, AND RENAL TOXICITY AND HYPERKALEMIA, AND PRECAUTIONS; GERIATRIC USE). GERIATRIC PATIENTS STUDIES INDICATE THAT ALTHOUGH TOTAL PLASMA CONCENTRATION OF NAPROXEN IS UNCHANGED, THE UNBOUND PLASMA FRACTION OF NAPROXEN IS INCREASED IN THE ELDERLY. CAUTION IS ADVISED WHEN HIGH DOSES ARE REQUIRED AND SOME ADJUSTMENT OF DOSAGE MAY BE REQUIRED IN ELDERLY PATIENTS. AS WITH OTHER DRUGS USED IN THE ELDERLY, IT IS PRUDENT TO USE THE LOWEST EFFECTIVE DOSE. PATIENTS WITH MODERATE TO SEVERE RENAL IMPAIRMENT NAPROXEN-CONTAINING PRODUCTS ARE NOT RECOMMENDED FOR USE IN PATIENTS WITH MODERATE TO SEVERE AND SEVERE RENAL IMPAIRMENT (CREATININE CLEARANCE < 30 ML/MIN) (SEE WARNINGS: RENAL EFFECTS). RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS THE RECOMMENDED DOSE IS 250 MG, 375 MG, OR 500 MG TWICE DAILY. DURING LONG-TERM ADMINISTRATION, THE DOSE OF NAPROXEN MAY BE ADJUSTED UP OR DOWN DEPENDING ON THE CLINICAL RESPONSE OF THE PATIENT. A LOWER DAILY DOSE MAY SUFFICE FOR LONG-TERM ADMINISTRATION. THE MORNING AND EVENING DOSES DO NOT HAVE TO BE EQUAL IN SIZE AND THE ADMINISTRATION OF THE DRUG MORE FREQUENTLY THAN TWICE DAILY IS NOT NECESSARY. IN PATIENTS WHO TOLERATE LOWER DOSES WELL, THE DOSE MAY BE INCREASED TO NAPROXEN 1500 MG/DAY FOR LIMITED PERIODS OF UP TO 6 MONTHS WHEN A HIGHER LEVEL OF ANTI-INFLAMMATORY/ANALGESIC ACTIVITY IS REQUIRED. WHEN TREATING SUCH PATIENTS WITH NAPROXEN 1500 MG/DAY, THE PHYSICIAN SHOULD OBSERVE SUFFICIENT INCREASED CLINICAL BENEFITS TO OFFSET THE POTENTIAL INCREASED RISK. THE MORNING AND EVENING DOSES DO NOT HAVE TO BE EQUAL IN SIZE AND ADMINISTRATION OF THE DRUG MORE FREQUENTLY THAN TWICE DAILY DOES NOT GENERALLY MAKE A DIFFERENCE IN RESPONSE (SEE CLINICAL PHARMACOLOGY). JUVENILE ARTHRITIS NAPROXEN TABLETS MAY NOT ALLOW FOR THE FLEXIBLE DOSE TITRATION NEEDED IN PEDIATRIC PATIENTS WITH JUVENILE ARTHRITIS. A LIQUID FORMULATION MAY BE MORE APPROPRIATE. IN PEDIATRIC PATIENTS, DOSES OF 5 MG/KG/DAY PRODUCED PLASMA LEVELS OF NAPROXEN SIMILAR TO THOSE SEEN IN ADULTS TAKING 500 MG OF NAPROXEN (SEE CLINICAL PHARMACOLOGY). THE RECOMMENDED TOTAL DAILY DOSE OF NAPROXEN IS APPROXIMATELY 10 MG/KG GIVEN IN 2 DIVIDED DOSES. ONE-HALF OF THE 250 MG TABLET WILL BE NEEDED FOR DOSING LOWER-WEIGHT CHILDREN. DOSING WITH NAPROXEN TABLETS IS NOT APPROPRIATE FOR CHILDREN WEIGHING LESS THAN 25 KILOGRAMS. THE RECOMMENDED TOTAL DAILY DOSE OF NAPROXEN IS APPROXIMATELY 10 MG/KG GIVEN IN 2 DIVIDED DOSES (I.E., 5 MG/KG GIVEN TWICE A DAY). NAPROXEN TABLETS ARE NOT WELL SUITED TO THIS DOSAGE SO USE OF NAPROXEN ORAL SUSPENSION IS RECOMMENDED FOR THIS INDICATION. MANAGEMENT OF PAIN, PRIMARY DYSMENORRHEA, AND ACUTE TENDONITIS AND BURSITIS BECAUSE THE SODIUM SALT OF NAPROXEN IS MORE RAPIDLY ABSORBED, NAPROXEN SODIUM IS RECOMMENDED FOR THE MANAGEMENT OF ACUTE PAINFUL CONDITIONS WHEN PROMPT ONSET OF PAIN RELIEF IS DESIRED. NAPROXEN MAY ALSO BE USED. THE RECOMMENDED STARTING DOSE OF NAPROXEN IS 500 MG, FOLLOWED BY 500 MG EVERY 12 HOURS OR 250 MG EVERY 6 TO 8 HOURS AS REQUIRED. THE INITIAL TOTAL DAILY DOSE SHOULD NOT EXCEED 1250 MG OF NAPROXEN. ACUTE GOUT THE RECOMMENDED STARTING DOSE IS 750 MG OF NAPROXEN FOLLOWED BY 250 MG EVERY 8 HOURS UNTIL THE ATTACK HAS SUBSIDED.