Recommended Dosage: General: After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used. Although naproxen and naproxen-sodium-containing products all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking Safrosyn S Tablet and within 1 hour in patients taking Safrosyn S Tablet.
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. Safrosyn S Tablet is not recommended in patients with baseline creatinine clearance less than 30 ml/minute because accumulation of naproxen metabolites has been seen in patients with severe renal failure or those on dialysis.
Recommended formulations: Because the sodium salt of naproxen is more rapidly absorbed, Safrosyn S Tablet is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Safrosyn S Tablet may be given orally either in fasting state or with meals and/or antacids.
Dose in adults: Acute conditions: Analgesia/Dysmenorrhea/Acute musculoskeletal conditions/Acute pain states in which there is an inflammatory component.
Because the sodium salt of naproxen is more rapidly absorbed, Safrosyn S Tablet is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. The recommended starting dose is 550 mg followed by 275 mg every 6-8 hours as required.
Acute gout: The recommended starting dose is 825 mg followed by 275 mg every 8 hours as needed.
Menorrhalgia: 825-1375 mg per day taken in 2 doses on the first day of menstrual bleeding. Thereafter, the total daily dose should not exceed 1100 mg.
Migraine: For treatment of acute migraine headache, the recommended dose is 825 mg at the first symptom of an impending attack. An additional dose of Safrosyn S Tablet 275 mg to 550 mg can be taken throughout the day, if necessary, but not before half an hour after the initial dose. For prophylaxis of migraine headache, the dose is 550 mg twice daily. If no improvement is seen within 4 to 6 weeks, the drug should be discontinued. A total daily dose of 1375 mg per day should not be exceeded.
Dose in children: Not recommended for use in children below 16 years of age.
Route of Administration: Oral.