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Anaprox Indications, Dosage, Storage, Stability - Naproxen Sodium
INDICATIONS
Naprelan is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.
DOSAGE AND ADMINISTRATION
Rheumatoid Arthritis, Osteoarthritis, And Ankylosing Spondylitis
The usual daily dose of Naprelan is two Naprelan 375 mg tablets (750 mg) once daily, or two Naprelan 500 mg tablets (1000 mg) once a day. Both larger and smaller doses may be required in individual patients (see Individualization Of Dosage). Regardless of indication, the dosage should be individualized to achieve effective dose and minimize adverse events, however the maximum daily dose is three Naprelan 500 mg once daily.
Management Of Pain, Primary Dysmenorrhea, And Acute Tendinitis And Bursitis
The recommended starting dose is two Naprelan 500 mg tablets (1000 mg) once daily. For patients requiring greater analgesic benefit, three Naprelan 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two Naprelan 500 mg tablets (1000 mg).
Acute Gout
The recommended dose on the first day is two to three Naprelan 500 mg tablets (1000 - 1500 mg) once daily, followed by two Naprelan 500 mg tablets (1000 mg) once daily, until the attack has subsided.
HOW SUPPLIED
Naprelan™ (naproxen sodium) Controlled Release Tablets are available as follows:
Naprelan 375: white, capsule-shaped tablet with "W" on one side and "901" on the reverse; in bottles of 100; NDC 0008-0901-03. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen.
Naprelan 500: white, capsule-shaped tablet with "W" on one side and "902" on the reverse; in bottles of 75; NDC 0008-0902-02. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen.
Caution: Federal law prohibits dispensing without prescription.
US Patent Pending.
Store at controlled room temperature, 20° - 25° C (68° - 77° F).
Dispense in a well-closed container.
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