Progut-N is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. Progut-NTM is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.
Dosage & Administration
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis: The dosage is one tablet twice daily of Progut-NTM 375/20 or Progut-NTM 500/20 tablet. The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. Progut-NTM is to be taken at least 30 minutes before meals. Geriatric Patients: Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required and some adjustment of dosage may be required in elderly patients. Patients with Moderate to Severe Renal Impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance < 30 ml/min). Hepatic Insufficiency: Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of Progut-NTM. Progut-NTM is not recommended in patients with severe hepatic impairment because esomeprazole doses should not exceed 20 mg daily in these patients. Pediatric Patients: The safety and efficacy of Progut-NTM in children younger than 18 years have not been established. Progut-NTM is therefore not recommended for use in children.
Cardiovascular Thrombotic Events: clinical trials of several COX-2 selective and nonselective NSAIDS of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Hypertension: NSAIDS, including naproxen, a component of Progut-NTM, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Congestive Heart Failure and Edema: Fluid retention, edema, and peripheral edema have been observed in some patients taking NSAIDs and should be used with caution in patients with fluid retention or heart failure. Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation: NSAIDs, including naproxen, a component of Progut-NTM, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. While naproxen and esomeprazole combination has been shown to significantly decrease the occurrence of gastric ulcers compared to naproxen alone, ulceration and associated complications can still occur. Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Use in Pregnancy: Pregnancy Category C: In late pregnancy, as with other NSAIDs, naproxen, a component of Progut-NTM, should be avoided because it may cause premature closure of the ductus arteriosus.