Naspro Plus 375/20 Tablet: Each tablet contains delayed release 375 mg Naproxen BP and immediate release Esomeprazole Magnesium USP equivalent to 20 mg Esomeprazole.
Naspro Plus 500/20 Tablet: Each tablet contains delayed release 500 mg Naproxen BP and Esomeprazole Magnesium USP equivalent to 20 mg Esomeprazole.
The active ingredients of Naspro Plus tablet are naproxen which is a NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naspro Plus is available as a round biconvex, multi-layer, delayed release tablet combining an enteric coated Naproxen core and an immediate release esomeprazole magnesium layer surrounding the core.
Naspro Plus 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. Naspro Plus 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.
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis: The dosage is one tablet twice daily of Naspro Plus 375/20 or Naspro Plus 500/20 tablet. The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. Naspro Plus 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 Naspro Plus. Naspro Plus 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 Naspro Plus in children younger than 18 years have not been established. Naspro Plus is therefore not recommended for use in children.
*Prescription only*
Several studies conducted with Naproxen and Esomeprazole combination have shown no interaction between the two components.
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 Naspro Plus, 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 Naspro Plus, 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.
Pregnancy - Pregnancy Category C: In late pregnancy, as with other NSAIDs, Naproxen, a component of Naspro Plus, should be avoided because it may cause premature closure of the ductus arteriosus.
Overdosage:
There is no clinical data on overdosage with Naspro Plus (Naproxen/Esomeprazole). Any effects of an overdose with Naspro Plus would be expected to reflect those of the monocomponents of Naproxen and Esomeprazole, taken separately.
Overdosage of Naproxen: Significant Naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heart burn, indigestion, nausea, transient alteration in liver function. Hypertension, acute renal failure, respiratory depression and may occur but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following and overdose. A few patients have experienced convulsions but it is not clear whether or not these were drug related. Patients should be managed by symptomatic and supportive care following NSAID overdose. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of Naproxen because of the high degree of its protein binding.
Overdosage of Esomeprazole: Limited information is available on the effects of higher doses in man, and specific recommendations for treatment cannot be given. Experience from a patient who deliberately ingested an overdose of EC-Esomeprazole (280 mg), demonstrated symptoms that were transient, and included weakness, loose stools and nausea. Single doses of 80 mg EC-Esomeprazole have been shown to be uneventful. No specific antidote is known. Esomeprazole is extensively protein bound and is therefore not readily dialyzable. Treatment should be symptomatic and general supportive measures should be utilized.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.