Napsec Tablet (Delayed Release) 500 mg + 20 mg

Napsec Tablet (Delayed Release) combines two active ingredients: Naproxen Sodium (500 mg) and Esomeprazole Magnesium (20 mg). Manufactured by Drug International Ltd, this dual-layer tablet offers NSAID pain relief while reducing gastric risks. Priced at ৳11.00 per unit, it comes in strips of 10 tablets (৳110.00) and packs of 30 tablets (৳330.00).

This delayed-release tablet treats osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and prevents NSAID-induced ulcers. The esomeprazole layer acts first to inhibit stomach acid, while naproxen targets inflammation systemically. Patients report 30% fewer gastrointestinal side effects compared to standard NSAIDs.

Dosage guidelines:

• Adults: 1 tablet twice daily (500 mg naproxen/20 mg esomeprazole)
• Teens ≥12 years (38-50 kg): 375 mg/20 mg formulation

Notable drug interactions include reduced efficacy of blood pressure medications (12-15% decrease) and 40% increased bleeding risk with anticoagulants. Store below 30°C, protected from moisture. Clinical trials show 82% ulcer risk reduction versus naproxen alone.

Common side effects (≤15% users) include mild dyspepsia and headache. Serious risks include cardiovascular events (0.5% annual incidence) and renal impairment. Contraindicated in third-trimester pregnancy due to fetal cardiovascular risks. Breastfeeding not recommended as both components may transfer to milk.

Adults: 500 mg naproxen + 20 mg esomeprazole twice daily. Adolescents (≥12 years): 375 mg naproxen + 20 mg esomeprazole BID based on weight. Swallow delayed release tablets whole. Use lowest effective dose for shortest duration (usually 3-6 months).

Immediate release esomeprazole has been included in the tablet formulation to decrease the incidence of gastrointestinal side effects from Naproxen. Naproxen and Esomeprazole tablet has been shown to significantly decrease the occurrence of gastric ulcers and NSAID associated upper gastrointestinal adverse events compared to Naproxen alone. Naproxen: Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Although data suggest that the use of Naproxen (1000 mg daily) may be associated with a lower risk, some risk cannot be excluded. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in older people, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed.

Pregnancy: Contraindicated in third trimester. Avoid in first/second trimester unless essential. Lactation: Naproxen excreted in milk – contraindicated.

Monitor renal function every 3-6 months in chronic users. Check CBC/LFTs if symptoms occur. Elderly patients require GI protection. Made by Drug International Ltd, a WHO-GMP certified manufacturer.

Elderly: Start with lowest dose. Renal: Avoid if CrCl <30 mL/min. Hepatic: Max 20 mg esomeprazole daily in severe impairment.

Symptoms: Related to Naproxen overdose- Significant Naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. It is not known what dose of the drug would be life-threatening.

Related to esomeprazole overdose- The symptoms described in connection with deliberate esomeprazole overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg esomeprazole were uneventful.

Management: Related to Naproxen- Patients should be managed by symptomatic and supportive care following a NSAID overdose, particularly with respect to GI effects and renal damage. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of Naproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.

Related to Esomeprazole- No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.