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Indications & Uses
Napgin Plus is indicated for:
Pharmacology
This combination tablet has two parts: an immediate-release layer of Esomeprazole Magnesium and an enteric-coated core of Naproxen. So the Esomeprazole is released first, in the stomach, and the Naproxen dissolves later in the small intestine.
Naproxen is an NSAID with analgesic and antipyretic properties. It works by inhibiting prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion. It does this by specifically inhibiting the H+/K+ -ATPase in the gastric parietal cell. By acting on the proton pump, Esomeprazole blocks the final step in acid production, and so gastric acidity is reduced.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage
Before you decide to use this tablet (naproxen sodium with esomeprazole magnesium), carefully consider its possible benefits and risks against those of other treatment options. Use the lowest effective dose for the shortest time that fits the patient's treatment goals. If a dose of esomeprazole lower than a total daily dose of 40 mg is more suitable, a different treatment should be considered.
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
Adults: one tablet twice daily of either 375 mg naproxen/20 mg esomeprazole, or 500 mg naproxen/20 mg esomeprazole.
Juvenile idiopathic arthritis in adolescent patients 12 years of age and older
Weight greater than 50 kg: 375 mg naproxen/20 mg esomeprazole, or 500 mg naproxen/20 mg esomeprazole.
Weight 38 kg to less than 50 kg: one tablet twice daily of 375 mg naproxen/20 mg esomeprazole.
Side Effects
Immediate release esomeprazole is included in the Naproxen and Esomeprazole tablet to lower the chance of gastrointestinal side effects from Naproxen. The tablet has been shown to significantly reduce gastric ulcers and NSAID associated upper gastrointestinal adverse events when compared with Naproxen alone. Naproxen: Clinical trial and epidemiological data suggest that coxibs and some NSAIDs may carry a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke), particularly at high doses and in long-term treatment. Data suggest that Naproxen at 1000 mg daily may carry a lower risk, but some risk cannot be excluded. Oedema, hypertension and cardiac failure have been reported with NSAID treatment. The adverse events seen most often are gastrointestinal. Peptic ulcers, perforation or GI bleeding can occur, and these are sometimes fatal, particularly in older people. After administration, people have reported nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and exacerbation of colitis and Crohn's disease. Gastritis has been seen less frequently.
Cautions & Contraindications
Warnings & Precautions
General Don't combine the Naproxen and Esomeprazole tablet with other NSAIDs, including cyclooxygenase-2 selective inhibitors, because the risks of serious NSAID-related adverse events add up. The tablet can be used with low dose acetylsalicylic acid. Undesirable effects can be kept down by using the lowest effective dose for the shortest time needed to control symptoms. Risk factors for NSAID related gastro-intestinal complications include high age, concomitant use of anticoagulants, corticosteroids, or other NSAIDs (including low-dose acetylsalicylic acid), debilitating cardiovascular disease, Helicobacter pylori infection, and a history of gastric and/or duodenal ulcers and upper gastrointestinal bleeding. In patients with conditions such as inducible porphyries, systemic lupus erythematosis and mixed connective tissue disease, Naproxen should only be used after a rigorous benefit-risk ratio. Patients on long-term treatment, particularly those treated for more than a year, should be kept under regular surveillance. Older people Older people have more adverse reactions with Naproxen, especially gastro-intestinal bleeding and perforation, which may be fatal. The esomeprazole part of the Naproxen and Esomeprazole tablet lowered the incidence of ulcers in older people. Gastrointestinal effects With Naproxen, GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation rises with higher NSAID doses, in patients with a history of ulcer (particularly if it was complicated by haemorrhage or perforation), and in older people. These patients should start treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for them, and also for patients who need concomitant low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk. Patients with a history of GI toxicity, particularly older people, should report any unusual abdominal symptoms (especially GI bleeding), mainly in the early stages of treatment. Take caution when NSAIDs are given with medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin-reuptake inhibitors, or anti-platelet agents like acetylsalicylic acid. If GI bleeding or ulceration occurs in a patient taking the Naproxen and Esomeprazole tablet, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may get worse. With Esomeprazole, dyspepsia could still occur even though Esomperazole is added to the combination tablet. Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infections such as Salmonella and Campylobacter. Like all acid-blocking medicines, Esomeprazole might reduce the absorption of vitamin B12 (cyanocobalamin) because of hypo- or achlorhydria. This should be considered in patients on long-term therapy who have reduced body stores or risk factors for reduced vitamin B12 absorption. Cardiovascular and cerebrovascular effects With Naproxen, patients with a history of hypertension and/or mild to moderate congestive heart failure need appropriate monitoring and advice, because fluid retention and oedema have been reported with NSAID therapy. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Naproxen after careful consideration. The same care should be taken before starting longer-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Renal effects With Naproxen, long-term use of NSAIDs has resulted in renal papillary necrosis and other renal injury.
Contraindications
Don't give this tablet to anyone with a known allergy to any of its components, or to substituted benzimidazoles. It also shouldn't be used by people who have had asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs. The tablet is also contraindicated in the peri-operative period of coronary artery bypass graft (CABG) surgery.
Pregnancy & Breastfeeding
Pregnancy: If a woman is trying to conceive, or is in the first or second trimester of pregnancy, the Naproxen and Esomeprazole tablet should not be given unless the likely benefit to the patient outweighs the possible risk to the foetus. In the third trimester of pregnancy, the tablet is contraindicated.
Breast-feeding: Naproxen passes into human milk in low quantities. It is not known whether esomeprazole passes into human milk. The Naproxen and Esomeprazole tablet should not be used during breastfeeding.
Fertility: NSAIDs like Naproxen may impair female fertility. For this reason, the Naproxen and Esomeprazole tablet is not recommended for women who are trying to conceive.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Elderly patients: studies show that the total plasma concentration of naproxen doesn't change in the elderly, but the unbound fraction of naproxen in plasma goes up. Be careful when high doses are needed, because some dose adjustment may be required in elderly patients. As with other medicines used in the elderly, give the lowest effective dose.
Patients with moderate to severe renal impairment: products that contain naproxen are not recommended for patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: patients with mild to moderate hepatic impairment should be monitored closely, and a dose reduction may be considered based on the naproxen component of this tablet. The combination is not recommended in patients with severe hepatic impairment, because the esomeprazole dose should not go above 20 mg daily in these patients.
Overdose
Symptoms
With the naproxen part of Naproxen Sodium + Esomeprazole Magnesium, a significant overdose may cause 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 they are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and they may also follow an overdose. It is not known what dose of the drug would be life-threatening.
For esomeprazole, the symptoms seen after deliberate overdose are transient (experience with doses in excess of 240 mg/day is limited). Single doses of 80 mg esomeprazole were uneventful.
Management
For naproxen, patients should be managed with symptomatic and supportive care after an NSAID overdose, particularly for GI effects and renal damage. There are no specific antidotes. Hemodialysis does not lower the plasma concentration of naproxen because the drug is so highly protein bound. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or an osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms, or after a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful, again because of the high protein binding.
For esomeprazole, no specific antidote is known. Esomeprazole is extensively bound to plasma protein, so it is not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be used.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Naproxen Sodium + Esomeprazole Magnesium below 30°C. Protect it from light and moisture, and keep it out of reach of children.
Drug Interactions
Common questions about Napgin Plus 375 mg+20 mg
What is Napgin Plus 375 mg+20 mg Tablet (Delayed Release)?
Napgin Plus 375 mg+20 mg Tablet (Delayed Release) is a medicine that contains Naproxen Sodium + Esomeprazole Magnesium. It is made by Biopharma Ltd. It belongs to the Drugs for Osteoarthritis group of medicines.
What is Napgin Plus used for?
Napgin Plus is used for: Osteoarthritis, Rheumatoid Arthritis.
What are the side effects of Napgin Plus?
Immediate release esomeprazole is included in the Naproxen and Esomeprazole tablet to lower the chance of gastrointestinal side effects from Naproxen. The tablet has been shown to significantly reduce gastric ulcers and NSAID associated upper gastrointestinal adverse events when compared with Naproxen alone.
Can I take Napgin Plus during pregnancy or while breastfeeding?
Pregnancy: If a woman is trying to conceive, or is in the first or second trimester of pregnancy, the Naproxen and Esomeprazole tablet should not be given unless the likely benefit to the patient outweighs the possible risk to the foetus. In the third trimester of pregnancy, the tablet is contraindicated. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Napgin Plus?
Symptoms With the naproxen part of Naproxen Sodium + Esomeprazole Magnesium, a significant overdose may cause 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. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Napgin Plus?
Store Naproxen Sodium + Esomeprazole Magnesium below 30°C. Protect it from light and moisture, and keep it out of reach of children.
Can I take other medicines with Napgin Plus?
Some medicines can interact with Naproxen Sodium + Esomeprazole Magnesium, for example: Digoxin, Iron, Ketoconazole, Esomeprazole, Warfarin Sodium. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Napgin Plus is already among the lowest-priced brands of Naproxen Sodium + Esomeprazole Magnesium at this strength.
Do I need a prescription for Napgin Plus?
Napgin Plus is a prescription (Rx) medicine. Take it as your doctor advises.