Naprolinplus

Description

💊 Naprolinplus – Naproxen + Esomeprazole 

Manufacturer: SinoHealth Pharmaceuticals LTD

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1. Indications:

Naprolinplus is indicated for the relief of signs and symptoms of:

• Osteoarthritis (OA)

• Rheumatoid Arthritis (RA)

• Ankylosing Spondylitis

• To decrease the risk of developing gastric ulcers in patients at risk of NSAID-associated gastric ulcers

রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

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2. Pharmacology:

• Naproxen: NSAID with analgesic and antipyretic properties; inhibits prostaglandin synthesis to reduce pain and inflammation.

• Esomeprazole: Proton pump inhibitor; suppresses gastric acid secretion by inhibiting H⁺/K⁺ ATPase in gastric parietal cells, reducing gastric acidity.

• The tablet has an immediate-release Esomeprazole layer and an enteric-coated Naproxen core, releasing Esomeprazole first to protect the stomach before Naproxen absorption.

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3. Dosage & Administration:

Adults (OA, RA, Ankylosing Spondylitis):

• One tablet twice daily:

  • 375 mg Naproxen / 20 mg Esomeprazole or

  • 500 mg Naproxen / 20 mg Esomeprazole

Adolescents (12+ years, Juvenile Idiopathic Arthritis):

• Weight >50 kg: same as adult dose

• Weight 38–50 kg: 375 mg Naproxen / 20 mg Esomeprazole twice daily

Administration:

• Do not split, chew, crush, or dissolve.

• Take at least 30 minutes before meals.

Use the lowest effective dose for the shortest duration necessary.

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4. Interaction:

• ACE inhibitors, diuretics, beta-blockers: May reduce antihypertensive effect

• Warfarin: Increased risk of bleeding

• Drugs dependent on gastric pH (ketoconazole, iron salts, digoxin): Absorption may be affected

• Food: High-fat meals may prolong tmax of Naproxen by 10 hours and reduce peak plasma concentration by ~12%

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5. Contraindications:

• Hypersensitivity to Naproxen, Esomeprazole, or benzimidazoles

• History of asthma, urticaria, or NSAID/aspirin allergy

• Peri-operative use in coronary artery bypass graft (CABG) surgery

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6. Side Effects:

• Reduced GI side effects due to Esomeprazole layer

• Common NSAID effects: GI discomfort, peptic ulcers, nausea, vomiting, dyspepsia, abdominal pain, diarrhea, flatulence, constipation

• Cardiovascular: oedema, hypertension, cardiac failure

• Rare: serious arterial thrombotic events (MI, stroke), GI bleeding, ulceration, perforation

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7. Pregnancy & Lactation:

• Pregnancy: Avoid in women attempting to conceive or during first and second trimesters unless benefit outweighs risk; contraindicated in third trimester

• Breastfeeding: Naproxen excreted in low quantities; Esomeprazole unknown; avoid use

• Fertility: NSAIDs may impair female fertility; avoid if planning conception

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8. Precautions & Warnings:

• Avoid cumulative NSAID use including COX-2 inhibitors

• Use with low-dose aspirin only if necessary

• Minimize risk by using lowest effective dose for shortest duration

• Monitor elderly and patients with GI history closely

• Cardiovascular risk: monitor patients with hypertension, heart failure, ischemic heart disease, or cerebrovascular disease

• Renal: Long-term NSAID use may cause renal injury

• Hepatic: Monitor mild-to-moderate impairment; avoid severe hepatic impairment

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9. Overdose Effects:

Naproxen: lethargy, dizziness, drowsiness, GI discomfort, heartburn, nausea, liver/renal dysfunction, hypotension, coma (rare)
Esomeprazole: transient effects with doses >240 mg/day; single 80 mg doses uneventful

Management:

• Symptomatic and supportive care

• No specific antidote

• Activated charcoal, emesis, osmotic cathartics if ingestion <4 hours

• Hemodialysis ineffective due to high protein binding

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10. Therapeutic Class:

• Drugs for Osteoarthritis

• Drugs used for Rheumatoid Arthritis

• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

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11. Storage Conditions:

• Store below 30°C, protected from light and moisture

• Keep out of reach of children