Nexicure 10 mg Sachets for oral suspension 14 pcs

Nexicure 10 mg Sachets for oral suspension 14 pcs

Composition:
Each sachet contains esomeprazole magnesium trihydrate equivalent to 10 mg esomeprazole.
Excipients:
Maltodextrin, anhydrous citric acid, sucralose, xanthan gum, strawberry flavor, colloidal silicon dioxide, povidone K30, isopropyl alcohol, Quinoline Yellow.
Description:
Proton pump inhibitor that reduces gastric acid secretion.
Used for treatment and prevention of acid-related gastrointestinal disorders.
Indications for Use:
- Healing of erosive esophagitis in adults and children 1 month to 17 years
- Maintenance of healing of erosive esophagitis in adults
- Symptomatic treatment of GERD (heartburn, dyspepsia)
- Prevention of NSAID-associated gastric ulcers
- H. pylori eradication as part of triple therapy in adults
- Treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.
Dosage and Administration:
Adults:
- Healing of erosive esophagitis: 20-40 mg once daily for 4-8 weeks; if needed, treatment may be extended by an additional 4-8 weeks.
- Maintenance of healing: 20 mg once daily, controlled studies up to 6 months.
- Symptomatic GERD: 20 mg once daily for 4 weeks; if symptoms persist, extend by 4 more weeks.
- NSAID-associated ulcer prevention: 20-40 mg once daily.
- H. pylori eradication (triple therapy): 40 mg once daily for 10 days, combined with amoxicillin 1000 mg twice daily and clarithromycin 500 mg twice daily.
- Pathological hypersecretory conditions including Zollinger-Ellison syndrome: starting dose 40 mg twice daily, individualized up to 240 mg/day.
Pediatric Patients:
- 12-17 years: 20-40 mg once daily for erosive esophagitis; 20 mg once daily for symptomatic GERD.
- 1-11 years: <20 kg - 10 mg once daily; ≥20 kg - 10-20 mg once daily, up to 8 weeks.
- 1 month-11 months: 2.5-10 mg once daily, up to 6 weeks.
Administration Instructions:
- Granules are dissolved in water: 2.5 and 5 mg in 5 ml, 10 and 20 mg in 15 ml.
- Stir, leave 2-3 minutes to thicken, drink within 30 minutes.
- For nasogastric or gastric tube: add water, shake, leave 2-3 minutes, administer via tube, flush residual with water.
- Missed dose: take as soon as possible; do not double the dose.
Contraindications:
- Hypersensitivity to esomeprazole, other proton pump inhibitors, or excipients
- Concurrent use with rilpivirine-containing products
- History of severe allergic reactions to benzimidazoles (anaphylaxis, angioedema, bronchospasm).
Precautions:
- Monitor renal function and electrolytes during prolonged use
- Risk of Clostridium difficile-associated diarrhea
- Increased risk of hip, wrist, or spine fractures with long-term or high-dose therapy
- Potential for severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AGEP)
- Possible vitamin B12 deficiency with long-term use
- Caution in patients with liver or kidney disease
- May mask symptoms of underlying gastric disease, including malignancy.
Side Effects:
Common: headache, diarrhea, abdominal pain, nausea, vomiting, flatulence, rash.Less common but serious: severe skin reactions, hypomagnesemia, vitamin B12 deficiency, bone fractures, acute tubulointerstitial nephritis, Clostridium difficile-associated diarrhea.
Pregnancy and Lactation:
Pregnancy: Use only if clearly needed; safety data are limited.
Lactation: Esomeprazole is the S-isomer of omeprazole, and limited data suggest that omeprazole may be present in human milk.
There are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Nexicure and any potential adverse effects on the breastfed infant from Nexicure or from the underlying maternal condition.
Storage Conditions:
Store below 30 °C, in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing 14 sachets and leaflet.