Esmorap 10 mg 7 sachets

Esmorap 10 mg 7 sachets

Composition:
Each sachet contains 49.46 mg of esomeprazole pellets (22.5% w/w), equivalent to 10 mg esomeprazole as magnesium trihydrate.10 mg esomeprazole (as magnesium trihydrate 11.13 mg).
Excipients:
Talc, Hydroxypropyl methylcellulose (HPMC E5), Titanium dioxide, Sodium hydroxide, Polysorbate 80, Methacrylic acid copolymer dispersion, Polyethylene glycol 6000, Lactose, Sucralose, Xanthan gum, Orange flavor, Citric acid, Povidone K30.
Description:
White to off-white powder containing white to off-white granules.
After reconstitution with water, it forms a white to pale yellow oral suspension with delayed release.
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H⁺/K⁺-ATPase enzyme.
It promotes healing of acid-related lesions and alleviates symptoms of gastroesophageal reflux.
Indications for Use:
- Healing of erosive esophagitis due to acid-mediated disorders in adults and pediatric patients aged 1 year and above.
- Maintenance of healing of erosive esophagitis in adults.
- Treatment of symptomatic gastroesophageal reflux disease (GERD), including heartburn and regurgitation.
- Eradication of Helicobacter pylori (as part of combination therapy) to reduce the risk of duodenal ulcer recurrence.
- Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Dosage and Method of Administration:
For oral use only.
Dissolve the contents of one sachet in a small amount of water and consume immediately after preparation.
Recommended dose for adults and children aged 1 year and older: 10 mg once daily.
Duration of treatment: 4 to 8 weeks, depending on the indication and patient response.
Dosage and duration should be determined by the physician.
Contraindications:
- Hypersensitivity to esomeprazole, substituted benzimidazoles, or any excipient of the formulation.
- Concomitant use with rilpivirine-containing medicinal products.
Precautions:
- A symptomatic response does not exclude gastric malignancy; further investigation is required if malignancy is suspected.
- Acute tubulointerstitial nephritis may occur at any time during therapy; discontinue treatment if suspected.
- Proton pump inhibitors may increase the risk of Clostridium difficile-associated diarrhea, particularly in hospitalized patients.
- Long-term therapy may lead to hypomagnesemia, vitamin B12 deficiency, or increased risk of bone fractures.
- Rarely, serious cutaneous adverse reactions may occur (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, subacute cutaneous lupus erythematosus).
- Use the lowest effective dose for the shortest duration possible.
Side Effects:
Common: headache, diarrhea, abdominal pain, constipation, flatulence, nausea, vomiting.
Uncommon: dizziness, rash, pruritus, urticaria, peripheral edema, sleep disturbances.
Rare: severe cutaneous reactions (SJS, TEN, DRESS), anaphylaxis, hepatitis, interstitial nephritis, hypomagnesemia.
Pregnancy and Lactation:
Use during pregnancy only if the potential benefit justifies the possible risk to the fetus.
Esomeprazole may be excreted in human milk; breastfeeding should be discontinued if treatment is necessary.
Storage Conditions:
Store in a dry place at a temperature not exceeding 30°C.
Keep out of reach of children.
Packaging:
Carton box containing 7 sachets and a package leaflet.