AIG Esomeprazole 40 mg 28 capsules

AIG Esomeprazole 40 mg 28 capsules

Composition:
Active ingredient:
Esomeprazole magnesium trihydrate 44.5 mg, equivalent to Esomeprazole 40 mg.
Inactive ingredients:
Sugar spheres, hydroxypropyl methylcellulose E-5, sodium hydroxide, polysorbate 80, methacrylic acid copolymer dispersion type C, talc, diethyl phthalate, gelatin, titanium dioxide, Brilliant Blue (CI No. 42090).
Description:
Esomeprazole is the S-isomer of omeprazole, a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H⁺/K⁺-ATPase in the gastric parietal cells.
It is indicated for the treatment and prevention of acid-related disorders, including gastroesophageal reflux disease (GERD), erosive esophagitis, gastric and duodenal ulcers (including those associated with NSAID therapy).
It is also used in combination therapy for the eradication of Helicobacter pylori and for the management of pathological hypersecretory conditions such as Zollinger-Ellison syndrome.
Indications for Use:
- Treatment of gastroesophageal reflux disease (GERD);
- Healing of erosive esophagitis;
- Maintenance of healed erosive esophagitis;
- Symptomatic treatment of heartburn and other GERD symptoms;
- Reduction of the risk of NSAID-associated gastric ulcers;
- Eradication of Helicobacter pylori (in combination with amoxicillin and clarithromycin) to reduce duodenal ulcer recurrence;
- Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Dosage and Method of Administration:
Administer orally, at least one hour before meals, with water.
Recommended doses:
- GERD / Erosive esophagitis: 20-40 mg once daily for 4-8 weeks.
- Maintenance therapy: 20 mg once daily.
- Symptomatic GERD: 20 mg once daily for 4 weeks.
- NSAID ulcer prevention: 20-40 mg once daily.
- H. pylori eradication: Esomeprazole 40 mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for 10 days.
- Zollinger-Ellison syndrome: 40 mg twice daily.
- Pediatric use: weight-based dosing (2.5-10 mg daily for children under 12 years).
Contraindications
- Hypersensitivity to esomeprazole, substituted benzimidazoles, or any component of the formulation;
- Contraindications to amoxicillin or clarithromycin when used in combination therapy;
- Pregnancy (only if clearly needed), infants under 1 month.
Precautions:
- Exclude gastric malignancy before initiating therapy.
- Risk of acute interstitial nephritis, Clostridium difficile-associated diarrhea, bone fractures with long-term use.
- Rare cases of cutaneous or systemic lupus erythematosus, hypomagnesemia, vitamin B12 deficiency.
- Avoid concomitant use with clopidogrel (reduced antiplatelet activity).
- In severe hepatic impairment (Child-Pugh C), do not exceed 20 mg/day.
Side Effects
- Common: Headache, diarrhea, abdominal pain, constipation, flatulence, nausea, rash.
- Uncommon: Dizziness, somnolence, paresthesia, dry mouth, edema.
- Rare/Very rare: Anaphylaxis, angioedema, interstitial nephritis, pancreatitis, hepatitis, photosensitivity, alopecia, myalgia, hypomagnesemia, bone fracture, lupus erythematosus.
Pregnancy and Lactation:
There are no adequate data in pregnant women.
Esomeprazole may be excreted in breast milk; discontinue breastfeeding if therapy is required.
Use during pregnancy only if the potential benefit outweighs the risk.
Storage Conditions:
Store below 30°C, in a dry place, protected from light.
Packaging:
Carton box containing 4 blisters, each with 7 capsules (28 capsules total), and a package leaflet.