Esomeprazole

Esomeprazole

Indication: Nexum is indicated for the treatment of - Gastroesophageal Reflux Disease (GERD), Healing of Erosive Esophagitis, Maintenance of healing of Erosive Esophagitis, Symptomatic Gastroesophageal Reflux Disease (GERD), Risk Reduction of NSAIDassociated gastric ulcer & H. pylori eradication (Triple therapy).

Dosage & Administration: Tablet and capsule: Recommended adult dosage schedule of Esomeprazole is –

Indications	Dose	Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of erosive esophagitis	20 mg or 40 mg	Once daily for 4 to 8 weeks*
Maintenance of healing of erosive esophagitis	20 mg	Once daily**
Symptomatic GERD	20 mg	Once daily for 4 weeks ***
Risk Reduction of NSAID associated gastric ulcer	20 mg or 40 mg	Once daily for up to 6 months**
H. pylori eradication (Triple therapy)
Esomeprazole	20 mg	Twice daily for 10 days
Amoxicillin	1000 mg	Twice daily for 10 days
Clarithromycin	500 mg	Twice daily for 10 days

Paediatric use (12 years and older)

Short term treatment of GERD: 20 mg or 40 mg once daily for up to 8 weeks.

• The majority of patients are healed within 4 to 8 weeks. For patients who do not heal

after 4-8 weeks, an additional 4-8 weeks treatment may be considered.

• Controlled studies did not extend beyond 6 months.

• If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Injection

Duodenal ulcer, gastric ulcer, gastrointestinal lesions refractory to H2 blockers, Zollinger-Ellison syndrome	40 mg per day intravenously
Reflux esophagitis	20-40 mg per day intravenously

Direction for use of IV Injection

Esomeprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Esomeprazole injection 40 mg should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 5 ml 0.9% Sodium Chloride Injection to the vial containing powder.

After reconstitution the injection should be given slowly over a period of at least 3 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30oc) for a maximum 12 hours. Half of the IV injection should be used when 20 mg to be administered.

Direction for use of IV Infusion

Esomeprazole IV 40 mg should be given as an intravenous infusion over a period of 10 to 30 minutes. Esomeprazole IV should be reconstituted with 5 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 5% Dextrose Injection or 0.9% Sodium Chloride Injection or Lactated Ringer’s Injection to a final volume of 50 ml. The

reconstituted solution may be stored at room temperature (up to 30oc) for a maximum 12 hours prior to dilution. The admixed solution may be stored at room temperature (up to 30oc) and must be used within 12 hours when reconstituted with 0.9% Sodium Chloride Injection or Lactated Ringer’s Injection and within 6 hours when reconstituted with 5% Dextrose Injection.

Contraindication & Precaution:

Esomeprazole is contraindicated in those patients who have known hypersensitivity to any other components of the formulation. Exclude the possibility of malignancy when gastric ulcer is suspected and before treatment for dyspepsia.

Side-Effect:

Side Effects reported with Esomeprazole include headache, diarrhea and abdominal pain.

Use in Pregnancy & Lactation:

US FDA Pregnancy Category - ‘B’. This drug should be used during pregnancy only if clearly needed. Because Esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Preparation:

20 mg Tablet & Capsule, 40 mg Tablet & Capsule and 40 mg IV Injection.