| a) Generic Name |
Esomeprazole INN
|
| b) Trade/Brand Name |
To be submitted at the time of inclusion.
|
| a) Presentation |
Tablet
Each Tablet contains Esomeprazole INN 20 mg.
|
| b) Indications |
Treatment of Gastroesophageal Reflux Disease (GERD): Healing of Erosive Esophagitis; Esomeprazole is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 week course of Esomeprazole may be considered.
Maintenance of Healing of Erosive Esophagitis: Esomeprazole is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease: Esomeprazole is indicated for treatment of heartburn and other symptoms associated with GERD.
H. pylori Eradication to Reduce the Risk Duodenal Ulcer Recurrence: Triple Therapy (Esomeprazole plus amoxicillin and clarithromycin): Esomeprazole, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H.pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H.pylori. Eradication of H.pylori has been shown to reduce the risk of duodenal ulcer recurrence.
|
| c) Dosage & administration |
Recommended Adult Dosage Schedule of Esomeprazole
Indication Dose Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of Erosive 20 mg or Once Daily for
Esophagitis 40 mg 4 t0 8 Weeks
*
Maintenance of Healing
of Erosive Esophagitis 20 mg Once Daily
**
Symptomatic
Gastroesophageal Once Daily for 4
Reflux Disease 20 mg Weeks
***
H.pylori Eradication to Reduce the Risk of Duodenal
Ulcer Recurrence
*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 for treatment may be considered.
**Controlled studies did not extend beyond six months.
***If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
|
| d) Contraindications
|
Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles. Clarithromycin is contraindicated in patients with a known hypersensitivity to any macrolide antibiotic.
|
| e) Side Effects |
Esomeprazole is well tolerated in both short and long term clinical trials. The most frequently occurring adverse events headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.
|
| f) Precautions and
Warnings
|
PPI should be used with caution in liver disease, in pregnancy, and in breast feeding. PPI may mask symptoms of gastric cancer; particular care is required in those whose symptoms change and in those over 45 years of age; the presense of gastric malignancy should be excluded before treatment. For patients with severe liver impairment a dose of 20 mg should not be exceeded.
|
| g)Paediatric Use |
Safety and effectiveness in pediatric patients have not been established.
|
| h)Use in Pregnancy |
There are no adequate and well-controlled studies in pregnant women.
|
| i)Use in Lactation |
The excretion of esomeprazole in milk has not been studied. 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.
|
| j) Package Quantity |
To be submitted at the time of inclusion.
|
