ESPRAM

ESPRAM

Commercial Name

ESPRAM®

Generic Name

Esomeprazole USP

Composition

Espram ® 20 Tablet Each enteric coated tablet contains Espram ® USP 20 mg as Esomeprazole Magnesium Trihydrate.

Description

Espram ® Tablet (Esomeprazole) is indicated for the relief of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) and for the healing of erosive esophagitis, a potentially serious condition associated with GERD. The FDA approved Esomeprazole for maintenance of healing of erosive esophagitis and in combination with Amoxicillin and Clarithromycin, for the eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.

Indication

Indication Dose Frequency
Gastroesophageal Reflux Diseases 20mg or 40mg Once daily for 4 to 8 weeks
(GERD) Healing of Erosive Esophagitis
Maintenance of healing Erosive esophagitis 20mg once daily
Symptomatic Gastroesophageal Reflux 20mg once daily for 4 weeks
H. pylori Eradication to reduce the Risk of 20mg
Duodenal Ulcer Recurrence
Espram ® 40mg Once daily for 10 days
Amoxicillin 1000mg Twice daily for 10 days
Clarithromycin 500mg Twice daily for 10 days

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 six months. If symptoms do not resolve after 4 weeks, an additional 4 weeks of treatment may be considered. Espram ® is supplied as tablets which should be swallowed whole with liquid.

Dosage & Administration

Recommended adult dosage schedule of Espram ®

Contraindication

Esomeprazole is contraindicated in those patients who have known hypersensitivity to any component of the formulation.

Precaution

Exclude the possibility of malignancy when gastric ulcer is suspected and before treatment for dyspepsia. When using in combination with antibiotic, refer to the prescribing information of the respective antibiotics.
Use in paediatric patients:
Safety and effectiveness have not yet been established in paediatric patients.
Special precaution:
Geriatric: no dosage adjustment is necessary.
Renal insufficiency: no dosage adjustment is necessary.
Hepatic insufficiency: no dosage adjustment is necessary in patients with mild to moderate Liver impairment. For patients with severe Liver impairment a dose of 20mg Espram ® should not be exceeded.

Side Effect

Side effects reported with Esomeprazole include the following:
Headache, Diarrhea, Abdominal pain

Drug Interaction

Esomeprazole appears to be a selective inhibitor of cytochrome P-450 monoxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainly over the effect of Esomeprazole on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with Omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization to the stomach and duodenum and also vitamin B12 absorption.

Overdose

Storage

Keep in a cool and dry place, away from light and moisture.
Keep out of the reach of children.

Pack Size

Espram ® Tablet:
Box containing 3×10’s & 5×10’s tablets in Alu-Alu blister pack.

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