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Emep

Esomeprazole

Esomeprazole is the S-isomer of Omeprazole, a proton pump inhibitor. Esomeprazole suppresses gastric acid secretion by specific inhibition of the H+/K+ATPase in the gastric parietal cell.

Product Details

Presentation

Emep-20 Capsule: Each capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg as enteric coated pellets.
Emep-40 Capsule: Each capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg as enteric coated pellets.
Emep Tablet: Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate USP equivalent to esomeprazole 20 mg.
Emep IV Injection: Each vial contains lyophilized Esomeprazole Sodium equivalent to Esomeprazole 40 mg.

Pharmacology

Esomeprazole is the S-isomer of Omeprazole, a proton pump inhibitor. Esomeprazole suppresses gastric acid secretion by specific inhibition of the H+/K+ATPase in the gastric parietal cell.

Indication

Emep Tablet/Capsule:
•For the treatment of heart burn and other symptoms associated with GERD
•For the healing of erosive esophagitis
•For maintenance of healing of erosive esophagitis
•In duodenal and gastric ulcer
•In combination with amoxycillin, clarithromycin, esomeprazole is used for the treatment of H. pylori infection and duodenal ulcer disease to eradicate.

Emep IV Injcetion:

Emep IV injection is indicated for gastric antisecretory treatment when the oral route is not possible such as bleeding peptic ulcer, short-term treatment of GERD, erosive esophagitis, pre and post operative hyperacidity.

Dosage & Administration

Emep Tablet / Capsule:
Esomeprazole tablet/capsule should be taken one hour before meal.

IndicationsDoseFrequency
Symptomatic Gastroesophageal
Reflux Disease
20 mgOnce daily for 4 weeks
Healing of Erosive Esophagitis20 or 40 mgOnce daily for 4-8 weeks*
Maintenance of Healing of Erosive Esophagitis20 mgOnce daily
Duodenal Ulcer20 mg Once daily for 2-4 weeks
Gastric Ulcer20-40 mgOnce daily for 8 weeks
H. pylori eradication reduces the risk of duodenal ulcer recurrence
Triple therapy
Emep40 mg

Once daily for 10 days

Amoxycillin
1000 mgTwice daily for 10 days
Clarithromycin500 mgTwice 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.
Emep IV Injcetion:
The recommended adult dose is either 20 mg or 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Emep IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Emep IV injection should be discontinued as soon as the patient is able to resume treatment with Emep capsule/tablet. Safety and effectiveness in paediatric patients have not been established.
Method of administration:
Injection:
Esomeprazole IV injection is obtained by adding 5 ml 0.9% sodium chloride to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 3 minutes. The injection should be used within 12 hours after reconstitution and can be stored at room temperature.
Infusion:
Esomeprazole intravenous infusion is prepared by first reconstituting the content of vial with 5 ml of 0.9% Sodium Chloride injection or 5% dextrose injection and further diluting the resulting solution to a final volume of 50 ml. The reconstituted solution should be administered as an intravenous infusion over a period of 10-30 minutes. The reconstituted solution should be used within 12 hours when Esomeprazole is dissolved in 0.9% Sodium Chloride and within 6 hours when dissolved in 5% dextrose. The reconstituted solution can be stored at room temperature.

Contraindications

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

Warning & Precautions

Geriatric patients: 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 servere liver impairment a dose of 20 mg of esomeprazole should not be exceeded.

Side effects

In general, esomeprazole is well tolerated in both short and long term use. Adverse events reported with esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth.

Drug interaction

Esomeparzole is extensively metabolized in the liver. Drug interactions studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxycillin. Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. ketoconazole, iron salts and digoxin).

Use in special groups

Use in pregnancy: Pregnancy Category B; This drug should be used during pregnancy only if clearly needed.
Use in lactation: 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.
Use in children: Children over 1 year are recommended to use oral Esomeprazole.

Packing

Emep-20 Capsule: Each box contains 60's capsules in Alu-Alu blister pack.
Emep-40 Capsule: Each box contains 40's capsules in Alu-Alu blister Pack.
Emep Tablet: Each box contains 60's tablets in Alu-Alu blister pack.
Emep IV Injection: Each box contains one vial with 1 ampoule of 5 ml 0.9% Sodium Chloride BP injection and 5 ml disposable syringe.

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