Gaspro

Esomeprazole
Antiulcerant

Gaspro

Description

Composition:

Gaspro 20 Capsule: Each delayed release capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg in the form of enteric coated pellets.
Gaspro 40mg Capsule: Each capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg as enteric coated pellets.

Gaspro 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. By acting specifically on the proton pump, Gaspro blocks the final step in acid production, thus reducing gastric acidity.

 

Indications:

Treatment of Gastroesophageal Reflux Disease (GERD)

-Healing of Erosive Esophagitis

-Maintenance of Healing of Erosive Esophagitis

-Symptomatic Gastroesophageal Reflux Disease

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Zollinger-Ellison Syndrome

Acid Related Dyspepsia

Duodenal and Gastric Ulcer

 

Dosage & Administration:

Capsule: Gaspro capsule should be swallowed whole and taken at least one hour before eating.
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 of treatment may be considered.
If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
Directions for reconstitution of solution
Solution for injection is prepared by adding 5 ml of 0.9% Sodium Chloride for intravenous injection into the vial containing the dry powder. The reconstituted solution for injection is clear and colorless to very slightly yellow.
Administration IV injection must be administered intravenously over a period of at least 3 minutes. Half of the IV injection should be used when 20 mg is to be administered. Prepared solution must be used within 12 hours of preparation and can be exposed to normal indoor lighting at a maximum of 30 °C.
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 20 mg of Esonix should not be exceeded.

 

Contraindication:

Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.

 

Warning & Precaution:

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.

Pregnancy and Lactation:

Pregnancy: There are no adequate and well-controlled studies on the use of Esomeprazole in pregnant women. Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Esomeprazole should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.

Lactation: Esomeprazole is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

 

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).

 

Storage:

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

 

Packing:

Gaspro-20 Capsule: Each box contains 50’s capsules in Alu-Alu blister pack.
Gaspro-40 Capsule: Each box contains 30’s capsules in Alu-Alu blister Pack.

Gaspro-IV Injection: Each box contains one vial with 1 ampoule of 5 ml 0.9% Sodium Chloride BP injection and 5 ml disposable syringe.