| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | For oral administration |
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Indications:
• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease
• Treatment of NSAID-associated gastric and duodenal ulcers
• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
• Treatment of reflux oesophagitis
• Long-term management of patients with healed reflux oesophagitis
• Treatment of symptomatic gastro-oesophageal reflux disease
Dosage and Administration:
It is recommended to take Omeprazole capsules in the morning, , swallowed whole with half a glass of water. The capsules must not be chewed or crushed.
For patients with swallowing difficulties and for children who can drink or swallow semi-solid food.
Patients can open the capsule and swallow the contents with half a glass of water or after mixing the contents in a slightly acidic fluid e.g., fruit juice or applesauce, or in non-carbonated water. Patients should be advised that the dispersion should be taken immediately (or within 30 minutes) and always be stirred just before drinking and rinsed down with half a glass of water.
Alternatively patients can suck the capsule and swallow the pellets with half a glass of water. The enteric-coated pellets must not be chewed.
Storage instructions:
Do not store above 25°C.
| Testing terms | Standards | Results |
| Description | Hard capsules, the contents for the white or off-white enteric-coated pellets or particles. | Complies |
| Identification | Should positive reaction | Positive |
| Related substances |
To comply with CP2015 | Complies |
| Uniformity of content | To comply with CP2015 | Complies |
| Release | ≥80% | 94% |
| Resistance to acid | ≥90% | 97% |
| Assay | 90.0%-110.0% | 100.2% |
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