Omepral

Composition:
Omeprazole (as enteric coated pellets)                             20 mg

Properties:
Omeprazole acts as an anti-secretory compound that suppresses gastric acid secretion by specific inhibition of the  H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell.
Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, Omeprazole is characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.

Indications & Usage:
Omepral is indicated for:
- Short term treatment of active duodenal ulcer.
- Treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1 year history), in combinatiom with clarithromycin and amoxicillin.
- Short term treatment of active benign gastric ulcer.
- Treatment of heart burn and other symptoms associated with gastroesophageal reflux disease.
- Treatment of erosive esophagitis.
- Treatment of pathological hypersecretory conditions (e.g. Zollinger-Ellison syndrome and multiple endocrine adenomas).

Contraindications:
Omepral is contraindicated in patients with known hypersensitivity to any component of the formulation.

Side effects:
Some of the following side effects may occur in some cases:
Allergic reactions, fatigue, tachycardia, bradycardia, elevated blood pressure, anorexia, flatulence, dry mouth, hypoglycemia, myalgia, headache, diarrhea, abdominal pain, nausea, dizziness, vomiting, rash, constipation, cough, asthenia and back pain.

Drug interactions:
- Omepral can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver. Although in normal subjects no interaction with theophylline or propranolol was found, there have been clinical reports of interaction with other drugs metabolized via the cytochrome P-450 system (e.g. cyclosporine, disulfiram, benzodiazepines).
Patients should be monitored to determine if it is necessary to adjust the dosage of these drugs when taken concomitantly with Omepral.
- Omepral may interfere with absorption of Ketoconazole, ampicillin esters and iron salts.

Warnings & precautions:
- Symptomatic response to therapy with Omepral does not preclude the presence of gastric malignancy.
- Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Omepral.
- Omepral should be taken before eating and the capsule should not be opened, chewed or crushed and should be swallowed whole.

Pregnancy:
Omepral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation:
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.

Overdosage :
- Manifestations of overdosage include confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache and dry mouth.
- Treatment should be symptomatic and supportive.

Dosage & administration :
- Short-term treatment of active Duodenal ulcer: One capsule of  Omepral ( 20 mg) once daily.
- H. pylori Eradication for the reduction of the risk of Duodenal ulcer Recurrence:-

Triple therapy:
One capsule of Omepral (20 mg)+ Clarithromycin 500 mg + amoxicillin 1000 mg each given twice daily for 10 days.
In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omepral once daily is recommended for ulcer healing and symptom relief.
Dual therapy :
- Two capsules of Omepral (40 mg) once daily + Clarithromycin 500 mg tid for 14 days.
In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omepral once daily is recommended for ulcer healing and symptom relief.

Gastric ulcer: Two capsules of Omepral (40 mg) once daily for 4-8 weeks.
- Gastroesophageal Reflux disease with no esophageal lesions: One capsule of Omepral (20 mg) daily for up to 4 weeks.
- Erosive esophagitis and accompanying symptoms due to Gastroesophageal
Reflux disease: One capsule of Omepral (20 mg) daily for 4 to 8 weeks.
- Maintenance of healing of Erosive esophagitis: One capsule of Omepral (20 mg) daily.
- Pathological hypersecretory conditions: Three capsules of Omepral (60 mg) once daily.
Doses up to six capsules (120 mg) t. i. d. have been administered.                                 

Therapeutic Category: Gastric acid pump inhibitor (antiulcer agent).

Legal Category: POM.

Package: Box containing 14 capsules.
              
Storage: Store in a dry place at a temperature below 30ºC, protect from light.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.