Omeprazole Oubari – Capsules

Composition

Each capsule contains :

• Omeprazole: 20 mg.
• Excipients: S.Q. for one capsule.

Indications

• Duodenal Ulcer : Omeprazole Oubari Delayed-Release capsules are indicated for short-term treatment of active duodenal ulcer, and in combination with clarithromycin and amoxicillin , for treatment of patients with Helicobacter Pylori infection and duodenal ulcer disease(active or up to 1-year history) to eradicate H.Pylori  . Eradication of this bacteria has been shown to  reduce the risk of duodenal ulcer recurrence.
• Gastric Ulcer : short-term treatment (4 – 8 weeks) of active benign gastric ulcer.
• Treatment of Gastroesophageal Reflux Disease (GERD):for the treatment of symptoms of GERD as heartburn, and for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.
• Maintenance of Healing of Erosive Esophagitis.
• Pathological Hypersecretory Conditions: for the long-term treatment of such conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis).

Dosage & Administrations

Short-term treatment of active duodenal ulcer:

the dose in adult patients is 20 mg once daily, most patients heal within four weeks, some patients may require an additional 4 weeks of therapy.

H.pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence:

Triple Therapy (Omeprazole Oubari / clarithromycin / amoxicillin ) :

The recommended adult oral regimen is Omeprazole Oubari  20 mg plus clarithromycin 500 mg  plus  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 Omeprazole Oubari 20 mg once daily is recommended for ulcer healing and symptom relief .

Dual Therapy (Omeprazole Oubari / clarithromycin ):

The recommended adult oral regimen is Omeprazole Oubari 40 mg once daily plus clarithromycin  500 mg  t.i.d. for 14 days , in patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Oubari 20 mg once daily is recommended for ulcer healing and symptom  relief .              

Gastric ulcer:

The oral dose in adult patients is 40 mg once a day from 4 – 8 weeks.

Gastroesophageal Reflux Disease (GERD):

The oral dose in adult patients with symptomatic (GERD) and no esophageal lesions is 20 mg daily for up to 4 weeks, the oral dose for the treatment of adult patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

Maintenance of Healing of Erosive Esophagitis:

The  adult  oral  dose  is 20 mg daily.

Pathological hypersecretory conditions:

The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients with Zollinger–Ellison syndrome have been treated continuously for more than 5 years.

No dosage adjustment for Omeprazole Oubari is necessary in patients with renal impairment or elderly patients.