Omeprazole

COMPOSITION:

Each capsule contains:
Omeprazole 20mg (Enteric Coated Pellets)
Duodenal Ulcer (adults)

INDICATION:

PEPTAZ (omeprazole) is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.PEPTAZ (omeprazole) in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.

PEPTAZ (omeprazole) in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Among patients who fail therapy, PEPTAZ (omeprazole) with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.

Gastric Ulcer (adults)

PEPTAZ (omeprazole) is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults.

Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)
Symptomatic GERD
PEPTAZ (omeprazole) is indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.
Erosive Esophagitis
PEPTAZ (omeprazole) is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults.
The efficacy of PEPTAZ (omeprazole) used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

DOSAGE AND ADMINISTRATION

PEPTAZ (omeprazole) Capsules should be taken before eating.

Short-Term Treatment of Active Duodenal Ulcer
The recommended adult oral dose of PEPTAZ (omeprazole) is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence
Triple Therapy (PEPTAZ (omeprazole) /clarithromycin/amoxicillin)
The recommended adult oral regimen is PEPTAZ (omeprazole) 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 PEPTAZ (omeprazole) 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy (PEPTAZ (omeprazole) /clarithromycin)
The recommended adult oral regimen is PEPTAZ (omeprazole) 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of PEPTAZ (omeprazole) 20 mg once daily is recommended for ulcer healing and symptom relief.

Gastric Ulcer

The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

Gastroesophageal Reflux Disease (GERD)

The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of 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 recommended adult oral dose is 20 mg daily.

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