MedPath
HSA Approval

OMESEC CAPSULE 20 mg

SIN11519P

OMESEC CAPSULE 20 mg

OMESEC CAPSULE 20 mg

May 16, 2001

DUOPHARMA (SINGAPORE) PTE LTD

DUOPHARMA (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantDUOPHARMA (SINGAPORE) PTE LTD
Licence HolderDUOPHARMA (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

CAPSULE

**RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND ROUTE OF ADMINISTRATION** **Benign Gastric & Duodenal Ulcer** : 20 mg once daily for 4 weeks in duodenal ulceration or 8 weeks in gastric ulceration. In severe or recurrent cases, the dose may be increased to 40 mg once daily. Long term therapy for patients with a history of recurrent duodenal ulcer is recommended at a dosage of 20 mg once daily, up to one year. For the prevention of relapse in patients with duodenal ulcer disease, the recommended dose is 10 mg once daily. If needed, the dose can be increased to 20–40 mg once daily. **Gastro-Oesophageal Reflux Disease** : 20 to 40 mg once daily for 4 to 8 weeks; thereafter maintenance therapy can be continued with 10 mg once daily. **Zollinger-Ellison Syndrome** : Initially 60 mg once daily; usual range 20 to 120 mg daily. Doses above 80 mg should be divided and given twice daily. The dosage should be adjusted individually and therapy continued for as long as clinically indicated. **Helicobacter Pylori Eradication** : **Dual Therapy (2 Week Regimens)** A combination of Omeprazole 40 mg daily with Amoxycillin 750 mg twice daily or with Clarithromycin 500 mg three times daily for 2 weeks. **Triple Therapy (1-Week Regimens)** A combination of Omeprazole 20 mg twice daily or 40 mg once daily with Amoxycillin 500 mg 3 times daily and Metronidazole 400 mg 3 times daily for 7 days; A combination fo Omeprazole 20 mg twice daily or 40 mg once daily with Clarithromycin 250 mg twice daily and Metronidazole 400 mg (or Tinidazole 500 mg) twice daily for 7 days; A combination of Omeprazole 20 mg twice daily or 40 mg once daily with Amoxycillin 1g twice daily and Clarithromycin 500 mg twice daily for 7 days. **Note** : Dual therapy regimens have lower eradication rates than triple therapy regimens. _Paediatric_ Dosage has not been established. Geriatric The daily doses usually should not exceed 20 mg. _Impaired hepatic function_ As bioavailability and plasma half-life of Omeprazole are increased in patients with impaired hepatic function, a daily dose of 10 – 20 mg may be sufficient. **Administration** Omeparazole should be taken immediately before meals, preferably in the morning. The capsule should be swallowed whole with liquid. The contents of the capsule should not be chewed or crushed. For patients with difficulties in swallowing, the capsule might be opened and the contents swallowed or suspended in a slightly acidic fluid e.g. juice, yoghurt or soured milk. The suspension should be taken within half an hour. Alternatively, the contents can be swallowed by sucking the capsule.

ORAL

Medical Information

**INDICATIONS** Omeprazole is used in the treatment of gastro-oesophageal reflux disease; duodenal ulcer, benign gastric ulcer and Zollinger-Ellison Syndrome. It is also combined with antibacterial agents in dual or triple therapy regimens for the elimination of Helicobacter Pylori infection in patients with duodenal ulcer.

**CONTRAINDICATIONS** Omeprazole is contra-indicated in patients who are sensitive to it.

A02BC01

omeprazole

Manufacturer Information

DUOPHARMA (SINGAPORE) PTE. LTD.

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Active Ingredients

OMEPRAZOLE

20 mg

Omeprazole

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OMESEC CAPSULE 20 mg - HSA Approval | MedPath