Gastro-Intestinal

Inbiotech LTD., Bulgari; Pharma PLC., Bulgari

VN-23228-22

11/10/2022

INBIOTECH L.T.D

Omeprazole pellet

20mg

Adults
• Prevention of relapse of duodenal, gastric ulcers
• Treatment of gastric ulcers
• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease
• Treatment and prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
• Long-term management of patients with healed reflux oesophagitis
• Treatment of symptomatic gastro-oesophageal reflux disease
• Treatment of Zollinger-Ellison syndrome
Paediatric use
Children over 1 year of age and ≥ 10 kg
• Treatment of reflux oesophagitis
• Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease
Children and adolescents over 4 years of age
• In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori.

- Duodenal ulcer:
• Recommended dose is 20 mg/time/day.
• Symptoms subside quickly and most patients heal within 2 weeks. For patients whose ulcers do not heal completely after the first treatment, they usually heal completely within the next 2 weeks of treatment.
• In patients who do not respond to other treatment regimens. Bioprazole 20 mg, 2 tablets/time/day is used and ulcer healing is usually achieved within 1 week.
- Stomach ulcer: The recommended dose is 20 mg/time/day. Symptoms subside quickly and most patients heal within 4 weeks. For patients who do not respond to other treatment regimens, Bioprazole 20 mg, 2 tablets once daily has been used and ulcer healing is usually achieved within 8 weeks.
- Reflux esophagitis:
• Recommended dose is 20 mg/time/day. Symptoms subside quickly and most patients heal within 4 weeks. For patients whose ulcers do not heal completely after the first treatment, they will usually heal completely within the next 4 weeks of treatment.
• For patients who do not respond to other therapies, Bioprazole 20 mg, 2 tablets once daily is used and heals the inflammation, usually within 8 weeks.
- Prevention of recurrence in patients with gastric ulcer: Recommended dose is 1 tablet/time/day. If necessary, the dose can be increased to 40 mg/time/day.
- Eradication of Helicobacter pylori (Hp): There are many treatment regimens to eradicate Helicobacter pylori. Success rates vary and regimens are improving. Currently accepted treatment regimens include:
• Two-drug regimen: Bioprazole 20 mg and amoxicillin 750 – 1000 mg, all used 2 times/day for 2 weeks.
• Three-drug regimen: Bioprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all taken twice a day for 1 week.
Or:
Bioprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg) all taken twice daily for 1 week.
Always keep in mind that there are high rates of resistance to metronidazole or tinidazole in many countries.
- Gastrointestinal ulcer or erosive gastroduodenal inflammation due to the use of non-steroidal anti-inflammatory drugs, currently with or without concurrent treatment with non-steroidal anti-inflammatory drugs: The recommended dose is 20 mg/time/day. Symptoms subside quickly and most patients heal within 4 weeks. For patients who do not respond to other therapies. Bioprazole 20 mg, 2 tablets/time/day has been used and cured the disease, usually used for 4 weeks.
- Prevention of symptoms of digestive ulcers, duodenal erosive gastritis or symptoms of digestive disorders caused by the use of non-steroidal anti-inflammatory drugs: The recommended dose is 20 mg/time/day.
- Treatment of symptomatic gastroesophageal reflux: The recommended dose is 20 mg/time/day. Symptoms decrease quickly. If symptom control is not achieved after 4 weeks of treatment with Bioprazole 20 mg, further evaluation is required.
- Zollinger – Ellison syndrome: Initial dose is 60 mg per day. Dosage should be adjusted individually and treatment continued as long as clinically indicated. All patients with severe disease and inadequate response to other therapies were effectively controlled and more than 90% of patients were adequately treated with doses of 20 - 120 mg daily. When the dose exceeds 80 mg of Bioprazole per day, the dose should be divided into 2 times/day.
- Renal impairment: No dose adjustment is required in patients with impaired renal function.
- Hepatic impairment: Because the bioavailability and half-life of omeprazole are increased in patients with impaired liver function, a dose of 10 - 20 mg/day is sufficient.
- Elderly: No dosage adjustment is required in the elderly.
- Children under 4 years of age: Experience in treating Bioprazole 20 mg in children is limited.

36

Hard capsule contains enteric-coated pellets

Box of 1 bottle of 14 capsules; 28 capsules