- Approval Id
- a7a7d4017aaf52e9
- Drug Name
- PROMESEC GASTRO-RESISTANT CAPSULES 20 MG
- Product Name
- PROMESEC GASTRO-RESISTANT CAPSULES 20 MG
- Approval Number
- SIN15522P
- Approval Date
- 2018-08-14
- Registrant
- DUOPHARMA (SINGAPORE) PTE LTD
- Licence Holder
- DUOPHARMA (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE, ENTERIC COATED
- Dosage
- <p><strong>POSOLOGY</strong><br>
<em>Duodenal ulcer</em><br>
The recommended dosage in patients with an active duodenal ulcer is omeprazole 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 2 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 2 week treatment period.<br>
In patients with poorly responsive duodenal ulcer omeprazole 40mg once daily is recommended and healing is usually achieved within 4 weeks.<br>
For the prevention of relapse in patients with duodenal ulcer disease the recommended dose is omeprazole 10 mg once daily. If needed the dose can be increased to omeprazole 20–40mg once daily.<br>
For NSAID associated duodenal ulcers see NSAID associated gastroduodenal lesions.<br>
For eradication of Helicobacter pylori see Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease.</p>
<p><em>Gastric ulcer</em><br>
The recommended dosage is omeprazole 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks’ treatment period.<br>
In patients with poorly responsive gastric ulcer omeprazole 40 mg once daily is recommended and healing is usually achieved within 8 weeks.<br>
For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is omeprazole 20 mg once daily. If needed the dose can be increased to omeprazole 40 mg once daily.<br>
For eradication of Helicobacter pylori see Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease.</p>
<p>NSAID associated ulcers or gastroduodenal erosions<br>
NSAID associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients without continued NSAID treatment the recommended dosage of omeprazole is 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period.<br>
For the prevention of NSAID associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms the recommended dosage of omeprazole is 20 mg once daily.</p>
<p><em>Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease</em><br>
Triple therapy regimens:<br>
Omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice a day for one week<br>
or Omeprazole 20 mg, metronidazole 400 mg (or tinidazole 500 mg) and clarithromycin 250mg, all twice a day for one week, or<br>
Dual therapy regimens:<br>
Omeprazole 20 mg twice daily with amoxicillin 1.5–2 g daily for two weeks.</p>
<p><em>Reflux oesophagitis</em><br>
The recommended dosage is omeprazole 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks’ treatment period.<br>
In patients with severe reflux oesophagitis omeprazole 40 mg once daily is recommended and healing is usually achieved within 8 weeks.<br>
For the long term management of patients with healed reflux oesophagitis the recommended dose is omeprazole 10 mg once daily. If needed the dose can be increased to omeprazole 20–40mg once daily.</p>
<p><em>Symptomatic gastro-oesophageal reflux disease</em><br>
The recommended dosage is omeprazole 20 mg daily. Symptom relief is rapid. Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered. If symptom control has not been achieved after 4 weeks treatment with omeprazole 20mg daily, further investigation is recommended.</p>
<p><em>Acid related dyspepsia</em><br>
In the relief of symptoms in patients with epigastric pain/discomfort with or without heartburn the recommended dosage is omeprazole 20 mg once daily.<br>
Patients may respond adequately to 10 mg daily and therefore this dose could be considered as a starting dose.<br>
If symptom control has not been achieved after 4 weeks treatment with omeprazole 20mg daily, further investigation is recommended.</p>
<p><em>Zollinger Ellison Syndrome</em><br>
In patients with Zollinger-Ellison syndrome the dosage should be individually adjusted and treatment continued as long as is clinically indicated. The recommended initial dosage is omeprazole 60 mg daily. All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of omeprazole 20–120 mg daily. When doses exceed omeprazole 80 mg daily, the dose should be divided and given twice daily.</p>
<p><em>Impaired renal function</em><br>
Dose adjustment is not needed in patients with impaired renal function.</p>
<p>Impaired <em>hepatic function</em><br>
As bioavailability and plasma half-life of omeprazole are increased in patients with impaired <em>hepatic function</em> a daily dose of 10–20 mg may be sufficient.</p>
<p><em>Elderly</em><br>
Dose adjustment is not needed in the elderly.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS</strong><br>
Promesec Gastro-Resistant Capsules 20 mg are indicated for treatment of:</p>
<ul>
<li>Duodenal ulcer</li>
<li>Gastric ulcer</li>
<li>NSAID associated gastric and duodenal ulcers or erosions</li>
<li>In combination with antibiotics for treatment of duodenal ulcer caused by Helicobacter pylori</li>
<li>Reflux oesophagitis</li>
<li>Symptomatic gastro-oesophageal reflux disease</li>
<li>Zollinger-Ellison syndrome</li>
<li>Acid related dyspepsia</li>
</ul>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients. Omeprazole like other proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir.</p>
- Atc Code
- A02BC01
- Atc Item Name
- omeprazole
- Pharma Manufacturer Name
- DUOPHARMA (SINGAPORE) PTE. LTD.
- Company Detail Path
- /organization/duopharma-singapore-pte-ltd
