- Approval Id
- 366193c553dbc3bd
- Drug Name
- LOSEC MUPS TABLET 20 mg
- Product Name
- LOSEC MUPS TABLET 20 mg
- Approval Number
- SIN10700P
- Approval Date
- 1999-01-21
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Posology and method of administration</strong><br>
LOSEC MUPS tablets are recommended to be given in the morning and swallowed whole with half a glass of water. The tablet must not be chewed or crushed.</p>
<p><strong>For patients with swallowing difficulties</strong><br>
Break the MUPS tablet and disperse it in a spoonful of non-carbonated water - if so wished, mix with some fruit juices or applesauce. The dispersion should be taken immediately (or within 30 minutes). Always stir just before drinking. Rinse it down with half a glass of water. DO NOT USE milk or carbonated water. Ingest without chewing the enteric-coated pellets.</p>
<p><strong><em>Duodenal ulcer</em></strong><br>
The recommended dosage in patients with an active duodenal ulcer is LOSEC MUPS 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.</p>
<p>In patients with poorly responsive duodenal ulcer LOSEC MUPS 40 mg 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 LOSEC MUPS 10 mg once daily. If needed the dose can be increased to LOSEC MUPS 20–40mg once daily.</p>
<p><em><strong>Gastric ulcer</strong></em><br>
The recommended dosage is LOSEC MUPS 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.</p>
<p>In patients with poorly responsive gastric ulcer LOSEC MUPS 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 LOSEC MUPS 20 mg once daily. If needed the dose can be increased to LOSEC MUPS 40 mg once daily.</p>
<p><em><strong>NSAID associated ulcers or gastroduodenal erosions</strong></em><br>
NSAID associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients with or without continued NSAID treatment the recommended dosage of LOSEC MUPS 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.</p>
<p>For the prevention of NSAID associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms the recommended dosage of LOSEC MUPS is 20 mg once daily.</p>
<p><em><strong>Helicobacter pylori eradication</strong></em><br>
There are many treatment regimens for eradication of Helicobacter pylori. Success rates vary and the regimens are evolving. Currently acceptable regimens include the following:</p>
<p><u>Dual therapy regimens</u><br>
LOSEC MUPS 20 mg twice daily with amoxicillin 1.5–2g daily for two weeks</p>
<p><u>Triple therapy regimens</u><br>
LOSEC MUPS 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice a day for one week</p>
<p>or</p>
<p>LOSEC MUPS 20 mg, clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg) all twice a day for one week.</p>
<p>To ensure healing in patients with active peptic ulcer disease, see further dosage recommendations for duodenal and gastric ulcer.</p>
<p>In each regimen if the patient is still Helicobacter pylori positive, therapy may be repeated.</p>
<p><strong><em>Reflux oesophagitis</em></strong><br>
The recommended dosage is LOSEC MUPS 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.</p>
<p>In patients with severe reflux oesophagitis LOSEC MUPS 40 mg once daily is recommended and healing is usually achieved within 8 weeks.</p>
<p>For the long-term management of patients with healed reflux oesophagitis the recommended dose is LOSEC MUPS 10 mg once daily. If needed the dose can be increased to LOSEC MUPS 20–40 mg once daily.</p>
<p><em><strong>Severe reflux oesophagitis in children from one year and older</strong></em><br>
The recommended dosage for healing is:</p>
<table class="borderless-100">
<tbody>
<tr>
<td><u>Weight</u></td>
<td><u>Dosage</u></td>
</tr>
<tr>
<td>10–20 kg</td>
<td>10 mg once daily</td>
</tr>
<tr>
<td>>20 kg</td>
<td>20 mg once daily</td>
</tr>
</tbody>
</table>
<p>If needed the dosage may be increased to 20 mg and 40 mg respectively. The duration of treatment in these patients should be between 2 to 8 weeks.</p>
<p><em><strong>Symptomatic gastro-oesophageal reflux disease</strong></em><br>
The recommended dosage is LOSEC MUPS 20 mg daily. Symptom relief is rapid. Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.</p>
<p>If symptom control has not been achieved after 4 weeks treatment with LOSEC MUPS 20 mg daily, further investigation is recommended.</p>
<p><em><strong>Acid related dyspepsia</strong></em><br>
In the relief of symptoms in patients with epigastric pain/discomfort with or without heartburn the recommended dosage is LOSEC MUPS 20 mg once daily.</p>
<p>Patients may respond adequately to 10 mg daily and therefore this dose could be considered as a starting dose. If symptom control has not been achieved after 4 weeks treatment with LOSEC MUPS 20 mg daily, further investigation is recommended.</p>
<p><strong><em>Zollinger-Ellison syndrome</em></strong><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 LOSEC MUPS 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 LOSEC 20–120 mg daily. When doses exceed LOSEC MUPS 80 mg daily, the dose should be divided and given twice daily.</p>
<p><em><strong>Impaired renal function</strong></em><br>
Dose adjustment is not needed in patients with impaired renal function.</p>
<p><em><strong>Impaired hepatic function</strong></em><br>
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.</p>
<p><em><strong>Elderly</strong></em><br>
Dose adjustment is not needed in the elderly.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
LOSEC MUPS is indicated for the 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>Acid related dyspepsia</li>
<li>Zollinger-Ellison syndrome</li>
</ul>
- Contraindications
- <p><strong>Contraindications</strong><br>
Known hypersensitivity to omeprazole, substituted benzimidazoles or any other constituent of the formulation.<br>
Omeprazole like other proton pump inhibitors must not be used concomitantly with nelfinavir (see section Interactions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- Pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- ZUELLIG PHARMA PTE. LTD.
