- Approval Id
- 106305dc147c5786
- Drug Name
- PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG
- Product Name
- PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG
- Approval Number
- SIN15041P
- Approval Date
- 2016-07-04
- Registrant
- MEDICELL PHARMACEUTICAL (S) PTE. LTD.
- Licence Holder
- MEDICELL PHARMACEUTICAL (S) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, ENTERIC COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p><u>Mild reflux disease and associated Symptoms (e.g. heartburn,acid regurgitation, pain on swallowing)</u></p>
<p>The recommended oral dosage is one gastro-resistant tablet Pantoprazole Gastro-Resistant Tablets 20 mg per day. Symptom relief is generally accomplished within 2–4 weeks, and a 4-week treatment period is usually required for healing of associated oesophagitis. If this is not sufficient, healing will normally be achieved within a further 4 weeks.</p>
<p><u>Long‐term management and prevention of relapse in reflux oesophagitis</u></p>
<p>For long-term management, a maintenance dose of one gastroresistant tablet Pantoprazole Gastro-Resistant Tablets 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs.</p>
<p>Pantoprazole Gastro-Resistant Tablets 40 mg is available for this case. After healing of the relapse the dosage can be reduced again to 20 mg pantoprazole.</p>
<p><u>Treatment of Moderate and severe reflux oesophagitis</u></p>
<p>For the treatment of reflux esophagitis one tablet of Pantoprazole Gastro-Resistant Tablets 40mg per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole Gastro-Resistant Tablets 40mg daily) especially when there has been no response to other treatment.</p>
<p><u>Special Populations</u></p>
<p><u>Hepatic Impairment</u></p>
<p>A daily dose of pantoprazole 20mg should not be exceeded in patients with severe liver impairment.</p>
<p>In patients with severe liver impairment the dose has to be reduced to 1 tablet (40 mg pantoprazole) every other day. Furthermore, in these patients the liver enzymes should be monitored during Pantoprazole Gastro-Resistant Tablets 40 mg therapy. In the case of a rise of the liver enzymes, Pantoprazole Gastro-Resistant Tablets 40 mg should be discontinued.</p>
<p><u>Renal Impairment</u></p>
<p>No dose adjustment is necessary in elderly patients of in those with impaired renal function.</p>
<p><u>Elderly</u></p>
<p>The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients or in patients with impaired kidney function.</p>
<p><u>General instructions</u></p>
<p>Pantoprazole Gastro-Resistant Tablets tablets should not be chewed or crushed, and should be swallowed whole with water 1 hour before a meal.</p>
<p>A 4-week period is usually required for the treatment of reflux esophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATION AND USAGE</strong></p>
<p><u>Pantoprazole Gastro-Resistant Tablets 20mg:</u></p>
<p>Mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing).</p>
<p>Long-term management and prevention of relapse in reflux oesophagitis.</p>
<p><u>Pantoprazole Gastro-Resistant Tablets 40mg:</u></p>
<p>Moderate and severe reflux oesophagitis.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>Pantoprazole gasro-resistent tablets must not be used in cases of known hypersensitivity to the active ingredient or/and any of the other constituents of Pantoprazole gasro-resistent tablets.</p>
<p>Pantoprazole, like other PPIs, should not be co-administered with atazanavir (see Interaction with other medicinal products and other forms of interaction).</p>
- Atc Code
- A02BC02
- Atc Item Name
- pantoprazole
- Pharma Manufacturer Name
- MEDICELL PHARMACEUTICAL (S) PTE. LTD.
