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PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG [SIN15041P]
Active ingredients: PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG
Product Info
PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG
[SIN15041P]
Product information
Active Ingredient and Strength | PANTOPRAZOLE SODIUM SESQUIHYDRATE 45.11 MG EQV PANTOPRAZOLE - 40 MG |
Dosage Form | TABLET, ENTERIC COATED |
Manufacturer and Country | HETERO LABS LIMITED - INDIA |
Registration Number | SIN15041P |
Licence Holder | MEDICELL PHARMACEUTICAL (S) PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A02BC02 |
INDICATION AND USAGE
Pantoprazole Gastro-Resistant Tablets 20mg:
Mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing).
Long-term management and prevention of relapse in reflux oesophagitis.
Pantoprazole Gastro-Resistant Tablets 40mg:
Moderate and severe reflux oesophagitis.
DOSAGE AND ADMINISTRATION
Mild reflux disease and associated Symptoms (e.g. heartburn,acid regurgitation, pain on swallowing)
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.
Long‐term management and prevention of relapse in reflux oesophagitis
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.
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.
Treatment of Moderate and severe reflux oesophagitis
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.
Special Populations
Hepatic Impairment
A daily dose of pantoprazole 20mg should not be exceeded in patients with severe liver impairment.
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.
Renal Impairment
No dose adjustment is necessary in elderly patients of in those with impaired renal function.
Elderly
The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients or in patients with impaired kidney function.
General instructions
Pantoprazole Gastro-Resistant Tablets tablets should not be chewed or crushed, and should be swallowed whole with water 1 hour before a meal.
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.
CONTRAINDICATIONS
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.
Pantoprazole, like other PPIs, should not be co-administered with atazanavir (see Interaction with other medicinal products and other forms of interaction).
