Pantonar-DSR
| Brand name | PANTONAR –DSR |
| Composition | Each hard gelatin capsule of PANTONAR-DSR contains three smartlets: Each yellow enteric-coated smartlet contains: Pantoprazole Sodium Sesquihydrate equivalent to Pantoprazole 40mg Each white film coated smartlet contains: Domperidone 30 mg IR |
| Indications and Clinical Use: | PANTONAR-DSR which is in hard gelatin capsule form is indicated in the management of gastroesophageal reflux disease; gastritis, non-ulcer dyspepsia, gastric or duodenal ulcer, dyspepsia, bloating, fullness, belching, NSAID-induced dyspepsia. |
| Clinical Use in special population: | Pantoprazole :
Hepatic impairment:
There is a slight increase (1.5 fold) in maximum drug concentrations in patients with mild to severe hepatic impairment. No dosage adjustment is needed in patients with mild to severe hepatic impairment.
Renal impairment:
Pharmacokinetic parameters for Pantoprazole in patients with severe renal impairment are similar to those of healthy subjects. No dosage adjustment is needed in patients with renal impairment.
Gender:
No dosage adjustment is needed based on gender.
Pediatrics:
The pharmacokinetics of Pantoprazole have not been investigated in patients < 18 years of age.
Geriatrics:
No dosage adjustment is recommended based on age. Domperidone : Hepatic impairment: There is no published pharmacokinetic data in patients with hepatic impairment. Because Domperidone is extensively metabolized, response to the drug should be carefully monitored in this patient population. Neonates: Domperidone is not recommended for use in neonates. Breast milk: Domperidone may precipitate galactorrhea and improve postnatal lactation. It is secreted in breast milk in very small quantities and thus insufficient to be considered harmful. Pediatrics: Domperidone is not recommended other than for treatment of nausea and vomiting in patients undergoing cancer therapy. There may be an increased risk for extrapyramidal reactions in young children because of an incompletely developed blood brain barrier. Pregnant women: The safety of Domperidone has not been proven, therefore its use is not recommended in pregnant women. Geriatrics: No special precautions are necessary in older patients. |
| CONTRAINDICATIONS: | PANTONAR-DSR is contraindicated in patients with known hypersensitivity to Pantoprazole or Domperidone |
| Pregnancy and Lactation | Due to lack of controlled studies in pregnant and lactating women, use of PANTONAR-DSR is contraindicated in |
| WARNING AND PRECAUTIONS: | PANTONAR-DSR shall be given with care to patients with renal dysfunction or hepatic dysfunction |
| ADVERSE EFFECTS : | Pantoprazole
the adverse reactions associated with Pantoprazole include Headache, Diarrhoea, Skin rash, Pruritus and Dizziness. Domperidone Serum prolactin level may rise resulting in galactorrhea in females and less frequently gynaecomastia in males due to Domperidone. Dry mouth, Thirst, Headache, Nervousness, Drowsiness, Diarrhoea, Skin rashes and Itching may follow treatment with Domperidone. |