ENTERIC COATED PANTOPRAZOLE SODIUM AND DOMPERIDONE SR CAPSULES
Each Capsule Contains :
Pantoprazole Sodium Sesquihydrate
Equivalent to Pantoprazoled…………………40 mg.
(As enteric Coated Pellets)
Domperidone BP ………………………………..30 mg.
(As Sustained Release Pellets)
Excipients : q.s.
Pantoprazole, the No. 1 PPI, is superior in relieving the symptoms associated with dyspepsia than H2 receptor antagonist. In addition, Pantoprazole also prevents recurrences.
Domperidone, a peripherally acting dopamine (D2)
receptor antagonist, is the ideal prokinetic which can be combined with Pantoprazole.
Pantoprazole exerts its full effect in a strongly acidic environment (pH<3) and remains mostly inactive at higher pH valuse, which explains its selectivity for the acid secreting parietal cells of the stomach. Therefore, the complete pharmacological and therapeutic effect for Pantoprazole can only be achieved in the acid-secreting parietal cells. By means of a feedback mechanism this effect is diminished at the same rate as acid secretion is inhibited.
Domperidon is a dopamine antagonist with antiemetic properties. Domperidone does not readily cross the blood-brain barrier. It seldom causes extrapyramidal side effects, but does cause a rise in prolactin levels. Its antiemetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of central dopamine receptors in the chemoreceptor trigger zone which lies in the area postrema and is regarded as being outside the blood-brain barrier.
It also antagonises the behavioural effects of dopamine much more effectively when administered intracerebrally than when given systemically. These findings, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors.
Studies in humans have shown intravenous and oral domperidone to increase lower oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying. Domperidone has no effect on gastric secretion.
- DYSPEPSIA Non ulcer Dyspepsia (NUD)
- Reflux like Dyspepsia
- Ulcer like Dyspepsia — Upper abdominal pain is prominent
- HEARTBURN / GERD Retrosternal burning sensation after meals or on lying down. This is due to the presence of acid. Commonly associated with nausea, vomiting and epigastric pain.
- Inflammation of the mucosal lining of the stomach which may lead to erosion, resulting in nausea, vomiting & epigastric pain
- NAUSEA AND VOMITING:
DOSAGE AND ADMINISTRATION
In Dyspepsia, Heartburn and Gastritis,
1 OD for 10-14 days or more as directed by the physician.
Hypersensitivity to Pantoprazole.
Safety in pregnancy and during lactation has not been established. Safety and efficacy in children have not been established.
Severely impaired liver function.
- Known hypersensitivity to domperidone or any of the excipients
- Prolactin-releasing pituitary tumour (prolactinoma)
- Co-administration with oral ketoconazole (see Interactions)
DOMPERIDONE should not be used whenever stimulation of gastrointestinal motility might be dangerous such as in the presence of gastrointestinal haemorrhage, mechanical obstruction, or perforation.
ADVERSE EFFECTS / SPECIAL PRECAUTIONS
Headaches and gastro-intestinal complaints such as upper abdominal pain, diarrhoea, constipation or flatulence have been reports. With continued treatment complaints usually diminish.
There have been less frequent reports of nausea, dizziness or disturbances in vision (blurred vision).
Peripheral edema, depression, fever or myalgia have been reported in individual cases.
Pantoprazole is not indicated for mild gastro-intestinal complaints such as nervous dyspepsia.
Prior to treatment, the possibility of a malignant gastric ulcer or a malignant disease of the oesophagus should be excluded, as the treatment with Pantoprazole may alleviate the Diagnosis of reflux oesophagitis should be confirmed by endoscopy.
The adverse drug reactions are ranked by frequency using the following convention: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), including isolated reports.
Immune system: Very rare: allergic reaction
Endocrine: Rare: increased prolactin levels
Nevous system: Very rare: extrapyramidal side effects
Gastrointestinal: Rare: gastrointestinal disorders, including very rate transient intestinal cramps
Skin and subcutaneous tissue: Very rare: urticaria
Reproductive system: Rare: amenorrhoea
Other: Rare: galactorrhoea, gynaecomastia
As the hypophysis is outside the blood brain barrier, domperidone may cause an increase in prolactin levels. In rare cases this hyperprolactinaemia may lead to neuro-endocrinological side effects such as galactorrhoea, gynaecomastia and amenorrhoea.
Extrapyramidal phenomena are very rare in neonates and infants, and exceptional in adults. These side effects reverse spontaneouly and completely as soon as the treatment is stopped.
Strip of 10 Sustained Released Capsules