PERISTAD 10 Tablet

The relief of the symptoms of nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric contents.

Dosage and administration

Orally. It is recommended to take the tablets before meals.

The initial duration of treatment is 4 weeks. Patients should be reevaluated after 4 weeks and the need for continued treatment reassessed.

- Adults and adolescents (over 12 years and weighing 35kg or more): 1-2 tablets 3-4 times/day. Maximum daily dose: 80mg.

- Tablets are unsuitable for use in children weighing less than 35kg.

- Known hypersensitivity to domperidone or any ingredient in the formulation.

- Prolactin-releasing pituitary tumour (prolactinoma).

- Domperidone should not be used when stimulation of gastric motility could be harmful: gastrointestinal haemorrhage, mechanical obstruction or perforation.

Plasma-prolactin concentration may be increased, which may lead to galactorrhoea or gynaecomastia. There have been reports of the reduced libido, and rashes and other allergic reactions.

Domperidone does not readily cross the blood-brain barrier and the incidence of central effects such as extrapyramidal reactions or drowsiness may be lower than with metoclopramide, however, there have been reports of dystonic reactions.

- There is a theoretical potential that domperidone may antagonize the hypoprolactinaemic effect of drugs such as bromocriptine.

- The prokinetic effects of domperidone may alter the absorption of some drugs. Opioid analgesic and antimuscarinics may antagonize the prokinetic effect of domperidone.

- Co-administration with oral ketoconazole, erythromycin or other potent CYP3A4 inhibitors that prolong the QTc interval should be avoided. A slight increase of the QT interval (mean less than 10sec) was reported in a drug-drug interaction study with oral ketoconazole.

Pregnancy

The potential risk for humans is unknown. Therefore, domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.

Lactation

Breast-feeding is not recommended for mothers who are taking domperidone. (see the package insert about the details.)

See the package insert about the details below.

- Since domperidone is highly metabolised in the liver, domperidone should be not used in patients with hepatic impairment.

- In patients with severe renal insufficiency (serum creatinine >6mg/100mL).

- Domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. .

Use of domperidone and other drugs which prolong QTc interval.

Domperidone is a dopamine antagonist with antiemetic properties. In domperidone users, especially in adults, extra pyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. Its anti-emetic effect may be due to a combination of peripheral (gastro kinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema. Studies in man have shown oral domperidone to increase lower oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric secretion.