DOMETIC Tablet

Indication:

- Dyspepsia which is accompanied with delayed gastric emptying time or oesophageal reflux.

- Feeling of fullness in the epigastric or abdomen.

- Nausea and vomiting

- Heartburn.

- Nausea, vomiting and bloating due to various causes: digestive intolerance caused by anticancer chemotherapy, L-dopa, and any others, including radiotherapy.

Dosage and administrations:

- Chronic dyspepsia:

Adults: 10 mg (1 tablet) 3 times daily, 15-30 min before meals and if necessary 1 tablet before bed time.

- Nausea and vomiting:

Adult: 10-20 mg (1-2 tablets), 3-4 times daily before meals and bed time.

- The course of treatment should not exceed 12 weeks.

- Hypersensitive to domperidone.

- In patients where stimulation of gastric motility may be dangerous e.g. in the presence of haemorrhage, perforation of mechanical obstruction.

- In patients with prolactinoma, prolactin-releasing pituitary tumor.

- Transient intestinal cramps, allergic reactions: rash & urticaria, hyperprolactinaemia.

- Extrapyramidal phenomena are rare in children and exceptional in adults, they reverse spontaneously as soon as treatment is terminated.

- in isolated cases, hyperprolactinaemia may cause neuroendocrinologic phenomena such as galactorrhoea and gynaecomastia.

- Anticholinergics may antagonize the effect of domperidone.

- Antacids % H2-antagonist may reduce the bioavailability of domperidone.

- Theoretically, due to gastrokinetic effect of domperidone, it could influence the absorption of concomitantly drugs. But in patients already stabilized with digoxin or paracetamol, concomitantly administration with domperidone does not influent the blood level of these drugs.

- CYP3A4 inhibitors, such as azole antifungals, macrolide antibiotics, HIV protease inhibitors, Nefazodone, may reduce the metabolism of domperidone.

Domperidone can be administered concomitantly with:

- Neurologic drugs with do not cause potentiation effects.

- Dopaminergic agonist (bromocriptine, L-dopa) which have a peripheral side effects, e.g. digestive disorders, nausea and vomiting can be suppressed without counteracting its central properties.

- Not recommended in pregnant and lactation women.

- Caution when use to patients with liver function impairment and severe renal function impairment.

- If antacid or antisecretory agents is given simultaneously with domperidone, the administration must be after meals and may not be given at the same time.

- Domperidone is not recommended for long term treatment or for the routine prophylaxis of post-operative vomiting.

- Children: the tablet are not intended to be administered to children below the age of 5 years.

- Domperidone is not recommended for use in children unless indicated for the management of nausea and vomiting following cancer chemotherapy or radiation.

DOMETIC (Domperidone) is a dopamine antagonist with antiemetic property.

Domperidone does not across through the blood brain barrier. Domperidone has peripheral action and rare extrapyramidal side effects. The antiemetic effect of domperidone is due to its peripheral plus antagonism effect against dopamine in the chemoreceptor trigger zone (located outside the blood brain barrier).

Beside the antiemetic effect, domperidone also has an antagonist dopamine effect on motility and gastric emptying. Domperidone can increase lower oesophageal sphincter pressure. Domperidone also increase peristaltic activity of the antrum and duodenum, therefore increases gastric emptying of liquid and semi solid food.

Domperidone has no significant effect on gastric acid secretion, volume secretion, intragastric pH or serum gastric concentration.