Each tablet contains Domperidone maleate as :

Domperidone ……..10 mg

Description :

Motildon (domperidone) is a derivative of benzimidazole that possesses both prokinetic and antiemetic properties.

 Pharmacological Properties:

* Motildon (domperidone) is a dopamine antagonist. Because it does not penetrate well into the CNS, its effects are confined to the periphery, It crosses the blood-brain barrier to such a limited extent that it rarely causes extrapyramidal side effects.

* Motildon (domperidone) antagonizes dopamine receptors in the posterior pituitary; like other D2 antagonists, it produces hyperprolactinemia. The effects of Motildon (domperidone) on gastrointestinal motility resemble those of metoclopramide but are not reduced by * muscarinic cholinergic antagonists.

The beneficial effects of (domperidone) inhibition of receptive relaxation, enhancement of coordinated antraduodenal motility, and acceleration of transit in the small intestine currently are ascribed to D2 receptor antagonism. The drug has negligible effects on colonic motility.

* Motildon (domperidone) appears to be rapidly absorbed after oral administration, but its bioavailability is only about 15%; most of the drug and its metabolites are excreted in the feces. The half-time for its elimination from plasma is about 7 to 8 hours.

Indications :

- Nausea and vomiting, dyspepsia, gastro-oesophageal reflux

- When nausea and gastric retention are chronic and debilitating, Motildon  may be a useful agent for the long term. Since the drug produces few if any effects in the CNS, it does not interfere with the treatment of Parkinson's disease and may be useful in counteracting the gastrointestinal effects of levodopa and bromocriptine. As an antiemetic, Motildon is effective against mild-to-moderate emetogenic chemotherapy.

Dosage & administration :

Adults : by mouth, 10–20 mg 3–4 times daily; 30 minutes before meals and before going to bed.

Children : 5-12 years old 10 mg 3–4 times daily; 30 minutes before meals and before going to bed.

Children under 5 years : Motildon  not used under this age.

 Contraindications :

Motildon (domperidone) is contraindicated in the following situations :

* Known hypersensitivity for Domperidone or any excipients.

* Prolactin - releasing pituitary tumor (prolactinoma).

* Co-administration with potent CYP3A4 which prolong QTc interval such as fluconazole ketoconazole erythromycin...etc.

Cautions :

When antacids or antisecretory agents are used, they should not be taken simultaneously with Motildon.

* Renal impairment : It is advisable to reduce dose.

* Hepatic impairment : It is advisable to be used with caution.

* Breast feeding : The amount excreted in human breast milk is probably too small, but it is not known whether this is harmful to the newborn therefore breast- feeding is not recommended for mothers who are taking Motildon.

* Pregnancy : It is advisable to avoid during pregnancy.

 Drug interaction :

- Amantadine increased risk of extrapyramidal side-effects when Motildon   given with amantadine.

- Antimuscarinics effects of Motildon on gastro-intestinal activity antagonised by antimuscarinics  Many drugs have antimuscarinic effects; concomitant use of two or more such drugs can increase side-effects such as dry mouth, urine retention, and constipation; concomitant use can also lead to confusion in the elderly.

- Bromocriptine Motildon possibly antagonises hypoprolactinaemic effects of bromocriptine.

- Cabergoline Motildon antagonises hypoprolactinaemic effects of cabergoline.

- Ketoconazole risk of arrhythmias with Motildon possibly increased by ketoconazole.

- Opioid Analgesics effects of Motildon on gastro-intestinal activity antagonised by opioid analgesics.

 Side Effects :

* Rarely gastro-intestinal disturbances (including cramps) and hyperprolactinaemia; very rarely extrapyramidal effects and rashes.

* Motildon causes headaches and the problems resulting from an elevation of serum prolactin (breast enlargement and tenderness, galactorrhea, amenorrhea).

Instructions to the patients:

- Motildon relieves nausea and vomiting, dyspepsia, gastro-oesophageal reflux.

- Tell your doctor or pharmacist: about all other medicines you are taking, including non-prescription medicines; if you are a frequent user of drinks with caffeine or alcohol; if you smoke; or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medicines.

 Pregnancy & lactation :

Generally it is not recommended  in pregnancy & lactation.

Motildon  pack of 1 blister X 20 tablets .

Hospital packs of different sizes.