GASTROMOTIL 5 MG / 5 ML SUSP 200 ML * Indications: – The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux and oesophagitis; – epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain; – bloating, eruction, flatulence; – nausea and vomiting; – heartburn with or without regurgitations of gastric contents in the mouth. – Nausea and vomiting of functional, organic, infectious or dietetic origin or induced by radiotherapy or drug therapy. A specific indication is nausea and vomiting induced by dopamine agonists, as used in parkinson’s disease (such as L-dopa and bromocriptine). – It is given with paracetamol in the symptomatic treatment of migraine. – As Prokinetic: Gastroesphageal reflux disease – Diabetic gastroparesis – Irritable bowel syndrome. – As Antiemetic: Short-term treatment of nausea and vomiting of various ateologies including those associated with cancer therapy. * Dosage and administration: – Adults: 2-4 teaspoonfuls (10-20 mg) every 4-8 hours. – Children: 0.2-0.4 mg/kg body-weight by mouth every 4-8 hours. – Gastromotil should be given 15-30 minutes before meals and, if necessary, before retiring. 1- Chronic dyspepsia (mainly oral administration): Adults: 10 mg ( 10 mL) 3 times daily, 15-30 minutes before meals and, if necessary, once more before retiring. Children: Oral suspension: 2.5 mL per Kg body weight, 3 times daily before meals and, if necessary, once more in the evening. When results are not satisfactory, the above dosage may be doubled in adults and in children over 1 years of age. 2- Acute and Subacute conditions (particularly nausea and vomiting): Adults: Oral: 20 mg (20 mL) 3-4 times daily before meals and before bedtime. Children: Oral: 5 mL per 10 Kg body weight, 3-4 times daily before meals and before bedtime. 3- Migraine: A dose of 20 mg by mouth may be taken up to every 4 hours, with paracetamol, as required up to a maximum of 4 doses in 24 hours. * Precautions: – Gastromotil is not recommended for chronic nausea and vomiting or for the routine prophylaxis of postoperative nausea and vomiting. – Gastromotil should be used cautiously in patients with hepatic or renal impairment or to elderly. – Hypertensive crisis may occur in patients with pheochromocytoma. – In the treatment of nausea and vomiting in parkinsonian patients, therapy may be continued for a maximum of 12 weeks. – Use in infants: Because the metabolic and blood-brain barrier functions are not fully developed during the first months of life, any drug should only be given to infants with great caution and under close medical supervision. Since the typical absence of neurological side effects with Gastromotil is due to its poor penetration through the blood-brain barrier, the possible occurrence of such effects cannot be totally excluded in infants under 1 year of age. * Pregnancy and lactation: Gastromotil should only be used during the first trimester of pregnancy if this is justified by the anticipated therapeutic benefit. Up till now, there has been no evidence of any increase in the risk of malformations in humans. Domperidone concentrations in breast milk are 4 times lower than corresponding plasma concentrations. It is not known whether this is harmful to the newborn. Therefore, nursing is not recommended for mothers are taking Gastromotil, unless the expected benefits outweigh any potential risk. * Contraindications: – Hypersensitivity to the product. – When stimulation of gastric motility might be dangerous as in gastrointestinal haemorrhage, mechanical obstruction, perforation or immediately after surgery. – Patients with prolactin-releasing pituitary tumor (prolactinoma). – Pregnancy and lactation.