* 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. |