Domperidone safety alert

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Domperidone safety alert

Posted Apr 26, 2016 by Admin

Concomitant use of the following substances is not recommended. Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides. (see section 4.3) Concomitant use of the following substances requires caution in use. 4.5 Interaction with other medicinal products and other forms of interaction. The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of creased risk of.

Renal Impairment. The elimination half-life of domperidone is prolonged in severe renal impairment. For repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment.

4.4 Special warnings and precautions for use. Precautions for use Domperidone tablets contain lactose and may be unsuitable for patients with lactose intolerance, galactosaemia or glucose/galactose malabsorption. Use in infants Neurological side effects are rare (see "Undesirable effects" section).

Since metabolic functions and the blood-brain barrier are not fully developed in the first months of life the risk of neurological side effects is higher in young children. Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration.

Fda domperidone warning

If taken after meals, absorption of the drug is somewhat tients should try to take each dose at scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed.

4.8 Undesira.

Co-administration with potent CY3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5) Known hypersensitivity to domperidone or any of the excipients. Prolactin-releasing pituitary tumour (prolactinoma.) Renal impairmentDomperidone should not be used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction.

The dose should not be doubled to make up for a missed ually, the maximum treatment duration should not exceed one week. Adults and adolescents (12 years of age and older and weighing 35 kg or more) One 10mg tablet up to three times per.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia or bradycardia, or in patient with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia.