Dompel Special Precautions

General Precautions: As domperidone is mainly metabolized in the liver, it should be administered cautiously in patients with liver injury.
In patients with severe renal impairment (serum creatinine 6 mg/100 mL). The elimination t_½ is prolonged from 7.4 hrs to 20.8 hrs, but the plasma concentration of domperidone is lower than that in healthy volunteers. As very small proportion of domperidone is excreted in the urine as unchanged drug, it is unnecessary to control the dosage in the first administration. But in repeated administration, frequency of dosing and dosage should be decreased according to the severity of renal impairment. The condition of patients receiving decreased long-term therapy should be monitored regularly.
Use in pregnancy & lactation: Although studies in animals, with the dosage of 160 mg/kg/day and general clinical use of domperidone in human have not demonstrated teratogenic effects, Dompel should be used in pregnant women and suspected pregnant women only if the potential benefit justifies the potential risk.
It is reported that domperidone is secreted in milk mainly as metabolites in animal studies (rat): Following oral and IV administration of 2.5-mg/kg dose, maximum concentrations in the breast milk were 40 mcg/mL and 800 mcg/mL, respectively. A small proportion of Dompel can be excreted in human milk, but harm to neonates has not been reported. Therefore, Dompel should be used in nursing mothers only if the potential benefit justifies the potential risk.
Use in children: Care should be exercised when Dompel is used in children especially in infants <1 year. Repeated use over 7 days is not recommended in children <3 years.
As Dompel does not readily cross the blood-brain barrier, it does not produce the adverse central effects. However, adverse central effects may occur in infants <1 year with premature blood-brain barrier.