Enablex Dosage/Direction for Use

For oral use.
Adults (≥18 years): The recommended starting dose is 7.5 mg daily. After 2 weeks of starting therapy, patients should be reassessed. For those patients requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response.
ENABLEX should be taken once daily with liquid. The tablets can be taken with or without food, and be swallowed whole and not chewed, divided or crushed.
Elderly patients (≥65 years): The recommended starting dose for the elderly is 7.5 mg daily. After 2 weeks of starting therapy, patients should be reassessed for efficacy and safety. For those patients who have an acceptable tolerability profile but requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response (see Pharmacology: Pharmacokinetics under Actions).
Children: No studies have been performed in children. Therefore, until more information is available, ENABLEX is not recommended for use in children.
Use in renal impairment: No dose adjustment is required in patients with impaired renal function. However, caution should be exercised when treating this population (see Pharmacology: Pharmacokinetics under Actions).
Use in hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A). However, there is a risk of increased exposure in this population (see Pharmacology: Pharmacokinetics under Actions).
In patients with moderate hepatic impairment (Child Pugh B), patients should only be treated if the benefit outweighs the risk, and patients should be restricted to 7.5 mg daily (see Pharmacology: Pharmacokinetics under Actions).
Patients receiving concomitant treatment with drugs that are potent inhibitors of CYP2D6 or moderate inhibitors of CYP3A4: In patients receiving drugs that are potent CYP2D6 inhibitors such as paroxetine, terbinafine, quinidine and cimetidine, treatment should start with the 7.5 mg dose. The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated. However, caution should be exercised.
In patients receiving drugs that are moderate CYP3A4 inhibitors such as fluconazole, grapefruit juice and erythromycin, the recommended starting dose is 7.5 mg daily. The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated. However, caution should be exercised.