Generic name: galantamine hydrobromide 8mg
Dosage form: capsules, tablets and oral solution
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RAZADYNE® ER Extended-Release Capsules
RAZADYNE® ER extended-release capsules should be administered once daily in the morning, preferably with food.
The recommended starting dosage of RAZADYNE® ER is 8 mg/day. The dosage should be increased to the initial maintenance dose of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day should be attempted after a minimum of 4 weeks at 16 mg/day. Dosage increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
The dosage of RAZADYNE® ER shown to be effective in a controlled clinical trial is 16–24 mg/day.
Patients currently being treated with RAZADYNE® tablets or oral solution can convert to RAZADYNE® ER (extended-release capsules) by taking their last dose of RAZADYNE® tablets or oral solution in the evening and starting RAZADYNE® ER once daily treatment the next morning. Converting from RAZADYNE® to RAZADYNE® ER should occur at the same total daily dosage.
RAZADYNE® Immediate-Release Tablets and Oral Solution
The dosage of RAZADYNE® tablets shown to be effective in controlled clinical trials is 16–32 mg/day given as twice daily dosing. As the dosage of 32 mg/day is less well tolerated than lower dosages and does not provide increased effectiveness, the recommended dosage range is 16–24 mg/day given twice daily. The dosage of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dosage of 24 mg of RAZADYNE® might provide additional benefit for some patients.
The recommended starting dosage of RAZADYNE® tablets and oral solution is 4 mg twice a day (8 mg/day). The dosage should be increased to the initial maintenance dosage of 8 mg twice a day (16 mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice a day (24 mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice a day (16 mg/day).
Dosage increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
RAZADYNE® tablets and oral solution should be administered twice a day, preferably with morning and evening meals.
Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for more than three days, the patient should be restarted at the lowest dosage and the dosage escalated to the current dose.
The abrupt withdrawal of RAZADYNE® ER and RAZADYNE® in those patients who had been receiving dosages in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same dosages of that drug. The beneficial effects of RAZADYNE® ER and RAZADYNE® are lost, however, when the drug is discontinued.
Dosage in Patients with Hepatic Impairment
In patients with moderate hepatic impairment (Child-Pugh score of 7–9), the dosage should generally not exceed 16 mg/day. The use of RAZADYNE® ER and RAZADYNE® in patients with severe hepatic impairment (Child-Pugh score of 10–15) is not recommended [see Clinical Pharmacology (12.3)].
Dosage in Patients with Renal Impairment
In patients with creatinine clearance of 9 to 59 mL/min, the dosage should generally not exceed 16 mg/day. In patients with creatinine clearance less than 9 mL/min, the use of RAZADYNE® ER and RAZADYNE® is not recommended [see Clinical Pharmacology (12.3)].
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- Drug class: cholinesterase inhibitors
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