Reminyl

Reminyl Dosage/Direction for Use

galantamine

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Dosage-Adults: Ensure adequate fluid intake during treatment.
Starting dose: The recommended starting dose of REMINYL prolonged release capsules is 8 mg/day for 4 weeks.
Conversion from immediate-release formulations to prolonged release capsules: Patients currently being treated with REMINYL immediate-release formulations (tablets or oral solution) can convert to REMINYL prolonged-release capsules by taking their last dose of REMINYL immediate-release tablets or oral solution in the evening and starting REMINYL prolonged-release capsules once daily treatment the next morning. When converting from REMINYL twice daily immediate-release formulations to REMINYL once daily prolonged-release capsules, the same total daily dose should be administered.
Maintenance dose: The initial maintenance dose is 16 mg/day (16mg once a day with capsules) and patients should be maintained on 16 mg/day for at least 4 weeks.
An increase to the maximum recommended maintenance dose of 24 mg/day (24mg once a day with capsules) should be considered after appropriate assessment including evaluation of clinical benefit and tolerability.
Treatment withdrawal: There is no rebound effect after abrupt discontinuation of treatment (e.g., in preparation for surgery).
Special Populations: Pediatrics: Use of REMINYL in children is not recommended. No data on the use of REMINYL in pediatric patients are available.
Renal impairment: Galantamine plasma concentrations may be increased in patients with moderate (creatinine clearance = 52-104 ml/min) to severe (creatinine clearance = 9-51 ml/min) renal impairment.
For patients with a creatinine clearance ≥ 9 ml/min no dosage adjustment is required (see Pharmacology: Pharmacokinetics: Special populations under Actions).
The use of REMINYL is not recommended in patients with creatinine clearance less than 9 ml/min because no data are available.
Hepatic impairment: Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment.
In patients with moderately impaired hepatic function (Child-Pugh score 7-9), based on pharmacokinetic modeling, dosing should begin with 8 mg every other day for at least one week, preferably taken in the morning. Thereafter, patients should proceed with 8 mg once daily for prolonged-release capsules for at least four weeks. In these patients, total daily doses should not exceed 16 mg.
In patients with severe hepatic impairment (Child-Pugh score > 9), the use of REMINYL is not recommended.
Concomitant treatment: In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered (see Other drugs affecting the metabolism of galantamine under Interactions).
Administration: REMINYL is administered orally.
REMINYL prolonged-release capsules should be administered once daily in the morning, preferably with food.
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