Reminyl Indications, Dosage, Storage, Stability - Galantamine Hydrobromide

Reminyl Indications, Dosage, Storage, Stability - Galantamine Hydrobromide

INDICATIONS

REMINYL^® (galantamine hydrobromide) is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.

DOSAGE AND ADMINISTRATION

The dosage of REMINYL^® (galantamine hydrobromide) shown to be effective in controlled clinical trials is 16-32 mg/day given as twice daily dosing.As the dose of 32 mg/day is less well tolerated than lower doses and does not provide increased effectiveness, the recommended dose range is 16-24 mg/day given in a BID regimen. The dose of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dose of 24 mg of REMINYL^® might provide additional benefit for some patients.

The recommended starting dose of REMINYL^® is 4 mg twice a day (8 mg/day). After a minimum of 4 weeks of treatment, if this dose is well tolerated, the dose should be increased to 8 mg twice a day (16 mg/day).A further increase to 12 mg twice a day (24 mg/day) should be attempted only after a minimum of 4 weeks at the previous dose.

REMINYL^® should be administered twice a day, preferably with morning and evening meals.

Patients and caregivers should be informed that if therapy has been interrupted for several days or longer, the patient should be restarted at the lowest dose and the dose escalated to the current dose.

Caregivers should be instructed in the correct procedure for administering REMINYL^® Oral Solution. In addition, they should be informed of the existence of an Instruction Sheet (included with the product) describing how the solution is to be administered. They should be urged to read this sheet prior to administering REMINYL^® Oral Solution. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist. The abrupt withdrawal of REMINYL^® in those patients who had been receiving doses in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same doses of that drug. The beneficial effects of REMINYL^® are lost, however, when the drug is discontinued.

Doses in Special Populations

Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment. In patients with moderately impaired hepatic function (Child-Pugh score of 7-9), the dose should generally not exceed 16 mg/day. The use of REMINYL^® in patients with severe hepatic impairment (Child-Pugh score of 10-15) is not recommended.

For patients with moderate renal impairment the dose should generally not exceed 16 mg/day. In patients with severe renal impairment (creatinine clearance < 9 mL/min), the use of REMINYL^® is not recommended.

HOW SUPPLIED

REMINYL^® (galantamine hydrobromide) tablets are imprinted "JANSSEN" on one side, and "G" and the strength "4", "8", or "12" on the other.

4 mg off-white tablet: bottles of 60 NDC 50458-390-60 8 mg pink tablet:bottles of 60 NDC 50458-391-60 12 mg orange-brown tablet:bottles of 60 NDC 50458-392-60

REMINYL^® (galantamine hydrobromide) 4 mg/mL oral solution (NDC 50458-399-10) is a clear colorless solution supplied in 100 mL bottles with a calibrated (in milligrams and milliliters) pipette. The minimum calibrated volume is 0.5 mL, while the maximum calibrated volume is 4 mL.

Storage and Handling

REMINYL^® tablets should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

REMINYL^® Oral Solution should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].DO NOT FREEZE.

Keep out of reach of children.

7517304
October 2001
US Patent No. 4,663,318
© Janssen 2001
REMINYL® tablets are manufactured by:
Janssen-Cilag SpA
Latina, Italy
REMINYL® oral solution is manufactured by:
Janssen Pharmaceutica N.V.
Beerse, Belgium
REMINYL® tablets and oral solution are distributed by:
Janssen Pharmaceutica Products, L.P.
Titusville, NJ 08560