Razadyne (Galantamine Hydrobromide) - Indications and Dosage

INDICATIONS AND USAGE

RAZADYNE^® ER/RAZADYNE^® (galantamine hydrobromide) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

DOSAGE AND ADMINISTRATION

RAZADYNE^® ER Extended-Release Capsules

The dosage of RAZADYNE^® ER (galantamine hydrobromide) Extended-Release Capsules was shown to be effective in a controlled clinical trial is 16-24mg/day.

The recommended starting dose of RAZADYNE^® ER is 8 mg/day. The dose 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. Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.

RAZADYNE^® ER should be administered once daily in the morning, preferably with food.

Patients currently being treated with RAZADYNE^® tablets can convert to RAZADYNE^® ER by taking their last dose of RAZADYNE^® tablets 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 dose.

RAZADYNE^® Immediate-Release Tablets

The dosage of RAZADYNE^® Tablets was 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 RAZADYNE^® might provide additional benefit for some patients.

The recommended starting dose of RAZADYNE^® Tablets and Oral Solution is 4 mg twice a day (8 mg/day). The dose should be increased to the initial maintenance dose 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). Dose 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 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 RAZADYNE^® 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 RAZADYNE^® Oral Solution. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist.

The abrupt withdrawal of RAZADYNE^® ER/RAZADYNE^® 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 RAZADYNE^® ER/RAZADYNE^® 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 total daily dose should generally not exceed 16 mg/day. The use of RAZADYNE^® ER/RAZADYNE^® 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 RAZADYNE^® ER/RAZADYNE^® is not recommended.

HOW SUPPLIED

RAZADYNE^® ER (galantamine hydrobromide) Extended-Release Capsules contain white to off-white pellets.

8 mg white opaque, size 4 hard gelatin capsules with the inscription“GAL 8.”

16 mg pink opaque, size 2 hard gelatin capsules with the inscription “GAL 16.”

24 mg caramel opaque, size 1 hard gelatin capsules with the inscription “GAL 24.”

The capsules are supplied as follows:

8 mg capsules – bottles of 30 NDC 50458-387-30

16 mg capsules– bottles of 30 NDC 50458-388-30

24 mg capsules – bottles of 30 NDC 50458-389-30

RAZADYNE^® 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 50458-396-60

8 mg pink tablet: bottles of 60 NDC 50458-397-60

12 mg orange-brown tablet: bottles of 60 NDC 50458-398-60

RAZADYNE^® 4 mg/mL oral solution (NDC 50458-490-10) 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

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

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

RAZADYNE^® 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.

RAZADYNE® ER Extended-Release Capsules contents are manufactured by:

Janssen Pharmaceutica N.V. Olen, Belgium.

RAZADYNE^® ER Extended-Release Capsules and RAZADYNE^® Tablets are manufactured by:
JOLLC, Gurabo, Puerto Rico 00778

RAZADYNE^® Oral Solution is manufactured by:
Janssen Pharmaceutica N.V.
Beerse, Belgium

RAZADYNE^® ER Extended-Release Capsules and RAZADYNE^® Tablets and Oral Solution are manufactured for:

Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560

7517316

April 2008

US Patent No. 4,663,318
© Ortho-McNeil-Janssen Pharmaceuticals, Inc.