Reminyl (Galantamine Hydrobromide) - Indications and Dosage

INDICATIONS AND USAGE

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). The dose should be increased to the initial maintenance dose of 8 mg twice a day (16 mg/day) after 4 weeks. If this initial maintenance dose is well tolerated, a further increase to 12 mg twice a day (24 mg/day) should be attempted only 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.

REMINYL® 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 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.

7519003

247170

March 2003

US Patent No. 4,663,318

© Janssen 2001

REMINYL® tablets are

manufactured by:

JOLLC, Gurabo, Puerto Rico or

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

USING YOUR REMINYL®
DISPENSING-PIPETTE
AND BOTTLE

Follow the directions below to use your REMINYL® Dispensing-Pipette and bottle, unless your doctor gave you different directions.

IMPORTANT: Read these instructions before using REMINYL® oral solution.

To open the bottle and use the pipette (plastic tube)

The bottle comes with a child-proof cap. Here is how to open it:

1. Push the plastic cap on the bottle down while turning the cap counter-clockwise (to the left) (Figure 1). Remove the unscrewed cap.
   
2. Pull the pipette out of its case. The pipette is a tube that you use to measure your dose of REMINYL®. Place the pipette fully into the bottle of REMINYL®. (Figures 2a-2b)
   
   
3. While holding the bottom ring of the pipette, pull the pipette plunger up to the level that equals the dose prescribed by your doctor. Use the markings on the pipette to guide you. This will draw the medicine into the pipette. (Figures 3a-3b)
   
   
4. Be careful not to push the plunger in during this step. Hold the bottom ring of the pipette. Remove the entire pipette from the bottle. (Figures 4a-4b)
   
   
5. Empty all the medicine in the pipette into 3-4 ounces (100 mL) of any non-alcoholic drink. To do this, push the plunger all the way in. (Figures 5a-5b)
   
   
6. Stir the drink well (Figure 6). Drink all of the mixture right away.
   
7. Replace the plastic cap on the bottle by turning it clockwise (to the right). (Figure 7)
   
8. Rinse the empty pipette by inserting the open end of the pipette into a glass of water, pulling the plunger out, and pushing the plunger in to remove the water. (Figures 8a-8b)
   
   

For more information about REMINYL®, see the leaflet that came with the package.

STORAGE:   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

NDC 50458-399-10 100 mL

REMINYL®

(galantamine hydrobromide)

Oral Solution

4 mg/mL

Each 1 mL contains:    4 mg of galantamine hydrobromide in an aqueous solution.

7519003

March 2003

US Patent No. 4,663,318

© Janssen 2001

Manufactured by:

Janssen Pharmaceutica N.V.

Beerse, Belgium

Distributed by:

Janssen Pharmaceutica Products, L.P.

Titusville, NJ 08560