July 6, 2015
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Razadyne ER

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Razadyne ER




Indications
Dosage
How Supplied

INDICATIONS

RAZADYNE® ER and RAZADYNE® are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

DOSAGE AND ADMINISTRATION

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].

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].

HOW SUPPLIED

Dosage Forms And Strengths

RAZADYNE® ER extended-release capsules contain white to off-white pellets and are available in the following strengths:

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

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

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

RAZADYNE® tablets are available in the following strengths:

4 mg circular biconvex, off-white tablet imprinted with “JANSSEN” on one side and “G 4” on the other side

8 mg circular biconvex, pink tablet imprinted with “JANSSEN” on one side and “G 8” on the other side

12 mg circular biconvex, orange-brown tablet imprinted with “JANSSEN” on one side and “G 12” on the other side

RAZADYNE® 4 mg/mL oral solution 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.

RAZADYNE® ER (galantamine hydrobromide) extended-release capsules are supplied as follows:

8 mg white opaque, size 4 hard gelatin capsules with the inscription “GAL 8” – bottles of 30 NDC 50458-387-30

16 mg pink opaque, size 2 hard gelatin capsules with the inscription “GAL 16” – bottles of 30 NDC 50458-388-30

24 mg caramel opaque, size 1 hard gelatin capsules with the inscription “GAL 24” – bottles of 30 NDC 50458-389-30

RAZADYNE® (galantamine hydrobromide) tablets are supplied as follows:

4 mg circular biconvex, off-white tablets imprinted with “JANSSEN” on one side and “G 4” on the other side – bottles of 60 NDC 50458-396-60

8 mg circular biconvex, pink tablets imprinted with “JANSSEN” on one side and “G 8” on the other side – bottles of 60 NDC 50458-397-60

12 mg circular biconvex, orange-brown tablets imprinted with “JANSSEN” on one side and “G 12” on the other side – bottles of 60 NDC 50458-398-60

RAZADYNE® (galantamine hydrobromide) oral solution is supplied as follows:

4 mg/mL clear colorless oral solution – 100 mL bottle NDC 50458-490-10

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.

Manufactured by: Janssen Pharmaceutica NV Olen, Belgium. Extended-release capsules and tablets are manufactured by: Janssen Ortho LLC Gurabo, Puerto Rico 00778. Oral solution is manufactured by: Janssen Pharmaceutica NV Beerse, Belgium. Extended-release capsules, tablets, and Oral solution are manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560. Revised: Feb 2015

Last reviewed on RxList: 2/20/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Razadyne ER - User Reviews

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