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Razadyne ER

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Razadyne ER

INDICATIONS

RAZADYNE® ER and RAZADYNE® (galantamine hydrobromide) 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 (galantamine hydrobromide) 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.

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 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.

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 of 7-9), the total daily 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.

Renal Impairment

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

HOW SUPPLIED

Dosage Forms And Strengths

RAZADYNE® ER (galantamine hydrobromide) 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 off-white tablet imprinted with “JANSSEN” on one side and “G 4” on the other side

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

12 mg 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 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® (galantamine hydrobromide) Tablets are supplied as follows:

4 mg tablets – bottles of 60 NDC 50458-396-60
8 mg tablets – bottles of 60 NDC 50458-397-60
12 mg tablets – bottles of 60 NDC 50458-398-60

RAZADYNE® (galantamine hydrobromide) Oral Solution is supplied as follows:

4 mg/mL 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.

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: Janssen Ortho LLC, Gurabo, Puerto Rico 00778. RAZADYNE® Oral Solution is manufactured by: Janssen Pharmaceutica N.V. Beerse, Belgium. RAZADYNE® ER Extended-Release Capsules, RAZADYNE® Tablets, and RAZADYNE® Oral Solution are manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Revised June 2013

Last reviewed on RxList: 8/6/2013
This monograph has been modified to include the generic and brand name in many instances.

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