d once daily in the morning, preferably with food.
Patients currently being treated with galantamine hydrobromide tablets can convert to galantamine hydrobromide extended-release capsules by taking their last dose of galantamine hydrobromide tablets in the evening and starting galantamine hydrobromide extended-release capsules once daily treatment the next morning. Converting from galantamine hydrobromide tablets to galantamine hydrobromide extended-release capsules should occur at the same total daily dose.
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.
The abrupt withdrawal of galantamine hydrobromide extended-release capsules 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 galantamine hydrobromide extended-release capsules 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 to 9), the total daily dose should generally not exceed 16 mg/day. The use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment (Child-Pugh score of 10 to 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 galantamine hydrobromide extended-release capsules is not recommended.
HOW SUPPLIED
Galantamine hydrobromide extended-release capsules are available as follows:
8 mg (Size ‘2’ white opaque/white opaque capsules imprinted ‘835’ with black ink on cap and body filled with white color capsule shaped uncoated tablet plain on both sides)
Bottles of 30’s with CRC…...NDC 47335-835-83
Bottles of 100’s with CRC…...NDC 47335-835-88
Bottles of 100’s with NCRC…...NDC 47335-835-08
Bottles of 1000’s with NCRC …...NDC 47335-835-18
16 mg (Size ‘2’ pink opaque/pink opaque capsules imprinted ‘836’ with black ink on cap and body filled with pink color capsule shaped uncoated tablet plain on both sides)
Bottles of 30’s with CRC…...NDC 47335-836-83
Bottles of 100’s with CRC…...NDC 47335-836-88
Bottles of 100’s with NCRC…...NDC 47335-836-08
Bottles of 1000’s with NCRC …...NDC 47335-836-18
24 mg (Size ‘2’ caramel opaque/caramel opaque capsules imprinted ‘837’ with black ink on cap and body filled with caramel color capsule shaped uncoated tablet plain on both sides)
Bottles of 30’s with CRC…...NDC 47335-837-83
Bottles of 100’s with CRC…...NDC 47335-837-88
Bottles of 100’s with NCRC…...NDC 47335-837-08
Bottles of 1000’s with NCRC …...NDC 47335-837-18
rage and Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° a |
