Razadyne Fact Sheet

Medication Name (brand):

Razadyne

Medication Name (clinical):

galantamine

Manufacturer:

Janssen; patent expires 2008.

Indications:

Mild to moderate Alzheimer’s dementia.
Used off-label for both mild cognitive impairment and severe dementia.

Mechanism:

Acetylcholinesterase inhibitor, stimulates nicotine receptors.

Dosing:

Supplied as:
Immediate-release (IR): 4 mg white, 8 mg pink, 12 mg orange-brown tablets.
Extended-release (ER): 8 mg white, 16 mg pink, 24 mg orange-brown capsules.
Oral solution available in 4 mg/mL strength.
IR: start at 4 mg BID, increase to 8 mg BID after four weeks. If needed, increase to 12 mg BID after another 4 weeks.
ER: start at 8 mg QD, increase to 16 mg QD after four weeks. If needed, increase to 24 mg QD after another 4 weeks.
You may need to decrease the dose in both hepatic and renal impairment.

Side Effects:

Most common: nausea, appetite loss, diarrhea.
FDA advisory noted a higher mortality rate in patients with mild cognitive impairment (MCI) taking Razadyne (1.5%) versus those randomly assigned to placebo (0.5%).
May aggravate stomach ulcers (potential class effect of all cholinesterase inhibitors).
Pregnancy risk category B.

Drug-drug Interactions:

Paxil and other 2D6 inhibitors may increase levels.
3A4 inducers such as Tegretol may decrease levels

Pharmokinetics:

Metabolized hepatically by P450 2D6 and 3A4.
Half-life 7 hours.

Pearls:

Most clinicians use the ER version exclusively because it can be dosed once a day.

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