General

Pronunciation
ga-LANT-a-meen

Trade Name(s)

• Razadyne

• Razadyne ER

Pregnancy Category
Category B

Ther. class.
anti-Alzheimers's agents

Pharm. class.
cholinergics
cholinesterase inhibitors

Indications

Mild to moderate dementia of the Alzheimer's type

Action

Enhances cholinergic function by reversible inhibition of cholinesterase

Therapeutic Effect(s):

• Decreased dementia (temporary) associated with Alzheimer's disease

• Cognitive enhancer

Pharmacokinetics

Absorption: Well absorbed (90%) following oral administration

Distribution: Unknown

Metabolism and Excretion: Mostly metabolized by the liver; 20% excreted unchanged in urine

Half-life: 7 hr

TIME/ACTION PROFILE (antihcholinesterase activity)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1 hr	12 hr
PO-ER	unknown	1 hr	24 hr

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity

• Severe hepatic or renal impairment

• Children or lactation

Use Cautiously in:

• Patients with supraventricular cardiac conduction defects or concurrent use of drugs that may slow heart rate (increased risk of bradycardia)

• History of ulcer disease/GI bleeding/concurrent NSAID use

• Severe asthma or obstructive pulmonary disease

• Mild to moderate renal impairment (avoid use if CCr <9 ml/min)

• Mild to moderate hepatic impairment (cautious dose titration recommended)

• May increase risk of cardiovascular mortality

• OB: Use only if potential benefit outweighs potential risk to fetus

Adverse Reactions/Side Effects

CNS: fatigue, dizziness, headache, syncope.

CV: bradycardia, chest pain.

GI: anorexia, diarrhea, dyspepsia, flatulence, nausea, vomiting.

GU: bladder outflow obstruction, incontinence.

Neuro: tremor.

Misc: weight loss.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• Will neuromuscular blockade from succinylcholine-type neuromuscular blocking agents

• May effects of other cholinesterase inhibitors or other cholinergic agonists, including bethanechol

• May effectiveness of anticholinergic medications

• Blood levels and effects may be by ketoconazole, paroxetine, amitriptyline, fluvoxamine, or quinidine

Route/Dosage

• PO (Adults):
Immediate-release tablets4 mg twice daily initially, dose increments of 4 mg should be made at 4 wk intervals, up to 12 mg twice daily. Doses up to 16 mg twice daily have been used (range 16–32 mg/day;
Extended-release capsules— 8mg/day as a single dose in the morning, may be increased to 16 mg/day after 4 wk, then up to 24 mg/day after 4 wk, increments based on benefit/tolerability.

Renal Impairment

• PO (Adults):
Moderate renal impairment—Daily dose should not exceed 16 mg.

Hepatic Impairment

• PO (Adults):
Moderate hepatic impairment—Daily dose should not exceed 16 mg.

Availability

• Immediate-release tablets: 4 mg, 8 mg, 12 mg

• Extended-release capsules: 8 mg, 16 mg, 24 mg

• Oral solution: 4 mg/ml in 100 ml bottles

Assessment

• Assess cognitive function (memory, attention, reasoning, language, ability to perform simple tasks) periodically during therapy

• Monitor heart rate periodically during therapy. May cause bradycardia

Potential Nursing Diagnoses

• Disturbed thought process (Indications)

• Risk for injury (Indications)

• Impaired environmental interpretation syndrome (Indications)

Implementation

• Patient should be maintained on a stable dose for a minimum of 4 weeks prior to increasing dose

» If dose has been interrupted for several days or longer, restart at the lowest dose and escalate to the current dose

• PO: Administer twice daily, preferably with morning and evening meal. Administration with food, the use of antiemetic medications, and ensuring adequate fluid intake may decrease nausea and vomiting

» Administer extended-release capsules in the morning, preferably with food. Razadyne XR can be opened and sprinkled on applesauce or yogurt; should be consumed within 10 min

• Use pipette provided with oral solution to administer accurate amount

Patient/Family Teaching

• Emphasize the importance of taking galantamine daily, as directed. Instruct patient and/or caregiver in correct use of pipette if using oral solution. Skip missed doses and return to regular schedule the following day; do not double doses. Do not discontinue abruptly; although no increase in frequency of adverse events may occur, beneficial affects of galantamine are lost when the drug is discontinued

• Caution patient and caregiver that galantamine may cause dizziness

• Advise patient and caregiver to notify health care professional if nausea or vomiting persists beyond 7 days or if new symptoms occur or previously noted symptoms increase in severity

• Advise patient and caregiver to notify health care professional of medication regimen prior to treatment or surgery

• Emphasize the importance of follow-up exams to monitor progress

• Teach patient and caregivers that improvements in cognitive functioning may take weeks to months to stabilize

• Caution that disease is not cured and degenerative process is not reversed

Evaluation/Desired Outcomes

Improvement in cognitive function (memory, attention, reasoning, language, ability to perform simple tasks) in patients with Alzheimer's disease

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