Dosing & Uses
Dosage Forms & Strengths
tablets
- 4mg
- 8mg
- 12mg
tablets, extended-release
- 8mg
- 16mg
- 24mg
oral solution
- 4mg/mL
Alzheimer Disease
Initial
- Conventional: 4 mg PO q12hr
- ER: 8 mg PO qAM
Maintenance
- Conventional: Titrate to 8-12 mg PO q12hr; increase by 4 mg q12hr at no less than 4 week intervals
- ER: 16-24 mg PO qAM; increase by 8 mg/d at no less than 4 week intervals
Hepatic Impairment
Moderate: (Child-Pugh score 7-9): Not to exceed 16 mg/day
Severe: Not recommended
Renal Impairment
Moderate: Not to exceed 16 mg/day
Severe (CrCl <9 mL/min): Not recommended
Administration
Take with food
Conversion from galantamine tablets and oral solution to galantamine ER should occur at same daily dosage with the last dose of galantamine tablets/oral solution taken in evening and starting galantamine ER once daily treatment next morning
Not recommended
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Nausea (20-25%)
Diarrhea (11-15%)
Vomiting (11-15%)
1-10%
Abdominal pain
Anorexia
Muscle cramp
Fatigue
Dizziness
Headache
Weight loss
Depression
Insomnia
UTI
Somnolence
Anemia
Syncope
Bradycardia
Other Information
Complete atrioventricular block
Warnings
Contraindications
Hypersensitivity
Cautions
Moderate hepatic or renal impairment: max 8 mg q12hr (conventional) or 16 mg qDay (ER)
Not recommended in severe hepatic or renal impairment
Renamed Razadyne from Reminyl in the US to avoid confusion with Amaryl
Serious skin reactions may occur; discontinue at first appearance of skin rash
All patients should be considered at risk for adverse effects on cardiac conduction, including bradycardia and AV block, due to vagotonic effects on sinoatrial and atrioventricular nodes
Active or occult gastrointestinal bleeding: monitor, especially those with an increased risk for developing ulcers
Cholinomimetics may cause bladder outflow obstruction
Monitor for respiratory adverse events in patients with a history of severe asthma or obstructive pulmonary disease
Pregnancy & Lactation
Pregnancy
There are no adequate data on developmental risk associated with use in pregnant women
Animal data
- In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically
Lactation
There are no data on presence of ddrug in human milk, effects on breastfed infant, or on milk production
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Derived from daffodil bulbs
Increases acetylcholine from surviving presynaptic nerve terminals by modulating the nicotinic acetylcholine receptor. Glutamate and serotonin levels may increase
Pharmacokinetics
Half-Life: 7 hr
Peak Plasma Time: 1 hr
Bioavailability: 90%
Protein Bound: 18%
Vd: 175 L
Metabolism: CYP2D6 & CYP3A4
Excretion: Urine
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Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
