Galantamine

Galantamine is a prescription medication indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

Galantamine is available under the following different brand names: Razadyne.

Tablets

• 4 mg
• 8 mg
• 12 mg

Tablets, extended release

• 8 mg
• 16 mg
• 24 mg

Oral solution

• 4 mg/ml

Dosage Considerations – Should be Given as Follows:

Alzheimer's Disease

Initial:

• Conventional: 4 mg orally every 12 hours
• Extended Release: 8 mg orally each morning

Maintenance

• Conventional: Titrate to 8-12 mg orally every 12 hours; increase by 4 mg every 12 hour at no less than 4 week intervals
• Extended Release: 16-24 mg orally each morning; increase by 8 mg/daily 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 (Creatinine clearance under 9 ml/min): not recommended

Pediatric

• Not recommended

Administration

• Take with food
• Conversion from galantamine tablets and oral solution to galantamine extended release should occur at the same daily dosage with the last dose of galantamine tablets/oral solution taken in evening and starting galantamine extended release once daily treatment next morning

Common side effects of galantamine include:

• abdominal discomfort or pain
• anemia
• blood in your urine or stool
• blurred vision
• chest pain
• clay-colored stools
• complete heart block or complete atrioventricular block
• confusion
• coughing up blood
• cuts (lacerations)
• dark urine
• decreased sweating
• depression
• diarrhea
• dizziness
• drowsiness
• extreme thirst
• fainting
• falls
• fatigue
• feeling unwell (malaise)
• headache
• hot dry skin
• indigestion
• insomnia
• itching
• lack of energy
• loss of appetite
• muscle cramp/spasms
• nausea
• runny nose
• sleep problems (insomnia)
• sleepiness
• slow heart rhythm
• tremor
• unusual or unpleasant taste in your mouth
• urinary tract infection
• urinating less than usual or not at all
• vomiting
• weakness
• weight loss
• yellowing of the skin or eyes (jaundice)

Postmarketing side-effects of galantamine include:

• hypersensitivity
• hallucinations
• convulsions (seizures)
• ringing in the ears (tinnitus)
• complete heart block or complete atrioventricular block
• high blood pressure (hypertension)
• hepatitis
• increased liver enzyme
• Stevens-Johnson syndrome
• rash caused by severe cutaneous adverse reaction (acute generalized exanthematous pustulosis [AGEP])
• red or purple rash (erythema multiforme)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Galantamine has no known severe interactions with other drugs.
• Serious interactions of galantamine include:
  • ambenonium
  • mefloquine
• Galantamine has moderate interactions with 99 different drugs.
• Galantamine has minor interactions with 155 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

This medication contains galantamine. Do not take Razadyne if you are allergic to galantamine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Galantamine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Galantamine?"

Cautions

• Moderate hepatic or renal impairment: maximum 8 mg every 12 hours (conventional) or 16 mg each day (extended release)
• Not recommended in severe liver or kidney impairment.
• Renamed Razadyne from Reminyl in the U.S. 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 and Lactation

• Galantamine may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk.
• It is unknown if galantamine is transferred to breast milk when breastfeeding. Consult your physician.