Galantamine Hydrobromide

Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. ( 1 )

Galantamine is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Known hypersensitivity to galantamine hydrobromide or any excipients. ( 4 )

• Serious Skin Reactions: discontinue at first appearance of skin rash. ( 5.1 )
• 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. ( 5.3 )
• Active or Occult Gastrointestinal Bleeding: monitor, especially those with an increased risk for developing ulcers. ( 5.4 )
• Cholinomimetics may cause bladder outflow obstruction. ( 5.5 )
• Monitor for respiratory adverse events in patients with a history of severe asthma or obstructive pulmonary disease. ( 5.7 )

5.1Serious Skin Reactions

Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine. Inform patients and caregivers that the use of galantamine should be discontinued at the first appearance of a skin rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed and alternative therapy should be considered.

5.2 Anesthesia Galantamine, as a cholinesterase inhibitor, is likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.

5.3Cardiovascular Conditions Because

of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities [see Adverse Reactions (6.1 , 6.2) ] . Therefore, all patients should be considered at risk for adverse effects on cardiac conduction.