Benzgalantamine DR

Class
Anti-dementia agents
Subclass
Acetylcholinesterase inhibitors
Substance name
Benzgalantamine DR
Brand names
Zunveyl®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment of Alzheimer's disease • Mild-to-moderate
•
Start at: 5 mg PO BID for at least 4 weeks
•
Maintenance: 10 mg PO BID
•
Maximum: 30 mg per day
Taken with or without food. Titrate at 4-week intervals based on response and tolerability.
Indications for use
Labeled indications
Adults
•
Treatment of Alzheimer's disease (mild-to-moderate)
Safety risks
Contraindications
Hypersensitivity to benzgalantamine or its components or galantamine
Concomitant use of alcohol
Warnings and precautions
Bladder outflow obstruction
•
Maintain a high level of suspicion, as cholinomimetics can cause bladder outflow obstruction.
Bradycardia, AV block
•
Maintain a high level of suspicion, as benzgalantamine has vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block.
Bronchospasm
•
Use caution in patients with asthma or COPD.
Cholinergic crisis
•
Use caution in patients taking other cholinesterase inhibitors or cholinomimetics.
Exacerbation of skeletal muscle relaxation
•
Use caution in patients receiving succinylcholine-type and similar neuromuscular blocking agents during anesthesia.
Gastrointestinal adverse events
•
Maintain a high level of suspicion, as benzgalantamine, being a cholinomimetic, can increase gastric acid secretion and may cause nausea, vomiting, diarrhea, loss of appetite, and weight loss. Monitor closely for symptoms of active or occult gastrointestinal bleeding, particularly in patients with an increased risk for ulcers, such as with a history of peptic ulcer disease or concomitant use of NSAIDs. Monitor weight during treatment with benzgalantamine.
Seizure
•
Maintain a high level of suspicion, as cholinomimetics can trigger seizures. Recognize that seizures can also be a manifestation of Alzheimer's disease.
Severe cutaneous adverse reactions
•
Maintain a high level of suspicion, as benzgalantamine has been associated with an increased risk of serious skin reactions, including Stevens-Johnson syndrome and acute generalized exanthematous pustulosis.
Specific populations
Renal impairment
CrCl ≥ 60 mL/min
•
Use acceptable. No dose adjustment required.
CrCl 9-59 mL/min
•
Maximal dose of 10 mg BID.
CrCl < 9 mL/min
•
Do not use.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Maximal dose of 10 mg BID.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Insufficient evidence. Evidence of fetal harm in animals.
Breastfeeding
Little information available on breastfeeding safety.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Nausea, vomiting
Common 1-10%
•
Bradycardia, lethargy, abdominal discomfort, abdominal pain, asthenia, depression, diarrhea, dizziness, dyspepsia, falls, fatigue, headache, loss of appetite, malaise, muscle spasms, somnolence, syncope, weight loss, tremor
Uncommon < 1%
•
Dehydration, dysgeusia, hypersomnia, blurred vision, paresthesia, AV block, palpitations, skin flushing, hypotension, belching, sweating, muscle weakness
Unknown frequency
•
Hepatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hallucinations, seizure, extrapyramidal signs, tinnitus, ↑ liver enzymes, erythema multiforme
Interactions
Drug(s)
Check Interactions
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