Version July 2025
Alzheimer disease, mild to moderate: Oral: Initial: 5 mg twice daily; may increase dose based on response and tolerability in 10 mg/day increments (divided twice daily) at intervals ≥4 weeks, up to a maximum dose of 30 mg/day (divided twice daily).
Reinitiation of therapy: If dosing is interrupted for >3 days, reinitiate at 5 mg twice daily and increase dose to current dose based on response and tolerability.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl >59 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling.
CrCl 9 to 59 mL/minute: Do not exceed 10 mg twice daily (20 mg/day).
CrCl <9 mL/minute: Use is not recommended.
Mild impairment (Child-Turcotte-Pugh class A): No dosage adjustment necessary.
Moderate impairment (Child-Turcotte-Pugh class B): Do not exceed 10 mg twice daily (20 mg/day).
Severe impairment (Child-Turcotte-Pugh class C): Use is not recommended.
Refer to adult dosing.
The following adverse drug reactions are derived from product labeling unless otherwise specified. Reactions listed are based on reports for galantamine and may not be specifically reported for benzgalantamine.
Frequency not defined:
Cardiovascular: Bradycardia, complete atrioventricular block, first-degree atrioventricular block, flushing, hypertension, hypotension, palpitations, sinus bradycardia, supraventricular extrasystole, syncope
Dermatologic: Acute generalized exanthematous pustulosis, erythema multiforme, hyperhidrosis, Stevens-Johnson syndrome
Endocrine & metabolic: Dehydration, weight loss
Gastrointestinal: Abdominal distress, abdominal pain, anorexia, decreased appetite, diarrhea, dysgeusia, dyspepsia, nausea, retching, vomiting
Hepatic: Hepatitis, increased liver enzymes
Hypersensitivity: Hypersensitivity reaction
Nervous system: Depression, dizziness, drowsiness, extrapyramidal reaction, falling, fatigue, hallucination, headache, hypersomnia, lethargy, malaise, myasthenia, paresthesia, seizure, tremor
Neuromuscular & skeletal: Muscle spasm
Ophthalmic: Blurred vision
Otic: Tinnitus
Miscellaneous: Laceration
Hypersensitivity (eg, serious skin reaction) to benzgalantamine, galantamine, or any component of the formulation.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
• Extrapyramidal effects: May exacerbate extrapyramidal symptoms due to an increase in cholinergic tone.
• Skin reactions: Skin reactions, including Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, and erythema multiforme, have been reported with galantamine. Discontinue treatment if skin reaction occurs; if rash is suspected to be drug related, do not resume therapy and consider alternative therapy.
• Vagotonic effects: Cholinesterase inhibitors may have vagotonic effects that may cause bradycardia and/or heart block with or without a history of cardiac disease.
• Weight loss: Weight loss has been observed; monitor body weight.
Disease-related concerns:
• Cardiac conduction abnormalities: Use with caution in patients with bradycardia or conduction abnormalities.
• Kidney impairment: Use with caution in patients with moderate kidney impairment; not recommended in severe impairment (CrCl <9 mL/minute).
• Liver impairment: Use with caution in patients with mild to moderate liver impairment; not recommended in severe impairment. Dose adjustment recommended in moderate impairment.
• Peptic ulcer disease: Use with caution in patients at risk of ulcer disease (eg, previous history, nonsteroidal anti-inflammatory drug use); may increase gastric acid secretion. Monitor for symptoms of bleeding.
• Respiratory disease: Use with caution in patients with chronic obstructive pulmonary disease and/or severe asthma.
• Seizure disorder: Use with caution in patients with a history of seizure disorder.
• Urinary tract obstruction: Use with caution in patients with bladder outlet obstruction; cholinomimetics may cause or worsen outflow obstructions.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Delayed Release, Oral, as gluconate:
Zunveyl: 5 mg
Zunveyl: 10 mg [contains carmine (cochineal extract), fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake]
Zunveyl: 15 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]
No
Tablet, EC (Zunveyl Oral)
5 mg (per each): $14.98
10 mg (per each): $14.98
15 mg (per each): $14.98
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer with or without food; swallow tablets whole and do not split, crush, or chew. Maintain sufficient hydration during treatment.
Alzheimer disease, mild to moderate: Treatment of mild to moderate dementia of Alzheimer disease.
Benzgalantamine may be confused with galantamine.
Substrate of CYP2D6 (Minor), CYP3A4 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits Acetylcholinesterase;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Clinically Relevant Anticholinergic Effects: Acetylcholinesterase Inhibitors may decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Amifampridine: Acetylcholinesterase Inhibitors may increase therapeutic effects of Amifampridine. Amifampridine side effects may also be increased. Amifampridine may increase therapeutic effects of Acetylcholinesterase Inhibitors. Acetylcholinesterase inhibitor side effects may also be increased. Risk C: Monitor
Antipsychotic Agents: Benzgalantamine-Galantamine may increase neurotoxic (central) effects of Antipsychotic Agents. Risk C: Monitor
Benoxinate: Acetylcholinesterase Inhibitors may increase therapeutic effects of Benoxinate. Specifically, the effects of benoxinate may be prolonged. Risk C: Monitor
Beta-Blockers: Acetylcholinesterase Inhibitors may increase bradycardic effects of Beta-Blockers. Risk C: Monitor
Bradycardia-Causing Agents: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Ceritinib: Bradycardia-Causing Agents may increase bradycardic effects of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider Therapy Modification
Chlorprothixene: Acetylcholinesterase Inhibitors may increase adverse/toxic effects of Chlorprothixene. Acetylcholinesterase Inhibitors may increase therapeutic effects of Chlorprothixene. Risk C: Monitor
Cholinergic Agonists: Acetylcholinesterase Inhibitors may increase adverse/toxic effects of Cholinergic Agonists. Specifically, cholinergic effects may be enhanced or increased. Risk C: Monitor
Corticosteroids (Systemic): May increase adverse/toxic effects of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor
Dipyridamole: May decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Etrasimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Fexinidazole: Bradycardia-Causing Agents may increase arrhythmogenic effects of Fexinidazole. Risk X: Avoid
Fingolimod: Bradycardia-Causing Agents may increase bradycardic effects of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider Therapy Modification
Gepotidacin: May increase therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Ivabradine: Bradycardia-Causing Agents may increase bradycardic effects of Ivabradine. Risk C: Monitor
Lacosamide: Bradycardia-Causing Agents may increase AV-blocking effects of Lacosamide. Risk C: Monitor
Landiolol: Bradycardia-Causing Agents may increase bradycardic effects of Landiolol. Risk X: Avoid
Midodrine: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Neuromuscular-Blocking Agents (Nondepolarizing): Acetylcholinesterase Inhibitors may decrease neuromuscular-blocking effects of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor
Ozanimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Ponesimod: Bradycardia-Causing Agents may increase bradycardic effects of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider Therapy Modification
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Siponimod: Bradycardia-Causing Agents may increase bradycardic effects of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider Therapy Modification
Succinylcholine: Acetylcholinesterase Inhibitors may increase neuromuscular-blocking effects of Succinylcholine. Risk C: Monitor
Alcohol-induced dose dumping has been observed with in vitro dissolution studies of benzgalantamine and 40% (v/v) alcohol. Management: Avoid co-administration with alcohol.
Based on data from animal reproduction studies, in utero exposure to benzgalantamine may cause fetal harm.
It is not known if benzgalantamine is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Kidney and liver function (baseline and as clinically indicated); weight (baseline and as clinically indicated).
Benzgalantamine, a prodrug of galantamine, is a centrally-acting cholinesterase inhibitor (competitive and reversible). It elevates acetylcholine by slowing the degradation of acetylcholine.
Distribution: Galantamine: 175 L.
Protein binding: Galantamine: 18%.
Metabolism: Hepatic metabolism primarily via CYP2D6 to O-desmethyl-galantamine and CYP3A4 to galantamine-N-oxide.
Bioavailability: Galantamine: ~90%.
Half-life elimination: Galantamine: 7 hours.
Time to peak: Galantamine: 2.5 to 3 hours (6 hours with food).
Excretion: Urine (galantamine 20%).
Altered kidney function: Galantamine: AUC increased 37% and 67% in moderate and severe kidney function impairment, respectively.
Hepatic function: Galantamine: Clearance decreased ~25% in moderate (Child-Turcotte-Pugh class B) hepatic function impairment.
Older adult: Galantamine: Concentrations are ~30% to 40% increased.
Sex: Galantamine: Clearance is ~20% lower in women.
