General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Zunveyl
BENZGALANTAMINE
1 INDICATIONS AND USAGE ZUNVEYL is indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults ( 1 )
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:ZUNVEYL
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- BENZGALANTAMINE
- Medicine class
- General Medicine
- Brand names
- ZUNVEYL
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of about 7 hours
- FDA approved
- Yes
What Is Zunveyl?
1 INDICATIONS AND USAGE ZUNVEYL is indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults ( 1 )
Zunveyl (BENZGALANTAMINE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Zunveyl. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Zunveyl with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Zunveyl is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE ZUNVEYL is indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults.
ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults ( 1 )
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 5 mg orally twice daily with or without food; increase to initial maintenance dosage of 10 mg twice daily after a minimum of 4 weeks based on clinical response and tolerability. Dosage may be increased to the maximum recommended dosage of 15 mg twice a day after a minimum of 4 weeks at 10 mg twice daily. ( 2.1 ) Ensure adequate fluid intake during treatment. Swallow whole; do not split, crush or chew. ( 2.1 ) May be taken with or without food. ( 2.1 ) Should not be taken with alcohol. ( 2.1 ) Hepatic impairment: Should not exceed 10 mg twice daily for moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended ( 2.2 ) Renal impairment: Should not exceed 10 mg twice daily for creatinine clearance 9 to 59 mL/min; use in patients with creatinine clearance less than 9 mL/min is not recommended. ( 2.3 ) 2.1 Recommended Dosage and Administration Dosage The recommended starting dosage is 5 mg twi
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail elsewhere in the labeling: Serious Skin Reactions [see Warnings and Precautions (5.1) ] Cardiovascular Conditions [see Warnings and Precautions (5.3) ] Gastrointestinal Conditions [see Warnings and Precautions (5.4) ] Genitourinary Conditions [see Warnings and Precautions (5.5) ] Neurological Conditions [see Warnings and Precautions (5.6) ] Pulmonary Conditions [see Warnings and Precautions (5.7) ] The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alpha Cognition Inc.
- at 1-877-257-4203 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- The safety of ZUNVEYL has been established in studies of galantamine immediate-release tablets and galantamine extended-release capsules [see Clinical Studies (14) ] .
- Below is a display of the adverse reactions of galantamine in these studies.
- Galantamine Extended-Release Capsules and Immediate-Release Tablets The safety of the extended-release capsule and immediate-release tablet formulations of galantamine was evaluated in 3956 galantamine-treated patients who participated in 8 placebocontrolled clinical studies and 1454 patients in 5 open-label clinical studies with mild to moderate dementia of the Alzheimer's type.
Serious
- 5 WARNINGS AND PRECAUTIONS 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, because of 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS 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, because of vagotonic effects on sinoatrial and atrioventricular nodes. ( 5.3 ) Active or occult gastrointestinal bleeding: Monitor, especially those with an increased risk fo
How Zunveyl Works
12.1 Mechanism of Action Although the etiology of cognitive impairment in Alzheimer's disease (AD) is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimer's disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimer's disease). ZUNVEYL is a prodrug of galantamine. Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase. While the precise mechanism of galantamine's action is unknown, it is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible in
Pharmacokinetics
Absorption
Absorption Galantamine is absorbed with time to peak concentration of about 2
Half-Life
half-life of about 7 hours
Metabolism
metabolite
Excretion
excretion of unchanged drug in the urine
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Zunveylwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
16.2 Storage and Handling Store ZUNVEYL delayed-release tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
Related on MedCentralHub
- Class hub
General Medicine alternatives
Compare all General Medicine medications — uses, side effects, and cost differences
- Detail
Zunveyl dosage guide
Adult, pediatric, renal, and hepatic dosing for Zunveyl
- Detail
Zunveyl side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Zunveyl
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.