Zunveyl
Generic name: benzgalantamine
Dosage form: delayed-release tablets (5mg, 10mg, 15mg))
What is Zunveyl?
Zunveyl is a prescription medicine used to treat mild to moderate dementia in Alzheimer's disease (AD) and improve thinking, memory, and the ability to perform daily activities. Zunveyl has the same effect on AD as another AD drug called galantamine, but Zunveyl reportedly has less gastric side effects, such as nausea and vomiting.
Zunveyl (benzgalantamine) is the prodrug of galantamine, which means that when you take benzgalantamine, it is converted into the active drug galantamine after it passes through the gastrointestinal tract. As a prodrug of galantamine, Zunveyl may reduce gastric side effects while still improving Alzheimer's disease symptoms.
Zynveyl is an FDA-approved medicine for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.
How does Zunveyl work?
Acetylcholine is a messenger in the brain that is involved in memory, motivation, and ability to learn tasks. It is thought that low levels of acetylcholine in the brain are related to dementia symptoms in AD. Zunveyl is an acetylcholinesterase inhibitor (AChEI) that works by stopping acetylcholine from being broken down and also increases the amount of acetylcholine that is released between the nerves (neurons) in the brain. It is thought that Zunveyl dual action increases levels of acetylcholine in the brain, and this improves dementia symptoms.
Alzheimer’s disease (AD) is a progressive brain disorder that slowly reduces memory and thinking skills, and eventually, they may lose the ability to perform daily activities and take care of themselves.
Zunveyl side effects
The most common side effects of galantamine tablets are nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
Also, see the Warnings section for more serious side effects and warnings.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
Leqembi, donepezil, memantine, Aricept, Namenda, rivastigmine, Exelon
Warnings
Zunveyl may cause serious side effects:
Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of (Zunveyl) tablets. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered.
Cardiovascular conditions: Cholinesterase inhibitors, including Zunveyl, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil.
Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including Zunveyl, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs).
Genitourinary conditions: Although not observed in clinical trials of Zunveyl, bladder outflow obstruction may occur.
Pulmonary conditions: Cholinesterase inhibitors, including Zunveyl, should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. Monitor for respiratory adverse effects.
Who should not take this medicine?
You should not take this medicine if you have a known hypersensitivity to benzgalantamine, galantamine, or any of the inactive ingredients in Zunveyl. The list of inactive ingredients is at the bottom of this document.
Before taking this medicine
You should not use Zunveyl if you are allergic to it or any of its inactive ingredients.
To make sure Zunveyl is safe for you, tell your doctor if you have:
- urination problems;
- heart disease or a heart rhythm disorder;
- a history of stomach ulcer or bleeding;
- seizures or epilepsy;
- kidney disease;
- liver disease; or
- a history of asthma or chronic obstructive pulmonary disease (COPD).
Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby.
Breastfeeding
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known whether this medicine passes into breast milk or if it could affect the nursing baby.
How should I take Zunveyl?
Zunveyl tablets are taken twice daily with or without food. They should be swallowed whole; do not split, crush, or chew. Ensure adequate fluid intake during treatment. Zunveyl should not be taken with alcohol.
Zunveyl dosing information
Dosing
- The recommended Zunveyl starting dosage is 5 mg orally twice daily
- After a minimum of 4 weeks, based on clinical response and tolerability, the dose may be increased to an initial maintenance dosage of 10 mg twice daily
- After a minimum of 4 weeks at 10 mg twice daily, the dose may be increased to the maximum recommended dosage of 15 mg twice a day.
Dose modifications:
Hepatic impairment: The dose should not exceed 10 mg twice daily for moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended.
Renal impairment: The dose 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.
Drug Interactions
Cholinesterase inhibitors, including benzgalantamine and galantamine, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.
This list is not complete. Other drugs may interact with Zunveyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Ingredients
Active ingredient: benzgalantamine.
The inactive ingredients are calcium silicate, colloidal silicon dioxide, hypromellose, magnesium stearate, mannitol, methacrylic acid, poloxamer 407, polyethylene glycol/macrogol, sodium bicarbonate, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide.
The 10 mg tablet also contains Carmine, FD&C Blue #2/Indigo Carmine Aluminum Lake, and FD&C Red #40/Allura Red AC Aluminum Lake.
The 15 mg tablet also contains FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, and FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake.
Storage
Store at 20°C to 25°C (68°F to 77°F).
Company
Manufactured for: Alpha Cognition, Inc. 1452 Hughes Rd Suite 200 Grapevine, TX 76051.
References
- A Quantitative-EEG Assessment of Alpha-1062, a Novel Pro-Drug of Galantamine for the Treatment of Mild to Moderate Dementia Associated with Alzheimer’s Disease
- Razadyne ER Package Insert FDA
- Zunveyl Package Insert FDA
- FDA Approves Zunveyl
- NIH National Library of Medicine: Physiology, Acetylcholine
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Further information
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