zunveyl
Zunveyl (Benzgalantamine Gluconate) is a medication used to treat Dementia.
Benzgalantamine Gluconate · by Alpha Cognition
Key facts
- Active ingredient
- Benzgalantamine Gluconate
- Form
- Tablet, delayed release
- Strength
- Benzgalantamine Gluconate EQ 10MG Base · Benzgalantamine Gluconate EQ 15MG Base · Benzgalantamine Gluconate EQ 5MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- dementia
- Manufacturer
- Alpha Cognition
- FDA application
- NDA218549
What is Zunveyl?
From the FDA label:ZUNVEYL (benzgalantamine) is a prodrug of galantamine, an acetylcholinesterase inhibitor . Benzgalantamine gluconate is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6- benzoate gluconate salt. It has an empirical formula of C 30 H 37 NO 11 and has a molecular weight of 587.61 (gluconate salt) and 391.46 (benzgalantamine). Benzgalantamine gluconate is a white to pale yellow powder and is soluble in water. Benzgalantamine has a pH of 5 to 6 and dissociation constant (pKa) of 7.0. It is slightly soluble in methanol and practically insoluble in acetone, acetonitrile and hexane. The structural formula for benzgalantamine gluconate is: ZUNVEYL contains 5 mg, 10 mg, 15 mg benzgalantamine equivalent to 7.49 mg, 14.98 mg, and 22.47 mg benzgalantamine gluconate, respectively. ZUNVEYL delayed-release tablets are for oral use. Inactive ingredients include 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…
How to use
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 twice a day (10 mg/day) by mouth. Increase to initial maintenance dosage of 10 mg twice daily (20 mg/day) 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 (30 mg/day) after a minimum of 4 weeks at 10 mg twice daily. Administration ZUNVEYL can be taken with or without food. ZUNVEYL should not be taken with alcohol [see…
Side effects
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…
Warnings
Important safety information
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. ( 5.7 ) 5.1 Serious Skin Reactions Serious skin reactions (e.g., Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of (ZUNVEYL) tablets. Inform patients and caregivers that the use of ZUNVEYL tablets 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 [see Contraindications (4) ]. 5.2 Anesthesia ZUNVEYL, as a cholinesterase inhibitor, is likely to increase the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia. 5.3 Cardiovascular Conditions Because of their pharmacological action, cholinesterase inhibitors, including ZUNVEYL, 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 taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope (placebo 0.7% [2/286]; 4 mg twice daily 0.4% [3/692]; 8 mg twice daily 1.3% [7/552]; 12 mg twice daily 2.2% [6/273]). 5.4 Gastrointestinal Conditions Through their primary action, cholinomimetics, including ZUNVEYL, may be expected to increase gastric acid secretion because of increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk for developing ulcers (e.g., those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs [NSAIDs]). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Galantamine, as a predictable consequence of its pharmacological properties, has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss [see Adverse Reactions (6.1) ]. Monitor the patient's weight during therapy with ZUNVEYL. 5.5 Genitourinary Conditions Although this was not observed in clinical trials with galantamine, cholinomimetics, including ZUNVEYL, may cause bladder outflow obstruction. 5.6 Neurological Conditions Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions [see Adverse Reactions (6.2) ]. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. 5.7 Pulmonary Conditions Because of its cholinomimetic action, ZUNVEYL should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Respiratory function should be monitored closely for the occurrence of respiratory adverse reactions.
Who should not take Zunveyl
ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredient in ZUNVEYL. Serious skin reactions have occurred [see Warnings and Precautions (5.1) and Adverse Reactions (6.2) ]. Known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL ( 4 )
Overdose — what happens if you take too much
Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug. As in any case of overdose, general supportive measures should be utilized. Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or fasciculations, some or all of the following signs of cholinergic crisis may develop: severe nausea, vomiting, gastrointestinal cramping, salivation, lacrimation, urination, defecation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Tertiary anticholinergics such as atropine may be used as an antidote for ZUNVEYL overdosage. Intravenous (IV) atropine sulfate titrated to effect is recommended at an initial dose of 0.5 to 1.0 mg IV with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics. It is not known whether…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Potential to interfere with the activity of anticholinergic medications ( 7.1 ) Synergistic effect expected when given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents, or cholinergic agonists ( 7.2 ) 7.1 Use with Anticholinergics Galantamine has the potential to interfere with the activity of anticholinergic medications. 7.2 Use with Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol.
May treat (source: NIH RxClass)
Dosage forms
Tablet, delayed release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Zunveyl treat?
- Zunveyl (Benzgalantamine Gluconate) may be used to treat dementia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Zunveyl?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zunveyl. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Zunveyl?
- Zunveyl is marketed by Alpha Cognition. You can see Alpha Cognition's full profile, rating, and other products on pharmaranks.
- Is Zunveyl a brand-name or generic drug?
- Zunveyl is a brand-name product with the active ingredient Benzgalantamine Gluconate.
- Is Zunveyl available over the counter?
- No. Zunveyl is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Zunveyl come in?
- Zunveyl is currently marketed as tablet, delayed release, per the FDA's National Drug Code Directory.
- Is Zunveyl FDA-registered?
- Zunveyl is on record with the U.S. FDA under application number NDA218549. You can verify this on its official FDA label.
- Is Zunveyl safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Zunveyl. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Zunveyl?
- Zunveyl's side effects are taken directly from its FDA label. From the label: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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