ZUNVEYL 5 mg/1
benzgalantamine · TABLET, DELAYED RELEASE · Alpha Cognition, Inc.
ZUNVEYL is a tablet, delayed release containing benzgalantamine at 5 mg/1, taken oral. Manufactured by Alpha Cognition, Inc..
Key Facts
- Brand Name
- ZUNVEYL
- Generic Name
- benzgalantamine
- NDC Code (Product)
84054-005- Manufacturer
- Alpha Cognition, Inc.
- Strength
- 5 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA218549
- Marketing Start
- 08/09/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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 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 …
Contraindications
4 CONTRAINDICATIONS 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 )
Drug Interactions
7 DRUG 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.
Adverse Reactions
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…
Frequently Asked Questions
What is ZUNVEYL used for?
ZUNVEYL contains benzgalantamine. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.
Is ZUNVEYL a controlled substance?
ZUNVEYL is not classified as a controlled substance by the DEA.
What is the generic name for ZUNVEYL?
The generic name for ZUNVEYL is benzgalantamine. There are no other listed brand versions of benzgalantamine.
What is the NDC code for ZUNVEYL 5 mg/1?
The NDC (National Drug Code) for ZUNVEYL 5 mg/1 is 84054-005, listed by Alpha Cognition, Inc..
Other ZUNVEYL Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)