Benzgalantamine
Generic Name: benzgalantamine
Brand Names:
Zunveyl
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
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
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.
Side Effects
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.
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.
Warnings
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. 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 )
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ZUNVEYL or galantamine in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Storage
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
What is Benzgalantamine used for?▼
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 )
What are the side effects of Benzgalantamine?▼
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.
Can I take Benzgalantamine during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ZUNVEYL or galantamine in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
What are the important warnings for Benzgalantamine?▼
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. 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 )
Related Medications
Paeonia Officinalis
paeonia officinalis
Vasopressin
vasopressin
11 DESCRIPTION Vasopressin is a polypeptide hormone. Vasopressin injection USP, is a sterile, clear, practically colorless aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, chlorobutanol, NF 0.5% as a preservative and Water for Injection, USP adjusted with glacial acetic acid, USP to pH 3.0 to 3.4.
Odevixibat Sesquihydrate
odevixibat sesquihydrate
Dosage form: POWDER. Active ingredients: ODEVIXIBAT SESQUIHYDRATE (1 kg/kg). Category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.