ZUNVEYL

Generic Name/API: benzgalantamine

Manufacturer: Alpha Cognition

Dosage Forms & Strength & Pack Size:
Delayed-release tablets: 5 mg, 10 mg, and 15 mg

Storage:
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].

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION

ZUNVEYL® (benzgalantamine) is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.

SAFETY INFORMATION

ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL.

WARNINGS and PRECAUTIONS

 

  • 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.

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