Donepezil 10 mg Tablets — Generic For Aricept — Macleod Pharma

These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS and DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS and DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS.

DONEPEZIL HYDROCHLORIDE tablets,for oral use

DONEPEZIL HYDROCHLORIDE orally disintegrating tablets

Initial U.S. Approval: 1996

Indications And Usage

Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease (1)

Dosage And Administration

Mild to Moderate Alzheimer’s Disease: 5 mg to 10 mg once daily (2.1)

Moderate to Severe Alzheimer’s Disease: 10 mg to 23 mg once daily (2.2)

Dosage Forms And Strengths

Tablets: 5 mg,10 mg, and 23 mg (3)

Orally Disintegrating Tablets (ODT) : 5 mg and 10 mg (3)

Contraindications

Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives (4)

Warnings And Precautions

• Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia (5.1)
• Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block (5.2)
• Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases (5.3)
• Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers (5.4)
• The use of donepezil hydrochloride tablets in a dose of 23 mg once daily is associated with weight loss (5.5)
• Cholinomimetics may cause bladder outflow obstructions (5.6)
• Cholinomimetics are believed to have some potential to cause generalized convulsions (5.7)
• Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease (5.8)

• Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia (5.1)
• Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block (5.2)
• Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases (5.3)
• Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers (5.4)
• The use of donepezil hydrochloride tablets in a dose of 23 mg once daily is associated with weight loss (5.5)
• Cholinomimetics may cause bladder outflow obstructions (5.6)
• Cholinomimetics are believed to have some potential to cause generalized convulsions (5.7)
• Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease (5.8)

Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia (5.1)

Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block (5.2)

Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases (5.3)

Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers (5.4)

The use of donepezil hydrochloride tablets in a dose of 23 mg once daily is associated with weight loss (5.5)

Cholinomimetics may cause bladder outflow obstructions (5.6)

Cholinomimetics are believed to have some potential to cause generalized convulsions (5.7)

Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease (5.8)

Adverse Reactions

Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications (7.1)

A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists (7.2)

Use In Specific Populations

Pregnancy: Based on animal data, may cause fetal harm (8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2023