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Drug overview for DONEPEZIL HCL (donepezil hcl):
Generic name: DONEPEZIL HCL (doh-NEP-eh-zil)
Drug class: Alzheimer's Disease Agents
Therapeutic class: Cognitive Disorder Therapy
Donepezil hydrochloride is a centrally active, reversible acetylcholinesterase inhibitor.
No enhanced Uses information available for this drug.
Generic name: DONEPEZIL HCL (doh-NEP-eh-zil)
Drug class: Alzheimer's Disease Agents
Therapeutic class: Cognitive Disorder Therapy
Donepezil hydrochloride is a centrally active, reversible acetylcholinesterase inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
- DONEPEZIL HCL 5 MG TABLET
- DONEPEZIL HCL 10 MG TABLET
- DONEPEZIL HCL 23 MG TABLET
The following indications for DONEPEZIL HCL (donepezil hcl) have been approved by the FDA:
Indications:
Mild to moderate Alzheimer's type dementia
Moderate to severe Alzheimer's type dementia
Professional Synonyms:
None.
Indications:
Mild to moderate Alzheimer's type dementia
Moderate to severe Alzheimer's type dementia
Professional Synonyms:
None.
The following dosing information is available for DONEPEZIL HCL (donepezil hcl):
The manufacturer of donepezil makes no specific recommendations for dosage adjustment in patients with renal or hepatic impairment.
Donepezil hydrochloride is administered orally as conventional film-coated or orally disintegrating tablets. The 2 formulations are bioequivalent. The drug is administered once daily, usually in the evening at bedtime.
Donepezil hydrochloride orally disintegrating tablets should be allowed to dissolve on the tongue and followed with water. The 23-mg conventional film-coated tablet should not be split, crushed, or chewed. Because food does not affect the rate or extent of absorption of donepezil when administered as conventional film-coated tablets, the drug may be administered with or without food.
The effect of food on absorption of donepezil when administered as orally disintegrating tablets has not been studied. However, the manufacturer states that any effects are expected to be minimal, and the orally disintegrating tablets may be taken without regard to meals. The fixed-combination preparation containing memantine hydrochloride and donepezil hydrochloride (Namzaric(R)) may be used in patients receiving a stable dosage of donepezil hydrochloride 10 mg daily.
The fixed-combination capsules may be administered with or without food, and should be swallowed intact (and not divided, chewed, or crushed) or may be opened, sprinkled on applesauce, and swallowed without chewing. The entire contents of each capsule should be consumed; the dose should not be divided.
Donepezil hydrochloride orally disintegrating tablets should be allowed to dissolve on the tongue and followed with water. The 23-mg conventional film-coated tablet should not be split, crushed, or chewed. Because food does not affect the rate or extent of absorption of donepezil when administered as conventional film-coated tablets, the drug may be administered with or without food.
The effect of food on absorption of donepezil when administered as orally disintegrating tablets has not been studied. However, the manufacturer states that any effects are expected to be minimal, and the orally disintegrating tablets may be taken without regard to meals. The fixed-combination preparation containing memantine hydrochloride and donepezil hydrochloride (Namzaric(R)) may be used in patients receiving a stable dosage of donepezil hydrochloride 10 mg daily.
The fixed-combination capsules may be administered with or without food, and should be swallowed intact (and not divided, chewed, or crushed) or may be opened, sprinkled on applesauce, and swallowed without chewing. The entire contents of each capsule should be consumed; the dose should not be divided.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for DONEPEZIL HCL (donepezil hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for DONEPEZIL HCL (donepezil hcl):
Drug contraindication overview.
Known hypersensitivity to donepezil or piperidine derivatives or any ingredient in the formulation.
Known hypersensitivity to donepezil or piperidine derivatives or any ingredient in the formulation.
There are 0 contraindications.
There are 12 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute decompensated heart failure |
| Acute myocardial infarction |
| Atrioventricular block |
| Congenital long QT syndrome |
| Gastrointestinal hemorrhage |
| Gastrointestinal ulcer |
| Neuroleptic malignant syndrome |
| Prolonged QT interval |
| Rhabdomyolysis |
| Sick sinus syndrome |
| Sinus bradycardia |
| Torsades de pointes |
There are 7 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| 30 day risk period post-myocardial infarction |
| Asthma |
| Bladder outflow obstruction |
| Chronic obstructive pulmonary disease |
| Hypokalemia |
| Hypomagnesemia |
| Seizure disorder |
The following adverse reaction information is available for DONEPEZIL HCL (donepezil hcl):
Adverse reaction overview.
Common adverse effects reported with donepezil in clinical studies include nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia.
Common adverse effects reported with donepezil in clinical studies include nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia.
There are 40 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea |
Anorexia Arthritis Dizziness Fatigue Increased urinary frequency Syncope |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Aggressive behavior Anemia Aphasia Ataxia Atrial fibrillation Blurred vision Bradycardia Cataracts Chest pain Dehydration Delusional disorder DRESS syndrome Dyspnea Fecal incontinence Flatulence Gastrointestinal hemorrhage Heart block Heart failure Hyperhidrosis Hypertension Hypotension Nervousness Neuroleptic malignant syndrome Paresthesia Peripheral edema Prolonged QT interval Rhabdomyolysis Seizure disorder Stevens-johnson syndrome Torsades de pointes Toxic epidermal necrolysis Urticaria |
There are 26 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cramps Insomnia Nausea Vomiting |
Depression Drowsy Ecchymosis Headache disorder Nightmares Pain Weight loss |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Altered mental status Bronchitis Drug-induced hot flash Genitourinary tract infections Irritability Libido changes Mood changes Nocturia Ocular irritation Pruritus of skin Tremor Urinary incontinence Vasodilation of blood vessels Vertigo |
The following precautions are available for DONEPEZIL HCL (donepezil hcl):
Safety and efficacy of donepezil have not been established in pediatric patients. Dementia of the Alzheimer's type occurs principally in patients older than 55 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate data to inform the developmental risks associated with the use of donepezil in pregnant women. Animal reproduction studies did not demonstrate any evidence of developmental toxicity when the drug was administered to pregnant rats and rabbits during the period of organogenesis; however, when the drug was administered at clinically relevant doses during later stages of pregnancy and throughout lactation, increased stillbirths and decreased offspring survival were observed.
It is not known whether donepezil is distributed into human milk or if the drug has any effects on nursing infants or milk production. The known benefits of breast-feeding should be considered along with the mother's need for the drug and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Donepezil | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insufficient human data available |
Population pharmacokinetic analysis indicates that clearance of donepezil decreases with increasing age. Compared with patients who were 65 years of age, clearance of donepezil was decreased by 17% in patients 90 years of age and increased by 33% in patients 40 years of age; however, the manufacturer states that these changes may not be clinically important.
Precaution Exists
Geriatric management or monitoring precaution exists.
Precaution Exists
Geriatric management or monitoring precaution exists.
| Drug Name | Narrative | REN | HEP | CARDIO | NEURO | PULM | ENDO |
|---|---|---|---|---|---|---|---|
| Donepezil | General-Recent rare reports of rhabdomyolysis and NMS. Cardiovascular-Cholinesterase inhibitors can have vagotonic effects on the SA & AV nodes resulting in bradycardia or AV block. Urogenital-May cause bladder outflow obstruction in those patients who are predisposed. Gastrointestinal-Use with caution in patients with history of or active PUD or GI bleeding. Dose dependent N/V, diarrhea. | N | N | Y | N | N | N |
The following prioritized warning is available for DONEPEZIL HCL (donepezil hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DONEPEZIL HCL (donepezil hcl)'s list of indications:
| Mild to moderate alzheimer's type dementia | |
| G30 | Alzheimer's disease |
| G30.0 | Alzheimer's disease with early onset |
| G30.1 | Alzheimer's disease with late onset |
| G30.8 | Other alzheimer's disease |
| G30.9 | Alzheimer's disease, unspecified |
| Moderate to severe alzheimer's type dementia | |
| G30 | Alzheimer's disease |
| G30.0 | Alzheimer's disease with early onset |
| G30.1 | Alzheimer's disease with late onset |
| G30.8 | Other alzheimer's disease |
| G30.9 | Alzheimer's disease, unspecified |
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