ARICEPT Film-coated tablet (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
PD-Rx Pharmaceuticals, Inc.
Λέξεις κλειδιά
55289-151
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1. Indications and Usage
ARICEPT is indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
2. Dosage and Administration
2.1 Dosing in Mild to Moderate Alzheimers Disease The recommended starting dosage of ARICEPT is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of ...
3. Dosage Forms and Strengths
ARICEPT is supplied as film-coated, round tablets containing 5 mg, 10 mg, or 23 mg of donepezil hydrochloride. The 5 mg tablets are white. The strength, in mg (5), is debossed on one side and ARICEPT is ...
4. Contraindications
ARICEPT is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.
5. Warnings and Precautions
5.1 Anesthesia ARICEPT, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. 5.2 Cardiovascular Conditions Because of their pharmacological action, ...
6. Adverse Reactions
The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Conditions <em>[see Warnings and Precautions (5.2)]</em> Nausea and Vomiting <em>[see Warnings ...
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 ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ARICEPT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Use with Anticholinergics Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications. 7.2 Use with Cholinomimetics ...
8. Use in Specific Populations
8.6 Lower Weight Individuals In the controlled clinical trial, among patients in the ARICEPT 23 mg treatment group, those patients weighing <55 kg reported more nausea, vomiting, and decreased weight than ...
8.1. Pregnancy
Risk Summary There are no adequate data on the developmental risks associated with the use of ARICEPT in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered ...
8.2. Lactation
Risk Summary There are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding ...
8.4. Pediatric Use
The safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
Alzheimers disease is a disorder occurring primarily in individuals over 55 years of age. The mean age of patients enrolled in the clinical studies with ARICEPT was 73 years; 80% of these patients were ...
10. Overdosage
Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose ...
11. Description
ARICEPT (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 <em>H</em> ...
12.1. Mechanism of Action
Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimers disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated ...
12.3. Pharmacokinetics
Pharmacokinetics of donepezil are linear over a dose range of 1-10 mg given once daily. The rate and extent of absorption of ARICEPT tablets are not influenced by food. Based on population pharmacokinetic ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenic potential was obtained in an 88-week carcinogenicity study of donepezil conducted in mice at oral doses up to 180 mg/kg/day (approximately 40 times the maximum recommended human ...
13.2. Animal Toxicology and/or Pharmacology
In an acute dose neurotoxicity study in female rats, oral administration of donepezil and memantine in combination resulted in increased incidence, severity, and distribution of neurodegeneration compared ...
14. Clinical Studies
14.1 Mild to Moderate Alzheimers Disease The effectiveness of ARICEPT as a treatment for mild to moderate Alzheimers disease is demonstrated by the results of two randomized, double-blind, placebo-controlled ...
16.1. How Supplied
16.1 ARICEPT Tablets Supplied as film-coated, round tablets containing 10 mg of donepezil hydrochloride. The 10 mg tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed ...
16.2. Storage and Handling
Store ARICEPT at room temperature between 59º to 86ºF (15º to 30ºC).
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients and caregivers to take ARICEPT only once per day, as prescribed. Instruct patients and caregivers that ...