donepezil hydrochloride


Also found in: Dictionary.

donepezil hydrochloride

Aricept

Pharmacologic class: Acetylcholinesterase inhibitor

Therapeutic class: Anti-Alzheimer's agent

Pregnancy risk category C

Action

Reversibly inhibits acetylcholinesterase hydrolysis in CNS, leading to increased acetylcholine level and temporary cognitive improvement in patients with Alzheimer's disease

Availability

Tablets: 5 mg, 10 mg, 23 mg

Tablets (orally disintegrating): 5 mg, 10 mg

Indications and dosages

Mild to moderate Alzheimer's disease

Adults: Initially, 5 mg P.O. daily. After 4 to 6 weeks, may increase dosage to 10 mg at bedtime.

Moderate to severe Alzheimer's disease

Adults: Initially, 10 mg P.O. daily. After 3 months, may increase dosage to 23 mg.

Contraindications

• Hypersensitivity to drug or piperidine derivatives

Precautions

Use cautiously in:
• cardiovascular disease, chronic obstructive pulmonary disease (COPD), asthma, or sick sinus syndrome
• patients at risk for developing ulcers, such as those with history of ulcer disease or those concurrently receiving NSAIDs
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Give with or without food.
• For best response, give at bedtime.

Adverse reactions

CNS: headache, dizziness, vertigo, fatigue, depression, aggression, irritability, restlessness, nervousness, paresthesia, insomnia, abnormal dreams, tremor, aphasia, seizures

CV: chest pain, bradycardia, hypertension, hypotension, vasodilation, atrial fibrillation, heart block

EENT: cataracts, blurred vision, eye irritation, sore throat

GI: nausea, vomiting, diarrhea, anorexia, bloating, epigastric pain, fecal incontinence, GI bleeding

GU: urinary frequency, increased libido, bladder outflow obstruction

Metabolic: dehydration

Musculoskeletal: muscle cramps, arthritis, bone fracture

Respiratory: dyspnea, bronchitis

Skin: pruritus, urticaria, bruising, diaphoresis, rash, flushing

Other: toothache, decreased appetite, weight loss, hot flashes, influenza

Interactions

Drug-drug.Anticholinergics: reduced donepezil effects

Anticholinesterases, cholinomimetics: synergistic effects

Carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin: accelerated donepezil elimination

NSAIDs: increased risk of GI bleeding

Patient monitoring

Watch closely for increased bronchoconstriction in patients with history of asthma or COPD.
• Assess cardiovascular status. Drug may cause bradycardia from increased vagal tone.
• Monitor closely for signs and symptoms of GI ulcers and bleeding, especially if patient takes NSAIDs concurrently.

Patient teaching

• Advise patient to take drug at bedtime with or without food.
• Instruct patient to allow orally disintegrating tablet to dissolve under tongue and then follow with a glass of water.
• Tell patient not to split, crush, or chew 23-mg tablet.
• Inform patient that drug may slow the heart rate, leading to fainting episodes.

Instruct patient to immediately report signs or symptoms of GI ulcers ("coffee-ground" vomitus, black tarry stools, and abdominal pain), or irregular heartbeat.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

donepezil hydrochloride

(dŏ-nĕp′ĭ-zĭl)
A cholinesterase inhibitor that improves cognitive abilities in patients with Alzheimer's dementia. Its most frequent side effects are diarrhea, nausea, and headache.
References in periodicals archive ?
Indian pharmaceutical firm Zydus Cadila (NSE: CADILAHC) has been granted final approval from the US Food and Drug Administration (FDA) to market Donepezil Hydrochloride tablets in the strength of 23 mg, the company said on Friday.
We are excited that with the new available dosage strengths patients with moderate to severe Alzheimer's disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg) can now start combination therapy directly with NAMZARIC.
Medical history included hypertension treated with clonidine hydrochloride and chronic obstructive pulmonary disease treated with albuterol inhaler; he was also receiving donepezil hydrochloride, 5 mg/d.
The ARICEPT[R] brand and Donepezil Hydrochloride tabletsgenerichad total combined U.
The settlement relates to a patent infringement litigation brought by Forest and Adamas in response to Amneal's abbreviated new drug application (ANDA) seeking approval to market generic versions of Allergan's NAMZARIC (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
The settlement relates to a patent infringement litigation brought by Forest and Adamas in response to Amneal's abbreviated new drug application seeking approval to market generic versions of Allergan's NAMZARIC (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
According to Adamas, it has developed a fixed-dose combination of memantine hydrochloride extended-release and donepezil hydrochloride initially, and Namzaric is the first and only such fixed-dose combination approved by the US FDA for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.
Tenders are invited for Donepezil Hydrochloride 10Mg Tablet
The generic donepezil hydrochloride orally disintegrating tablets, manufactured by Mutual Pharmaceutical of Philadelphia, have been approved in 5-mg and 10-mg strengths.
The usual initial adult dose for oral use is 3mg of donepezil hydrochloride once daily.
M2 EQUITYBITES-July 30, 2013-Dr Reddy's Laboratories introduces Donepezil Hydrochloride tablets 23mg in US(C)2013 M2 COMMUNICATIONS http://www.
M2 PHARMA-July 30, 2013-Dr Reddy's Laboratories introduces Donepezil Hydrochloride tablets 23mg in US(C)2013 M2 COMMUNICATIONS