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donepezil hydrochloride

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Overview

What is donepezil hydrochloride?

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]-1H-inden-1-one hydrochloride.

Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of CHNOHCl and a molecular weight of 415.96.

Donepezil hydrochloride (monohydrate), USP is a white to off-white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane.

Each donepezil hydrochloride tablet intended for oral administration contains 23 mg of donepezil hydrochloride (monohydrate), USP. In addition, each tablet contains the following inactive ingredients: corn starch, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide.

USP Dissolution Test pending.



What does donepezil hydrochloride look like?



What are the available doses of donepezil hydrochloride?

Donepezil hydrochloride tablets are supplied as film-coated, round tablets containing 23 mg of donepezil hydrochloride (monohydrate), USP.

The 23 mg tablets are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side.

What should I talk to my health care provider before I take donepezil hydrochloride?

How should I use donepezil hydrochloride?

Donepezil hydrochloride tablets are 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 ().

The recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride in patients with mild to moderate Alzheimer's disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.


What interacts with donepezil hydrochloride?

Sorry No Records found


What are the warnings of donepezil hydrochloride?

Sorry No Records found


What are the precautions of donepezil hydrochloride?

Sorry No Records found


What are the side effects of donepezil hydrochloride?

Sorry No records found


What should I look out for while using donepezil hydrochloride?

Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ()


What might happen if I take too much donepezil hydrochloride?

Because

strategies

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the

management

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overdose

are

continually

evolving

it

is

advisable

to

contact

a

Poison

Control

Center

to

determine

the

latest recommendations

for

the

management

of

an

overdose

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any

drug.

As in any case of overdose, general supportive measures should be utilized. Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Tertiary anticholinergics such as atropine may be used as an antidote for donepezil hydrochloride overdosage. Intravenous atropine sulfate titrated to effect is recommended: an initial dose of 1 to 2 mg IV with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when coadministered with quaternary anticholinergics such as glycopyrrolate. It is not known whether donepezil hydrochloride and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).

Dose-related signs of toxicity in animals included reduced spontaneous movement, prone position, staggering gait, lacrimation, clonic convulsions, depressed respiration, salivation, miosis, tremors, fasciculation and lower body surface temperature.


How should I store and handle donepezil hydrochloride?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light. Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows:NDC 68382-521-06 in bottle of 30 tabletsNDC 68382-521-16 in bottle of 90 tabletsNDC 68382-521-01 in bottle of 100 tabletsNDC 68382-521-05 in bottle of 500 tabletsNDC 68382-521-10 in bottle of 1000 tabletsNDC 68382-521-77  in unit-dose blister cartons of 100 (10 x 10) unit-dose tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer's disease attribute some of them to a deficiency of cholinergic neurotransmission.

Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. There is no evidence that donepezil alters the course of the underlying dementing process.

Non-Clinical Toxicology
Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ()

Caution should be exercised when propranolol is administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Coadministration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see   in ).





Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.

Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.

Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.

The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following coadministration with propranolol.

Caution should be exercised when administering propranolol with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers.

Digitalis Glycosides

Calcium Channel Blockers

There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.

Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high-degree heart block, and heart failure.

ACE Inhibitors

The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol should be administered cautiously to patients withdrawing from clonidine.

Alpha Blockers

Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.

Reserpine





Isoproterenol and Dobutamine





Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate.

Antidepressants

Anesthetic Agents

Warfarin

Neuroleptic Drugs

Thyroxine

Alcohol

Donepezil hydrochloride, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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