Donepezil Hydrochloride

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 debossed on the other side.
• The 10 mg tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.
• The 23 mg tablets are reddish. The strength, in mg (23), is debossed on one side, and ARICEPT is debossed on the other side.

ARICEPT ODT is supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride.

• The 5 mg orally disintegrating tablets are white. The strength, in mg (5), is debossed on one side and ARICEPT is debossed on the other side.
• The 10 mg orally disintegrating tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.

Storage And Handling

ARICEPT Tablets

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 debossed on the other side.

• Bottles of 30 (NDC# 62856-245-30)
• Bottles of 90 (NDC# 62856-245-90)
• Bottles of 1000 (NDC# 62856-245-11)
• Unit Dose Blister Package 100 (10x10) (NDC# 62856-245-41)

The 10 mg tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.

• Bottles of 30 (NDC# 62856-246-30)
• Bottles of 90 (NDC# 62856-246-90)
• Bottles of 1000 (NDC# 62856-246-11)
• Unit Dose Blister Package 100 (10x10) (NDC# 62856-246-41)

The 23 mg tablets are reddish in color. The strength, in mg (23), is debossed on one side and ARICEPT is debossed on the other side.

• Bottles of 30 (NDC# 62856-247-30)

ARICEPT ODT

Supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride.

The 5 mg orally disintegrating tablets are white. The strength, in mg (5), is debossed on one side and ARICEPT is debossed on the other side.

• 5 mg (White) Unit Dose Blister Package 30 (10x3) (NDC# 62856-831-30)

The 10 mg orally disintegrating tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.

• 10 mg (Yellow) Unit Dose Blister Package 30 (10x3) (NDC# 62856-832-30)

Store at controlled room temperature, 15ºC to 30ºC (59ºF to 86ºF).

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677. Revised: July 20 15

Included as part of the "PRECAUTIONS" Section

Do not take this medication if you are allergic to donepezil.

Before taking donepezil, tell your doctor if you are allergic to any drugs, or if you have:

• a heart rhythm disorder such as "sick sinus syndrome" (slow heartbeats);
• a history of stomach ulcers;
• an enlarged prostate or urination problems;
• epilepsy or other seizure disorder; or
• asthma or chronic obstructive pulmonary disease (COPD).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take donepezil.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether donepezil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Your pharmacist can provide more information about donepezil.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Centrally active, reversible acetylcholinesterase inhibitor.1 2 3 7

Administration

Oral Administration

Administer conventional or orally disintegrating tablets orally once daily, usually at bedtime.1 2

Administer with or without food.1 2

Orally disintegrating tablets: Place on tongue and allow to dissolve; follow with water.1

Donepezil hydrochloride orally disintegrating and conventional film-coated tablets are bioequivalent.1

Dosage

Available as donepezil hydrochloride; dosage expressed in terms of the salt.1

Adults

Initially, 5 mg daily.1 6 11

Some data suggest the possibility of additional benefit with higher (10 mg daily) dosage in some patients;1 2 6 12 however, additional benefit with the 10-mg dosage has not been demonstrated in controlled clinical studies.1 2 12 Adverse cholinergic effects are more likely with the 10-mg dosage.1 2

Daily administration of 10 mg should not be considered until patient has received 5 mg daily for 4–6 weeks, since occurrence of adverse effects may be influenced by the rate of increase in dosage.1 2 11

Special Populations

Hepatic Impairment

No specific recommendation for dosage adjustment.1

Metabolized by CYP3A4 and CYP2D6.1 Unlikely to cause clinically important induction or inhibition of CYP3A4 or CYP2D6; not known whether donepezil has any enzyme-induction potential.1

Drugs Highly Bound to Plasma Proteins

Pharmacokinetic interactions unlikely with drugs highly bound to plasma proteins.1

Drugs Affecting or Metabolized by Hepatic Enzymes

Unlikely to alter clearance of drugs metabolized by CYP3A4 or CYP2D6.1

Possible pharmacokinetic interaction (altered plasma donepezil concentrations) with CYP2D6 or CYP3A4 inducers or inhibitors.1

Specific Drugs

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 6

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)