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Donepezil Hydrochloride

Sun Pharmaceutical Industries Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets Donepezil Hydrochloride TabletsInitial U.S. Approval: 1996 INDICATIONS AND USAGE1DOSAGE AND ADMINISTRATION Mild to Moderate Alzheimer’s Disease - 5 mg or 10 mg administered once daily (2.1) Severe Alzheimer’s Disease - 10 mg administered once daily (2.2) 2.3DOSAGE FORMS AND STRENGTHS Tablets: 5 mg and 10 mg (3) CONTRAINDICATIONS Patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives (4) WARNINGS AND PRECAUTIONS Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia (5.1). Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block (5.2). Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases (5.3). Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers (5.4). Cholinomimetics may cause bladder outflow obstructions (5.6). Cholinomimetics are believed to have some potential to cause generalized convulsions (5.7). Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease (5.8). Side Effects6.1To report SUSPECTED ADVERSE REACTIONS, contact CARACO Pharmaceutical Laboratories Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications (7.3). A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists (7.4). USE IN SPECIFIC POPULATIONS Based on animal data, donepezil hydrochloride may cause fetal harm (8.1).


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE


2 DOSAGE AND ADMINISTRATION




2.1. Mild to Moderate Alzheimer's Disease




2.2. Severe Alzheimer's Disease


2.3. Titration


3 DOSAGE FORMS AND STRENGTHS






4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS

5.1. Anesthesia


5.2. Cardiovascular Conditions


5.3. Nausea and Vomiting




5.4. Peptic Ulcer Disease and GI Bleeding


5.6 Genitourinary Conditions


5.7 Neurological Conditions: Seizures


5.8 Pulmonary Conditions


6 ADVERSE REACTIONS

6.1. Clinical Studies Experience


Mild to Moderate Alzheimer’s Disease

Adverse Events Leading to Discontinuation



Table 1. Most Frequent Adverse Events Leading to Discontinuation from Controlled Clinical Trials by Dose Group
Dose Group Placebo 5 mg/day Donepezil Hydrochloride 10 mg/day Donepezil Hydrochloride
Patients Randomized
355
 350
 315
Event/%Discontinuing
 
  
  
Nausea
1%
 1%
 3%
Diarrhea
0%
 <1%
 3%
Vomiting
<1%
 <1%
 2%
Most Frequent Adverse Events Seen in Association with the Use of Donepezil Hydrochloride





Table 2. Comparison of Rates of Adverse Events in Mild to Moderate Patients Titrated to 10 mg/day over 1 and 6 Weeks
No titration One week titration Six week titration
Adverse Event Placebo (n=315) 5 mg/day (n=311) 10 mg/day (n=315) 10 mg/day (n=269)
Nausea
6%
 5%
 19%
 6%
Diarrhea
5%
 8%
 15%
 9%
Insomnia
6%
 6%
 14%
 6%
Fatigue
3%
 4%
 8%
 3%
Vomiting
3%
 3%
 8%
 5%
Muscle cramps
2%
 6%
 8%
 3%
Anorexia
2%
 3%
 7%
 3%
Adverse Events Reported in Controlled Trials

Table 3. Adverse Events Reported in Controlled Clinical Trials in Mild to Moderate Alzheimer’s Disease in at Least 2% of Patients Receiving Donepezil Hydrochloride and at a Higher Frequency than Placebo Treated Patients
Body System/Adverse Event Placebo
(n=355)		 Donepezil Hydrochloride (n=747)
Percent of Patients with any Adverse Event
72
74
Body as a Whole
Headache
9
 10
Pain, various locations
8
 9
Accident
6
 7
Fatigue
3
 5
Cardiovascular System
Syncope
1
 2
Digestive System
Nausea
6
 11
Diarrhea
5
 10
Vomiting
3
 5
Anorexia
2
 4
Hemic and Lymphatic System
Ecchymosis
3
 4
Metabolic and Nutritional Systems
Weight Decrease
1
 3
Musculoskeletal System
Muscle Cramps
2
 6
Arthritis
1
 2
Nervous System
Insomnia
6
 9
Dizziness
6
 8
Depression
<1
 3
Abnormal Dreams
0
 3
Somnolence
<1
 2
Urogenital System
Frequent Urination
1
 2
Other Adverse Events Observed During Clinical Trials



Frequent adverse eventsInfrequent adverse events

Body as a Whole: Frequent: Infrequent:

Cardiovascular System: Frequent: Infrequent:

Digestive System: Frequent: Infrequent:

Endocrine System: Infrequent:

Hemic and Lymphatic System: Infrequent:

Metabolic and Nutritional Disorders: Frequent: Infrequent:

Musculoskeletal System: Frequent: Infrequent:

Nervous System: Frequent: Infrequent:

Respiratory System: Frequent: Infrequent:

Skin and Appendages: Frequent: Infrequent:

Special Senses: Frequent: Infrequent:

Urogenital System: Frequent: Infrequent:

Severe Alzheimer’s Disease

Adverse Events Leading to Discontinuation



Most Frequent Adverse Events Seen in Association with the Use of Donepezil Hydrochloride



Adverse Events Reported in Controlled Trials

Table 4. Adverse Events Reported in Controlled Clinical Trials in Severe Alzheimer’s Disease in at Least 2% of Patients Receiving Donepezil Hydrochloride and at a Higher Frequency than Placebo Treated Patients
Body System/Adverse Event Placebo
(n=392)		 Donepezil Hydrochloride(n=501)
Percent of Patients with any Adverse Event
73
81
Body as a Whole
Accident
 12
 13
Infection
 9
 11
Headache
 3
 4
Pain
 2
 3
Back Pain
 2
 3
Fever
 1
 2
Chest Pain
 <1
 2
Cardiovascular System
Hypertension
 2
 3
Hemorrhage
 1
 2
Syncope
 1
 2
Digestive System
Diarrhea
 4
 10
Vomiting
 4
 8
Anorexia
 4
 8
Nausea
 2
 6
Hemic and Lymphatic System
Ecchymosis
 2
 5
Metabolic and Nutritional Systems
Creatine Phosphokinase Increased
 1
 3
Dehydration
 1
 2
Hyperlipemia
 <1
 2
Nervous System
Insomnia
 4
 5
Hostility
 2
 3
Nervousness
 2
 3
Hallucinations
 1
 3
Somnolence
 1
 2
Dizziness
 1
 2
Depression
 1
 2
Confusion
 1
 2
Emotional Lability
 1
 2
Personality Disorder
 1
 2
Skin And Appendages
Eczema
 2
 3
Urogenital System
Urinary Incontinence
 1
 2
Other Adverse Events Observed During Clinical Trials

Frequent adverse events Infrequent adverse events

Body as a Whole: Frequent: Infrequent:

Cardiovascular System: Frequent: Infrequent:

Digestive System: Frequent: Infrequent:

Endocrine System: Infrequent: Hemic and Lymphatic System: Frequent: Infrequent

Metabolic and Nutritional Disorders: Frequent: Infrequent

Musculoskeletal System: Frequent: Infrequent:

Nervous System: Frequent: Infrequent:

Respiratory System: Frequent: Infrequent:

Skin and Appendages: Frequent: Infrequent:

Special Senses: Infrequent:

Urogenital System: Frequent: Infrequent:

6.2 Postmarketing Experience


7 DRUG INTERACTIONS

7.1. Effect of Donepezil Hydrochloride on the Metabolism of Other Drugs


in vivo in vitro

7.2. Effect of Other Drugs on the Metabolism of Donepezil Hydrochloride


in vitro0-24max



7.3. Use with Anticholinergics


7.4. Use with Cholinomimetics and Other Cholinesterase Inhibitors


8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy


Pregnancy Category C:

222

8.3 Nursing Mothers


8.4 Pediatric Use


8.5 Geriatric Use


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 of any drug.



11 DESCRIPTION


H24293
Donepezil HydrochlorideDonepezil hydrochloride

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action




12.3 Pharmacokinetics




1

14in vitro

Hepatic Disease

Renal Disease2

Age:

Gender and Race:

Drugs Highly Bound to Plasma Proteinsin vitro

13 NONCLINICAL TOXICOLOGY

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility


22

in vitro in vitro tkin vitro in vivo

2

13.2. Animal Toxicology and/or pharmacology


14 CLINICAL STUDIES


14.1 Mild to Moderate Alzheimer’s Disease




Study Outcome Measures:









Thirty-Week Study



Effects on the ADAS-cog:


Donepezil HydrochlorideFigure 1. Time-course of the Change from Baseline in ADAS-cog Score for Patients Completing 24 Weeks of Treatment




Donepezil HydrochlorideFigure 2. Cumulative Percentage of Patients Completing 24 Weeks of Double-blind Treatment with Specified Changes from Baseline ADAS-cog Scores. The Percentages of Randomized Patients who Completed the Study were : Placebo 80%, 5 mg/day 85% and 10 mg/day 68%.

Effects on the CIBIC-plus:
Donepezil HydrochlorideFigure 3. Frequency Distribution of CIBIC plus Scores at Week 24

Fifteen-Week Study


 
Effects on the ADAS-Cog:
Donepezil HydrochlorideFigure 4. Time-course of the Change from Baseline in ADAS-cog Score for Patients Completing the 15-week Study.






Donepezil HydrochlorideFigure 5. Cumulative Percentage of Patients with Specified Changes from Baseline ADAS-cog Scores. The Percentages of Randomized Patients Within Each Treatment Group Who Completed the Study Were: Placebo 93%, 5 mg/day 90% and 10 mg/day 82%.

Effects on the CIBIC-plus:
Donepezil HydrochlorideFigure 6. Frequency Distribution of CIBIC plus Scores at Week 12

14.2 Severe Alzheimer’s Disease


Swedish 6 Month Study



Study Outcome Measures:





Effects on the SIB:


Donepezil HydrochlorideFigure 7. Time Course of the Change from Baseline in SIB Score for Patients Completing 6 months of Treatment


Donepezil HydrochlorideFigure 8. Cumulative Percentage of Patients Completing 6 Months of Double-blind Treatment with Particular Changes from Baseline in SIB Scores.
Donepezil HydrochlorideFigure 9. Time Course of the Change from Baseline in ADCS-ADL-Severe Score for Patients Completing 6 Months of Treatment

Effects on the ADCS-ADL-severe:


Donepezil HydrochlorideFigure 10. Cumulative Percentage of Patients Completing 6 Months of Double-blind Treatment with Particular Changes from Baseline in ADCS-ADL- Severe Scores.

Japanese 24-Week Study



16 HOW SUPPLIED/STORAGE AND HANDLING

16.1. Donepezil Hydrochloride Tablets



























Storage:

17 PATIENT COUNSELING INFORMATION













PATIENT PACKAGE INSERT

Donepezil Hydrochloride Tablets
5 mg and 10 mg



What are donepezil hydrochloride tablets?



  • Seem much better
  • Get better in small ways or stay the same
  • Get worse over time but slower than expected
  • Not change and then get worse as expected




Who should not take donepezil hydrochloride tablets?



What should I tell the doctor before the patient takes donepezil hydrochloride tablets?

Tell the doctor about all the patient’s present or past health problems.
  • Any heart problems including problems with irregular, slow, or fast heartbeats
  • Asthma or lung problems
  • A seizure
  • Stomach ulcers
  • Difficulty passing urine
  • Liver or kidney problems
  • Trouble swallowing tablets
  • Present pregnancy or plans to become pregnant. It is not known if donepezil hydrochloride tablets can harm an unborn baby.
  • Present breast-feeding. It is not known if donepezil hydrochloride passes into breast milk. Donepezil hydrochloride tablets are not for women who are breast-feeding.
Tell the doctor about all the medicines the patient takes,



  • surgery
  • medical procedures
  • dental surgery or procedures.


How should the patient take donepezil hydrochloride tablets?
  • Give donepezil hydrochloride tablets exactly as prescribed by the doctor. Do not stop donepezil hydrochloride tablets or change the dose yourself. Talk with the doctor first.
  • Give donepezil hydrochloride tablets one time each day. Donepezil hydrochloride tablets can be taken with or without food.
  • If you miss giving the patient a dose of donepezil hydrochloride tablets, just wait. Give only the next dose at the usual time. Do not give 2 doses at the same time.
  • If donepezil hydrochloride tablets are missed for 7 days or more, talk with the doctor before starting again.
  • If the patient takes too many donepezil hydrochloride tablets at one time, call the doctor or poison control center, or go to the emergency room right away.
What are the possible side effects of donepezil hydrochloride tablets?

Donepezil hydrochloride tablets may cause the following serious side effects:
  • slow heartbeat and fainting. This happens more often in people with heart problems. Call the doctor right away if the patient faints while taking donepezil hydrochloride tablets.
  • more stomach acid. This raises the chance of ulcers and bleeding. The risk is higher for patients who had ulcers, or take aspirin or other NSAIDs.
  • worsening of lung problems in people with asthma or other lung disease.
  • seizures.
  • difficulty passing urine.

Call the doctor right away if the patient has:

  • fainting.
  • heartburn or stomach pain that is new or won’t go away.
  • nausea or vomiting, blood in the vomit, dark vomit that looks like coffee grounds.
  • bowel movements or stools that look like black tar.
  • new or worse asthma or breathing problems.
  • seizures.
  • difficulty passing urine.

The most common side effects of donepezil hydrochloride tablets are:

  • nausea
  • diarrhea
  • not sleeping well
  • vomiting
  • muscle cramps
  • feeling tired
  • not wanting to eat
These side effects may get better after the patient takes donepezil hydrochloride tablets for a while. This is not a complete list of side effects with donepezil hydrochloride tablets. For more information, ask the doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should donepezil hydrochloride tablets be stored?



Keep donepezil hydrochloride tablets and all medicines out of the reach of children.
 
General information about donepezil hydrochloride tablets





What are the ingredients in donepezil hydrochloride tablets?

Active ingredient:

Inactive ingredients:

Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 5MG


NDC 62756-440-81
Donepezil Hydrochloride Tablets
5 mg
Rx only
90 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
Pharmacist: Dispense the Patient information sheet
Donepezil Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON - 5MG


NDC 62756-440-65
Donepezil Hydrochloride Tablets
5 mg
Rx only
For in-institution use only
100 (10 X 10) Unit-Dose Tablets
THIS UNIT-DOSE PACKAGE IS NOT CHILD-RESISTANT
SUN PHARMACEUTICAL INDUSTRIES LTD.
Pharmacist: Dispense the Patient information sheet
Donepezil Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 10MG


NDC 62756-445-81
Donepezil Hydrochloride Tablets
10 mg
Rx only
90 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
Pharmacist: Dispense the Patient information sheet
Donepezil Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON - 10MG


NDC 62756-445-65
Donepezil Hydrochloride Tablets
10 mg
Rx only
For in-institution use only
100 (10 X 10) Unit-Dose Tablets
THIS UNIT-DOSE PACKAGE IS NOT CHILD-RESISTANT
SUN PHARMACEUTICAL INDUSTRIES LTD.
Pharmacist: Dispense the Patient information sheet
Donepezil Hydrochloride

Donepezil Hydrochloride

Donepezil Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-440
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE DONEPEZIL 5 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
hydroxypropyl cellulose
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
talc
MAGNESIUM STEARATE
polyethylene glycol 6000
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 7 mm 440 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-440-83 30 in 1 BOTTLE
2 NDC:62756-440-81 90 in 1 BOTTLE
3 NDC:62756-440-88 100 in 1 BOTTLE
4 NDC:62756-440-08 100 in 1 BOTTLE
5 NDC:62756-440-18 1000 in 1 BOTTLE
6 10 in 1 BLISTER PACK
7 10 in 1 BLISTER PACK
8 NDC:62756-440-65 10 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090493 2011-06-01


Donepezil Hydrochloride

Donepezil Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-445
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE DONEPEZIL 10 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
hydroxypropyl cellulose
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
talc
MAGNESIUM STEARATE
polyethylene glycol 6000
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
YELLOW 9 mm 445 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-445-83 30 in 1 BOTTLE
2 NDC:62756-445-81 90 in 1 BOTTLE
3 NDC:62756-445-88 100 in 1 BOTTLE
4 NDC:62756-445-08 100 in 1 BOTTLE
5 NDC:62756-445-18 1000 in 1 BOTTLE
6 10 in 1 BLISTER PACK
7 10 in 1 BLISTER PACK
8 NDC:62756-445-65 10 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090493 2011-06-01


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