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These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: | DONEPEZIL HYDROCHLORIDE

04:36 EDT 27th August 2014 | BioPortfolio

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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%
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%
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
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

Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications.

A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol.

IMAGE Donepezil Structure.jpg

In a published study, female rats were given single doses of donepezil and memantine by intraperitoneal injection, each alone or in combination. When given in combination with memantine, donepezil increased the incidence and severity of memantine-induced neurodegeneration. The relevance of this finding to humans is unknown.

IMAGE Donepezil figure 1.jpgIMAGE Donepezil figure 2.jpgIMAGE Donepezil figure 3.jpgIMAGE Donepezil figure 4.jpgIMAGE Donepezil figure 5.jpgIMAGE Donepezil figure 6.jpgIMAGE Donepezil figure 7.jpgIMAGE Donepezil figure 8.jpgIMAGE Donepezil figure 9.jpgIMAGE Donepezil figure 10.jpgIMAGE Donepezil 5 mg_30 Tablets.jpgIMAGE Donepezil 10 mg_30 Tablets.jpg

Manufacturer

WOCKHARDT LIMITED

Active Ingredients

Source

Drugs and Medications [603 Associated Drugs and Medications listed on BioPortfolio]

Donepezil hydrochloride [Sun Pharmaceutical Industries Limited ]

These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets Donepezil Hydroch...

Donepezil hydrochloride [WOCKHARDT USA LLC]

These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezi...

Donepezil hydrochloride [Major Pharmaceuticals]

These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezi...

Donepezil hydrochloride [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets.Donepezil Hydroch...

Donepezil hydrochloride [Solco Healthcare US LLC]

These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil hydroc...

Clinical Trials [2130 Associated Clinical Trials listed on BioPortfolio]

Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial

The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of done...

A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease

The primary objectives are to confirm that donepezil hydrochloride has superior efficacy in improving cognitive function, as measured by Alzheimer's Disease Assessment Scale-Cognitive subs...

An Evaluation Of The Efficacy And Safety Of Donepezil Hydrochloride (E2020) In Migraine Prophylaxis

The purpose of this extension study was to evaluate the safety and efficacy of donepezil hydrochloride after extended use in migraine prophylaxis. Efficacy will continue to be evaluated.

Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease

Twenty-four week, prospective, randomized, double-blind, placebo-controlled, parallel-group study.

Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17

The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, a...

PubMed Articles [238 Associated PubMed Articles listed on BioPortfolio]

Evidence for the involvement of TNF-α, IL-1β and IL-10 in the antinociceptive and anti-inflammatory effects of indole-3-guanylhydrazone hydrochloride, an aromatic aminoguanidine, in rodents.

Indole-3-guanylhydrazone hydrochloride (LQM01) is a new derivative of aminoguanidine hydrochloride, an aromatic aminoguanidine.

Chemometrics-assisted spectrophotometric green method for correcting interferences in biowaiver studies: Application to assay and dissolution profiling study of donepezil hydrochloride tablets.

A green, simple and cost effective chemometric UV-Vis spectrophotometric method has been developed and validated for correcting interferences that arise during conducting biowaiver studies. Chemometri...

Donepezil for Compulsive Behavior in Degenerative Dementia: Case Series.

Diagnosing and managing dementia, presenting with compulsions is challenging. Presented are three cases, a possible representative subset of the Donepezil responders. Selective degeneration of dorsola...

Association between ABCA1 gene polymorphisms and the therapeutic response to donepezil therapy in Han Chinese patients with Alzheimer's disease.

It is reported that ABCA1, which plays a key role in cholesterol transport and apolipoprotein E (APOE) metabolism in the brain, is related to Alzheimer's disease. However, few studies have focused on ...

Association between total dose of ritodrine hydrochloride and pulmonary oedema in twin pregnancy: a retrospective cohort study in Japan.

Pulmonary oedema is recognised as a severe side effect of ritodrine hydrochloride. Recently, the number of twin pregnancies has been increasing. Few studies have reported the association between total...

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