Aricept Evess 10mg Eisai treat symptoms of Azheimer disease (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Donepezil Hydrochloride
Ingredient Intelligence due to cerebrovascular blood vessels, Alzheimer

Ingredient

Composition information	Content
Donepezil Hydrochloride	10mg

Uses

indications

Aricept Evess 5mg is indicated in the following cases:

The treatment of Alzheimer disease is mild, medium and severe.

Treatment of intellectual dementia due to blood vessels (dementia in cerebrovascular disease).

Pharmacokology

Donepezil Hydrochloride is a special inhibitor and recovery of acetylcholininesterase is a dominant cholinesterase in the brain. In In Vitro test, Donepezil Hydrochloride inhibits this enzyme 1,000 times stronger than butyrylcholininesterase, an enzyme present mainly outside the central nervous system.

Intellect dementia in Alzheimer's disease

Alzheimer's disease is mild to medium level:

In patients with intellectual dementia in Alzheimer's disease participating in the sieve test, the use of Aricept Evess 5mg The only dose per day 5 mg or 10 mg creates an inhibition of active activity Acetylcholinesterase in a stable state (measured in the pink blood cell membrane) is 63.6% and 77% in accordance with the corresponding corresponding measurement of the corresponding measurement of the corresponding measured by the corresponding measurement of the corresponding measured by the correspondence Dosage. Therefore, Aricept Evess 5mg is not considered any effect on the progression of the disease. Statistics depend on the dose with percentage of patients considered to be responding to treatment.

The efficiency of Aricept Evess 5mg in the treatment of intellectual dementia due to blood vessels has been studied in three verified trials with a place of place of place that lasts for 6 months, of which the standard of dementia diagnosis due to NinDS -Aen groups (National Institute of Neurological Disorders and Stroke - International Association for research and teaching of neurological science) is used to identify research groups. All use all 3 criteria for evaluation has been conducted to conclude Donepezil therapy. Aricept Evess 5mg proves a significant increase in statistical significance with a percentage of patients who are considered to be responding to treatment.

The highest concentration in plasma is about 3 to 4 hours after drinking.

Series in plasma and area under the curve increases proportional to the dose. The half -life is about 70 hours, so the only daily dose will lead to a stable state of stability.

The stable state is achieved within 3 weeks after the beginning of the therapy.

Once a stable state, the concentration of Donepezil hydrochloride in plasma and the activity of the relevant pharmacological energy shows that there is very little change throughout the day. Food does not affect the absorption of Donepezil hydrochloride.

Distribution:

About 95% Donepezil Hydrochloride is attached to human plasma proteins.

The cohesion with the plasma protein of 6-O-Desmethyl Donepezil metabolic works is not well known. Donepezil Hydrochloride distribution in different tissues has not been clearly researched.

However, in a large -scale study conducted on healthy volunteers, 240 hours after using the single dose of 5mg Donepezil Hydrochloride was marked 14C, about 28% of the healed islands have not been recovered. This shows that Donepezil Hydrochloride and/or its metabolites can exist in the body for more than 10 days.

Metabolism/excretion:

Donepezil Hydrochloride is eliminated in urine in both forms of unchanged and metabolic forms by the Cytochrome P450 system into many metabolites, not all of these metabolites are determined.

After using the single dose of 5mg Donepezil Hydrochloride is marked by 14C, the radioactive level in plasma, shown by the percentage of the dose percentage, is mainly present in the form of Donepezil Hydrochloride unchanged (30%), 6-O-Desmethyl donepezil (11%-the only metabolic substance that shows similar activity with Doneepe Hydrochloride), Donepezil-Cis-N-Oxide (9%), 5-O-Desmethyl Donepezil (7%) and Glucuronide Complex of 5-O-Desmethyl Donepezil (3%).

About 57% of the total amount of radioactivity has been recovered from urine (17% in the form of unchanged Donepezil), and 14.5% are recovered from feces, showing the biological change and the excretion of urine is the main excretion sugar. There are no signs that Donepezil Hydrochloride and/or any of its metabolites participate in the intestinal cycle.

Donepezil concentration in plasma decreases over 70 hours of sale.

Sex, race and history of smoking have no clinical significant effect on the concentration of Donepezil Hydrochloride in plasma. Donepezil's pharmacokinetics have not been officially studied in healthy elderly people or in patients with dementia in Alzheimer's disease or patients with dementia due to blood vessels. However, the average concentration in the plasma of patients is almost equivalent to healthy volunteers.

Patients with mild to medium-sized liver failure have an increase in Donepezil concentration in a stable state, the area under the average concentration curve is about 48% and the highest concentration in plasma (CMAX) is about 39%.

Before taking Aricept Evess 10mg Eisai treat symptoms of Azheimer disease (2 blisters x 14 tablets)

How to use

drink in the evening right before going to bed. Must put the tablet in the tongue and let the tablet disintegrate before swallowing, or not with the water, depending on the wishes of the patient.

Dosage

Elderly/Elderly:

The treatment begins at a dose of 5 mg/day (1 -dose per day). The dose of 5 mg/day should be maintained for at least 1 month to be able to evaluate the earliest clinical response to the treatment as well as help achieve the concentration of Donepezil Hydrochloride in a stable state. After 4 - 6 weeks of clinical evaluation in patients treated at 5 mg/day, ARICEPT EVESS dose can be increased by 5mg to 10 mg/day (1 -day dose/day). The maximum dose/day is recommended for 10mg. Doses greater than 10 mg/day have not been studied in sieve tests.

When stopping treatment, it is possible to see the decrease in the beneficial effects of Aricept Evess 5mg. There is no sign of feedback effect after sudden treatment.

kidney failure and liver failure:

A similar regimen can be used for patients with renal failure, because this condition does not affect the clearance of Donepezil Hydrochloride.

Because there may be significant changes in the liver failure to moderate to moderate (see pharmacokinetics), the dose should be adjusted depending on the tolerance of each patient. No data in patients with severe liver failure.

Children:

Aricept Evess 5mg is not recommended for children.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Signs of cholinergic stimulation related to the dose recorded in experimental animals include: reducing arbitrary movements, lying on your stomach, staggering gait, tearing, vibration convulsions, reduced respiratory relief, saliva secretion, pupils, local muscle spasms and surface heat decreases.

Overdose of CholineseTerase inhibitors can lead to a stimulation of the cholinergic system characterized by serious nausea, vomiting, saliva secretion, sweating, slow heartbeat, lowering blood pressure, reducing respiratory, circulatory and seizures. It is likely to increase my body weakness and can lead to death if the respiratory muscles are affected.

As well as in any case of overdose, use measures to support the whole body. The third -order anti -anti -cholinergic such as atropine can be used as an antidote in the case of an overdose of Aricept Evess 5mg.

Should use intravenous Atropine sulphate with titration doses until the desired effect: the starting dose from 1 to 2mg intravenously with the next dose is based on clinical response.

The typical response to blood pressure and heart rate has been recorded with drugs that are similar to cholin when used simultaneously with four -level anti -cholinergic drugs like glycopyrrolate. It is unclear whether Donepezil Hydrochloride and/or its metabolites can be eliminated by the fertilizer (hemolysis, peritoneal or dialysis).

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Aricept Evess 5mg, you may experience unwanted effects (ADR).

The most common side effects are diarrhea, muscle spasms, fatigue, nausea, vomiting and insomnia. Records of side effects for similar severe alzheimer disease for mild to moderate alzheimer disease. The table below reflects the frequency of side effects in patients being treated with Aricept Evess 5mg at all stages of Alzheimer's disease.

Very common, ADR> 1/10

Gastrointestinal disorders: diarrhea, nausea.

all body: headache.

Common, ADR> 1/100

Infections and parasites infection: Common cold.

Mental disorders: illusion, agitation, aggressive behavior.

Nervous system disorders: fainting, dizziness, insomnia.

Gastrointestinal disorders: Vomiting, abdominal disorders.

Skin and subcutaneous tissue disorders: rash, itching.

Muscle disorders, connective tissue and bone: Muscle spasticity.

Kidney and urinary disorders: urinary incontinence.

Body: fatigue, pain.

Lesion and poisoning: Accidents.

Uncommon, 1/1000

Nervous system disorders: epilepsy.

Heart disorders: Slow heart rate.

Gastrointestinal disorders: gastric bleeding, gastrointestinal ulcer.

Testing: slight increase in the concentration of creatine kinase in the blood.

Rare, 1/10000

Nervous system disorders: Symptoms of foreign tower.

Heart disorders: Sinus, atrioventricular block.

Liver and bile disorders: liver dysfunction, including hepatitis.

Instructions on how to handle ADR

Cases of hallucinations, agitation and aggressive behaviors can improve by reducing the dose, cases of liver dysfunction of unknown causes, should consider stopping treatment.

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Aricept Evess 5mg contraindications in the following cases:

Patients with hypersensitivity to Donepezil Hydrochloride, Piperidine derivatives or any excipients in the formula.

Pregnant women and nursing women.

Be cautious when using

Treatment should be started by an experienced physician in the treatment of dementia. The diagnosis should be based on recognized instructions (such as DSM IV, ICD 10). Donepezil treatment should only start when there are people who take care of patients, responsible for monitoring patients taking medication regularly. Maintenance treatment may continue when the drug is still effective for patients.

Therefore, the clinical effect of Donepezil should be re -evaluated on a regular basis. Should consider stopping treatment when the treatment effect is no longer available. The response of each individual for Donepezil cannot predict. Using Aricept Evess 5mg for patients with other types of intellectual dementia or other types of memory decline (such as mild loss of memory loss) is being studied.

Anesthesia: Aricept Evess 5mg is a cholinesterase inhibitor capable of enhancing the muscle relaxation of Succinylcholine in anesthesia.

Cardiovascular disease: Due to the pharmacological effect of the drug, the cholinesterase inhibitors may have sympathetic neurological effects on the heart rate (such as slow heart rate). This tolerance can be especially important for patients with "sinus node impairment syndrome" or transmission diseases on the ventricle of the heart, such as atrial sinus or atrial block. There have been reports to record cases of fainting and epilepsy. When examining such patients, it is important to pay attention to the ability to have a cardiac bloc or a long sinus stop.

Gastric - intestinal pathology: Patients with high risk of ulcer, such as a history of ulcerative or simultaneous use of nonsteroidal anti -inflammatory drugs (NSAIDs) should be monitored with symptoms of stomach. However, Aricept clinical studies show that there is no increase, compared to placebo, in terms of digestive ulcers or stomach bleeding.

Genital - Urology: Although not recorded in Aricept's clinical trials, drugs have the same effect as choline that can cause urinary retention.

neuropathy - epilepsy: The drugs that have the same effect as choline are thought to be capable of causing body convulsions. However, epilepsy can also be a manifestation of Alzheimer's disease. Drugs that have the same effect as choline can worsen or cause foreign symptoms.

Respiratory pathology: Be careful when prescribing cholinesterase inhibitors for patients with a history of asthma or obstructive pulmonary disease due to the cholin -like effect of the drug. The simultaneous use of Aricept Evess 5mg should be avoided with acetylcholinininininiserase inhibitors, the owner or antagonist of the cholinergic system.

Severe liver failure: There is no data for patients with severe liver failure.

This pharmaceutical contains lactose. Patients with galactose tolerance problems, lactase deficiency or absorbent glucose-galactose due to rare genetics, no use of this drug.

The mortality rate in clinical trials of blood vessel decline: 3 clinical trials in 6 months include E2020-307 test (n = 404), E2020-308 (n = 423) and E2020-319 (n = 648) to study each patient that meets NinDS-aliren standards, surely or may be in intelligence due to blood vessels (VAD).

NinDS-aliren standards are set to identify patients whose dementia is only due to blood vessels and to eliminate patients with Alzheimer's disease.

In the first study, the mortality rate was 2/198 (1.0%) at a dose of 5mg of Donepezil Hydrochloride, 5/206 (2.4%) at a dose of 10mg Donepezil Hydrochloride and 7/199 (3.5%) with placebo.

In the second study, the mortality rate is 4/208 (1.9%) at a dose of 5mg of Donepezil Hydrochloride, 3/215 (1.4%) with a dose of 10 mg Donepezil Hydrochloride and 1/193 (0.5%) with placebo.

In the third study, the mortality rate is 11/648 (1.7%) at a dose of 5 mg of Donepezil hydrochloride and 0/326 (0%) with placebo.

The mortality rate in 3 studies of blood vessels in beoccus using Donepezil Hydrochloride (1.7%) is higher in terms of the place of placebo (1.1%), but this difference is not significant in terms of statistical. Most deaths occur when the patient is taking or Donepezil Hydrochloride or placebo is due to blood vessel -related causes because it cannot be excluded in these older objects often have vascular disease.

Analysis in all serious vascular events whether or not life -threatening indicates that there is no difference in the ratio of re -appearing in the Donepezil Hydrochloride group compared to the placebo group.

In the common studies of Alzheimer (N = 4146), and when these Alzheimer studies are combined with other intellectual dementia studies (all n = 6888), the death rate in the placebo group exceeds the Donepezil hydrochloride group in quantity.

The ability to drive and operate machinery

Donepezil has a light to medium influential influence on the ability to drive and use machinery. Intellectual dementia may reduce the ability to drive or reduce the ability to use machines. Moreover, Donepezil can cause fatigue, dizziness and muscle spasms, mainly at the beginning of treatment or dose increase.

The treating doctor should assess regularly about the possibility of a patient treated with Donepezil for continuing driving or operating complex machinery.

Pregnancy

Study studies have been conducted in pregnant mice with a dose of about 80 times the dose in humans and in pregnant rabbits with a dose of about 50 times the dose in humans does not show any signs of the ability to give birth.

However, in a study of pregnant mice given by a dose of about 50 times the dose in humans from the 17th day of pregnancy to the 20th day after birth, there is a slight increase in the amount of property and a slight decrease in the number of mice surviving to the 4th day after birth.

There is no acknowledgment in the test dose lower, about 15 times the dose in humans. Aricept Evess 5mg is not recommended during pregnancy. There is no clinical data on Donepezil during pregnancy.

The period of breastfeeding

It is unclear whether Donepezil Hydrochloride is secreted into breast milk or not and no research in breastfeeding women. Therefore, women are using Donepezil without breastfeeding.

Drug interaction

Donepezil Hydrochloride and/or any of its metabolic products do not inhibit the conversion of theophylin, Warfarin, Cimetidin or Digoxin in humans. The metabolism of Donepezil hydrochloride is not affected by simultaneous use of digoxin or cimetidine.

In vitro studies show that isoenzyme 3A4 and a small part of isenzyme 2D6, in the Cytochrome P450 system that affects the metabolism of Donepez.

Studies on drug interactions have been conducted in vitro showing that ketoconazole, CYP3A4 and quinidine inhibitors, CYP2D6 inhibitors, metabolic inhibitors of Donepezil. Therefore, these substances as well as CYP3A4 inhibitors, such as iTraconazole and erythromycin, and CYP2D6 inhibitors, such as Fluoxetine, can inhibit the metabolism of Donepezil.

In a study in healthy volunteers, Ketoconazole increases the average concentration of Donepezil about 30%.

Enzyme induction agents, such as rifampicin, phenytoin, carbamazepine and alcohol can reduce the concentration of Donepezil.

Because the level of inhibition or induction effects has not been well known, the use of such combined drugs should be cautious.

Donepezil Hydrochloride has the potential to affect drugs with anti -anti -anti -anti -anti -anti -anti -cholinergic activity drugs. It also has the ability to impact the force when treated simultaneously with drugs such as Succinylcholine, other neurological inhibitors, or cholinergic agreements or beta blockers that have the effect on cardiac transmission.

Storage

Do not store over 30 ° C.

Keep the medicine in aluminum blisters before use.

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