HANIA 10MG Verisfield medicine supports the treatment of intellectual decline (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Donepezil

Ingredient

Composition information	Content
Donepezil	10mg

Uses

indications

HANIA drug indicated in the following cases:

Treatment of symptoms and temporarily reduces mild, medium and severe dementia in Alzheimer's disease (dementia before old age or old age dementia). Cholinininesase.

ATC code: N06DA02

Donepezil Hydrochlorid, a derivative of piperidin, is a reversible inhibitor Acetylcholininininininisterase, a dominant cholinesterase in the brain. The drug is a reversible cholinesterase against cholinesterase (such as acetylcholininesterase) and causes this active ingredient, thus inhibiting acetylcholin hydrolysis. This increases the concentration of acetylcholine in the synap cholinergic. Donepezil's anti -anti -acetylicase activity is relatively typical for acetylcholinesase in the brain compared to the inhibition of butyrylcholininesterase in peripheral tissues.

The deficiency of acetylcholin due to the selective loss of cholinergic nerve cells in the cerebral cortex, frontal lobe, peak lobe, hydrostatic, fillet and horses and also in the base lymph nodes and lowering the brain stitches are recognized as one of the first pathophysiological characteristics of Alzheimer's disease that causes dementia and disabilities.

Because the cortex shortage has this neurotransmitter has explained a number of clinical manifestations of mild and medium -sized dementia, the enhancement of cholinergic function with an acetylcholininesterase inhibitors such as Tacrin or Donepezil is one of the treatments.

Because the central nerve cell system finally comes to broad degeneration in patients with Alzheimer's disease, in theory and effectiveness of anti -cholinesterase drugs can decrease when the disease progresses and when there is fewer cholinergic nerve cells.

Dynamic pharmacokinetics

absorption

Donepezil hydrochlorid is well absorbed through the gastrointestinal tract, the maximum concentration of 10 mg tablets in plasma is achieved within 3-4 hours after drinking. The concentration in plasma and the area under the curve increases proportional to the dose. The last half -life of the drug is about 70 hours, so the only daily dose will lead to gradual approach to a stable state.

The almost stable state will be achieved within 3 weeks after the beginning of treatment. Once a stable state has been achieved, the concentration of donepezil hydrochlorid in plasma and related pharmacokinetic parameters will be very little changing at different times of the day.

Food does not affect the absorption of Donepezil Hydrochlorid.

distribution

about 95% Donepezil hydrochlorid binds to plasma proteins. The binding to plasma protein of metabolites has the unknown 6-O-Desmetheponepezil. The distribution of Donepezil hydrochlorid in different tissues of the body is not well known.

However, in a large-scale rescue, the male volunteer is healthy, using a single dose of 5 mg 'C-Donepezil Hydrochlorid, after 240 hours, about 28% of the marks have not been recovered. This shows that Donepezil hydrochlorid and
or its metabolites can exist in the body for more than 10 days.

metabolism, excretion

Donepezil hydrochlorid excreted through urine in both constant forms and metabolites.

Most metabolic drugs through the Cytochrom P450 system into many different metabolites and have not yet identified all the metabolites of the drug. After taking a single dose of 5 mg Donepezil hydrochlorid marking 14C, the radioactive level in plasma, calculated in%dose%, is mainly in the form of constant (30%), 6-O-Desmethyl Donepezil (11%)-the only metabolitus shows the same activity as Donepezil Hydrochlorid), DONEPELI-CIS-N-OXID (9%), 9%), 9%), 9%), 9%), 9%), 9%), 9%), 9%), 9%) 5-O-Desmethyl Donepezil (7%) and Glucuronid complexes
of 5-O-Desmethyl Donepezil (3%). About 57% of the total amount of radioactivity is recovered from urine (17% in constant form), and 14.5% are recovered from feces, showing biological changes and elimination through urine is the main exhaust pathway of the drug. There is no evidence that Donepezil Hydrochloride and/or any of its metabolic substances are involved in the gut cycle.

Donepezil concentration in plasma decreases with a half -life of about 70 hours. Gender, race and history of smoking do not significantly affect the plasma concentrations of Donepezil Hydrochlorid. Donepezil's pharmacokinetics are not officially studied in healthy elderly people or Alzheimer patients or dementia in cerebrovascular disease. However, the average concentration in the blood in these patients is close to its concentration in healthy volunteers.

Patients with mild hepatic impairment have increased the concentration of Donepezil in a stable state, the area under the average curve 48% and an increase of CMAX 39%.

Before taking HANIA 10MG Verisfield medicine supports the treatment of intellectual decline (3 blisters x 10 tablets)

How to use

oral medication. The drug can be used with meals or no, food does not affect the speed and level of absorption of Donepezil.

Swallow all the tablets with water. Take medicine in the evening, before going to bed.

Dosage

adults

The starting dose is 5 mg x 1 time/ day. Maintain a dose of 5 mg/ day for at least 1 month to evaluate the original clinical response to treatment as well as achieve stable drug concentration.

After a month of clinical observation at a dose of 5 mg/day, the dose can be increased to 10 mg once a day. The maximum recommended dose is 10 mg. Doses greater than 10 mg have not been studied in clinical trials.

The treatment process should be started and monitored by a doctor who has experience in diagnosis and memory impairment. The diagnosis should be conducted according to the related instructions (such as DSM IV, ICD 10). Donepezil should only start treatment if the patient has caregivers to regularly monitor the patient's oral medication.

Continue to maintain treatment if there is still benefit of treatment. Therefore, the benefits of Donepezil's sieve should be re -evaluated regularly. Donepezil can be considered in case of treatment is no longer effective. No prediction of each patient's response to Donepezil.

When stopping treatment, the beneficial effects of Donepezil will decrease.

Children

Do not recommend using drugs for children and teenagers under 18 years old.

liver failure, kidney failure

Can use the same treatment regimen for patients with renal failure because in this case, the clearance of Donepezil Hydrochlorid is not affected.

may consider increasing the dose according to the ability to tolerate each patient, but normally, no dose adjustment in mild and medium liver failure people. There is no data on drug use for patients with severe liver failure.

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? There is likelihood of increasing myasthenia and death if the respiratory muscles are affected.

Handling: In any overdose of the acetylcholininininiserase inhibitors, the body -to -body support should be used. Antolinergic anti -cholinergic drugs can be used as an antidote in case of overdose with Donepezil. Atropin Sulfate is used at 1-2 mg starting dose, intravenous injection, the next dose is based on clinical response.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

The most common ADR is diarrhea, muscle spasms, fatigue, anorexia, nausea, vomiting, dizziness, insomnia.Common

: ADR> 1/100

TKTW: Insomnia, headache, pain, fatigue, dizziness, abnormal dreams, agitation, hallucinations, depression, confusion, emotional, personality disorders, fever, drowsiness, abnormal moans, aggression, anxiety, loss of language, paranoia, restlessness, irritability, dizziness. Electrolyte is normal, edema, heart failure, peripheral edema, vasodilation. Itching, rash, skin ulcers, urticaria.

Neuromeria - muscle and bone: Muscle spasticity, back pain, increased creatinine phosphokinase, arthritis, loss of coordination, fracture, abnormal gait, increased lactat dehydrogenase, abnormal, tremor, weak.

Uncommon: 1/1000

TKTW: Epilepsy.

TKTW: Symptoms of the pagoda.

In case of hallucinations, agitation and acts of aggression, need to reduce the dose or stop treatment with Donepezil. In the case of unexplained liver dysfunction, it is advisable to consider stopping treatment with Donepezil.

Warnings

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

Contraindicated

HANIA drug contraindicated in the following cases:

Contraindicated to patients with hypersensitivity to Donepezil, Piperidin derivatives or any ingredients of the drug.

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 drugs on patients with other types of intellectual dementia or other types of memory decline (such as mild loss of memory loss) are being studied.

Anesthesia: Like cholinesterase inhibitors, the drug may increase the sucinylcholin muscle relaxation effect during anesthesia.

Cardiovascular: Due to the mechanism of action, cholinesterase inhibitors may increase the sympathetic effect on the heart rate (such as slow heart rate). This effect may be particularly significant for patients with sinus node impairment syndrome or pulse transmission abnormalities on the heart, for example, atrial sinus block or atrioventricular block. There have been reports on cases of fainting and seizures. Therefore, when treating patients. This needs to consider the ability to block heart or long sinus rest.

Digestive: Patients with high risk of ulcers such as a history of ulcerative disease or being used simultaneously nonsteroidal anti -inflammatory drugs (NSAID) should be monitored to detect ulcerative symptoms. However, clinical studies show that Donepezil does not increase the rate of
stomach ulcers or gastrointestinal bleeding compared to fake.

Genital - urinary: Although not observed in clinical trials, drugs that have the same effect as choli can clog the bladder, urinary retention.

Neurology: The drugs that are like choli are thought to be able to cause seizures. However, convulsions can also be a manifestation of Alzheimer's disease. Choli medications are more aggravated or causing foreign symptoms.

Syndrome of the province of mental illness (NMS): NMS is a province that can be life -threatening, with manifestations of body temperature, muscle hardness, impaired or autonomous neurological disorders, consciousness changes and increased creatinine phosphokinase levels in serum; Reported rare when using Donepezil, especially in patients with simultaneous treatment with anti -psychotic drugs. Other signs may include myoglobin urinary (muscle globin) and acute renal failure. If the patient develops the signs and symptoms of NMS, or the high fever manifestation of unknown causes without clinical manifestations of NMS, should stop treatment.

Lung: Due to the effect of choli -like effects, be careful when using cholinesterase inhibitors for patients with a history of asthma or obstructive pulmonary disease. Donepezil should not be used with acety lcholinesterase inhibitors, shipping owners or cholinergic antagonists.

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

Products containing lactose, patients with rare genetic problems such as galactose intolerance, lactase deficiency or glucose-galactose abutment should not use this product.

Use drugs for pregnant and lactating women

Pregnant women

There is no sufficient data using Donepezil in pregnant women. Animal studies do not show a teratogenic effect but show toxicity in the period of birth and postpartum. The toxicity of the drug has not been determined.

Do not use Donepezil for pregnant women in the case of really necessary.

breastfeeding women

In mice, Donepezil excreted in milk. It is unknown whether Donepezil Hydrochlorid has excreted in human milk or not and has no research on nursing women. Therefore, do not breastfeed during donepezil.

The effect of the drug on driving, operating machinery

Donepezil has a slight or medium impact on the ability to drive and operate machinery. Memory impairment can reduce driving and operate machinery. Moreover, Donepezil can cause fatigue, marriage, dizziness and cramps, which occur mainly when starting to treat or increase the dose. Therefore, be careful when driving or operating machinery.

Drug interaction

Donepezil hydrochlorid and/ or any of its metabolites do not inhibit theophyllin metabolism, warfarin, cimetidin or humoxin in humans. Donepezil metabolism Hydrochlorid is not affected by the use of digoxin or cimetidine. In vitro studies have shown that Cytochrom P450 isoenzyme 3A4 and a small part 2D6 is related to the metabolism of Donepezil.

In Vitro interactive studies shows ketoconazole and quinidine - corresponding to CYP3A4 and 2D6 inhibitors, inhibiting Donepezil metabolism. Therefore, CYP3A4 inhibitors such as otraconazol and erythromycin; And CYP2D6 inhibitors such as fluoxetin can inhibit the metabolism of Donepezil. In a healthy volunteer study, Ketoconazole increased the average Donepezil concentration of about 30%.

Enzyme induction such as rifampicin, phenytoin, carbamazepine and alcohol can reduce the concentration of Donepezil. Because the level of stimulation or inhibition is unknown, it is necessary to be careful when combining these drugs together. Donepezil Hydrochlorid is likely to affect the effect of drugs with anti -anti -anti -anti -anti -cholinergic activity. In addition, the drug has a synergistic effect when treated simultaneously with the drugs that have the effect on the heart transmission such as Succinylcholin, Cholinergic Hematics, Neurology - Muscle Sentors or Beta blockers.

Donepezil can reduce the concentration/ effect of anti -cholinergic drugs, neuromuses - non -reducing muscles.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

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