Rizax 5mg medicine Davipharm treat symptoms of dementia (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Donepezil HCl

Ingredient

Composition information	Content
Donepezil HCl	5mg

Uses

Indications

Rizax 5 mg Davipharm 4x7 drugs are indicated in cases of symptomatic treatment and temporarily reduce mild and medium -sized dementia in Alzheimer's disease (intellectual dementia before old age or old age dementia).

Pharmacy

Donepezil HCl has the effect of inhibiting acetylcholininesterase (the main cholinalase in the brain) 1000 times higher than buturylinesterase (enzyme present mainly outside the central nervous system).

In patients with memory loss in Alzheimer's disease participating in clinical trials, the daily donepzil use daily from 5 to 10 mg creates an inhibition of Acetylcholininininininininisterase enzyme in equilibrium state (measured in red blood cell membranes) of 63.6% and 77.3% (in order as the above dose) when measuring the last dose. The acetylcholinininininisterase inhibitor of Donepezil HCl (ACNE) in red blood cells is equivalent to the change in the ADAS measurement scale, a sensitive scale that helps to assess memory. However, the possibility of Donepezil changes the process of neurology that has not been studied. So Donepezil cannot be considered to affect the progression of the disease.

pharmacokinetic

absorption

The maximum concentration in plasma is about 3-4 hours after drinking. Plasma and AUC concentrations increase proportional to the dose. The donepezil disposal time is about 70 hours, so the use of daily order is repeated, resulting in a slow equilibrium. The equilibrium state is achieved within 3 weeks after the beginning of treatment. When the equilibrium of Donepezil HCl plasma is reached and the pharmacological properties are relevant to change throughout the day. Food does not affect the absorption of Donepezil HCl.

Distribution

Donepezil HCl binds about 95% of plasma proteins in humans. It is unclear that the ratio of plasma protein binding of metabolites has 6-O-Desmethylonepezile activity. The distribution of Donepezil HCl in many tissues of the body has not been studied. However, in a balanced study study on a healthy male volunteer, after taking the single donepezil HCl, 14C 240 hours, about 28% of the dose was not recovered. This suggests Donepezil HCl and/or its metabolites can exist in the body for more than 10 days.

Metabolism and elimination

Donepezil HCl is eliminated in urine in both non -metabolic form and many metabolites through cytochrom P450, and has not yet identified all these metabolites. After taking the single dose of Donepezil HCl 5 mg highlighted 14C, the concentration of plasma radio isotopes in the form of% compared to the main dose is Donepezil HCl without metabolism (30%), 6-O-Desmethyl Donepezil (11%-the only metabolic substance showing the same activity as Donepezil), Donepezil-CIS-N-Oxyd (9%), 5-DESMYLYLYLYLYLYLYLYLYLYLYLYLYLYLYLYLYLYLYLY Donepezil (7%) and glucuronid conversion agent of 5-O-Desmethyl Donepezil (3%). About 57% of total radioactive dose found in urine (17% in the form of non -metabolic Donepezil), and 14.5% found in feces, suggested biological metabolism and excreted through urine is the main excretion path of Donepezil. There is no evidence that Donepezil and/ or its metabolites have a diverse cycle.

Donepezil's sale time is about 70 hours.

Special subjects

Sex, race and history of smoking do not significantly affect the blood concentration of Donepezil HCl. Donepezil's pharmacokinetics have not been officially studied in healthy elderly people or in patients with Alzheimer or patients with intellectual dementia due to blood vessels. However, the concentration of plasma drugs in patients is similar to young people.

Patients with mild hepatic impairment to have a concentration of Donepezil in a stable state; The average AUC increased by 48% and the average CMAX increased by 39%.

Before taking Rizax 5mg medicine Davipharm treat symptoms of dementia (4 blisters x 7 tablets)

How to use

Donepezil is taken in the evening before going to bed, no need to care for the meal; Food does not affect the speed and level of absorption.

Dosage

Adults, the elderly

Starting treatment at a dose of 5 mg/day (1 time). The 5 mg dose should be maintained for at least 1 month to be able to evaluate the clinical response as soon as possible for treatment and achieve concentration in the stable state of Donepezil HCl. After clinical evaluation after 1 month of using Donepezil HCl dose 5 mg/day, Donepezil HCl can be increased to 10 mg/day (1 time). The maximum recommended dose is 10 mg. There is no study using a dose higher than 10 mg/day.

It is advisable to start treatment under the supervision of a doctor who has experience in the diagnosis and treatment of intellectual dementia caused by Alzheimer. Treatment should only be started with Donepezil if there is a regular care person to monitor the medication of the patient. It is possible to continue treatment as long as the drug still has the benefit of treatment for patients. Therefore, the clinical benefits of Donepezil should be re -evaluated regularly. It is advisable to consider stopping the drug when there is no longer effective treatment. Unable to predict the response of each patient with Donepezil.

When stopping treatment, the beneficial effect of Donepezil HCl will slowly decrease.

Patients with kidney failure and liver failure

Can use the same dose regimen for patients with renal failure, because the clearance of Donepezil HCl is not affected by this condition.

Because the AUC of Donepezil HCl can increase in mild to medium liver failure patients, increasing the dose based on the ability to tolerate each patient. There is no medication information for patients with severe liver failure.

Children

Do not recommend taking drugs for children under 18 years old.

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?

Symptoms

Overdose from cholinesterase inhibitors can lead to a gain of chololinner There is a possibility of increasing myasthenia gravis and may lead to death if the respiratory muscles are affected.

Handling

In any case of overdose with any cholinesterase inhibitors, body support measures should be used. The third -generation cholinergic anti -anticholic drugs like atropine can be used as an antidote in the case of an overdose with Donepezil. Atropin Sulfate is used at 1-2 mg starting dose, intravenously; The next dose is based on clinical response. There has been an abnormal response to blood pressure and heart rate with other antihypertensive drugs when used with the 4th -generation Cholinergic drugs like Glycopyrrolat. It is unclear whether Donepezil HCl and/or its metabolic substance can be removed by hematopopsoamus (hemodialysis, peritoneal dialysis or dialysis).

What to do when forgetting a dose? Do not drink twice as doses.

If you forget to use the drug for more than 1 week, contact your doctor before using the medication again.

Side Effects

When using Rizax 5 mg Davipharm 4x7, you may experience unwanted effects (ADR).

The most common ADR is diarrhea, cramps, fatigue, nausea, vomiting and insomnia. Unwanted effects of frequency and organ system.

Very common, ADR ≥ 1/10

Digestive: diarrhea, nausea.

Body and sugar use: headache.

Common, 1/100

Infections and parasites: Usually.

Metabolism and nutrition: Anorexia.

Mental: illusion, agitation, extremist behavior, nightmares.

nerve: faint, dizziness, insomnia.

digest: vomiting, stomach discomfort.

Skin and subcutaneous tissue: rash, itching.

Muscle and connective tissue: cramps.

Kidney and urinary tract: urinary incontinence.

Systemic and sugar used: fatigue, pain.

Trauma and poisoning: Accidents.

Uncommon, 1/1000

Neurological: convulsions.

heart: Slow heart rate.

digestive: gastrointestinal bleeding, stomach and duodenal ulcer, increased salivation.

Testing: slight increase in serum creatinine concentration in serum.

Rare, 1/10000

Neurological: Symptoms of foreign tower.

heart: Atrial sinus block, atrial block.

liver: Liver dysfunction includes hepatitis.

Very rare, ADR

Neurological: Malignant neuron sense.

Bone muscle and connective tissue: Muscle pattern.

Instructions on how to handle ADR

The drug can cause other unwanted effects, advising patients to notify unwanted effects when taking the drug.

Warnings

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

Contraindicated

Rizax 5 mg Davipharm 4x7 contraindications in cases of hypersensitivity to Donepezil, piperidin derivatives or any ingredients of the drug.

Caution when using

There has been no study on the use of Donepezil HCl for patients with severe dementia due to Alzheimer, other types of intellectual decline or other forms of memory impairment (such as age -on -age loss).

Anesthesia

Donepezil HCl, such as cholinesterase inhibitors, can cause sucinylcholin stretchy muscle relaxation during anesthesia.

Cardiovascular condition

Because of its pharmacological properties, the cholinesterase inhibitors may have a sympathetic effect on the heartbeat (such as slow heart rate). This effect may be particularly important in patients with sinus syndrome or transmission disorders on the ventricular heart of another heart, such as atrial sinus block or atrial atrial block.

There have been fainting reports and epilepsy. When testing these patients, it is recommended to consider the ability to block heart or stop sinus.

digestion

Patients with an increased risk of ulcer, such as patients with a history of ulcerative disease or patients with NSAIDs, should be monitored with symptoms. However, clinical research with Donepezil HCl shows that there is no increase in the rate of stomach ulcers or gastrointestinal bleeding compared to the control group.

urinary system

Although it has not been clinically not seen when using Donepezil HCl, drugs that work like cholin may cause obstruction of the urethra.

Neurological condition

Medications that are like cholin can cause a whole body convulsions. However, epilepsy can also be a manifestation of Alzheimer's disease. Cholin similar substances are likely to cause or aggravate the surgeon syndrome.

Malignant neuroleptic syndrome (NMS) is a condition that can be life -threatening characteristic by fever, hard muscle, loss of sympathetic air conditioning, consciousness changes and increasing serum creatinine levels; Other signs may include myoglobinuria (pattern) and acute renal failure. NMS has been reported when using Donepezil, especially in patients with anti -psychotic drugs. Treatment should be stopped if the patient shows signs and symptoms of NMS, or has an unexplained high fever without other clinical manifestations of NMS.

Lung condition

Because of its cholin -like effect, cholinesterase inhibitors should be carefully used in patients with a history of bronchial asthma or obstructive pulmonary disease.

Avoid using Donepezil HCl in combination with other acetylcholininesotase inhibitors, shipping or cholinergic antagonists.

Patients with severe liver failure

There is no information on Donepezil in patients with severe liver failure.

The ability to drive and operate machinery

Dizziness, sleep, fatigue and muscle spasms may occur, especially when starting treatment or when increasing the dose of Donepezil, so it is necessary to be cautious when driving or operating machinery.

Pregnancy

There is no clinical data on the use of Donepezil HCl for pregnant women, so it is not used for women during pregnancy.

Breastfeeding period

whether Donepezil HCl whether or not the secretion is in human milk and there is no data on the use of this medication for breastfeeding women. Therefore, women who are using Donepezil should not breastfeed.

Drug interaction

Donepezil HCl and/or any of its metabolites do not inhibit the metabolism of theophyllin, warfarin, cimetidine or digoxin in humans. The metabolism of Donepezil HCl is not affected when used with digoxin or cimetidine. In vitro research shows the isenzyme cytochrom P450 3A4 and a small part 2D6 involved in the metabolism of Donepezil.

Research on drug interactions conducted on in vitro shows ketoconazole and quinidine, CYP3A4 and 2D6 inhibitors correspond, inhibit the metabolism of Donepezil. So these drugs and CYP3A4 inhibitors such as otraconazole and erythromycin, and CYP2D6 inhibitors such as fluoxetin can inhibit Donepezem metabolism.

In a study in a healthy volunteer, Ketoconazole increased the average concentration of Donepezil about 30%. Enzyme induction drugs such as rifampicin, phenytoin, carbamazepin and alcohol can reduce the concentration of Donepezil. Because the level of inhibition or induction is unknown, it is careful when using Donepezil with these drugs.

Donepezil HCl can affect drugs with anti -anti -anti -anti -anti -anti -cholinergic activity drugs. Donepezil HCl may also have a synergistic effect when used with drugs such as Succinylcholin, other neurological inhibitors or cholinergic agreeds or beta blockers that affect cardiac transmission.

Storage

Keep the drug in the original packaging of the manufacturer, covered.

Put the drug in a dry place, avoid light, the temperature does not exceed 30 ° C and out of the reach of children.

Do not use the drug after the expiry date indicated on the packaging (box and blister box).

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