Aronfate 200 Savi treated acute and chronic schizophrenia (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Amisulpride
Ingredient Savi Pharmaceutical Joint Stock Company

Ingredient

Composition information	Content
Amisulpride	200mg

Uses

indications

Aronfat 200 drugs are indicated in the following cases:

Acute and chronic schizophrenia treatment, with positive symptoms (paranoia, hallucinations, thought disorders ...) and/or negative symptoms (do not show emotions, like isolation ...), including patients with negative symptoms that dominate.

ATC code: n05al05.

Amisulprid has a high affinity, selected with Dopamine receptor group D2/D3 and has no affinity with the receptor D1, D4 and D5.

Unlike classical and typical neuroleptics, Amisulprid has no affinity for serotonin receptors, symptomic nerve receptors, H1 histamine receptors and sympathetic nerve receptors. Amisulprid is also not attached to the sigma position.

In animal studies, high doses of Amisulprid inhibit the dopamine receptor in the border structure more than in the pattern.

In low willow, Amisulprid inhibits the priority of the D2/D3 receptor money Synap, causing Dopamine release.

Amisulprid is effective on both positive symptoms and negative symptoms of schizophrenia.

Dynamic pharmacokinetics

absorption

Amisulprid has two absorption nails: 1 hour and 3-4 hours after drinking. After taking the dose of 50 mg, the amisulprid concentration in plasma corresponds to the two vertices of absorption is 39 ± 3 ng/ml and 54 ± 4 ng/ml. Absolute 48%bioavailability.

A carbohydrate -rich meal significantly reduces AUC (area under the curve - Area Under the Curve), TMAX (time to reach the maximum concentration - Time to Peak Concentration) and CMAX (Maximum Concentration), but fat -rich meals do not affect the above parameters. However, the meaning of this influence clinically has not been determined.

distribution

Amisulprid's distribution volume is 5.8 1/kg. Ratio combined with low protein (16%).

transformation

Amisulprid is less metabolized (about 4% of the dose), forming 2 inactive metabolites.

Elimination

Amisulprid has a 12 -hour waste selling time. The drug is eliminated in the form of unchanged urine.

The renal clearance is 20 liters/hour or 330 ml/min.

Amisulprid does not accumulate and pharmacokinetics does not change after taking the dose repeated. Very few drugs are separated.

Special patient groups

Renal failure: The sale time does not change in patients with renal impairment while the total clearance is 2.5 to 3 times. AUC doubled in patients with mild renal impairment and almost 10 times in medium renal failure patients.

There is no data with a dose of over 50 mg.

Elderly (> 65 years old): Selling time, cmax and AUC increased from 10% to 30% after taking the dose of 50 mg.

There is no data on repeated dose.

Before taking Aronfate 200 Savi treated acute and chronic schizophrenia (3 blisters x 10 tablets)

How to use

oral tablets, oral medications before eating.

Dosage

adjust the dose depending on the response to each patient. Should use the lowest dose effectively.

Adults:

Acute psychosis: 400 - 800 mg/day. In some cases, the dose may be increased to 1200 mg/day. Dosage> 1200 mg/day has not been assessed for safety.

In case the patient has both positive and negative symptoms, prioritizing the dose adjustments to control positive symptoms.

Maintain treatment: The lowest dose is effective depending on the response of each patient.

In case the patient has an dominant negative symptom, taking a dose of 50 - 300 mg/day.

with a dose of ≤ 300 mg/day, oral 1 time/day. With a dosage> 300 mg/day, it should be divided into 2 times.

Children (15 - 17 years old):

Use the dose of adults, under the supervision of a doctor.

Contraindicated use of Amisulprid in children has not puberty.

Elderly:

Be cautious when indicating Amisulprid in the elderly. May need to reduce the dose due to renal failure.

kidney failure:

Creatinine clearance 30 - 60 ml/minute: decrease by 1/2 dose.

Creatinine clearance 10 - 30 ml/minute: Take 1/3 dose. There is no data on patients with severe renal impairment (creatinine clearance Hepatic failure:

Because the drug is less metabolized, there is no need to reduce the dose in patients with 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 do

do when overdose? There have been reports on the enhancement of pharmacological impacts of drugs such as drowsiness, sedation, coma, hypotension and symptoms of foreign tower.

There have been some deaths when combined with other anti -psychotic drugs. In the case of acute poisoning, it is necessary to find out if there is any other drug.

Amisulprid is poorly appraised and no specific antidote.

It is necessary to take appropriate support measures and monitor living functions such as mental monitoring (QT) until the patient recovers.

If serious pagoda symptoms occur, sympathetic inhibitors need to be used.

In case of 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 doses to compensate for missed dose.

Side Effects

When using Aronfat 200 drugs, you may experience unwanted effects (ADR) such as:

Very common, ADR ≥ 1/10

Nervous system: Symptoms of the pagoda (tremor, muscle hard, reduced exercise function, increased salivation, restlessly standing restless, movement disorders). These symptoms are usually mild when using the optimal dose and recover when using anti -vibration drugs without the need to stop Amisulprid. The frequency of outsider symptoms depends on the dose, very low in patients with negative symptoms that dominate with 50 - 300 mg/day.

Common, 1/100 ≤ ADR

Nervous system: drowsiness; Acute muscle tone (crooked neck, eye rotation, jaw tight), these symptoms will cure when taking anti -vibration drugs without stopping Amisulprid. Men, big breasts in men, chest pain, erectile dysfunction. ProLactin concentration will return to normal after stopping amisulprid.

cardiovascular system: lower blood pressure.

The nervous system: convulsions, unmarried movement, have the main rhythm on the tongue and/or face that has been recorded, especially after prolonged medication. Anti -vibration drugs are not effective or worse these symptoms.

Blood and lymphatic system: leukopenia, neutropenia and granulocytes. Cardiac arrest, sudden death. ADR:

Notify the physician the 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

Aronfate 200 drugs contraindicated in the following cases:

Contraindicated in patients with hypersensitivity to any ingredients of the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Malignant neuroleptic syndrome can occur, characterized by hyperthermia, muscle stiffness, autonomous nervous system disorders, mental changes, CPK increase (Creatin phosphokinase). Should stop the drug if increased body temperature, especially when using high doses.

There has been a report on patients with hyperglycemia when taking Amisulprid. Therefore, blood sugar monitoring is needed in patients who have diagnosed diabetes or at risk of diabetes when starting to treat with Amisulprid.

Because Amisulprid is eliminated through the kidneys, if the patient has renal failure, the dose should be reduced or non -medication.

Amisulprid may reduce the seizure threshold. If the patient has a history of epilepsy, it is necessary to closely monitor during treatment.

Be cautious when indicating Amisulprid in the elderly due to the risk of hypotension and sedation. May need to reduce the dose due to kidney failure.

Be cautious when indicating Amisulprid for Parkinson patients because it can make the disease worse.

If you stop sudden after using high doses of anti -psychotic drugs, although rare, you may experience acute drug stops such as nausea, vomiting, and insomnia. In addition, psychotic symptoms can recur and the appearance of incontinence disorders (restlessly standing restlessly, muscle disorders, movement disorders).

Be cautious when indicating Amisulprid for patients with cardiovascular disease or a family history of a long QT range. Should avoid simultaneous use with sedative.

In randomized clinical trials that are controlled to placebo, performed in the group of elderly patients who have dementia is treated with some typical anti -psychotic drugs, the risk of cerebrovascular events is tripled. The mechanism of this increase is unclear. The possibility of increasing the risk of stroke in other anti -psychotic drugs or other patient groups. Precautions when indicating Amisulprid in patients with risk factors.

Increased risk of death in elderly patients with dementia is treated with anti -psychotic drugs.

It is necessary to identify the risk factors of venous thrombosis before and during treatment with amisulprid and take preventive measures.

Amisulprid may increase prolactin levels. Closely monitor during the treatment process if the patient has a history or a history of a family with breast cancer.

There have been reports on cases of leukopenia, neutropenia and grain leukocytes due to anti -psychotic drugs. If the infection is unexplained or fever (may be a sign of hematopoietic disorders), it is necessary to perform hematological tests immediately.

Patients with lactose intolerance, lactase deficiency, or malabsorption Glucose-Galactose should not take this medicine.

The effect of the drug on the ability to drive and operate machinery

unknown effects of the drug.

Use drugs for women during pregnancy and lactation

The case of pregnancy

Amisulprid has no reproductive toxicity on animals.

There has been no report on drug cases.

The drug may reduce the fertility through the prolactin intermediaries. Clinical data on the impact of Amisulprid on pregnant women is very limited. Therefore, only amisulprid for pregnant women when benefits is greater than the risk. Women who are likely to be pregnant need to take contraception when using this drug.

If the mother uses Amisulprid in the last 3 months of pregnancy, the child may have a surgeon syndrome and/or symptoms of stopping drugs. There have been reports that children agitated, increased or decreased muscle tone, tremor, drowsiness, respiratory failure, anorexia. That's it, careful monitoring.

Cases of breastfeeding

It is unclear whether Amisulprid will excrete in breast milk or not.

Contraindicated Amisulprid in breastfeeding women.

Drug interaction

Levodopa antibodies with anti -psychotic drugs. Amisulprid can resist impact on dopamine dregs (bromocriptin, Ropinirol).

Do not coordinate:

Amisulprid may increase the impact of alcohol on the central nervous system.

Note when coordinating:

Central neurological inhibitors: addictive drugs, anesthesia, analgesics, H antihistamine H, sedative effects, barbiturat, benzodiazepine and other anxiety drugs, clonidin and drugs in the same group. disopyramid), anti -arrhythmic drug group III (Amiodaron, Sotalol), some antihistamine, Mefloquin, Pimozid, Haloperidol, 3 -round antidepressants, pulse or hypotension drugs (beta blockers, calcium channel blockers, digoxin, guanfacin, losing drugs, liti) Other.

Storage

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

To be out of reach of children, read the instructions carefully before use.

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