Gayax Davipharm medicine treatment of schizophrenia (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Amisulpride

Ingredient

Composition information	Content
Amisulpride	200mg

Uses

indications

Gayax 200 drugs are indicated in cases of acute and chronic schizophrenia treatment.

There are positive symptoms (for example, paranoia, hallucinations, thought disorders) and/or negative symptoms (for example: withdrawing from social life), including patients with negative symptoms that dominate.

Pharmacology

Amisulprid has high affinity with Dopamine D2/D3 receptor, without affinity for D1, D4 and D5. Amisulprid also has no affinity for serotonin receptors, alpha-adrenergic, H1 Cholinergic H1 Cholinergic. Amisulprid is also not attached to the Sigma position.

In high doses, Amisulprid prioritizes the dopamine receptor blocking in the border structure rather than in the pattern.

In low doses of Amisulprid priority priority to the D2/D3 receptor blocker SYNAP, causing Dopamine release. This pharmacological properties explain the clinical effect of the drug on both negative and positive symptoms of schizophrenia.

Pharmacokinetics

absorption

After taking 1 dose of 50 mg, Amisulprid has two absorption vertices: 1 hour after taking (plasma concentration is 39 ± 3 ng/ml), after taking 3-4 hours (plasma concentration is 54 ± 4 ng/ml).

Meals rich in carbohydrates (containing 68% of liquids) significantly reduces AUC, Tmax and CMAX of Amisulprid, but there is no change after a fat -rich meal. The clinical influence of the above changes.

Distribution

The distribution voltage is 5.8 l/kg, low cohesion to plasma proteins (16%), pharmacokinetic interaction due to compete associated with almost no occurrence.

Metabolism

Absolute bioavailability is 48%. Amisulprid is less metabolized, about 4% of the dose is converted into non -active substances. Amisulprid does not accumulate and pharmacokinetics of the drug is constant after taking the dose repeated.

Elimination

Selling time is about 12 hours. Elimination through urine is mainly in the form of unchanged. 50% of the intravenous dose is eliminated through urine, of which 90% excreted in the first 24 hours. The renal clearance is 20 l/hour or 330 ml/min.

Before taking Gayax Davipharm medicine treatment of schizophrenia (4 blisters x 7 tablets)

How to use

Take the whole tablet with water, do not chew pills, take medicine before meals. If you feel the effect of the drug is too strong or too weak, do not arbitrarily change the dose, notice and consult your doctor.

Dosage

Adults

Dosage of 300 mg/day or less: Take 1 time/day.

Dosage of over 300 mg/day: divided into 2 times/day.

Patients with positive symptoms of acute phase: 400 - 800 mg/day. In some cases, the dose may increase to 1200 mg/day. The dose of over 1200 mg/day has not been fully assessed for safety, so it should not be used. There is no need to adjust the dose when starting treatment with Amisulprid. Adjust the dose according to the response of each patient.

For patients with both types of negative and positive symptoms, the dose should be adjusted to optimize positive symptoms.

Maintenance dose should be adjusted to each patient with the lowest dose effectively.

For patients mainly negative symptoms, the dosage should be used about 50 - 300 mg/day. Adjust the dose according to the response of each patient.

Elderly

Amisulprid should be used carefully due to the risk of hypotension and sedation. May need to reduce the dose if there is kidney failure.

Children

Contraindicated for children under 15 years old (before puberty) due to lack of safety data.

kidney failure

Amisulprid is eliminated through the kidneys, so the dose should be adjusted in patients with renal failure.

Patients with CLCR about 30 - 60 ml/minute: Take 1/2 dose.

Patients with CLCR about 10 - 30 ml/minute: Take 1/3 dose.

Contraindicated for patients with CLCR

Hepatic failure

Because the drug is metabolized through the liver, there is no need to adjust the dose.

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? Cases of death are often reported when used simultaneously with other anti -psychotic drugs.

In case of acute overdose, it is advisable to consider the ability to use multiple drugs at the same time.

Ineffective hemorrhage for amisulprid overdose. There is no specific antidote. Monitoring patients and taking appropriate physical support measures. If there is severe foreign symptoms, cholinergic drugs should be taken. Monitor electrocardiograms due to the risk of extending the QT until the patient recovers.

What to do when you forget 1 dose? If the time to remember is near the time of taking the next dose, not using the forgotten dose but taking the drug in accordance with the old schedule. Do not drink twice as doses.

Side Effects

When using Gayax 200, you may experience unwanted effects (ADR).

Very common, ADR> 1/10:

Neurological: Possible symptoms may occur: tremor, spasticity, movement disorders, increased salivation. These symptoms are often mild when using the optimal dose and partially recover without the need to stop Amisulprid when using Parkinson's medication. The frequency of pagoda symptoms depends on the dose, low frequency in patients with mainly negative symptoms using the dose of 50 - 300 mg/day.

Common, ADR> 1/100:

Neurological: Acute neurotransmitter disorders (twisting neck, eye rotation, jaw hard) may appear (these symptoms are often mild when using the optimal dose and will recover partly without the need to stop Amisulprid when using Parkinson treatment drugs), drowsiness. Dry mouth. 1/100:

Neurological: Late movement disorders are characterized by non -self -control movement mainly in the tongue and/or face that has been reported, usually after long -term use (Parkinson's treatment is ineffective or can cause more severe symptoms), convulsions. The liver, mainly transferase.

The immune system: Hypersensitivity reaction.

Hematology: leukopenia, neutropenia, granulocytosis.

Mental: Confusion. use anti -psychotic drugs.

Skin and subcutaneous tissue: angioedema, urticaria.

Stop medication and contact the nearest medical center if the following reactions are encountered:

Malignant sedative syndrome (high fever, sweat, muscle, fast heartbeat, fast breathing, and feel confused, drowsy or agitated). bridge).

Warnings

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

contraindicated

Gayax 200 drugs contraindicated in the following cases:

Patients with amisulprid hypersensitivity or any ingredients of the drug. When there is an appropriate contraceptive method. Sparfloxacin.

does not coordinate with levodopa.

Caution when using

Malignant neurological syndrome: Like other neuroleptics, malignant neurological syndrome (high fever, muscle stiffness, plant neurological disorders, CPK increases ...) can occur. When high fever, especially when taking high doses, it is necessary to stop using all mental drugs.

Patients with diabetes: Hyperglycemia has been recorded in patients treated with typical anti -psychotic drugs, including Amisulprid, so patients need to be closely monitored.

Patients with renal impairment: Amisulprid is eliminated through the kidneys, so the dose adjustment is needed in patients with renal impairment.

Patients with epilepsy: Amisulprid lower the epilepsy threshold. Should be cautious with patients with a history of epilepsy.

Elderly patients: Like other sedatives, so they are especially cautious in elderly patients due to the risk of hypotension and sedation. The patient's renal function may be reduced.

Parkinson Patient: Only amisulprid for Parkinson's patient when really necessary, because it will worsen Parkinson's condition.

Symptoms of cessation: Acute cessation symptoms include nausea, vomiting and insomnia described after stopping a sudden dosage of sedation. The relapse of mental symptoms and the occurrence of incontinence disorders. Therefore, when you want to stop using, gradually reduce the dose, avoid sudden stopping.

Cardiovascular effects: Amisulprid extends the section-Q, the risk of severe ventricular arrhythmias such as torsion if the patient previously had a slow heart rate (below 55 beats/ minute), reduced potassium, prolonged congenital QT segment.

Patients with a stroke risk factor: The risk of cerebrovascular events tripled and unknown mechanism. Caution should be used with amisulprid in patients at risk of stroke.

Elderly memory impairment: Elderly memory losses treated with psychotic drugs are at higher risk of death.

VTE blood clots (VTE): Patients with anti -psychotic drugs often suffer from VTE risk factors, so all VTE risk factors should be identified before, during and after using Amisulprid.

Breast cancer: Amisulprid increases prolactin levels. Therefore, be careful in patients with a history or family history of breast cancer.

leukopenia: leukopenia, neutropenia and grain leukopenia have been recorded with anti -psychotic drugs, including Amisulprid. Infection or unexplained fever may be evidence that the drug affects blood, and is needed immediately blood tests.

Preparations containing lactose monohydrates, so patients with rare genetic diseases are galactose tolerance, lapp lactase deficiency or glucose-galactose absorption disorders should not be used.

The ability to drive and operate machinery

Even when using the dose as recommended Amisulprid can still cause drowsiness, drowsiness, affecting the ability to drive and operate machinery, so be cautious.

pregnancy

do not recommend the use of drugs during pregnancy unless the benefits are superior to the risk. Women who are likely to be pregnant should talk to the doctor about effective contraception before using the drug.

Babies exposed to anti -psychotic drugs (including Amisulprid) in the last 3 months of pregnancy are at risk of unwanted effects including symptoms of foreign tower and/or symptoms of quitting smoking with different severity and different times. There have been reports of symptoms such as excitement, spasticity, reduced tone, tremor, drowsiness, respiratory failure or eating disorders. Therefore, babies need to be carefully monitored.

Lactation period

Contraindicated for breastfeeding women.

Drug interaction

Contraindicated in combination with the following drugs:

Medications can cause heart torsion:

IAA anti -arrhyths such as Quinidin, Disopyramid, Procainamid.

Anti -arrhythmia group III such as amiodaron, sotalol.

Medicines such as Bepridil, Cisaprid, SultoPrid, Thioridazin, Erythromycin intravenously, intravenous venomin, halofantrin, pentamidin, sparfloxacin.

There may be other drugs in addition to the drugs listed above.

levodopa and effective antagonistic nerve drugs.

Do not coordinate:

Amisulprid increases the effects of alcohol on central nerves.

Be careful when coordinating:

Medications increase the risk of heart torsion.

Medications that slow heart rate such as beta receptor blockers, calcium channel blockers such as diltiazem, verapamil, clonidin, guanfacin, digitalis.

Medications that cause hypokalemia: Diuretics lower potassium, laxative stimulants, amphoticin b intravenously, glucocorticoid, tetracosate.

Neurolarity such as pimozid, hiloperidol, imipramin, lithium.

Should consider when coordinating:

Central neurological inhibitors such as sedatives, anesthesia, analgesics, Histamine H cause drowsiness, barbiturat, benzodiazepine and other anti -anxiety drugs.

Hemotic drugs.

Dopamine owners (such as levodopa): because Amisulprid can reduce the effects of these drugs.

Storage

In a dry place, avoid light, the temperature does not exceed 30 ° C.

Other drugs

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