Gayax 400 Davipharm Treatment of schizophrenia (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Amisulpride

Ingredient

Composition information	Content
Amisulpride	400mg

Uses

indications

Gayax 400 drug is indicated in the case:

Treatment of acute and chronic schizophrenia has positive symptoms (for example, paranoia, hallucinations, thought disorders) and/or negative symptoms (for example, withdrawal from social life), including patients with negative symptoms that dominate. D2/D3, without affinity for D1, D4, and D5. Amisulpride also has no affinity for the receptor of serotonin, alpha-adrenergic, histamine H1, Cholinergic. Amisulpride is also not attached to the sigma position.

In high doses, Amisulpride prioritizes dopamine receptors in the border structure rather than in the pattern.

In low doses, Amisulpride prioritizes receptors D2/D3 money synapse, 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 a dose of 50 mg, AmisulPride has two vertices absorbing: 1 hour after taking (plasma concentration is 39 ± 3 ng/ml) and after taking 3-4 hours (plasma concentration is 54 ± 4 ng/ml). Absolute bioavailability is 48%. A meal rich in carbohydrates (containing 68% of liquids) significantly reduces AUC, TMAX and CMAX.

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

Amisulpride is less metabolized, about 4% of the dose is converted into non -active substances. Amisulpride is not accumulated and pharmacokinetics of the drug is constant after taking the dose repeated.

Elimination

Selling time is about 12 hours. The drug excreted in urine 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 400 Davipharm Treatment of schizophrenia (4 blisters x 7 tablets)

How to use

oral medication. Should take medicine before eating.

Dosage

Dosage ≤ 300 mg/day: Take 1 time/day.

Dosage> 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 with amisulpride. Adjust the dose according to the response of each patient.

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

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

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

Children

Contraindicated for children under 15 years of age (before puberty) due to lack of safety data. The safety and effectiveness of Amisulpride from puberty to 18 years of age has not been studied. Data on the use of amisulpride in minors is still small. Therefore, it is not recommended for children from puberty to 18 years old.

Elderly

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

Patients with renal failure

Amisulprid is eliminated through the kidneys.

CICR is about 30 - 60 ml/minute: Take 1/2 dose.

CLCR is about 10 - 30 ml/minute: taking 1/3 dose.

Contraindicated for patients with CICR

Patients with liver 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 do

do when overdose? Carrying a pills along with the packaging so that the doctor knows what medicine you take and takes measures to handle it in time.

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 the electrocardiogram due to the risk of extending the QT until the patient recovers. Hemorrhage is ineffective for amisulpride overdose.

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 400, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: Symptoms of the pagoda (tremor, spasticity, movement disorders, increased salivation), acute neural movement disorders (convulsions, eye rotation, jaw stiff), drowsiness.

Mental: Insomnia, restlessness, anxiety, orgasm. digestive: constipation, nausea, vomiting, dry mouth. Endocrine: Amisulpride increases the level of prolactin that can recover after the drug stops, causing increased milk secretion, menstruation, female mammary glands, breast pain, erectile dysfunction. cardiovascular: Hypotension.

Weight gain.

Uncommon, 1/1000

Neurological: Late movement disorders are characterized by non -control movement mainly in the tongue and/or face, convulsions.

Metabolism: Hyperglycemia.

Cardiovascular: Slow heart rate. liver: increased liver enzyme, mainly transferase. immune: Hypersensitivity reaction.

Not determined frequency

Hematology: leukopenia, neutropenia, granular leukopenia.

Metabolism: Increased triglycerides and blood cholesterol.

Mental: Confusion.

Neurological: Malignant sedative syndrome is likely to be fatal. Heart: extends the QT range, ventricular arrhythmia such as arrhythmia, ventricular, can lead to ventricular or cardiac arrest, sudden death. blood vessels: Tagnetic thrombosis, including pulmonary embolism, sometimes fatal, deep vein thrombosis.

Skin and subcutaneous tissue: Evaluation, urticaria.

Cowdown syndrome in babies.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Gayax 400 drug contraindicated in the following cases:

Hypersensitivity to Amisulpride or any ingredients of the drug.

Pro -dependent prolactin such as breast cancer, pituitary tumor.

Chromic cells.

Children under 15 years old (before puberty).

Pregnant and lactating women.

Women are likely to get pregnant unless appropriate contraception.

Not coordinated with the following drugs because it can cause heart torsion: quinidine, disopyramide, processaamide, amiodarone, sotalol, bepridil, cisapride, sultopride, thioridazine, erythromycin intravenously, vincamine intravenous injection, halofanide, pentamidine, pentamidine, pentamidine, pentamidine, pentamidine, pentamidine, pentamidine, pentamidine, pentamidine, pentamidine, pentamidine, pentamidine Sparfloxacin.

Not coordinated with Levodopa.

Patients with renal failure with ClCr

Caution when using

Malignant neurological syndrome (high fever, muscle hardness, plant neurological disorders, increased CPK ...) can occur when taking the drug. Patients with high fever, especially when taking high doses, must stop using all mental drugs.

Patients who have been diagnosed with diabetes or risk of diabetes when they start treatment with Amisulpride should closely monitor blood sugar.

Amisulpride is eliminated through the kidneys, so the dose adjustment is needed in patients with renal failure.

Amisulpride lowered the epilepsy threshold. Should be cautious with patients with a history of epilepsy.

As other sedatives, should be especially cautious in elderly patients due to the risk of lowering blood pressure and sedation. The patient's renal function may be reduced.

Only use Amisulpride for Parkinson patients when really necessary because it will worsen Parkinson's disease.

Symptoms of acute cessation include nausea, vomiting and insomnia have been described after stopping a sudden sudden sedation. The recurrence of mental symptoms may occur and the occurrence of non -autonomous movement disorders have been reported. Therefore, when you want to stop the drug, you should gradually reduce the dose, avoid sudden stopping.

Amisulpride extends the QT range, which is at risk of severe ventricular arrhythmia such as twisting if the patient has previously had a slow heart rate (

Should be used with caution amisulpride in patients at risk of stroke.

Elderly memory impairment is treated with anti -psychotic drugs that increase the risk of death.

A few cases of vasica thrombosis (VTE) have been reported in patients using anti -psychotic drugs. Because patients treated with anti -psychotic drugs often suffer from VTE risk factors, all VTE risk factors should be identified before, during and after using AmisulPride.

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

leukopenia, neutrophils and granulocytes have been recorded with anti -psychotic drugs, including Amisulpride. Infections or unexplained fever may be due to drugs that affect blood and need blood test immediately.

Preparations containing lactose monohydrates, so patients with rare genetic diseases are poorly tolerant galactose, Lapp Lactase deficiency or glucose -galactose absorption disorders should not be used.

The ability to drive and operate machinery

should be cautious when taking Gayax 400 because the drug can cause drowsiness, drowsiness, affecting the ability to drive and operate machinery.

Pregnancy

Clinical data used drugs for pregnant women is limited. Therefore, safety in pregnant women has not been established.

It is not recommended to use 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 Amisulpride) in the last 3 months of pregnancy are at risk of unwanted effects including symptoms of foreign tower and/or symptoms of cessation with different severity and time. 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.

Breastfeeding period

contraindicated use in breastfeeding women.

Drug interaction

Contraindicated in combination with the following drugs

The drugs that can cause torsion such as anti -arrhythmic drugs IA (Quinidine, Disopyramide, Procainamide), anti -arrhythmic drugs Group III (Amiodarone, Sotalol), Bepridil, Cisapride, Sultopride, Thioridazine, Erythromycin intravenous injection, Vincamine injected intravenously, halofantrine, pentamidine, pentamidine, pentamidine, pentamidine, pentamide Sparfloxacin).

levodopa and effective antagonistic nerve drugs.

Do not coordinate with alcohol because Amisulpride increases the effects of alcohol on the central nervous system.

Be careful when coordinating with drugs that increase the risk of heart torsion

Heart rhythms such as beta receptor blockers, calcium channel blockers such as Diltiazem, Verapamil, Clonidine, Guanfacine, Digitalis.

Hypotenic hypotension such as diuretics lower potassium, laxative stimulants, amphoticin b intravenously, glucocorticoid, tetracosactide.

Neurology such as pimozide, haloperidol, imipramine, lithium.

Should consider when coordinating

Central neurological inhibitors such as sedatives, anesthesia, analgesics, H1 antihistamine H1, Barbiturate, Benzodiazepine and other anti -anxious drugs.

Hydropulation drugs.

Dopamine owner (like levodopa) because amisulpride can reduce the effects of drugs.

Storage

Store in a dry place, avoid light, temperature not exceeding 30 ° C.

Other drugs

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