Zapnex-10 Davipharm medicine treatment schizophrenia (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Olanzapine

Ingredient

Composition information	Content
Olanzapine	10mg

Uses

indications

Zapnex drugs are indicated in the following cases:

Treatment of diseases schizophrenia .

Note: Used in children 13 - 17 years old must be very cautious and under the close supervision of a specialist.

Pharmacokology

olanzapin is a neuroleptic (anti -psychotic) that is not typical (second generation) and is the substance of dibenzodiazepin.

The drug has many other pharmacological properties different from the typical anti -psychotic drugs that are the substance of phenothiazin or butyrophenon such as less causing foreign tower syndrome, less prolactin secretion, less dysplasia when treated for prolonged treatment and effectively on both positive, negative and inhibitors of schizophrenia.

Olanzapin's anti -psychotic effect has a complex mechanism and has not been completely clarified. This mechanism is related to the antagonism of the drug in serotonin type 2 (5-HT2A, 5-HT2C), Typ 3 (5-HT3, Typ 6 (5-HT6) and Dopamine in the central nervous system.

olanxapin has the effect of inhibiting and reducing the response (negative air conditioner) for the 5-HT2A receptor, related to the anti-revolt effect of the drug. In addition, olanzapine also stabilizes the temperament due to part of the receptor inhibitor D2 of dopamine .

olanzapin is also opposed to the Muscarinic receptor (M1, M2, M3, M4, and M5). The anti -cholinergic effect of the drug explains the risk of reducing the occurrence of extracurricular syndrome, on the other hand, related to some other unwanted effects of olanzapine.

olanzapin has the H1 receptor antagonistic effect of histamine and alpha1 adrenergic. This effect is related to the ability to sleep, hypotension posture when using olanzapine.

Pharmacokinetics

absorption

After drinking, olanzapin is absorbed quickly and almost completely through the digestive tract, but due to initially metabolized in the liver, Olanzapin's bioavailability is only 60%. The absorption is not affected by food.

The peak concentration of plasma is achieved within 5 - 8 hours. Achieving a stable state after 7-10 days of reminded dose. The concentration of drugs in plasma changes between individuals, depending on age, gender and whether the patient smokes or not.

A concentration of women's blood is about 30-40% higher than that of men. The concentration of olanzapin treatment in plasma is not clearly defined. The correlation between blood concentration and treatment effect and toxicity of olanzapin has not been established.

Distribution

olanzapin is distributed quickly and much to the tissues, including the central nervous system. The distribution of the drug is about 1000 l.

Olanzapin's plasma protein binding ratio is about 93%, mainly linked to albumin and al-glycoprotein, olanzapin and conjugated metabolic metabolites through the placenta and is excreted into breast milk. The amount of stabilized drug in babies is about 1.8% of the mother's dosage.

In addition, the peak of breast milk is about 5.2 hours slower after reaching the most concentration. In the mother's plasma.

Metabolism

olanzapin is metabolized in the liver before excreting mainly. Through CYP1A2, a small part through CYP2D6 is then conjugated with glucuronic acid.

Two main metabolites are 4'-N-Desmethyl and 10-N-Glucuronid no longer retain the activity of olanzapin.

Elimination

After drinking, the semi -discharged time in olanzapin's plasma. Other symptoms may be: about 30 hours (ranging from 21 - 54 hours). The selling time increased by about 1.5 times in the elderly.

Olanzapin's clearance increased by about 40% in smokers with non -smokers and decreased by about 30% in women compared to men.

About 57% and 30% of the drug is excreted in the urine and feces, mainly in the form of metabolites, a small part (7%) in the original form. The pharmacokinetics of the drug does not change much in patients with renal failure.

Children

Adolescents (from 13-17 years old): Mobile pharmacokinetics of adolescents are similar to adults.

In clinical research, AUC average olanzapin in teenagers is about 27%higher. Different factors of demographics between adolescents and adults as if they are lower and have fewer smoking young people can contribute to the above results.

Before taking Zapnex-10 Davipharm medicine treatment schizophrenia (3 blisters x 10 tablets)

How to use

oral medication. Drink at meals or away from meals. Patients with prolonged drowsiness may be used daily dose in the evening before going to bed.

Olanzapin dose must be carefully corrected on each patient and the lowest dose is effective. Dosage should be increased gradually divided into doses in the day at the beginning of treatment to minimize unwanted effects.

Dosage

daily dose of olanzapine in the range of 5 - 20 mg.

Adults

schizophrenic mental: Olanzapine starting dose is recommended for 5 - 10mg/ day. Then increase about 5 mg/ day for 5-7 days until the destination of 10 mg/ day. Maintenance dose: 10 - 20 mg x 1 time/ day.

Single therapy: The starting dose is 10 - 15mg/ day, taking 1 time daily. Maintenance dose: 5 - 20 mg/ day. The maximum dose recommends 20 mg/ day.

Combined therapy (with lithium or valproear): starting dose 10 - 15mg/ day, drink once a day. Dosage can fluctuate within 5 - 20 mg/ day.

Prevention of bipolar disorders: The dose of 5 - 20 mg/day. For patients who have used olanzapine to treat manic attacks, it is advisable to continue treating prophylaxis at the same dose. If a new mania occurs, a mixture or a depression, it is advisable to continue treating olanzapine (with the optimal dose if necessary), with additional therapy to treat mood symptoms as clinically indicated.

Children

Children under 13 years of age: Not determined safety and efficiency.

Children aged 13-17 years old: When using olanzapin, it is necessary to be cautious and closely supervised by a specialist physician.

schizophrenia: Starting dose: 2.5 - 5 mg/day oral 1 time. Dosage of 10 mg /day. Adjustable increase or decrease in the dose of 2.5 mg or 5 mg. Dark dose is 20 mg/day.

Bipolar disease: Starting dose: 2.5 - 5 mg/day oral 1 time. Dosage of 10 mg/day. Adjustable increase or decrease in the dose of 2.5 mg or 5 mg. Maximum dose of 20 mg/ day.

Elderly

Low starting dose (5mg/day) is not prescribed regularly but should consider patients over 65 years old when clinical factors are guaranteed.

kidney failure and/or liver failure

Low starting dose (5mg/day) should consider these patients. In case of medium liver failure (cirrhosis, Child-Pugh A or B), start at a dose of 5mg/day and be cautious when increasing the dose.

Smokers: The starting dose and the dose is usually not changed. Clinical monitoring recommendations and may consider increasing olanzapine dose if necessary.

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?

Signs and symptoms:

Symptoms are very common when overdosing of the drug (10%), including fast heartbeat, agitation, aggression, speech, many symptoms of foreign tower and reducing the level of consciousness from sedation to coma.

Significant sequelae of overdose include delirium, convulsions, coma, may have malignant neurolithic syndrome, respiratory failure, choking, hypotension or hypertension, arrhythmia (

Management:

There is no specific antidote for olanzepine. It is not recommended to stimulate vomiting. Standard overdose treatment (such as gastric lavage, activated carbon). Simultaneous use of activated carbon shows reduced bioavailability of olanzepin 50-60%.

Symptomatic treatment should be treated and monitored the lifestyle -based signs, including hypotension treatment and circulatory failure and respiratory function support.

Do not use epinephrine, dopamine or beta -contrary drugs, as stimulating beta can worsen hypotension. Cardiovascular monitoring is needed to detect possible arrhythmia. Should monitor patients carefully until recovery.

What to do when you forget 1 dose?

Take that dose as soon as you remember. Do not use 2 doses in the same day.

Side Effects

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

Very common, ADR ≥ 1/10

Metabolism and nutrition: weight gain.

Neurological: Drowsy.

Vascular blood pressure: Hypotenary pressure vertical.

Testing: Increased blood prolactin level.

Common, 1/100 ≤ ADR ≤ 1/10:

Blood and lymphatic system: Acidic leukemia, leukopenia, neutropenia.

Metabolism and nutrition: Increasing cholesterol levels, increasing glucose levels, increasing triglycerides, glucose materials, increasing appetite.

Neurological: dizziness Sitting is not still, Parkinson, movement disorders. Digestive: Mild, fleeting anti -cholinergic effect includes constipation and dry mouth. liver: Increased cholesterol, glucose, trilyceride levels.

Skin and subcutaneous tissues: rash.

muscle and connective tissue: joint pain.

Genital and mammary glands: erectile dysfunction in men, reducing sexual desire in both men and women. Systemic: weakness, fatigue, edema, fever.

Testing: increasing alkaline phosphate, high kinase creatinine. Gamma glutamyltransferase, high uric acid.

Uncommon, 1/1000 ≤ ADR

Immune: Hypersensitivity.

metabolism and nutrition: Diabetes progress or severe than often accompanied by ceton or coma, death. Neurology: convulsions, late movement disorders, memory impairment, language disorder. heart: Slow heart rate, extending the QT range. blood vessels: thrombosis (pulmonary embolism, deep vein thrombosis).

Respiratory, chest and mediastinum: nosebleeds.

digestion: bloating.

Skin and subcutaneous tissues: sensitive to light, hair loss.

Kidney and urinary tract: uncontrolled mini.

Genital and mammary glands: Big breasts, secretion of milk in women, female mammary glands in men.

Testing: Increase bilirubin.

Rare, 1/10,000 ≤ ADR

Blood and lymphatic system: thrombocytopenia.

Metabolism and nutrition: lower body heat.

heart: ventricular tachycardia/ventricular, sudden death. digestion: pancreatitis.

Hepatitis: Hepatitis.

Muscle and connective tissue: Muscle pattern.

Genital and mammary glands: prolonged erection.

Unknown frequency:

Syndrome of cessation in infants.

dress: skin reactions (rash, flaking dermatitis), hyperlemm, lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonia , myocarditis and/or pericarditis.

Instructions on how to handle ADR

Stop drugs in the case of manifestations of malignant neurolithic syndrome. Treatment of positive support and closely monitor patients. Caution should be careful when reusing olanzapin for patients after appearing malignant neuronal syndrome:

Should choose the drugs that cause less syndrome and need to increase the dose slowly for patients. Blood lipids if appearing during olanzapin treatment. It is possible to consider using replacement with other neuroleptic drugs that are less affected on lipid metabolism such as Risperidon, Ziprasidon or Aripiprazol.

Warnings

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

contraindicated

Zapnex drugs contraindicated in the following cases:

Hypersensitivity to olanzapine or any ingredients of the drug.

Patients are at risk of narrow angle glaucoma.

Lactating women.

Be cautious when using

During the treatment of anti -psychotic drugs, the improvement of the patient's clinical condition may take several days to a few weeks. Patients should be closely monitored during this time.

suicide: The risk of suicide inherent in schizophrenia and bipolar mental illness, closely monitoring patients with high risk of drug use.

Mental disorders and/or behavioral disorders related to dementia: It is recommended not to use olanzapine in this group of patients because the drug may increase mortality and increase the risk of brain vessels.

Parkinsion: There is no recommendation for the use of olanzapine.

Malignant neuropular syndrome: When signs of this syndrome include high fever, mental state change and indicating signs of unstable autonomy ... should stop using all anti -psychotic drugs, including olanzapine.

Hyperborn and diabetes: Be cautious when using anti -psychotic drugs, including olanzapine should be monitored with signs and symptoms of hyperglycemia (drinking, urinating, eating a lot, and losing weight), and diabetes patients with risk factors for diabetes should be monitored regular blood sugar control.

Change of blood lipids: Need to monitor lipid regularly according to the instructions for using anti -psychotic drugs when using any anti -psychotic drugs.

Weight gain: The consequences of weight gain should be considered before starting treatment. Monitor regular weight.

Cholinergic resistance: Be cautious when using olanzapine for patients with prostate hypertrophy, narrow -angle glaucoma or intestinal paralysis and related conditions.

Liver function: Precautions when using olanzapine and monitoring in patients with hypertension ALT and/or AST, patients with signs and symptoms of liver failure, patients have conditions that limit the liver reserve function before and in patients being treated with drugs that can poison the liver. In the case of hepatitis (including liver, cholest liver or mixed liver damage), which is diagnosed, should be discontinued with olanzapine.

leukopenia: Caution should be careful in patients with reduced number of leukocytes and/or neutrophils due to any reasons. Leukopenia is often reported when used simultaneously olanzapine with valproate.

Stop drugs: When olanzapine suddenly stops, olanzapine may appear acute symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting (very rare).

QT interval: Be cautious when using olanzapine with drugs that increase the QTC range, especially in the elderly, patients with congenital QT syndrome, congenital heart failure, heart hypertrophy, hypotension or hypoglycemia.

Venous thrombosis: It is necessary to identify all risk factors for venous thrombosis before using olanzapine, and take preventive measures.

Activity on the central nervous system: Precautions when using olanzapine along with alcohol and other central effects.

Convulsions: Be cautious when using olanzapine for patients with a history of epilepsy or easily affected by factors that can reduce epilepsy threshold.

Late movement disorders: The risk of late movement disorders increases when long -term treatment of olanzapine, so when there are signs or symptoms of late movement disorders in patients using olanzapine, dose reduction or treatment stop.

Hypotension posture: periodic blood pressure should be measured in patients over 65 years old.

Suddenly due to heart: There has been a report on the heart of the heart due to the heart in patients using olanzapine.

Children: Do not use olanzapine for children under 13 years old.

Lactose: Do not use drugs for patients with galtose intolerance, lactase deficiency or malposine-galactose.

soy lecithin: Do not use drugs for patients too sensitive to peanuts or soybeans.

The ability to drive and operate machinery

There has been no research on the influence of olanzapine on the ability to drive and operate machinery. However, because olanzapine can cause drowsiness and dizziness, patients should be cautious about driving or operating machinery.

During pregnancy

Not enough research in pregnant women, notifying the doctor during pregnancy or intending to get pregnant during treatment with olanzapine.

Babies exposed to anti -psychotic drugs in the last 3 months of pregnancy are at risk of unwanted effects such as pagoda symptoms and/ or symptoms of quitting drugs with different severity and degrees. There is an excited report, increased / decreased muscle tone, tremor, drowsiness, respiratory failure or difficulty feeding in babies, babies should be carefully monitored.

The period of breastfeeding

olanzapine can be excreted through breast milk, should not be breastfeeding while using the drug.

Drug interaction

avoid coordination with levomethadyl due to the risk of toxicity on the heart, not coordinating with Metoclopramide due to increased risk of outsurers of extracurricular syndrome, malignant neuron syndrome.

Interactions that can influence olanzapine:

Diazepam: shared, increases the risk of posture.

CYP1A2 induction: Olanzapine metabolism may increase due to smoking (nicotine) and CYP1A2 induction drugs (carbamazepine, phenobarbital , phenytoin, rifampicin , omeprazole), which can lead to reduced olanzapine levels. Olanzapine clearance increases small or medium. Clinical effects are usually small, recommendation to monitor forestry and increase olinzepine dose if necessary.

CYP1A2 inhibitors: Fluvoxamine, a specialized CYP1A2 inhibitor that has been shown to significantly inhibit the metabolism of olinzapine. Lower starting dose should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as Ciprofloxacin. Olanzapine dose should be considered if they have been treated with CYP1A2 inhibitors.

Reduce bioavailability:

Activated carbon reduces olanzapine's oral bioavailability from 50-60% and should be used for at least 2 hours before or after using olanzapine.

Warfarin (single dose of 20 mg), fluoxetine (CYP2D6 inhibitors), single dose Antacid (aluminum, magnesi) or cimetidine does not significantly affect the pharmacokinetics of olanzapine.

Pharmacological interaction:

Do not use dopamine, adrenalin or other sympathetic effects on the beta receptor in patients who are treating olanzapine, due to the ability to worsen hypotension due to olanzapine's Alpha receptor inhibitors.

olanzepin can affect other drugs:

olanzepin may be opposed to the effect of levodopa and dopamine agents. Vitro (such as 1A2, 2D6, 2C9, 2C19, 3A4). Therefore, there is no risk of interaction. Research in vivo, no inhibition of the following active ingredients: triple antidepressants (representing metabolism via CYP2D6), warfarin (CYP2C9), Theophyllline (CYP1A2) or diazepam (CYP3A4 and 2C19).

Monitoring plasma Valproate concentrations shows no need to adjust Valproate dose when used dynamic with olanzapine.

Impact on the central nervous system:

should be cautious in patients with alcohol or use of central nervous system inhibitors.

It is not recommended to simultaneously use olanzapine with Parkinson anti -Parks in patients.

QT interval: Should be cautious when using olanzapine simultaneously with drugs that increase the QT range.

Storage

Store no more than 30 degrees Celsius in the original packaging, avoid light and avoid moisture.

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