Savi Olanzapine 5 drugs treat schizophrenia (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Olanzapine
Ingredient
| Composition information | Content |
| Olanzapine | 5mg |
Uses
Indications
Olanzapine 5 drugs are indicated in the following cases:
olanzapine has a stronger affinity with the receptor of Serotonin 5HT2 in vitro compared to D2 and the activity of 5HT2 In Vivo is stronger than D2 activity. Physiological electrophoresis studies have shown that olanzapine selectively reduces the activation of dopaminergic nerve cells in Mesolimbic (A10) but has little effect on the pattern (A9) in motor function. Olanzapine reduces conditional avoidance response, which is a test that determines the anti -psychotic effect when using the dose lower than the dose that causes the remedy (a side effect on the motor function). Unlike some other anti -psychotic drugs, olanzapine increases response in a "anxiety" test.
pharmacokinetic
absorption
olanzapine absorbs well when taken, reaching the peak plasma concentration within 5 - 8 hours. Food does not affect the absorption. The absolute oral use has not been determined compared to the vein. Olanzapine concentration in linear plasma and proportional to the dose in research tests with a dose of 1 - 20 mg.
Distribution
About 93% olanzapine is connected to plasma proteins with a concentration of 7 - 1000 ng/ml. Olanzapine is mainly connected to albumin and α1 - Glycoprotein.
Metabolism
olanzapine is metabolized in the liver through a conjugate and oxidative mechanism. The main circulation metabolites are 10 - n - glucuronide and cannot pass through the brain barrier. Cytochrome P450 CYP1A2 and CYP2D6 are involved in the creation of N - Desmethyl and 2 metabolites - Hydroxymethyl. Both metabolites have a much lower pharmacological activity in vivo than olanzapine in animal studies. Pharmacological effects are mainly caused by olanzapine.
Elimination
The average selling time in healthy people depends on age and gender. After drinking in healthy people, the average selling time is 33 hours and the average plasma clearance of olanzapine is 26 l/hour.
Before taking Savi Olanzapine 5 drugs treat schizophrenia (3 blisters x 10 tablets)
How to use
oral drugs, regardless of meals.
Dosage
Adults
schizophrenia
recommended starting dose is 10 mg/day.
The revival period
The starting dose is 15 mg/day in monomers or 10 mg/day in combination treatment.
Refuensions of bipolar disorders
The recommended starting dose is 10 mg/day. In patients who have used olanzapine to treat the revival, continue to keep the old dose when preventing bipolar disorders. If the attack appears, depression or mixture, it is advisable to continue treating with olanzapine (adjusting the dose if necessary) with other supportive therapies to improve the patient condition.
In the treatment of bipolar disorders, the stage of revolt or recurrence of bipolar disorders, based on clinical conditions, can change the dose of 5 - 20 mg/day. The increase in the dose is higher than the recommended starting dose should only be done after the appropriate clinical evaluation and is conducted no less than 24 hours.
When deciding to stop using olanzapine, you should consider reducing the dose slowly.
Patients with kidney failure or liver failure
Should reduce the dose in patients with liver failure, kidney failure. In the case of average liver failure (cirrhosis, Child - Pugh type A or b), the starting dose should be 5mg and cautious when increasing the dose.
Patients do not smoke compared to smokers
No difference in the starting dose and the usual treatment scope. Smoking can reduce olanzapine metabolism, may consider increasing the dose in this case and need to be clinically monitored.
When there is more than one factor that slows down the metabolism of olanzapine (gender, age, no smoking ...) should consider to use lower starting dose. Should be cautious when increasing the dose in these patients.
Children
It is not recommended to use olanzapine in children under 18 years of age due to lack of data on safety and efficiency.
Elderly
No need to reduce the dose but need to consider lower doses (5mg/day) for patients over 65 years old or when there are unfavorable clinical factors.
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? Therefore, it is necessary to start with appropriate supportive treatments. It is necessary to consider the overdose of many different drugs.
In the case of acute poisoning, need to establish and keep the respiratory tract, ensure adequate oxidation and ventilation. It is advisable to consider using activated carbon because they reduce the bioavailability of oral olanzapine by 50 - 60%. If necessary, gastric lavage should be washed (after placing the catheter into the trachea, if the patient is in a coma).
Dialysis does not remove much olanzapine.
Hypoglycemia and vascular collapse should be treated with appropriate measures such as infusion or sympathetic stimulants such as norepinephrine (not using epinephrine, dopamine or other sympathetic stimulants with beta activity, because beta stimulation can aggravate hypotension in the case of receptor alpha closed by Olanzapine). Cardiovascular monitoring should be monitored to detect arrhythmia. Continue to monitor carefully until the patient recovers.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using olanzapine 5, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Central nerve: Drinking, dizziness, restlessness, Parkinson, movement disorders. Increased plasma prolactin. DA: rash. Uncommon, 1/1000 metabolism and nutrition: worsen or cause diabetes exacerbations, sometimes combined with keton or coma, several deaths. Central nervous system: epilepsy, muscle disorders, late movement disorders, or forgetting, speech disorders. Rare, 1/10000 Central nervous system: malignant neurological syndrome, drug stop symptoms. Hepatitis: Hepatitis. Not determined frequency Instructions on how to handle ADR Stop taking medication and consult immediately with the treating doctor when severe ADR occurs.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Olanzapine 5 contraindications in the following cases:
People at risk of closed angle glaucoma.
Caution when using
Caution for elderly patients with mental disorders/behavioral disorders associated with intellectual decline due to the risk of increased mortality, mainly due to cardiovascular or bacterial causes.
Using olanzapine in the treatment of mental disorders related to dopamine owners in patients with Parkinson's disease is not recommended. In clinical trials, Parkinson's bad symptoms and hallucinations have been reported more often than placebo and oluzapine is not more effective than placebo in the treatment of psychotic symptoms.
Malignant syndrome caused by sedation (NMS: Neuroleptic Malignant Syndrome): is a condition related to anti -psychotic drug treatment, capable of life -threatening patients. Rarely reports on NMS related to olanzapine. The clinical manifestations of NMS are high fever, stiff muscle, mental state changes and have unstable manifestations of plant nervous systems (vessels or irregular blood pressure, tachycardia, sweating, arrhythmia). Other signs include increased creatine phosphokinase, myoglobinuria (pattern) and acute renal failure. All psychotic drugs should be stopped immediately, including olanzapine when the patient has symptoms and symptoms of NMS or when high fever is unknown cause without clinical manifestations of NMS. Be cautious when taking olanzapine for diabetes patients during treatment. Hyperglycemia or exacerbation of diabetes, sometimes combined with keton or coma has been reported, some deaths. Previous weight gain has also been reported. Clinical monitoring is required as well as testing blood sugar before taking the drug, 12 weeks after the beginning of treatment and each year later. Patients treated with psychotic drugs should monitor signs and symptoms of hyperglycemia (drink a lot, urinate, eat a lot, weak). Patients with diabetes or risk of diabetes should be monitored regularly (before taking the drug, 4 weeks, 8 weeks, 12 weeks after the beginning of treatment and every 3 months).
Lipid disorders occur in patients with olanzapine treatments in control of control with placebo. Lipid changes should be managed appropriately in terms of clinical, especially in patients with blood lipid disorders and patients at risk of lipid disorders. Patients taking anti -psychotic drugs such as olanzapine 5 should be tested for blood lipids before taking the drug, 12 weeks after the beginning of treatment and every 5 years later.
olanzapine has anti -anti -anti -vitro activity, but in clinical trials, relevant symptoms appear at a low rate. Due to the clinical experience using olanzapine in patients with little diseases, carefully when taking olanzapine for patients with prostate hypertrophy, bowel obstruction or glaucoma closed angle due to the drug's antibodgic effect of the drug.
Liver function: ALT liver enzymes (Alanine Amino Transferase), AST (Aspartate Amino Transferase) sometimes increase transient, no symptoms, especially in the early stages of the treatment. Careful monitoring patients with an increase in ALT or AST, patients with signs and symptoms of liver failure, patients with impaired liver function impairment and patients taking drugs toxicity on the liver. In case of diagnosis of hepatitis, it is advisable to stop treating with olanzapine.
leukemia: Similar to other anti -psychotic drugs, it is necessary to be cautious when using olanzapine in patients with low number of leukemia or neutrophils due to any cause, patients use medications that cause leukopenia, patients with a history of inhibition/bone marrow poisoning caused by drugs, patients with bone marrow inhibitor due to accompanying disease, radiation therapy or chemotherapy and patients with EOSIN or EOSIN hypercelluces. Reducing leukemia often occurs when using olanzapine and valproate simultaneously.
Stop treatment: acute symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting have been reported (rare) when stopping olanzapine suddenly.
QT interval: In clinical trials, it has been observed that the QT interval has clinical significance in patients using olanzapine (rarely), there is no significant difference in cardiovascular events compared to placebo. However, be careful when prescribing olanzapine along with the drug increases the QT interval, especially in the elderly, people with congenital QT syndrome, congenital heart failure, hypertrophic heart, hypotension or hypoglycemia.
Central nervous system: olanzapine has the main effect on the central nervous system (TKTW), so it must be careful when used in combination with other drugs that also work on the TKTW or when drinking alcohol.
Epilepsy: It is necessary to be cautious when using olanzapine in patients with a history of epilepsy or there are factors that reduce epilepsy threshold. Epilepsy rarely occurs in patients treated with olanzapine. Most of these patients have a history of epilepsy or risk factors for epilepsy.
Late movement disorders: In comparative studies for 1 year or less, the rate of complications of dysplasia in patients when taking olanzapine lower is statistically significant. However, the risk of late dysplasia increases when taking anti -psychotic drugs for a long time, so it is necessary to reduce the dose or stop the drug when there are signs or symptoms. Symptoms of late dysplasia may worsen over time or even appear after treatment.
Hypotension is rarely occurring in older adults in Olanzapine's clinical trials. Blood pressure should be measured periodically in patients over 65 years old.
Suddenly, the heart has been reported in patients using olanzapine.
Children: It is not recommended to use olanzapine in children under 18 years old. Studies in patients 13-17 years old show that other side effects such as weight gain, metabolic parameters and prolactin levels in these objects.
The drug contains lactose. Patients with rare genetic disorders in galactose tolerance, Lapp lactase deficiency or Glucose absorption disorders - Galactose should not use this drug.
ingredients Tartrazin Lake in preparations can cause some allergic reactions.
The ability to drive and operate machinery
Because the drug can cause sleep should be careful to use this drug when driving or operating machinery.
Pregnancy
There are no strict and complete studies in pregnancy. Patients should notify the doctor if they are pregnant or intend to get pregnant while taking olanzapine. Due to the limited experience of using olanzapine in humans, this drug should only be used in pregnant women when the benefits are more dangerous to the fetus.
Babies who have exposed to anti -psychotic drugs (including olanzapine) in the last 3 months of pregnancy are at risk of unwanted effects including peripheral syndrome and symptoms of quitting smoking with different time and severity after birth. There have been reports on anxiety, agitation, increase or decrease in muscle tone, dreaming, respiratory failure, eating disorders.
Breastfeeding period
Study in breastfeeding women shows that olanzapine has secretion into breast milk. Olanzapine concentration in breast milk is about 1.8% compared to the dose. It is not recommended to use olanzapine in breastfeeding women.
Drug interaction
The possibility of other drugs affects olanzapine:
Diazepam: Concomitant use with olanzapine will increase the risk of hypotension.
Anti -acid (Magnesi, Aluminum) or Cimetidine: The only dose does not affect the bioavailability of olanzapine oral.
Activated carbon: Using activated carbon (1g) reduces about 60% cmax and AUC of Olanzapine oral. Activated carbon can be an effective measure to overdose Olanzapine.
CYP1A2 touch substance: Olanzapine's metabolism may be touched by smoking (olanzapine's clearance is lower than 33% in non -smokers and a 21% longer duration of exit in non -smokers compared to smokers) or Carbamazepine treatment (44% clearance and 20% reduction in carbamazepine treatment). Smoking and carbamazepine treatment causes active touch CYP1A2.
Alcoholic beverages: Ethanol does not affect the pharmacokinetics of olanzapine. However, drinking olanzapine and alcoholic beverages can increase the risk of hypotension.
CYP1A2 inhibitor: Fluvoxamine is a CYP1A2 inhibitor, reducing the clearance of olanzapine. Olanzapine dose should be considered when patients are using fluvoxamine.
CYP2D6 inhibitor: Fluoxetine causes slight increase CMAX (16%) and slightly reduces the clearance (16%) of olanzapine. This change does not affect the effects of olanzapine as well as fluoxetine, so there is no need to adjust the dose in this case.
omeprazole and rifampin may increase the clearance of olanzapine.
warfarin does not affect the pharmacokinetics of olanzapine.
Olanzapine ability affects other drugs:
Medicines on central nervous system: Because olanzapine the main impact on the central nervous system should be cautious when used in combination with other drugs that also affect the central nervous system.
Anti -blood pressure: olanzapine can cause hypotension, thus increasing the hypotension effect of anti -hypertension drugs.
Levodopa and dopamine: olanzapine has antagonistic effects on levodopopa and dopamine agents.
Lithi: olanzapine with a repeated dose (10mg/day for 8 days) does not affect lithium pharmacokinetics. Therefore, there is no need to adjust the lithium dose when used in combination with olanzapine.
Valproate: olanzapine (10mg/day for 2 weeks) does not affect the stable concentration of valproate in plasma. Therefore, there is no need to adjust the dose of valproate when combined with olanzapine.
Effects of olanzapine on drug metabolic enzymes: In vitro studies on human liver microsome shows that olanzapine has very little ability to inhibit CYP1A2, CYP2C9, CYP2D6 and CYP3A. Therefore, olanzapine hardly causes any important drug interactions related to drug metabolic enzymes.
imipramine: The only dose olanzapine does not affect the pharmacokinetics of imipramine and its active metabolic is desipramine.
warfarin: The only dose olanzapine does not affect the pharmacokinetics of warfarin.
Diazepam: olanzapine does not affect Diazepam's pharmacokinetics and its active metabolites are N - Desmethyldiazepam. However, combinations of olanzapine and diazepam may increase the risk of hypotension.
Alcoholic beverages: Olanzapine repetition dose does not affect ethanol pharmacokinetics.
biperiden: The repeated dolinzapine dose does not affect the pharmacokinetics of biperiden.
Theophyllline: Olanzapine repeated dose does not affect the pharmacokinetics of theophylline and its metabolic substances.
Storage
Store in a dry place, the temperature does not exceed 30ºC, avoiding light.
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