Egolanza Egis Pharma drugs treat schizophrenia, bipolar disease (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Olanzapine

Ingredient

Composition information	Content
Olanzapine	10mg

Uses

indications

Egolanza drugs are indicated in the following cases:

Schizophime psychiatric treatment, bipolar disease: Execute or mixed, bipolype disease quickly, agitated due to schizophrenia or bipolar disease. (Use intramuscular form of olanzapin).

Pharmacology

olanzapin is a neuroleptic (anti -psychotic drug) 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, which are the substance of phenothiazin or butyrophenon such as less causing extracurricular syndrome, less prolactin secretion, less dysplasia when treated for prolonged treatment and effectively effective 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 Typs 2 receptors (5 - HT2A, 5 - HT2C), Typ 3 (5 - HT3), Typ 6 (5 - HT6) and Dopamine in the central nervous system. Olanzapin has the effect of inhibiting and reducing the response (negative air conditioner) for receptors 5 - HT2A, related to the anti -revolt effect of the drug.

In addition, olanzapin also stabilizes the temperament due to part of DOPamine's D2 receptor inhibitors. Olanzapin used intramuscularly to treat a partial epilepsy due to sedative effect, soothing than only due to the effect of sleeping.

olanzapin also has antagonistic effects on Muscarin receptors (M1, M2, M3, M4 and M5). The anti -cholinergic effect of the drug explains the risk of reducing the appearance of a peripheral syndrome, on the other hand, it is related to some other unwanted effects of olanzapin. Olanzapin also has the H1 receptor antagonistic effect of histamine and Alpha - 1 Adrenergic receptor. This effect is related to the ability to cause chicken sleep, hypotension posture when using olanzapin.

Pharmacokinetics

absorption

After drinking, olanzapin absorbed quickly and almost entirely through the digestive tract, but due to the metabolism of step 1 in the liver, the oral bioavailability reached only 60%. Food does not affect the absorption of drugs. The concentration of medication in the blood is maximum of about 6 hours (ranging from 5 hours to 8 hours) after taking the drug.

Plasma concentration in stable plasma after 7-10 days of reminded dose. When intramuscularly, blood concentration reaches maximum after about 15 minutes to 45 minutes with a concentration of 5 times compared to drinking. Olanzapin's plasma concentrations change between individuals, depending on age, gender and whether the patient smokes or not.

blood concentration in women is about 30-40% higher than 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 liters. The ratio of binding with plasma proteins is about 93%, mainly linked to albumin and alpha acid - 1 glycoprotein. Olanzapin and glucuronid conjugate metabolites pass the placenta and are exempted into breast milk. The amount of drug stabilized in babies is about 1.8% of the mother's dosage. In addition, the peak concentration in breast milk is about 5.2 hours slower after reaching the peak concentration in the mother's plasma.

Metabolism

olanzapin is metabolized in the liver before eliminating mainly through CYP1A2, a small part through CYP2D6 and then concluded with glucuronic acid. The two main metabolites are 4 ' - N - Demethyl olanzapin and 10 - N - Glucuronid no longer retain the activity of olanzapin.

Elimination

After drinking, half -life eliminated in olanzapin's plasma about 30 hours (ranging from 21 hours to 54 hours). Half life eliminates plasma after intramuscular injection similar to after drinking. Half -life elimination increased to about 1.5 times in the elderly.

Olanzapin's clearance increased by about 40% in smokers compared to non -smokers and decreased by about 30% in women compared to men. About 57% and 30% of the drug are excreted in urine and feces, mainly in the form of metabolites, a small part (7%) in the form of intact. The pharmacokinetics of the drug does not change much in patients with renal failure.

Before taking Egolanza Egis Pharma drugs treat schizophrenia, bipolar disease (4 blisters x 7 tablets)

How to use

Take oral, no meals.

Dosage

adults

schizophrenia

The starting dose of 5 - 10 mg, usually taken 1 time/day. The dose may increase by about 5 mg/day for 5-7 days to the destination dose of 10 mg/day. The dose adjustment in the later stage usually must be less than 7 days apart, increasing or decreasing 5 mg daily to the maximum dosage recommended 20 mg/day.

Maintenance dose: 10 - 20 mg/day, 1 time.

Diphagnic disease, acute or mixed revolt treatment

Single therapy: Starting 10 - 15 mg/day oral 1 time. The dose may increase by 5 mg/day apart not less than 24 hours apart. The maintenance dose is 5 - 20 mg/day. The maximum recommended dose is 20 mg/day.

Coordinate therapy (with lithium or valproat): Starting 10 mg/day, oral 1 time, the dose can fluctuate within: 5 - 20 mg/day.

Execcation treatment for Hunga (fixed -dose coordination with fluoxetin): The starting dose of olanzapin 6 mg and fluoxetin 25 mg.

Elderly

Initially 2.5 - 5 mg, after 2 hours can add 2.5 - 5 mg if necessary.

Dosage for children

Children

Not yet determined safety and efficiency.

Children from 13 - 17 years old

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. Maximum dose of 20 mg/day. 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.

kidney failure

No need to adjust the dose for patients with renal failure.

liver failure

Need to adjust the dose for patients with liver failure. However, there is no specific recommendation to adjust the specific dose. Need to closely monitor patients ..

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?

Symptoms

Overdose of death in patients is usually observed at a dose of over 200 mg.

Symptoms usually appear within 1-2 hours, the maximum effect within 4-6 hours after taking the drug:

agitated, tachycardia, cholinergic resistance, pupils dilate, symptoms of foreign tapes, muscle spasms, increased salivation. Sometimes cardiac arrest and respiration, tachycardia (tachycardia on ventricular), malignant neurolithic syndrome, respiratory inhibition, epilepsy, hypertension or hypotension (including vertical posture lowering).

Mainly treat symptoms, support care, maintenance of intravenous pathway accompanied by a tightening of cardiovascular function and survival signs.

Gastrointestinal lavage along with activated carbon with sorbitol to eliminate and prevent the absorption of the remaining drug in the digestive tract.

Maintain support ventilation and oxygen therapy. Treatment of hypotension and circulatory failure with intravenous solutions and vasodilators (noradrenalin, phenylephrin) but avoid dopamine and adrenalin. Control arrhythmia by appropriate treatments. Extending the QRS interval on electrocardiograms can be adjusted by transmitting bicarbonate solution.

Acute surgeon syndrome can be treated with anti -cholinergic drugs (such as diphenhydramin, Atropin). Physostigmin or benzodiazepine can be used if there is a severe and confused manifestation in patients with severe cholinergic poisoning with a short QRS complex on the electrocardiogram. No specific antidote. Dialysis and peritoneal fertilizer plays a very limited role in the treatment of olanzapin acute poisoning. Chronic poisoning: So far, olanzapin has not been systematically assessed whether the drug is addictive or not. Be careful with this risk.

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 Egolanza, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Central nervous: Sleeping chicken, pagoda syndrome, insomnia, dizziness, pronunciation disorders, fever, nightmares, refreshment, forgetting, manic.

digestive: indigestion, constipation, weight gain, dry mouth, nausea, vomiting, increased cravings.

liver: increase ALT.

muscle - bone: weak muscle, tremor, fall (especially in the elderly).

Cardiovascular: lower blood pressure, tachycardia, peripheral edema, chest pain. skin: burns.

In place: Pain at the injection site (intramuscularly).

Endocrine, metabolism: hyperkemia, hyperkemia, hyperglycemia, urinary hemorrhage.

Eye: Reduction of vision, conjunctivitis.

Uncommon, 1/1 000

leukopenia, neutropenia, slow rhythm, extending the QT range on the center of electrocardiogram, increasing sensitivity to light, epilepsy.

Rare, ADR

Pancreatitis, malignant neuronal syndrome (hyperthermia, muscle spasticity, mental state changes with self -management nervous system disorders: heart rate and blood pressure unstable).

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

Egolanza medicine is contraindicated in the following cases:

breastfeeding women.

Too hypersensitivity to olanzapin.

Be cautious when used

in children, although the effectiveness and safety of olanzapin in children under 18 years of age have not been established, olanzapin has been used effectively in schizophrenia at this age. The drug is indicated for schizophrenic treatment, coordinating the treatment for patients from 12 - 18 years old under the close supervision of a specialist physician.

Caution for elderly patients with mental disorders associated with dementia due to the risk of increased mortality, mainly due to cardiovascular causes (heart failure, sudden death) or bacterial infection (pneumonia).

Children from 13 to 17 years old tend to gain weight and the risk of increasing blood lipids more than adults. Therefore, it is necessary to evaluate the risk of long -term and detailed treatment plan before using olanzapin.

Be cautious when using olanzapin for people with benign prostatic hypertrophy, narrow -angle glaucoma or a history of intestinal paralysis due to the drug's anti -cholinergic effect.

It is necessary to assess body temperature and caution for patients who work severe physical work, dehydration, being treated with other anti -cholinergic drugs due to the risk of increasing the body's body temperature.

Be cautious when using olanzapin for people with heart disease, brain vessel disease or diseases that can cause hypotension (dehydration, decrease in circulatory volume, which are being treated with anti -hypertension drugs) due to the risk of increased posture of blood pressure with slow rhythms, fainting and stopping sinus nodes.

Be cautious with the ability to reduce concentration and motor activity related to the sedative effects of the drug.

Be cautious when using intramuscular olanzapin with injection benzodiazepin derivatives. There is no simultaneous use of these two drugs. In case of use, it is necessary to closely monitor the risk of excessive sedation, respiratory inhibition and heart.

Be cautious when using olanzapin for patients with diabetes, patients with hyperglycemia (thriving blood sugar from 100 to 126 mg/decaric) due to the risk of hyperglycemia, even uncontrolled even after stopping the drug. Need to monitor blood sugar during treatment.

Be cautious with the elderly, especially women due to the risk of increasing late movement disorders. In the event of this disorder may consider the ability to stop the drug.

Caution for patients with symptoms of liver function impairment, patients with diseases that affect the ability to preserve liver function or are being treated with toxic drugs to the liver. Periodically quantify transaminase concentration during the use of olanzapin for these objects.

Be cautious when taking olanzapin for patients with a history of epilepsy, head injury or being treated with drugs that can reduce epilepsy threshold due to convulsions depending on the dose that may appear during olanzapin treatment.

The ability to drive and operate machinery

should be cautious when used for driving objects and operating machinery.

pregnancy

Although animals do not show the effects of olanzapin on pregnancy, due to lack of data on humans, they should be cautious when used for pregnant women and consider risks - benefits before starting treatment for this object.

The period of breastfeeding

olanzapin is exported into milk can cause central neurological inhibiting effects in breastfed babies, so it is necessary to avoid using olanzapin for breastfeeding women or not breastfeeding when required to treat the mother.

Drug interaction

Avoid not to coordinate

Do not coordinate olanzapin with levomethadyl due to increased risk of heart toxicity (extending the QT range, torsion, cardiac arrest); With Metoclopramide due to an increase in the risk of outsider of extracurricular syndrome, malignant neuron syndrome.

Increases the effect and toxicity of olanzapin

Simultaneous use of olanzapin with central nervous system inhibitors: alcohol, benzodiazepine derivatives increase the effect of lowering the posture effect of olanzapin. CYP450 inhibitors (caffeine, cimetidin, erythromycin, ciprofloxacin, quinidine, some antidepressants such as fluvoxamine) increase blood levels so it can increase the effect and toxicity of clonzapin.

Do not use dopamine, adrenalin or other sympathetic effects on the beta receptor in patients being treated with olanzapin, due to the ability to worsen hypotension due to olanzapin's Alpha receptor inhibitors.

Reduce the effect of olanzapin

CYP450 induction drugs (phenobarbital, carbamazepin, phenytoin, rifampicin, omeprazol, nicotine) reduce olanzapin levels in the blood.

Increases the effects and toxicity of some other drugs

olanzapin increases the effect (constipation, dry mouth, urinary retention, sedation, visual disorders) of anti -cholinergic drugs, increasing the effect of lowering the blood pressure of anti -hypertension drugs.

Reduce the effect and toxicity of some other drugs

olanzapin may reduce the effects of Parkinson's medications.

Storage

In closed packaging, at a temperature not exceeding 30 ° C.

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