Olanstad 10 Stella tablets treat 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

Olanstad 10 is indicated in the following cases:

Olanstad 10 drugs are indicated for treatment for the treatment of schizophrenia and the treatment of Hung sympathy is both severe related to bipolar disorders.

Pharmacokological

olanzapin is a typical non -psychotropic drug of Thienobenzodiazepin group. The drug is affinity for the receptor of serotonin , muscarin, histamine H1 and α1 - Adrenergic as well as with different receptors of dopamine.

pharmacokinetic

absorption

olanzapin is well absorbed through the gastrointestinal tract after drinking, but is significantly metabolic. The peak concentration of the drug in plasma is about 5-8 hours after taking the drug.

Distribution

about 93% olanzapin binds to plasma proteins. Olanzapin distributed into breast milk.

Metabolism

The drug is strongly metabolized in the liver mainly by direct glucuronid and indirect oxidation through Cytochrom P450 Isoenzyme CYP1A2 and less than CYP2D6. The two main metabolites are 10 - n - glucuronid and 4 ’ - n - desmethyl olanzapin is not active.

Elimination

About 57% of the dose is excreted into urine mainly in the form of metabolites and 30% appears in feces. Selling waste time in plasma fluctuates for about 30 - 38 hours, the sale time tends to last for female patients than male patients.

Before taking Olanstad 10 Stella tablets treat schizophrenia (3 blisters x 10 tablets)

How to use

olanstad 10 is used by oral, regardless of meal.

Dosage

Adults

schizophrenia

The starting dose is 5 - 10 mg daily and recommends adjusting the dose of up to 10 mg daily to be performed by batches not less than 1 week apart. The daily dose is adjusted every step every 5 mg.

Heart

Acute Hung Cam Treatment:

Unit: 10 mg or 15 mg/day.

Combine: 10 mg.

The 5 mg dose adjustment is made from less than 24 hours apart if necessary so that the dose is within 5 - 20 mg/day. If there is a response, can continue treatment with the same dose to prevent recurrence.

Prevention of recurrence in the previous Hung Cam patient responded to olanzapin: The recommended starting dose is 10 mg daily.

Special patient group

Patients with liver failure or kidney failure

The starting dose of olanzapin 5 mg per day may be necessary for patients with renal failure; Patients with medium liver failure at the starting dose of 5 mg daily and cautious when increasing the dose.

Gender

often do not need to change the need for the starting dose and the dose for female patients compared to male patients.

Smokers

often do not need to change the need for the starting dose and the dose for patients not smoking compared to patients with smoking.

When there are more than one factor that can slow down the metabolism of olanzapin (women, old age, non -smoking condition), should consider reducing the starting dose. When indicated to increase the dose, you should be cautious in these patients.

Children and adolescents

olanzapin is not recommended for children and minors under 18 years old because of lack of safety and efficiency data.

Elderly

usually do not specify lower starting dose (5 mg/day) but should consider patients ≥ 65 years old when clinical factors have proven.

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

Symptoms are very common in the overdose (> 10%) including fast circuits, anxiety/aggression, vaginal disorder, diverse foreign symptoms and reducing the level of awareness from sedation to coma.

Other significant health sequelae in the overdose include delirium, convulsions, coma, malignant sedative syndrome, respiratory failure, hypertension or hypotension, arrhythmia ( Handling

There is no specific antidote for olanzapin overdose. Causing vomiting is not recommended. Standard measures for overdose treatment (such as stomach lavage, activated carbon). Drinking at the same time active carbon shows a 50-60% reduction in olanzapin.

Treatment of symptoms and monitoring of the vital function of organs based on clinical conditions, including treatment of hypotension and cardiovascular collapse, and support respiratory function. Do not use epinephrin , dopamine and other sympathetic stimulants that have beta activity, because beta stimulation can lower blood pressure.

Cardiovascular monitoring is essential to detect arrhythmia. Patients should continue to monitor and monitor medical 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 olanstad 10 , you may experience unwanted effects (ADR).

Very common (ADR ≥ 1/10)

Metabolism and nutrition: weight gain.

Neurological: Drowsy. circuit: Hypotension.

Relevant studies: Increased plasma prolactin levels.

Common (1/100

Blood and lymph: Eosin hypernagus, leukopenia, neutrophils.

metabolism and nutrition: Increasing cholesterol, glucose, triglyceride, urinary glucose, increasing appetite.

nerve: dizziness, restless sitting, Parkinson's disease, movement disorders.

digestive: has a light, transient anti -cholinergic effect, including constipation and dry mouth. liver - bile: Increased aminotransferase liver (ALT, AST) transient, asymptomatic, especially in the first stage of treatment.

Skin and subcutaneous tissue: rash.

muscle and connective tissue: joint pain.

Breeding and breast: erectile dysfunction in men, reducing sexual desire in men and women.

Systemic: weakness, fatigue, edema, fever.

Relevant studies: alkaline phosphatase, high dimidin phosphokinase, gamma glutamyltranspeptidase (GGT), high uric acid.

Uncommon (1/1000 ≤ ADR

Immune: Hypersensitivity.

metabolism and nutrition: progressing or aggravating diabetes sometimes accompanied by an acid-cetone or coma, including some deaths. Neurological: epilepsy occurs in most cases of epilepsy or risk factors of epilepsy, muscle -muscular disorder (including rotating eye motion), late movement disorders, dementia, speech disorders. heart: Slow heart rate, extending the QT range.

circuit: thrombosis (including pulmonary embolism and deep vein thrombosis).

Respiratory, chest and mediastinum: nosebleeds.

digestive: abdominal distention.
Skin and subcutaneous tissue: Reaction sensitive to light, hair loss.
Kidney and urinary tract: urine, urinary retention, difficulty urinating.
Reproduction and breast: amenorrhea, breast enlargement, melting milk in women, big breasts/breast enlargement in men.

Relevant studies: Increase of total bilirubin.
Rare (1/10000 ≤ ADR
Blood and lymph: platelets.

Metabolism and nutrition: lower body heat.
Neurology: malignant neuroleptic syndrome, drug stop symptoms.
Heart: ventricular tachycardia/ventricular, sudden death.
digestive: pancreatitis. liver - bile: hepatitis (including liver cell lesions, bile stasis or mixed liver damage).
Muscle and connective tissue: Muscle pattern.

Reproduction and breast: Penis pain prolonged.

Unknown frequency

During pregnancy, postpartum and after -birth: A cessation syndrome in newborns.

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

Olanstad 10 contraindicated in the following cases:

Hypersensitivity to olanzapin or any ingredients of the drug.

Patients who have known about the risk of narrow -angle glaucom.

Be cautious when using

olanstad 10 contains lactose excipients. Patients with rare genetic disorders in galactose tolerance, lactase lactase deficiency or glucose-galactose absorption disorders should not be used.

anti -cholinergic effect

While olanzapin shows anti -Vitro anti -Vitro activity, experience in clinical trials, relevant symptoms appear at a low rate. However, due to the clinical experience using olanzapin in patients with limited accompanying diseases, caution should be cautious when prescribing olanzapin for patients with pre -hypertrophy, or intestinal obstruction due to paralysis and related conditions.

Effects on the central nervous system

olanzapin has the main effect on the central nervous system, so it should be used cautiously when used in combination with drugs that act on the central nervous system and alcohol. Because olanzapin represents antagonism with dopamine in vitro, olanzapin can oppose the effect of indirect and direct dopamine owners.

Mental disorders related to dementia and/or behavioral disorders:

It is not recommended to use olanzapin for this group of objects because of increased death and risk of stroke.

Parkinson's disease

It is not recommended to use olanzapin in the treatment of mental disorders related to dopamine fortunes in Parkinson's patient. In clinical trials, the worse job of Parkinson's symptoms and the illusion that has been reported is more common and more common than placebo, and olinzapin is not more effective than placebo in the treatment of neurological symptoms.

Malignant neuropular syndrome

is a life -threatening situation associated with the use of anti -psychotic drugs. The clinical manifestations of this syndrome are high fever, stiffness, mental changes, with unstable manifestations of plant nervous systems (circuits or irregular blood pressure, tachycardia, sweating and arrhythmia), other signs including increased creatinine phosphokinase, myoglobin urine (Mechanical Prize), and acute renal failure. If a patient has signs and symptoms of malignant neuropular syndrome, or has a high fever of unknown cause without the clinical manifestations of malignant neuroleptic syndrome, mental disorder medications must be stopped (including olanzapin).

Hyperglycemia and diabetes

Hemorrhage increases blood glucose and/or making diabetes worse than diabetes, sometimes associated with Ceto-acid infection or coma has been reported rare, including some deaths. In some cases, the previous increase in body weight has been reported, may be related to a genetic factor. Proper clinical monitoring should be followed according to the instructions for use of anti -dysplasia drugs. Patients treated with any anti -neuropathy, including olanzapin, should be monitored with signs and symptoms of hyperglycemia (such as a lot of thirst, a lot of urination, eating a lot and weakness) and patients with diabetes or having risk factors of diabetes should be monitored regularly the worsening of blood glucose control. Should monitor regular weight.

Lipid disorders

In a controlled clinical trial with a group of evidence, unwanted lipid disorders have been observed in patients treated with olanzapin. Lipid disorders should be appropriate clinical control, especially patients with lipid disorders and patients with risk factors for progression of lipid disorders. Patients treated with any anti -dysliths, including olanzapin, should be monitored regularly as directed by the use of anti -dysplasia drugs.

grain leukemia

Use cautiously for patients with low number of leukemia and/or neutrophils due to any cause, patients taking medication causing neutrophils, patients with a history of inhibition/bone marrow poisoning due to drugs, patients with bone marrow inhibitor in combination with radiation or chemotherapy and patients with hyperlypes acid or hyperplasia. Neutral leukemia has been reported to be common when using olanzapin in combination with valproat and in patients with acidic leukemia or bone marrow hyperetopers.

Stop medicine

Very rare acute symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting when stopping olanzapin suddenly.

Increase QT

It is necessary to be cautious when prescribing olanzapin along with the known drugs that last to extend the QTC, especially in the elderly, patients with congenital QT syndrome, congenital heart failure, heart hypertrophy, hypotension and hypoglycemia.

blood vessel thrombosis

Very rare, the relationship between the occurrence of venous thrombosis and the use of olanzapin has not been clearly proven. However, because the patient with schizophrenia often has risk factors for intravenous thrombosis, such as motionless patients, should be identified and prophylactic evaluation.

Late movement

The risk of late dysplasia increases in long -term use. Therefore, if there are signs or symptoms of late dysplasia appears in patients using olanzapin, should consider reducing the dose or stopping the drug.

convulsions

Should use olanzapin caution for patients with a history of convulsions or risk factors that lower the seizure threshold. Convulsions have been reported rare in patients treated with olanzapin. In most of these cases, there are reports on convulsions or risk factors.

Hemodynamic effects

olanzapin can cause vertical hypotension accompanied by dizziness, tachycardia and in several patients, unconscious, especially in the starting stage of the initial dose, possibly due to the effect of α1-adrenergic receptor resistance.

Suddenly due to heart disease

In the test report after the market, the sudden deaths caused by heart disease were reported in patients using olanzapin. In the study, the risk of olanzapin is similar to that of non -typical anti -neuron drugs in a combined analysis.

Increase enzyme transaminase

Be cautious in patients with signs and symptoms of liver failure, the previous patient has a limited liver function and patients who are treating drugs that canxicate the liver. Proposal to periodically evaluate enzyme transaminase in patients with severe liver disease.

The regulation of body temperature

Psychotic medications lose the ability to lower the body's central body. Should be careful when prescribing olanzapin for patients who are in a state may increase the body temperature as if they are trying to exertion, hot infection, using anti -cholinergic drugs, or dehydration.

Difficulty swallowing

Loss of esophageal and respiratory movement is related to the use of psychotic drugs. Respiratory pneumonia is a common cause of raging and death in patients with Alzheimer's available. Olanzapin caution should be used with mental disorders in patients at risk of pneumonia - respiratory.

suicide

The inherent suicide of suicide in schizophrenia and bipolar disorder. Should closely monitor patients at high risk of suicide associated with drug treatment.

The ability to drive and operate machinery

There are no tests on the influence on driving and operating machinery. However, olanzapin can cause drowsiness and dizziness, so patients take this drug should be cautious when operating machinery and driving.

Pregnancy

There is no adequate test and strict control in pregnant women. Only use olanzapin for pregnant women when the benefits are higher than the risk of harm to the fetus.

Breastfeeding period

If you are taking olanzapin, patients should not breastfeed.

Drug interaction

olanzapin increases the effects on the nervous system of central neurotransmitter, including alcohol. Olanzapin may oppose the action of dopamin's ownership. Neutral leukemia may be more common when olanzapin is used with Valproat. There is a risk in theory of extending QT when using olanzapin combined with other drugs that have been known.

olanzapin metabolizes through cytochrom P450 ISOENZYM CYP1A2. The use of inhibitors, induction, or acts as a substrate of the above isenzyme, which can affect the plasma olinzapin levels and need to adjust the dose of olanzapin. Fluvoxamine inhibits CYP1A2 inhibits the metabolism of olanzapin significantly. Tobamazepine smoke and carbamazepin touch olanzapin metabolism.

Storage

Store in closed packaging, dry place. The temperature does not exceed 30 ° C.

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