Oleanzrapitab 5 Sun Pharma tablets treat schizophrenia (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Olanzapine

Ingredient

Composition information	Content
Olanzapine	5mg

Uses

Indications

Oleanzrapitab drug are indicated in the following cases:

Disease treatment schizophrenia . Olanzapine is effective in maintaining clinical symptoms while continuing treatment in patients who respond to initial treatment.

Pharmacokic

olanzapine associated with high affinity with the following receptors: Serotonin 5HT2A/2C, 5HT6 (ki = 4.11, and 5nm, in order), Dopamine d1 - 4 (ki = 11 - 31 Nm), Histamine H1 (KI = 7NM) (Ki = 19nm). Olanzapine is an antagonist with an average bonding force with 5HT3 receptors (ki = 57nm) and Muscarinic M1 - 5 (ki = 73, 96, 132, 32, and 48Nm, in order). Olanzapine loosely connect with the Gabaa, BZA and β - Drenergic receptors (Ki> 10m).

The antagonism in dopamine and 5HT2 receptors can explain some olanzapine therapies and side effects. The antagonism of olanzapine of Muscarinic M1 - 5 receptors can explain the effects similar to its cholinergic resistance. Olanzapine H1 H1 receptor antagonists can explain the phenomenon of sleeping chicken observed with this drug. Adrenergic α1 receptor can be explained to the hypotension effect of vertical potential observed with this drug.

pharmacokinetics

Used orally, single therapy - olanzapine is absorbed well and reaches the peak concentration for about 6 hours after taking a dose of oral. It is excreted throughout the body by the first metabolism of the liver with about 40% the dose is metabolized before entering the circulatory system. Olanzapine manifests linear dynamics on clinical dose. The sale period is from 21 to 54 hours and the indicated serum purification is from 12 - 47L/hour.

Use olanzapine once a day to create a stable concentration after about 1 week and this concentration is about 2 times the concentration after the single dose. Serum concentration, elimination time and purification of olanzapine may vary between individuals based on smoking, gender and age.

olanzapine is widely distributed throughout the body with an integral distribution of about 1000L. There are about 93% combined with serum protein on a concentration of 7 to 1100ng/ml, mainly linked to albumin and α1 - Glycoprotein acid.

Metabolism and elimination - After a single dose of olanzapine dose marked 14C, 7% of olanzapine dose found in urine in constant form, showing that olanzapine is highly metabolized. About 57% and 30% of the dose are found in urine and feces, in order. In serum, olanzapine only accounts for 12% of AUC for the total number of radioactive, showing a significant presence of metabolites. After using multiple doses, the main metabolites within the circulation are 10 - N - Glucuronide, present in a stable state at 44% of the concentration of olanzapine and 4 ' - N - Desmethyl olanzapine is present in a stable state at 31% of Olanzapine concentration. Both metabolites have no pharmacological effects at observation concentration.

Direct glucuronic and indirect oxidation Cytochrome P450 (CYP) are the main metabolic lines of olanzapine. In vitro research shows that CYPS 1A2 and 2D6 and Monoxygenase enzyme system contain Flavin are involved in the oxidation of olanzapine. The indirect oxidation in vivo in Vivo CYP2D6 is present to perform secondary metabolic lines because the purification of olanzapine does not decrease in these enzyme deficiency objects.

Before taking Oleanzrapitab 5 Sun Pharma tablets treat schizophrenia (5 blisters x 10 tablets)

How to use

oral.

Dosage

oleanzrapitab should be used once a day and is not related to meals, usually used at a dose of 5 - 10mg, with the desired dose of treatment is 10mg/day for a few days. Additional dose adjustment if indicated, usually occurs between doses and not less than 1 week. The daily dose can then be adjusted according to the clinical disease of each patient with a dose of 5 - 20mg/day. The increase in the dose is 10mg/day, for example, the dose of 15mg/day or higher is only proposed after the clinical re -evaluation appropriately.

in children

oleanzrapitab has not been studied in humans

On older patients

Low starting treatment dose (5mg/ivory) is not usually specified but considered for 65 -year -old patients or more when there are clinical warning factors.

On patients, there is a decrease in liver and/or kidney functions: low starting dose (5mg/day) can be considered for these patients.

Female patients compared to male patients: The starting dose and the dose does not need to change regularly for female patients relatively compared to male patients.

On patients who do not smoke compared to smoking patients: The starting dose and the dose does not need to change regularly for patients who do not smoke to patients with smoking. When there is a factor that can slow down the metabolic process (female, older patients, non -smoking), the consideration should be set to reduce the starting dose. The escalation dose, when indicated, should be used carefully in these 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 using overdose?

Symptoms: In patients, the largest amount is determined by 300mg, only reported symptoms of sleeping, stuttering. The limitations of patients are assessed at hospitals, including patients taking a dose of 300mg, there is no sign that there is a disadvantage in laboratory analysis or ECGS. Signs of life are usually within normal limits when overdose.

Based on animal data, the symptoms are expected to overdue the known pharmacological effects of the drug. These symptoms may include chickens, pupils, blurred vision, respiratory failure, hypotension and may be disorders.

Treatment: There is currently no antidote for olanzapine, so the appropriate support measures should be started. It is necessary to consider the possibility of a combination of many other drugs.

In case of acute overdose, setting and maintaining airway and must ensure adequate oxygen and ventilation. The use of activated carbon overdose should be considered because the use of activated carbon has shown to reduce the bioavailability of olanzapine 50 - 60%. Stomach lavage (after placing the trachea tube, if the patient is unconscious) may also be considered.

Hypotension and shock should be treated with appropriate measures such as intravenous infusion or sympathetic stimulants such as norepinephrine (not using epinephrine, dopamine or sympathetic nerve stimulants different from beta antagonism because beta stimulation can worsen blood pressure lowering). Cardiovascular monitoring should be considered to detect the possibility of arrhythmia. Continue to monitor and monitor closely until the patient recovers.

What to do when forgetting a dose? If it is nearly time to take the next dose, skip the forgotten dose and take medicine at the next recommended dose. Do not take double dose to compensate for the forgotten dose.

Side Effects

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

Common, ADR> 10%

Drowsy and weight gain is the only common side effect when using olanzapine. Weight gain is related to the body index (BMI) before treatment and the starting dose is 15mg/day or higher.

Uncommon, 1%

Dizziness, increased appetite, edema, hypotension posture and anti -anti -cholinergic effects, mild levels including fertilization, dry mouth are rare side effects when using olanzapine.

Increasing liver enzymes AST, asymptomatic ALT, fleeting are also rare, especially in the early stages of treatment.

Despite the different studies of olanzapine in the treatment of patients with lower incidence of Parkinson's disease, Akaithisia, and muscle tone disorders compared to the standardized dose according to Haloperidol. When there is no detailed information about the history of acute and chronic dysfunction in each patient, it is impossible to conclude that olanzapine is less likely to cause slow rhythmic disorders or other extracurricular syndrome.

Rare, ADR

Light sensitivity symptoms have been reported.

Other signs: Occasionally increase the level of prolactin in plasma, but with clinical manifestations of female mammary glands (male mammary gland condition enlarged due to hormone disorders), nipple milk, large mammary glands. In most patients, this prolactin level can return to normal without stopping treatment.

High concentration of Creatine Phosphokinase enamel is also recorded in rare cases. Like other sedatives, changes on asymptomatic hematology are also less common.

Instructions on how to handle ADR

Notify the doctor the effects of not being late when using.

Warnings

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

Contraindicated

Oleanzrapitab drug contraindicated in the following cases:

Patients who already know hypersensitivity to any ingredients of the drug.

Patients who already know the risk of narrow -angle glaucoma disease .

Precautions when using

Patients with combined disease

olanzapine proved to have a low rate of cholinergic resistance in clinical studies. Precautions should be carefully prescribed in patients with prostate hypertrophy, or semi -circuit intake and related cases because of clinical experience when treating olanzapine limited to accompanying patients.

Increasing liver enzymes, ALT, AST transient, no clinical symptoms occasionally noticed especially in the early stages of treatment. Caution should be used in patients with an increase in AST or ALT liver enzymes, in patients with symptoms of liver function reduction, patients are available with the accompanying disease with a limited reserve of liver function and on patients treated with liver toxic drugs. When there is an increase in AST or ALT liver enzymes during treatment, it is necessary to monitor and reduce the dose if needed.

As well as other sedatives, cautious when used for patients with leukemia or polygonal leukemia for any reason, patients with a history of pulp or medulla due to drugs, patients with bone marrow inhibitor due to the accompanying pathogens, radiation or chemotherapy and on patients with hyperllyed polymorphoners or bone marrow hyperbols. There are 32 patients with neutropenoma due to clozapine or a history of granulocytes due to oleanzapine use without reducing neutrophils compared to normal levels.

Malignant syndrome caused by sedatives (NMS)

NMS is a complex of symptoms at risk of death that has been reported related to other anti -psychotic drugs. In clinical studies, no NMS cases are reported in patients treated with olanzapine.

NMS is often accompanied by symptoms of fever, muscle spasticity, mental changes, evidence of unconscious insecurity (vascular or abnormal blood pressure, tachycardia, sweating and arrhythmia). Other signs may include increased creatine phosphokinase, myoglobin urine (ureter muscle) and acute renal failure. Or high fever in unexplained and no clinical symptoms of NMS, all sedatives, including olanzapine, need to stop immediately.

olanzapine should be used carefully in patients with epilepsy or seizures related to seizures.

Slow pacing disorder

olanzapine often comes with a statistical proportion in the treatment of dynamic disorder arising in comparative studies that last for 1 year or less. However, the risk of growing disorder increases with prolonged contact time and so if there are signs and symptoms of a slow -pacemaking disorder occurring in patients using olanzapine, it is necessary to consider reducing the dose or stopping medication. These symptoms may reduce the effect of temporary drugs or even after treatment.

Be cautious when taking olanzapine in patients with treatment in combination with other central and alcoholic drugs (stated in the central nervous effects of olanzapine). When there is an expression of dopamine's opposition, olanzapine may be opposed to direct and indirect effects on dopamine. Hypotension does not usually occur in older patients using olanzapine in clinical studies. Like other mental medications, periodic blood pressure is needed in patients> 65 years old.

In clinical studies, olanzapine should not be used for patients with abnormal increase in qt on the electrocardiogram. However, like other mental medications, cautious weight when taking oolanzapine with known drugs to increase QTC, especially in older patients.

The ability to drive and operate machinery

olanzapine is likely to cause drowsiness, patients should be carefully advised when operating dangerous machines, including motorcycles.

Pregnancy

There are no well -controlled and complete studies in pregnant women. Patients should be advised to notify physicians if they are pregnant or intend to get pregnant during treatment with olanzapine. However, due to the lack of medication experience in humans, this drug should only be used for pregnant women only when the benefits achieve more than the risk of harmful to the fetus.

Breastfeeding period

olanzapine is excreted in the mouse's milk for medication during breastfeeding. It is not known whether olanzapine will be excreted in human milk.

Patients should be advised not to breastfeed if they are taking olanzapine.

Drug interaction

The possibility of other drugs that can affect olanzapine:

Single dose of antacids (Al, Mg) or cimetidine does not affect the biological activity of oral olanzapine. Using at the same time with activated carbon can reduce the biological activity of olanzapine oral to 50 - 60%. Olanzapine's metabolism may be reduced when there is an accompanying smoking (olanzapine's clearance is 33% lower and the half -life of removal of drugs is longer than 21% in non -smokers compared to smokers) or carbamazepine treatment (the clearance increases to 44% and the sale time of removal of 20% reduced drugs when used with carbamazepine). Smoking and carbamazepine treatment reduces the activity of P450 - 1A2.

The pharmacokinetics of theophyllline, metabolized by P450 - 1A2, does not change by olanzapine. The impact of activated inhibitors P450 - 1A2 on pharmacokinetics of olanzapine has not been studied.

Olanzapine's impact ability on other drugs: olanzapine does not inhibit metabolism of imipramine/desipramine (P450 - 2D6 or P450 - 3A1/A2), Warfarin (P450 - 2C9), Theophylline (P450 - 1A2) or Diazepam (P450 - 3A4 and P450 and 2C19).

olanzapine does not give interactions when used in combination with lithium or biperiden.

Storage

Store drugs under 30 ° C in a cool, dry place, avoid light.

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