Nykob 10mg Genepharm SA tablets treatment of schizophrenia (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Olanzapine

Ingredient

Composition information	Content
Olanzapine	10mg

Uses

indications

Nykob 10mg drug indicated in the following cases:

schizophrenia. play.

In preclinical studies, olanzapine has affinity (KI;

Animal behavior studies have shown that olanzapine has an antagonistic effect on 5HT, with dopamine, and cholinergic resistance, suitable for the ability to attach to receptors. Olanzapine has a stronger affinity with the receptor of Serotonin 5HT2 on in vitro compared to D2 and activated 5HT2 on In vitro more than D2 activity.

Physiological electrophoresis studies have shown that olanzapine selectively reduces the activation of dopaminergic nerve cells in Mesolimbic (A 10), but has little effect on movement (A9) in motor function.

olanzapine reduces conditional avoidance response, is a test that determines the anti -psychotic effect when using the lower dose than the dose that causes the same, is a side effect on the motor function. Unlike some other anti -psychotic drugs, olanzapine increases response in a "anxiety" test.

In a single oral dosage study (10 mg) using a Positron (PET) solution in healthy volunteers, Olanzapine occupies a 5HT2A receptor than the Dopamine D2 receptor.

Moreover, an image study uses a method of cutting a single phroton transmission (specter) in schizophrenic mental illness showing that the patients responding to olanzapine occupy the D2 of the body less than those who respond to Risperidone and some other anti -chaotic drugs, but equivalent to those who respond to clozapine.

Both of the two trials cum ferococenters and two of the three tests have a comparative substance that is over 2,900 schizophrenia patients with both positive and negative symptoms, seeing olanzapine significantly improving positive as well as negative symptoms.

in children

Experience in the youth group (from 13-17 years old) is limited to treatment for less than 200 patients and only dose of short-term effectiveness with schizophrenic mental illness (6 weeks) and Hung Cam have bipolar disorder (3 weeks). Olanzapine is used in flexible dose from 2.5 to 20mg/day.

During treatment, patients of adolescents gain weight faster than adults. The change of total cholesterol index, ldl cholesterol, triglycerides and prolactin in adolescents, is more than changing in adults. No effective and safe data when long -term treatment.

Dynamic pharmacokinetics

absorption

olanzapine absorbs well when drinking, reaching peak plasma concentrations within 5 to 8 hours. Food does not affect the absorption. The absolute oral bioavailability has not been determined compared to the veins. Olanzapine concentration in plasma is linear and proportional to the dose in research tests with the dose of 1 to 20mg.

distribution

About 93% olanzapine is connected to plasma proteins when the concentration is 7 - 1000ng/ml. Olanzapine is mainly connected to albumin and al-acid-glycoprotein.

transformation

olanzapine is metabolized in the liver through a conjugate and oxidative mechanism. The main metabolite is 10-N-glueuronide, and does not pass the brain barrier. Cytochrom P450- CYPIA2 and P450-Cyp2d6 are involved in the creation of N-Desmethyl and 2-Hydroxymethyl metabolites. Both of these specialized substances have the physical activity on # vivo much lower than olanzapine in animal studies. The effect is mainly due to the mother medicine.

Elimination

After oral use, the average Thai sale time in healthy people depends on age and gender. After oral use in healthy people, the average disposal time is 33 hours (21 - 54 hours for the 5th to 95th bachelor) and the average plasma clearance of olanzapine is 261⁄ (12 to 47L/GI for the 5th to 95s).

In the elderly (65 and higher) healthy compared to young people, the average selling time is extended (51.8 compared to 33.8 hours) and reduced clearance (17.5 for 18.2L/hour). Pharmacokinetic changes in the elderly are still within the scope of changes of young people. In 44 people with schizophrenia (65 years), the dose is from 5 - 20mg/day there is no difference in side effects.

In women compared to men, the average disposal time is extended (36.7 compared to 32.3 hours) and the clearance of relief (18.9 compared to 27.31/hour). However, the safety of olanzapine (5-20mg) is similar in female patients (n = 467) and men (n = 869).

Renal failure: There is no significant difference in the average selling time (37.7 compared to 32.4) or clearance (21.2 compared to 25.01/hour) of olanzapine between kidney failure (creatinine clearance

Smoking

In patients with smoking that has mild disorders of liver function, the average pregnancy selling time (39.3 hours) is prolonged and the clearance (18.01/hour) decreases similarly to those who do not smoke healthy (equivalent to 48.8 hours and 14.1L/hour).

In non -smokers compared to smoking (men and women), the average selling time is longer (38.6 compared to 30.4 hours) and reduced clearance (18.6 compared to 27.7l/hour).

Olanzapine's plasma clearance is lower than in the elderly than young people, in women than men, and in non -smokers than smokers. However, the level of influence of age, gender, or smoking to the level of clearance and the sale time of olanzapine is small when compared to the common difference between individuals.

In a study in whites, Japan and China, there is no difference in parameters dynamic between these three groups of people.

Youth

Olanzapine pharmacokinetics are similar to adults and adults.

In clinical research, the exposure to olanzapine is about 27% higher in teenagers.

The difference in statistics between adolescents and adults has included teenagers' body weight factors, which are lighter and have fewer teenagers smoking. These weaknesses may have contributed to the higher exposure to olanzapine in teenagers.

Before taking Nykob 10mg Genepharm SA tablets treatment of schizophrenia (4 blisters x 7 tablets)

How to use

Olanzapine drugs used by oral.

Dosage

Adults

Nykob drugs used in the case of schizophrenia: The recommended starting dose is 10mg/day.

Nykob drugs for Hung Cam patients:

The starting dose is 15mg/ 1 time/ day in the monotherapy regimen or 10mg/ day in the combined regimen.

Used in the maintenance phase with bipolar disorder.

The recommended starting dose is 10mg/day. For patients who have been treated for the previous Olanzapine, continue treatment according to the equivalent dose to maintain the response.

If a new man is new, depression or mixed emotions (including a prize and depression) appears, it is advisable to continue using olanzapine and need to set the optimal dose in this case along with treatment support measures to treat symptoms by clinical condition.

In the treatment of schizophrenia, mania and maintenance treatment for patients with bipolar disorders, daily dose can be adjusted based on clinical condition between 5-20mg/day. Increasing the dose higher than the recommended dose should only be conducted after clinical reassessment and often occur in the period of no less than 24 hours.

Food does not photo towards absorption so you can use olanzapine without caring for meals.

Should reduce the dose slowly from stopping the drug.

with special patient groups:

Children:

olanzapine has not been studied in patients under 18 years of age due to the lack of safety and effectiveness.

Do not use the low starting dose is 5 mg, but it is advisable to consider for patients over 65 years old when there are unfavorable clinical factors. In the case of average liver failure (cirrhosis, type A or B Child-Pugh), the starting dose should be used 5mg and be careful when increasing the dose.

Patients with smoking:

There is no difference in the starting dose and the usual dosage range in patients who do not smoke and the patient smokes. It is necessary to need kidneys when indicated to increase the dose in these patients (see more drugs and pharmacokinetics).

What to do when overdose?

Other significant sequelae of overdose include delirium, convulsions, coma, malignant sedative syndrome, respiratory failure, hypertension or hypotension, arrhythmia (

Management

There is no specific antagonistic drug with olanzapine. Vomiting measures are not recommended. The overdose processing processes can be conducted (washing the intestine, using activated carbon). The use of activated carbon shows an oral bioavailability of olanzapine from 50-60%.

Treatment of symptoms and monitoring important organs should be performed depending on clinical manifestations, including treatment of hypotension and respiratory function support. Do not use epinephrine, dopamine, or other sympathetic drugs that activate the sympathetic beta because the beta stimulation can worsen the hemorrhage. Mach Mach Monitor to detect arrhythmia if appearing.

closely monitor until the patient recovers.

What to do when forgetting the dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Classification of unwanted effects:

Very common (> 10%); Common (1-10%); Rarely (0.1-1%); Rare (0.01-0.1%); Very rare (

Adults

Agency system

Frequency

Unwanted effects Not common leukopenia, neutrophilia Weight gain

Me, including 1
- the number of deaths; lower body temperature. In most cases of epilepsy or love at risk of convulsions, malignant neurological syndrome, muscular disorders (including eye rotation), late dysplasia Heart is not common Slow heart rate, prolonging Qt Fast loss, ventricular vibration, sudden death Meet mild and transient acetylcholin resistance, including constipation and dry mouth Unknown Hepatitis (including liver cells, bile stasis or liver damage)

musculoskeletal muscle

unknown muscle pepper Milk in women, breasts in men Increasing plasma prolactin
Pediatric patients
Do not prescribe treatment in children and minor patients under 18 years old. Although no clinical studies are designed to compare teenagers with adults, data from tests on young people are compared to the above data. Agency system

Frequency

Unwanted effects
Common High cholesterol Dry mouth
liver disorders very common increasing liver enzymes (ALT/AST)

Warnings

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

contraindicated

NYKOB drugs contraindicated in the following cases:

Contraindicated to use olanzapine in patients who have a history of hypersensitivity to caught any ingredients of the drug.

Caution when using

The accompanying diseases:

Olanzapine has anti -anti -anti -Vitro activity, but in clinical trials, relevant symptoms appear at a low rate. The disease has few diseases, so the kidneys need to be indicated when indicated for olanzapine for patients with prostate hypertrophy, intestinal obstruction, or related conditions.

Puppet mind is related to memory/behavioral disorder:

olanzapine is not approved to treat mental disorders involved in memory loss/or behavioral disorder because of the increase in mortality and the risk of stroke.

Parkinson's disease:

The use of olanzapine in the treatment of mental disorders related to dopamine agents in patients with Parkinson's disease is not recommended.

Hyperglycemia and diabetes:

It is necessary to follow the clinical indicators in accordance with the instructions for the use of anti -psychotic drugs, for example: measuring blood sugar at the beginning of the treatment, 12 weeks after treatment with olanzapine and every year. Diabetes or risk factors for diabetes should be regularly monitored to control blood sugar.

Lipid metabolic disorders:

Lipid specialized disorders have been observed in patients treated with olanzapine in placebo clinical trials. Now, including olanzapine, should be monitored regularly in the lipid index in accordance with the instructions for anti -psychotic drugs, for example at the beginning of treatment, 12 weeks after treatment with olanzapine and every 5 years later.

Liver function:

Transaminase, ALT, AST liver enzymes, sometimes fleeting, no symptoms) especially in the early stages of the treatment. In case of increasing ALT and/or AST while being treated, it is necessary to monitor and consider reducing the dose.

leukopenia:

As well as other anti -psychotic drugs, be careful when taking olanzapine in patients with low number of leukemia and/or neutrophils due to any causes, patients with a history of inhibition/bone marrow poisoning due to drugs, patients with bone inhibitors due to accompanying disease, radiation therapy or chemotherapy, and patients have eosinopocytic hypernage or bone hyperpathy.

Malangible neuroleptic:

Malignant neuroleptic syndrome is a potentially life -threatening condition, related to anti -psychotic drug treatment. Rarely report on cases of malignant neuron syndrome related to olanzapine.

The clinical manifestations of malignant neuropular syndrome are high fever, stiff muscle, mental state instead, and have unstable manifestations of plant nervous systems (circuits or irregular blood pressure, fast finding, foul tissue, arrhythmia).

Other signs include increased creatinin phosphokinase, myoglobin urine (pattern pepper), and acute renal failure. It is necessary to stop all anti -psychotic drugs, including olanzapine, when the patient has manifestations and symptoms of malignant neurolithic syndrome or when there is no high fever without causes without clinical manifestations of malignant neuroleptic syndrome.

epilepsy:

Be careful when using olanzapine in patients with a history of epilepsy or have factors that reduce epilepsy threshold. Epilepsy rarely occurs in patients treated with olanzapine.

Late movement:

In comparative studies for 1 year or less, the rate of dysplasia complications in patients when treating olanzapine lower statistical significance. Symptoms of late dysplasia may worsen over time or even appear after treatment.

Activities of the central nervous system:

Because olanzapine has the main effect on the central nervous system, it is necessary to be careful when used in combination with other drugs that also work on the central nervous system and alcohol.

Hypotenary pressure:

rarely occurs in older people in Olanzapine clinical trials.

Disorder QT:

In clinical trials, olanzapine is not related to an absolute increase in QT interval. There are only 8 out of 1685 subjects with an increase in QT in many cases.

Stop taking medicine:

acute symptoms such as sweating, sleeping eyes, tremor, anxiety, nausea, or vomiting appears at a rare rate (

thrombosis:

Venous thrombosis related to the treatment time has been reported at a common rate (> 0.1% and

Sudden cardiac arrest:

In the after -sales report, when olanzapine treatment, there were cases of patients sudden death due to the heart stopped working.

lactose:

This drug product contains lactose monohydrate.

aspartame:

This drug product contains aspartam. Can be harmful to patients with dysentery.

The effect of drugs on driving and operating machinery

There has been no research on the effect of the drug on the ability to drive and operate machinery, but because Olanzapine can cause a dream and drowsiness, patients need to be careful when driving or operating machinery.

used in pregnant and lactating women

fertility, pregnancy and lactation:

There is no complete and accurate data on the effects of the drug on pregnant women. Because of human treatment experiences, olanzapine should only be used if the benefits are superior to the risk of the fetus. There have been reports of excitement, increasing tone, reducing tone, tremor, drowsiness, respiratory failure, eating disorders. Therefore, these babies should be carefully monitored.

breastfeeding:

In a healthy and nursing woman's study, olanzapine is excreted in breast milk. Therefore, patients are advised not to breastfeed during treatment with olanzapine.

Interactive drug

drugs with interactions:

Because olanzapine is metabolized by CYP1A2, substances that have the ability to touch or inhibit this enzyme system are capable of affecting the pharmacokinetics of Olanzapine.

CYP1A2 touch substances:

The metabolism of olanzapine may be increased by cigarettes and carbamazepine and leads to reduced olanzapine concentration.

CYPIA2 inhibitors:

Fluvoxamine, a specific CYPIA2 inhibitor, has shown the ability to inhibit olanzapine metabolism. The AC of olanzapine increases an average of 52% in non -smoking people and 108% in smoking patients. Can reduce the dose if necessary.

Reduce bioavailability:

“Activated carbon reduces the bioavailability of oral olanzapine by 50 - 60% and should be used at least 2 hours before or after using olanzapine.

Ability to affect other drugs of olanzapine:

olanzapine may be opposed to the enhanced effect of direct/indirect dopamine. Therefore, Olanzapine has no special interaction and does not inhibit the metabolic process of the following active substances: Triple antidepressants (mainly represented by CYP2D6), Warfarin (CYP2C9), Theophylline (CYP1A2), or diazepam (CYP3A4 and 2C19).

There is no work when using olanzapine with lithium or biperen.

The plasma valproate concentration shows no need to adjust the valproate dose when used with oolanzapine.

Central neurological inhibition activity:

Be cautious in patients with alcohol or are taking central neurological inhibitors.

About QT adjustment:

Be cautious if olanzapine is being used simultaneously with drugs that can increase the adjustment range of QT.

Storage

Store at temperatures below 30 ° C.

Other drugs

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