Manzura-7.5 Davipharm tablets for schizophrenia (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Olanzapin

Ingredient

Composition informationContent
Olanzapin7.5mg

Uses

indications

Manzura-7.5 drugs of anti-psychotic drugs used for treatment in the following cases:

  • schizophrenia. God.

    olanzapin is an indispensable (anti -psychosis) (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 the serotonin type 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 the 5-HT2A receptor, related to the anti-sensitivity effect of the drug.In addition, olanzapin also stabilizes the temperament due to part of dopamine skin receptors. Olanzapin is also opposed to the Muscarinic receptor (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 Histamine and Alphai Adrenergic receptor resistance effect. This effect is related to the ability to sleep, hypotension posture when using olanzapin.

    pharmacokinetic

    absorption

    After drinking, olanzapin is absorbed quickly and almost completely through the digestive tract, but due to initially metabolized in the liver, oral bioavailability only reaches 60%. The absorption is not affected by food. The peak concentration of plasma is achieved within 5 - 8 hours. Achieving a stable state after 7-10 days of reminded dose. Plasma drug concentrations change between individuals, depending on age, gender and whether the patient smokes or not. The concentration of drugs in women's blood is about 30-40% higher than that of 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 1000L. Olanzapin's plasma protein binding ratio is the interconnected with albumin and al-glycoprotein. Olanzapin and glucuronid conjugate metabolites pass the placenta and are excreted 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-Desmethyl olanzapin and 10-N-Glucuronid no longer retain the activity of olanzapin.

    Elimination

    After drinking, the plasma sale time of olanzapin is about 30 hours (ranging from 21 - 54 hours). The selling time increased by about 1.5 times in the elderly. Olanzapin's clearance increased by about 40% in smokers with 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 metabolic derivatives, a small part (7%) in the form of intact.

    pharmacokinetics on special subjects

    kidney failure

    The pharmacokinetics of the drug does not change much in patients with renal failure.

    Children

    Adsbearing (from 13-17 years old): Olanzapin's dynamic pharmacokinetics in adolescents are similar to adults. In clinical research, AUC average olanzapin in teenagers is about 27%higher. Different factors of demographics between adolescents and adults as if in the lower average and fewer smoking young people can contribute to the above results.

  • Before taking Manzura-7.5 Davipharm tablets for schizophrenia (10 blisters x 10 tablets)

    How to use

    Oral drugs.

    olanzapin is used orally, can be taken during meals or away from meals. Patients with prolonged drowsiness may be used daily dose in the evening before going to bed. Olanzapin dose must be carefully corrected on each patient and the lowest dose used effectively. Dosage should be gradually increased and divided into doses of the day at the beginning of treatment to minimize unwanted effects.

    Dosage

    Adults

    schizophrenia

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

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

    Bipolar disease (a mix of or mixed)

    Single therapy: The starting dose of 10 - 15 mg/day oral 1 time.

    The dose may increase 5mg/day apart not less than 24 hours. The maintenance dose is 5 - 20mg/ day. The maximum dose recommends 20 mg/day.

    Serial therapy in combination with lithium or valproat: starting dose 10 - 15mg/ day, drinking 1 time. Dosage can fluctuate within: 5 - 20mg/day.

    Prevention of bipolar disorder

    The dose of 5 - 20mg/day. For patients who have treated an olanzapin batch of goods, continue to prevent the recurrence of bipolar disorders with such doses. If the appearance, mixture or depression should continue to be treated with olanzapin (with the dosage optimized if necessary), accompanied by treatment support for emotional symptoms, such as clinical indications.

    Children

    Children

    Not determined safety and efficiency.

    Children from 13 - 17 years old

    Using olanzapin in children must be very cautious and under the close supervision of a specialist physician.

  • schizophrenia: Starting dose: 2.5 - 5mg/ day oral 1 time. Dosage 10mg/ day. The adjustment can increase or decrease the dose of 2.5mg or 5mg. Maximum dose of 20mg/ day.
  • Bipolar disease: Starting dose: 2.5 - 5mg/ day oral 1 time. Dosage 10mg/ day. The adjustment can increase or decrease the dose of 2.5mg or 5mg. Maximum dose of 20mg/ day.
  • Elderly

    Low starting dose (5mg/ day) is not usually indicated but can be considered for patients aged 65 and over when clinical status is guaranteed.

    kidney failure or liver failure

    Low starting dose (5mg) should be considered in these patients. In the case of average liver failure (cirrhosis, group-pgh group A or b), the starting dose should be 5mg and only increased the dose carefully.

    Smokers

    The starting dose and the dose is usually not required to change in smokers compared to non -smokers. Olanzapin's metabolism may increase in smokers. Clinical monitoring recommendations and may consider increasing olanzapin dose if necessary. When there are more than one factor that can slow metabolism (women, elderly people, no smoking), should consider reducing the starting dose. Be careful when increasing the dose in these patients.

    What to do when overdose? Symptoms should be treated when needed. There is no specific antidote.

    In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

    What to do when forgetting a dose? Do not use 2 doses in the same day.

    constantly medication just because you feel better. Continuing to use olanzapin until the doctor tells you to stop very important for you. If you stop the drug suddenly, symptoms such as sweating, unable to sleep, tremble, anxiety or nausea and vomiting may occur. The doctor will guide you to reduce the dose from before stopping the drug. Always follow the doctor's instructions

    Should consider reducing the dose from stopping olanzapine.

    Side Effects

    When using Manzura-7.5, you may experience unwanted effects (ADR).

    Adults

    Very common, ADR> 1/10

  • Metabolism and nutrition: weight gain.
  • Neurological: Drowsy. blood vessel: Hypotenemably posture.
  • Testing: Increased plasma prolactin levels.
  • Common, 1/100

  • Blood and lymphatic system: Acidic leukemia, leukopenia, neutropenia.
  • Metabolism and nutrition: Increasing cholesterol levels, increasing glucose levels, increasing triglyceride levels, urinary glucose, increasing appetite.
  • nerve: dizziness, restless sitting, Parkinson, movement disorder. Digestive: Mild, fleeting anti -cholinergic effect includes constipation and dry mouth. liver: Increased liver aminotransferase (ALT, AST) transient, asymptomatic, especially when starting treatment.

    Skin and subcutaneous tissues: rash.

  • muscle and connective tissue: joint pain.
  • Genital and mammary glands: erectile dysfunction in men. Reduce sexual desire both men and women.
  • Systemic: weakness, fatigue, edema, fever.
  • Testing: increased phosphate, high -high creatinin, gamma glutamyltransferase, high uric acid.
  • Uncommon, 1/1,000

  • Immune: Hypersensitivity.
  • Metabolism and nutrition: Diabetes are progressive or severe than often accompanied by ceton or coma, including some deaths.

    Neuroscope: convulsions, most in cases of convulsions or risk factors of convulsions, muscular disorders (including eye rotation), late movement disorders, memory impairment, speech disorder. Heart: Slow heart rate, extend QT. blood vessels: thrombosis (including pulmonary and thrombosis).

  • Respiratory, chest and mediastinum: nosebleeds.
  • digestion: bloating. skin and subcutaneous tissue: light sensitive reaction, hair loss.

    Kidney and urinary: urinary incontinence, urinary retention, no urination.

  • Genital and mammary glands: Big breasts, dairy secretion in women, female mammary glands large in men.
  • Testing: Increase bilirubin.
  • Rare, 1/10,000

  • Blood and lymphatic system: thrombocytopenia.
  • Metabolism and nutrition: lower body heat.
  • Neurological: Malignant Mental Syndrome, Symptoms of CLetation.

    heart: ventricular tachycardia/ventricular, sudden death. digestive: pancreatitis. liver: hepatitis (including liver cells, cholestatic hepatitis or mixed liver damage).

  • Muscle and connective tissue: Muscle pattern.
  • Genital and mammary glands: prolonged erection.
  • Unknown frequency

  • Ceremony syndrome in infants.
  • dress: expressed through skin reactions (such as rashes or flaky dermatitis), hyperlypes, fever or lymphadenopathy, with systemic complications such as hepatitis, kidney inflammation, pneumonia, myocarditis or pericarditis.
  • Prolonged treatment (at least 48 months).
  • There is a proportion of patients with significant unexpected changes in clinical weight gain, glucose, total cholesterol/LDL HDL or triglycerides over time. In adults treated for 9 - 12 months, the growth rate of blood glucose slows down after about 4-6 months.
  • Special subjects

    in the elderly

    olanzapin is deadly and unwanted effects on brain vessels than frequency than placebo.

    Unwanted effects are very common

    abnormal gait and falling.

    Common

    pneumonia, increase body temperature, coma, erythema, visual illusion and incontinence.

    In patients with neuropathy due to drug use (Dopamine owner) when Parkinson's, Parkinson's symptoms and more severe illusion are reported very often and more often than placebo.

    In patients with bipolar sensuality, coordinating Valproat and olanzapin, increasing neutropic rate of neutropenia 4.1%. The cause part may be due to high plasma valproat levels. Using olanzapin with lithium or valproear increases the level of tremor (> 10%), dry mouth, increased appetite and weight gain. Language disorders are also commonly reported. When treated with olanzapin in combination with Lithi or Divalproex, increasing> 7% of the initial weight at 17.4% of patients during acute treatment (up to 6 weeks). Prolonged treatment with olanzapin (up to 12 weeks) to prevent recurrence of patients with bipolar disorder causes 27% of initial weight increase in 39.9% of patients.

    Children

    Unwanted reactions are reported with higher frequency in teenagers (13-17 years old) compared to adults and have unwanted reactions only in short -term clinical trials among teenagers.

    Very common, ADR> 1/10

  • Metabolism and nutrition: weight gain, increased triglyceride levels, increased appetite.
  • nervous: sedation (including: sleep, coma, drowsiness). liver: Increased liver aminotransferase (ALT/AST)
  • Testing: Reduce total bilirubin, increase gamma glutamyltransferase, increase plasma prolactin levels.
  • Common, 1/100

  • Metabolism and nutrition: Increased cholesterol levels.
  • digestive: dry mouth.

    Instructions on how to handle ADR

    Stop drugs in the case of manifestations of malignant neurolithic syndrome. Treatment of positive support and closely monitor patients. Caution should be used when reusing olanzapin for patients after the appearance of malignant neurolithic syndrome: Choose less drugs that cause this syndrome and need to increase the dose slowly for patients. Stop the drug or reduce olanzapin dose if the disorder appears late during the use of the drug.

    Dose or use 1 time/day when going to bed if drowsiness appears during the use of olanzapin. Use medical or non -drug treatments to adjust blood lipid disorders if appearing during olanzapin treatment. It is possible to consider using replacement with other neurolysis drugs that are less affected on lipid metabolism such as Risperidon, Ziprasidon or Aripiprazol.

    Warnings

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

    Contraindicated

    Manzura-7.5 contraindications in the following cases:

  • Hypersensitivity to olanzapin or any ingredients of the drug.
  • There is a risk of closing angle glaucoma.
  • Lactating women.
  • Precautions when used

    When treated with anti -psychotic drugs, the clinical improvement of the patient takes days to several weeks. Should carefully monitor patients in this stage.

    suicide

    The risk of suicide inherent in schizophrenia and bipolar mental illness, closely monitor patients with high risk of drug use. Olanzapin should be written with the least tablet in line with the patient's good compliance to avoid overdose.

    Mental disorders or behavioral disorders related to intellectual decline

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

    Parkinson's disease

    It is not recommended to use olanzapin to treat psychotic disorders related to dopamine fortunes in Parkinson's patients. Olanzapin increases the level and frequency of Parkinson's symptoms and hallucinations and does not show the effectiveness of symptoms of psychosis than placebo.

    Malignant neuropular syndrome

    There has been a rare case of malignant neuronal syndrome when using olanzapin. Clinical manifestations are high fever, mental state change and indicated autonomy signs (vessels or abnormal blood pressure, tachycardia, sweat and arrhythmia). Other signs may include increased creatinine phosphokinase, myoglobin urine (pattern) and acute renal failure. If the patient appears signs and symptoms, or high fever with unknown reasons without any additional clinical symptoms of malignant neurolithic syndrome, all sedatives must be stopped, including olanzapin.

    Hyperglycemia and diabetes

    Be cautious when using olanzapin for diabetes patients, patients with hyperglycemia (thriving blood sugar from 100 - 126mg/dl) due to the risk of hyperglycemia, maybe even controlled even when the drug has stopped. Need to monitor blood sugar during treatment.

    Change of blood lipid

    olanzapin may cause changes in blood lipids. The change of lipids must be appropriate clinical treatment, especially in patients with lipid disorders and in patients with risk factors for blood lipid disorders. Patients treated with any anti -psychotic drugs, including olanzapin, should be monitored regularly during treatment.

    weight gain

    The consequences of weight gain should be considered before starting treatment. Monitor regular weight.

    Animal anti -cholinergic activity

    Precautions when taking drugs for patients with prostate hypertrophy, narrow -angle glaucom or intestinal paralysis and related conditions due to the drug's anti -cholinergic effect.

    Liver function

    Caution in patients with symptoms of liver function impairment, patients with diseases that affect liver function conservation, or are being treated with liver toxic drugs. Periodically quantify transaminase concentration during the use of olanzapin for these objects. In the case of hepatitis (including liver cells, cholestasis or mixed liver damage), it is recommended to stop treating with olanzapin.

    leukopenia

    Be cautious in patients with low number of leukemia or neutrophils for any reason, patients who use drugs may cause leukopenia, patients with a history of medical failure/bone marrow failure, patients with bone marrow failure due to attached diseases, radiation or chemotherapy and patients with eosinophilia or bone marrow hyperbols. Leukopenia is often reported when used simultaneously olanzapin and valproat.

    Stop medicine

    There have been rare reports of acute symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting when stopping olanzapin suddenly.

    About qt

    The drug can cause a long range of QT (rarely). Be cautious when taking olanzapin with drugs that can extend the QT, especially in the elderly, in patients with congenital long -term QT ​​syndrome, congestive heart failure, heart hypertrophy, hypotension or hypoglycemia.

    thrombosis

    Venous thrombosis has been reported less. Causal relationship has not been established. However, because patients with schizophrenia often have risk factors for venous thrombosis, all the risks of venous thrombosis such as immovable, should be identified and implemented preventive measures.

    Central nervous system

    Due to the main effect on the central nervous system of olanzapin, it should be cautious when using the drug in combination with drugs that affect other central nerves and alcohol. Be cautious with the ability to reduce concentration and motor activity related to the sedative effects of the drug. Because olanzapin represents the antamet of dopamine in vitro, the drug can oppose the impact of direct or indirect dopamine owners.

    convulsions

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

    Late movement disorders

    Caution for the elderly especially for women due to the risk of increasing late movement disorders. In case of this disorder may consider the possibility of stopping the drug.

    posture hypotension

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

    Suddenly due to heart

    Suddenly, the heart of the heart has been reported in patients using olanzapin.

    Medicine allergic reactions with eosinophilia and systemic symptoms (dress)

    has been reported when using olanzapin. Dress can be manifested by skin reactions (such as rashes or flaky dermatitis), eosinophilia, fever or lymphadenopathy, with systemic complications such as hepatitis, nephritis, pneumonia, myocarditis or pericarditis. Dress is sometimes fatal. Stop olanzapin if the patient is suspected.

    Difficult to swallow

    Pedica can cause esophageal movement disorders. Choking pneumonia is a common cause of disease or death in Alzheimer patients. Olanzapin is not indicated to treat Alzheimer.

    Body temperature

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

    Hypertension hyperlactin

    As well as the Dopamine D2, olanzapin, which increases prolactin levels, and this increase is prolonged during chronic treatment.

    Children

    olanzapin is not indicated for children under 13 years old. Research in patients from 13-17 years old shows many unwanted reactions, including weight gain, metabolic parameters and prolactin levels.

    olanzapin must be used carefully and under the close supervision of experts in children from 13-17 years old.

    Manzura-7.5 drug contains cellactose (containing lactose), patients with rare genetic disorders in galactose tolerance, lapp lactase deficiency or glucose-galactose absorption disorders should not use this drug.

    Manzura-7.5 drug contains polysorbat 80 that can cause allergies and castor oil can cause nausea, vomiting, abdominal pain, diarrhea. Manzura-5 contains tartrazin yellow color that can cause allergies.

    The ability to drive and operate machinery

    There has been no research on the effect of olanzapin on the ability to drive and operate machinery. Because olanzapin can cause drowsiness and dizziness, patients should be cautious about driving or operating machinery.

    Pregnancy

    There is no adequate and controlled research on pregnant women. The patient should notify the doctor if you are pregnant or intend to get pregnant during treatment with olanzapin. However, due to limited human experience, olanzapin should only be used during pregnancy if the benefits are greater than the possible risks for the fetus.

    Babies exposed to anti -psychotic drugs in the last 3 months of pregnancy are at risk of unwanted effects such as pagoda symptoms or symptoms of cessation with different severity and degrees. There is an exciting report, increasing decrease in muscle tone, tremor, drowsiness, respiratory failure or difficulty feeding in babies, babies should be carefully monitored.

    Breastfeeding period

    In research in healthy women breastfeeding, olanzapin secreted through breast milk. The average exposure to infant (mg/kg) in a stable state is expected to be about 1.8% of olanzapin doses in the mother. It is recommended that patients do not breastfeed while taking olanzapin.

    Fertility: The impact on fertility is still unknown.

    Drug interaction

    Avoid not to coordinate

    Do not coordinate olanzapin with levomethadyl due to the risk of heart toxicity (extending the QT interval, causing torsion), with Metoclopramide due to increased risk of outsourcing syndrome, malignant neuron syndrome.

    Olanzapin interactions are likely to influence olanzapin

    Diazepam: shared, increases the risk of posture.

    CYP1A2 induction: Olanzapin metabolism may increase due to smoking (nicotine) and CYP1A2 induction drugs (carbamazepin, phenobarbital, phenytoin, rifampicin, omeprazol), which can lead to reduced olanzapin levels. Olanzapin clearance increases small or medium. Clinical effects are usually small, recommended clinical monitoring and increased olanzapin dose if necessary.

    CYP1A2 inhibitor: Fluvoxamin, a CYP1A2 inhibitor, shows a significant inhibition of olanzapin metabolism. Lower olanzapin starting dose in patients who are using Fluvoxamine or other CYP1A2 inhibitors, such as ciprofloxacin, caffeine, erythromycin, quinidine. Consider reducing the dose of olanzapin being used when starting treatment with CYP1A2 inhibitors.

    Reduce bioavailability: Activated carbon reduces the bioavailability of olanzapin orally by oral by 50 - 60% and should be used at least 2 hours before or after using olanzapin. Warfarin (single dose 20mg), fluoxetin (CYP2D6 inhibitors), single dose of Antacid (aluminum, magnesi) or cimetidine does not significantly affect the pharmacokinetics of olanzapin.

    Pharmacological interaction: Do not use dopamine, adrenalin or other sympathetic effects on the beta receptor in patients who are being treated olanzapin, due to the ability to severely lower the blood pressure due to olanzapin's Alpha receptor inhibitors

    olanzapin can affect other drugs

    olanzapin may be opposed to the effects of levodopa and dopamine owners. Olanzapin increases the effect (constipation, dry mouth, sedation, urinary retention, visual disorders) of anti -cholinergic drugs, increasing the hypotension effect of anti -hypertension drugs.

    olanzapin does not inhibit the main ISOENZYM CYP450 in vitro (such as 1A2, 2D6, 2019, 3A4). Therefore, there is no risk of interaction. Research in vivo, no inhibition of the following active ingredients: 3 -round drug treatment (representing metabolism via CYP2D6), Warfarin (CYP2C9), Theophylllin (CYP1A2) or Diazepam (CYP3A4 and 2019).

    olanzapin does not interact when used with lithium or biperiden. Monitoring Valproat concentration in plasma shows no need to adjust the dose of Valproat after use simultaneously with olanzapin.

    Impact on the central nervous system: Be careful when taking olanzapin in alcohol patients or drugs that can inhibit the central nervous system. It is not recommended to simultaneously use olanzapin with Parkinson's treatment in Parkinson patients and dementia.

    About QT: Be cautious when using olanzapin with drugs that can cause QT interval.

    Storage

    Keep the drug in the original packaging of the manufacturer, covered. Leave the medicine in a dry place, avoid light, the temperature does not exceed 30 ° C, and out of the reach of children.

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