Olmed tablets 10mg Actavis treat anti -psychosis (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Olanzapine
Ingredient
| Composition information | Content |
| Olanzapine | 10mg |
Uses
Indications
Olmed 10 drugs are indicated in the following cases:
pharmacokinetic
absorption
olanzapine is well absorbed after drinking, reaching a plasma peak concentration within 5 - 8 hours. Absorption is not affected by food. Absolute oral bioavailability compared to unprespable intravenous lines.
Distribution
About 93% olanzapine is connected to plasma proteins when the concentration is from 7 to 1,000N/ml. Olanzapine is mainly connected to albumin and glycoprotein.
Metabolism
olanzapine is metabolized in the liver through a conjugate and oxidative mechanism. The main metabolite in the circulation is 10-N-glucuronide, this substance does not go through the brain blood barrier. Cytochromes P450- CYP1A2 and P450-CYP2D6 are involved in the creation of N-Desmethyl and 2-Hydroxymethyl metabolites. Both metabolites have lower pharmacological activity in vitro than olanzapine in animal studies. Pharmacological effects are mainly caused by olanzapine.
Elimination
After drinking, the average selling time of olanzapine in healthy people varies with age and gender.
Before taking Olmed tablets 10mg Actavis treat anti -psychosis (4 blisters x 7 tablets)
How to use
Take oral use.
Dosage
Adults
schizophrenia
Olanzapine starting dose is recommended for 10mg/day.
Halfy
The starting dose is 15mg once daily in single therapy or 10mg daily in combined therapy.
Prevention of recurrence in bipolar disorders
The recommended starting dose is 10mg/day. For patients who have used olanzapine to treat manic attacks, it is advisable to continue treating prophylaxis at the same dose. If a new mania occurs, a mixture or a depression, it is advisable to continue treating olanzapine (with the optimal dose if necessary), with additional therapy to treat mood symptoms as clinically indicated.
During the schizophrenia treatment, the attack and the prevention of bipolar disorders, which can be adjusted daily for the following days based on the clinical condition of each patient within 5 - 20mg/day. The increase in the starting dose is recommended only after the appropriate clinical re -evaluation and usually at no less than 24 hours.
Using olanzapine may not need to care about the meal because the absorption is not affected by food. Should consider reducing the dose gradually when stopping olanzapine.
Children
olanzapine does not recommend used for children and teenagers under 18 years of age due to lack of data on validity and safety. In short -term studies, weight gain, lipid changes and prolactin in teenagers are larger than patients in adulthood.
Old people
The starting dose is lower (5mg/day) is not prescribed regularly but should consider patients over 65 years old when clinical factors are allowed.
kidney failure or liver failure
Lower starting dose (5mg/day) should consider these patients.
In case of average liver failure (cirrhosis, child-pugh a or b), it is advisable to start at a dose of 5mg/day and caution when increasing the dose.
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?
Signs and symptoms
The most common overdose symptom (10%ratio) includes tachycardia, agitation/aggression, vanity disorders, different pagoda symptoms, reducing consciousness to coma.
Other severe sequelae of overdose include delirium, convulsions, coma, and may have malignant neurolithic syndrome, inhibitors, hypertension or hypotension, arrhythmia ( Handling overdose
There is no specific antidote to olanzapine. Causing vomiting is not recommended. Can considers the standard overdose process (such as gastric lavage, activated carbon). Simultaneous use of activated carbon reduces oral bioavailability of olanzapine from 50% to 60%.
should conduct symptomatic treatment and monitor the function of the survival organ according to clinical manifestations, including the treatment of blood pressure and circulatory depravity and support respiratory function. Epinephrine, dopamine, or other beta sympathetic drugs should not be used because beta stimulation may lower blood pressure. Cardiovascular monitoring is needed to detect possible arrhythmia. Should continue monitoring and closely monitoring until the patient recovers.
What to do when forgetting 1 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
When using Olmed 10, you may experience unwanted effects (ADR).
Very common, ADR> 1/10
Common, ADR> 1/100
urinary tract.
Mobility disorders. Mild, fleeting anti -cholinergic anti -constipation and dry mouth, increased ALT, asymptomatic AST, especially in early treatment. fit. Uncommon, 1/1000 Neutral leukopenia. QTC lasts. Sensitive to light. Unknown (not estimated from available data) The worse of diabetes is sometimes associated with ceton acid infection or coma, some deaths. Late movement disorders. 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
Olmed 10 drugs in the following cases:
Precautions when used
During the treatment of anti -psychotic drugs, improving the clinical condition of the patient may take several days to several weeks. Patients should be closely monitored during this time.
Intelligence is related to mental disorders or behavioral disorders.
olanzapine is not approved to treat intellectual dementia associated with mental disorders or behavioral disorders and is not recommended for use for this group of patients due to increased mortality and increased risk of stroke.
Parkinson's disease
There is no recommendation to use olanzapine for Parkinson patients.
Malignant neuronal syndrome (NMS)
NMS is a life -threatening condition associated with the treatment of anti -psychotic drugs. There are very few reports on cases of NMS related to olanzapine. The clinical manifestation of NMS is high fever, stiffness, mental changes, and an institution in the automatic nervous system (vascular or blood pressure abnormalities, tachycardia, sweating, and arrhythmia). Other signs may include increased creatinine phosphokinase, myoglobinuria (pattern), and acute renal failure. When the patient has signs and symptoms of NMS, or with unknown fever without clinical manifestations of NMS, all anti -psychotic drugs must be stopped, including olanzapine.
Hyperglycemia and diabetes
Hyperglycemia or appearing or worse of diabetes sometimes combined with ceton acid or coma has been reported quite rare, including some deaths. In some cases, the previous weight gain has been reported may be a million million factor.
Should follow appropriate clinical monitoring according to the instructions for using anti -psychotic drugs. Patients treated with any anti -psychotic drugs, including Olmed film tablets, should be monitored with signs and symptoms of hyperglycemia (drinking, urinating, eating a lot, and losing weight), and patients with diabetes or risk factors for diabetes should be monitored regular blood sugar control. Should monitor regular weight.
Lipid changes
Unwanted lipid changes have been recorded in patients treated with olanzapine in clinical trials that are controlled to placebo. Lipid changes should be treated in accordance with clinical, especially in patients with lipid disorders and in patients with olmed film tablets, should be monitored regularly according to the instructions of anti -psychotic drugs.
Cholinergic resistance activities
While Olanzapine has proven that there is anti -cholinergic in vitro, the results of clinical trials show that there is a low proportion of related events. However, due to the limited clinical experience with olanzapine in patients with simultaneous diseases, caution should be used for patients with prostate hypertrophy, intestinal paralysis and related conditions.
Liver function
In air, no symptoms of liver, ALT, AST aminotrans, AST, especially in early treatment. Be cautious and monitor in patients with ALT or AST hypertension, patients with signs and symptoms of liver failure, patients have conditions that limit the liver reserve function before and in patients being treated with drugs that can toxic liver toxicity. In the case of hepatitis (including liver, cholest liver or mixed liver damage), which is diagnosed, should be discontinued with olanzapine.
leukopenia
Be cautious in patients with reduced number of neutrophils or neutropen cells due to any cause, in patients who use medications that cause neutropenia, patients with a history of medication inhibitors/bone marrow toxicity, bone marrow inhibitors due to simultaneous diseases, radiation or chemotherapy and patients with eol anids or oythsis hyperbols. Leukopenia is often reported when used simultaneously olanzapine with valproate.
Discount
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting are reported very rare ( About qt
As with other anti -psychotic drugs, should be cautious when using olanzapine with drugs that increase QTC, especially in the elderly, patients with congenital QT syndrome, congenital heart failure, heart hypertrophy, hypotension or hypoglycemia.
Venous thrombosis
Cases of venous thrombosis have been reported to anti -psychotic drugs. Because patients treating psychotic drugs often have risk factors for venous thrombosis, all these risk factors should be identified before and during treatment with olmed and conduct prevention measures.
Activity on the central nervous system
Based on the effects of olanzapine on the central nervous system, should be cautious when used with alcohol and other central impact drugs. Due to the antagonistic properties of dopamine in vitro, olanzapine may be directly and indirectly acting the effects of dopamine agreements.
epilepsy
Should be used carefully olanzapine in patients with a history of epilepsy or easily affected by factors that can reduce epilepsy threshold. The seizures have been reported rarely in patients who have been treated with olanzapine. In most of these cases, there is a history of epilepsy or kinetic risk factors that have been reported.
Late movement disorders
In comparative studies for one year or less, olanzapine treatment has a lower rates of early active disorders. However, the risk of late movement disorders increases in long -term treatment and therefore, if the signs or symptoms of late movement disorders in patients use olanzapine, should consider reducing the dose or stopping treatment. These symptoms may temporarily deteriorate or even appear after treatment.
posture hypotension
posture hypotension is often recorded in the elderly in clinical trials with olanzapine. Like other anti -psychotic drugs, it is recommended to measure blood pressure periodically in patients over 65 years old.
Suddenly due to heart
In the reports after use with olanzapine, the sudden death event due to the heart has been reported in patients using olanzapine. In a rescue observation study, the risk of sudden heart death in patients treated with olanzapine is assumed to be twice as much as the risk in patients who do not use anti -psychotic drugs. In this study, the risk of olanzapine is that it can be compared to the risk of typical anti -psychotic drugs included in an analysis.
Children
olanzapine is not indicated for use in the treatment of children and adolescents. Studies in patients aged 13-17 showed various adverse reactions, including weight gain, change of metabolic parameters and prolactin levels. The long -term outcome related to these events has not been studied and still unknown.
lactose
Olmed movie bap tablets contain lactose. Patients with rare genetic problems without galactose, Lactase Lapping or Glucose-Galactose should not be used.
soy lecithin
If the patient is too sensitive to peanuts or soybeans, this drug should not be used.
The ability to drive and operate machinery
There is no research on influence on the ability to control train and operate machinery. Because olanzapine can cause drowsiness and dizziness, patients should be warned of machinery operation, including motor vehicles.
Pregnancy
There is no enough research in pregnant women. Patients should notify the doctor if pregnant or intend to get pregnant during treatment with olanzapine. However, because studies are limited, olanzapine should only be used during pregnancy when the benefits are greater than the potential risk to the fetus.
Smart -up reports rarely show signs of tremor, muscle tone, indifference and drowsiness, in babies born from mothers who used olanzapine in the third trimester.
Breastfeeding period
In a study in the period of breastfeeding, healthy women, olanzapine are excreted through breast milk. The average dose in infants (mg/kg) in stable state is estimated at 1.8% of the maternal olinzapine dose (mg/kg). Patients should not breastfeed if taking olanzapine.
Drug interaction
Interactions affect olanzapine
Because olanzapine is metabolized by CYP1A2, these substances that can be stimulated or inhibited inhibitors can affect the pharmacokinetics of olanzapine.
Stimulating enamel CYP1A2
The metabolism of olanzapine may be stimulated by smoking and carbamazepine, which can lead to reduced olanzapine levels. Only increasing olanzapine clearance to mild to medium level.Clinical consequences may be limited, but clinical monitoring and may consider increasing olanzapine dose if necessary.
CYP1A2 inhibitors
Fluvoxamine, a specialized CYP1A2 inhibitor, has been shown to inhibit the metabolism of olanzapine significantly. Olanzapine's peak (CMAX) concentration increased average after using Fluvoxamine was 54% in non -smoking women and 77% in male smokers. Olanzapine's AUC increased by 52% and 108% respectively. Lower starting dose should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as Ciprofloxacin. Olanzapine dose should be considered for treatment with a CYP1A2 inhibitor.
Reduce bioavailability
Activated carbon reduces olanzapine oral bioavailability from 50 to 60% and should be used at least 2 hours before or after using olanzapine.
Fluoxetine (a CYP2D6 inhibitors), the only dose of antacids (aluminum, magnesium) or cimetidine does not significantly affect the pharmacokinetics of olanzapine.
The influence of olanzapine on other drugs
olanzapine can oppose the effect of direct and indirect dopamine agreement. Olanzapine does not inhibit the main isoenzymes CYP450 in vitro (such as 1A2, 2dó, 2C9, 2C19, 3A4). Therefore, it is expected that there will be no special interactions in in vitro studies without the inhibition of the following active ingredients: three -round antidepressants (most CYP2D6), Warfarin (CYP2C9), Theophyllline (CYP1A2) or Diazepam (CYP3A4 and 2C19).
olanzapine shows no interaction when combined with lithium or biperiden.
Monitoring plasma valproate levels shows no need to adjust the dose of valproate when used simultaneously with olanzapine.
Activity on the central nervous system
Should be cautious in patients drinking alcohol or using central nervous system inhibitors.
Concomitance the use of olanzapine with Parkinson anti -Parkons in patients with Parkinson's disease and dementia is not recommended.
About QTC
Should be cautious when using olanzapine simultaneously with drugs that increase QTC.
Storage
Store no more than 30 ° C in the original packaging to avoid light and avoid moisture.
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