Aritero 10 Heterero Treatment of schizophrenia, bipolar disorder (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Aripiprazole
Ingredient Hetero labs
Ingredient
| Composition information | Content |
| Aripiprazole | 10mg |
Uses
indications
Aritero 10mg drug is indicated in the following cases:
Aripiprazol represents the antagonistic properties on animal models by increasing dopamine levels and showing the ownership of animal models by reducing dopamine levels.
Aripiprazol has high In vitro cohesion affinity into Dopamine D2 and D3, Serotonin SHTLA and SHT2A and medium pressure with Dopamine D4, Serotonin SHT2C and SHT7, Alpha-1 adrenergic and histamine H1.
Aripiprazol also has an average affinity for serotonin reabsorption position and has no significant affinity for Muscarinic receptors.
Interaction with receptors other than dopamine and serotonin receptors can explain some other clinical effects of Aripiprazol.
pharmacokinetics
absorption and distribution
Aripiprazol is well absorbed, with peak plasma concentrations achieved within 3 to 5 hours after drinking.
Aripiprazol undergo a minimum metabolism before the system.
Absolutely use of oral medication in tablet form is 87%.
There is no impact from high -fat foods that are kinetic to Aripiprazol.
transformation
Aripiprazole is widely distributed throughout the body with an apparent distribution of 4.9 /kg, showing a wide distribution of external distribution. At the treatment concentration, Aripiprazol and Dehydro-Aripiprazole bind more than 99% to serum protein, mainly on albumin.
Elimination
Aripiprazol's average semi -excretion time is about 75 hours in people with strong CYP2D6 metabolic genotype and about 146 hours in people with poor CYP2D6 metabolic genotypes.
The whole body clearance of Aripiprazol is 0.7 ml/min/kg, mainly in the liver.
After taking a single dose of Aripiprazol marked 14C, about 27% of the radioactive active ingredient of the dose found in urine and about 60% in feces.
Not up to 1% of Aripiprazol is eliminated in urine in the form of unchanged and about 18% are found in the part in the form of unchanged.
Pharmacokinetic properties in special patients
Children: Pharmacokinetics of Aripiprazol and Dehydro-KiPiprazol in children from 13 to 17 years old are similar to adults after adjusting the dose by body weight.
Elderly: There is no difference in pharmacokinetics of Aripiprazole between the elderly group and the younger group, nor does it have any influence based on age in an analysis of pharmacokinetic properties in schizophrenia.
Sex: There is no difference in pharmacokinetics of Aripiprazole among healthy men and women or any gender -based effects in analyzing pharmacokinetic properties by gender in schizophrenia patients.
Smoking and racial: Group pharmacokinetic evaluation results show that there is no significant clinical difference related to race or the effects of smoking to the pharmacokinetics of Aripiprazol.
Kidney disease: The pharmacokinetic properties of Aripiprazol and Dehydro-kariprazol are recorded similarly to each other in patients with severe kidney disease compared to healthy young people.
Liver disease: A single dose study in cirrhosis patients with different degrees (levels A, B, and C according to the classification of Child-Pugh) does not show significant impact of liver failure on pharmacokinetics of Aripiprazol and Dehydro-Kipiprazol, but in this study, there are only 3 patients with cirrhosis, so they are not enough to draw their conclusions about their ability to exchange substances.
Before taking Aritero 10 Heterero Treatment of schizophrenia, bipolar disorder (3 blisters x 10 tablets)
How to use
Aritero 10mg tablets for oral tablets.
Dosage
adults
Dosage for schizophrenia patients:
Dosage of schizophrenia in teenagers aged 15 and over:
It is not recommended for treatment with Aripiprazol in patients under 15 years old because there is not enough data on the safety and effectiveness of the drug in these patients.
Patients with liver failure:
Elderly:
Smoking: Based on the metabolic line of Aripiprazol, do not need to adjust the dose in smokers.
Adjust the dose due to drug interaction:
Signs and symptoms that can be observed include coma, hypertension, insomnia, fast heartbeat, nausea, vomiting and diarrhea. In addition, reports on cases of overdose Aripiprazol (up to 195 mg) in children are also recorded, there are no deaths.
Signs of medical awareness and recognized symptoms include: drowsiness, fleeting consciousness and foreign symptoms.
To handle cases of overdose medication, it is necessary to focus on supportive treatment, respiratory support, oxygen supply and ensure ventilation space and combine handling of symptoms.
It is necessary to consider carefully when combining anti -psychotic drugs with other drugs.
Immediately monitor the patient's cardiovascular condition and need to monitor the electrocardiogram continuously to detect rhythmic phenomenon.
For cases of overdose of Aripiprazol or suspected overdose, it is necessary to closely monitor and monitor continuously until the patient recovers.
Activated carbon (50 g), taking an hour after Aripiprazol treatment will reduce cmax in Aripiprazol's plasma to about 41% and about 51%, this shows that activated carbon can be effective in the overdose treatment of Ariprazol.
Although there has been no acknowledgment on the effectiveness of dialysis in the treatment of overdose with Aripiprazol, the ability to use this therapy is not feasible because Aripiprazol is strongly connected to plasma proteins.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 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 Aritero 10mg, you may experience unwanted effects (ADR).
The most unwanted unwanted effects are recorded in the control tests with placebo are restless and nausea with each effect that occurs in more than 3% of patients treated with Aripiprazol oral.
The desired effects of the drug listed below occur more often (≥ 1/100) compared to placebo, or have been identified as unwanted effects that are possible to be related to the drug (*):
The frequency of unwanted effects (ADR) is arranged in accordance with the following: common (1/100 Mental disorders: Eye disorders: Vascular disorders: Gastrointestinal disorders: Symptoms of foreign tower (EPS): In schizophrenia patients in a 52 -week control test, patients who have been treated with Aripiprazol have the incidence of percentative symptoms including Parkinson's, restless sitting, muscle -dysching disorders, and lower movement disorders (25.8%) compared to patients treated with Haloperidol (57.3%). In a control test with a 26 -week pharmaceutical price, the incidence of percentive symptoms in patients treated with Aripiprazol is 19% and in patients treated with a placebo is 13.1%. In another 26 -week control test, the percentage of pagoda symptoms in patients treated with Aripiprazol is 14.8% and in patients treated with olanzapin is 15.1%. In patients with sensual events of bipolar disorders I, in a 12 -week control test, the rate of experienced symptoms is 23.5% in patients treated with Aripiprazol and 53.3% in patients treated with Haloperidol. In another 12 -week test, the rate of foreign symptoms is 26.6% in patients treated with Aripiprazol and 17.6% in patients treated with lithium. In a restraint test with a placebo in a 26 -week maintenance stage, the rate of experienced percentage symptoms is 18.2% in a group of patients treated with Aripiprazol and 15.7% in a group of patients treated with placebo. In the restraint tests with placebo, the incidence of lying-restlessness in patients with bipolar disorder is 12.1% in patients using Aripiprazol and 3.2% in placebo patients. In patients with schizophrenia, the ratio of restlessness is 6.2% in patients using Aripiprazol and 3.0% in placebo patients. muscle disorders: Group effects: Symptoms of muscular disorders such as prolonged abnormal spasms of muscle groups are likely to occur in sensitive individuals in the first few days of treatment. Symptoms of muscle tone disorders include: spasms of the muscles in the neck, sometimes progressing to the level of throat spasms, difficulty swallowing, shortness of breath, and/or stiff phenomena (overexposure). These symptoms may be encountered when taking low -dose anti -psychotic drugs, and occurs more often with a more serious level when taking high doses of first -generation anti -dysplasia drugs. Men and groups of young patients are at higher risk of muscle disorders than other groups. Compare clinical changes that can occur in normal tests and lipid parameters in patients with Aripiprazol anti -disorder and placebo patients showing no significant medical differences. The phenomenon of increasing the CPK (Creatin phosphokinase), usually transient and has no symptoms, recorded in 3.5% of patients treated with Aripiprazol compared to 2.0% in placebo patients. Other findings: Unwanted effects are related to anti -psychotropic therapy and the effects recorded when treated with Aripiprazol including malignant neurolithic syndrome, late movement disorders, epilepsy, stroke, increased mortality rate in elderly patients with dementia, hyperglycemia and diabetes. Children: In a short-term clinical test for control with placebo, performed in 302 patients in the age of teenagers (13-17 years old with schizophrenia shows that the frequency and unwanted effect are similar to adults, except for the following cases that have been more common in teenagers treated with aripiprazol compared to adults when treating Aripiprazol (more often than symbiotic symbols) Sleep and pagoda disorders are very common (ADR ≥ 1/10), dry mouth, increased cravings, and posture hypotension is also recorded as common. Safety level of drugs in clinical trial expansion is open with a 26 -week period for similar results in short -term tests and control tests with placebo. The effect of the drug on a group of patients with schizophrenia in adolescence (13-17 years old) has a period of up to 2 years, showing the rate of low serum prolactin levels recorded in women ( postpartum circulation: The following unwanted effects have been recorded in the process of official drugs circulating on the market. The frequency of these unwanted effects is not known (not estimated from existing data). Blood disorders and lymphatic systems: leukopenia, neutropenia, thrombocytopenia. Immune system disorders: Allergic reactions (such as anaphylactic reaction, angioedema including tongue swelling, tongue edema, face edema, itching, or urticaria). Endocrine disorders: Hyperglycemia, diabetes, diabetes contaminated with keratinatical acid, coma caused by diabetes. Nutrition and metabolic disorders: weight gain, weight loss, anorexia, sodium loss. Mental disorders: agitation, stress, pathological gambling addiction; Actively commit suicide, suicide intentions, and suicide successfully. Nervous system disorders: Speech disorders, malignant neurolithic syndrome (NMS), large seizures. Cardiovascular disorders: extending the QT range, ventricular arrhythmia, sudden death of unknown causes, cardiac arrest, torsion, slow heart rate. Vascular disorders: fainting, hypertension, venous thrombosis (including pulmonary and venous thrombosis). Respiratory, chest and mediastinum disorders: throat spasms, laryngeal spasms, inhaled pneumonia. Gastrointestinal disorders: pancreatitis, difficulty swallowing, abdominal pain, stomach pain, diarrhea. Liver disorders: Hepatic failure, jaundice, hepatitis, hyperlemen aminotransferase (ALT), increase aspartate aminotransferase (AST), increase gamma glutamyl transferase (GGT), increase alkalin phosphatase. Skin and subcutaneous tissue disorders: rash, sensitive reaction to light, hair loss, increased sweating. musculoskeletal disorders and connective tissue: muscle pattern, muscle pain, stiffness. Conditions during pregnancy, birth and postpartum: Calf syndrome in newborns. kidney disorders and urinary systems: urinary incontinence, urinary retention. Breast disorders and reproductive system: erect. Common disorders and whole body: temperature adjustment disorders (such as lower body heat, fever), chest pain, peripheral edema. A few research parameters: increased creatin phosphokinase, hyperglycemia, erratic blood sugar, increased glycosylated haemoglobin levels. Instructions on how to handle ADR: When experiencing side effects of the drug, patients need 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
Aritero 10mg drug is contraindicated in cases of hypersensitivity to any component of the drug.
Be cautious when using
during anti -psychotic treatment, it takes a few days to a few weeks to improve the patient's clinical condition.
Patients should be closely monitored during treatment.
The act of suicide is inherently common in patients with mental illness and psychological disorders, and there have been a few cases reported when they started or switched to anti -psychotic treatment, including treatment with Aripiprazol.
Need to closely monitor patients at high risk of suicide when treating mental disorders.
According to the results of an epidemiological study, Aripiprazol treatment for patients with schizophrenia or bipolar disorder will limit the risk of suicide compared to other anti -psychotic drugs.
Cardiovascular disorders: Be careful when using Aripiprazol in patients with a history of cardiovascular disease (a history of myocardial infarction or ischemic heart disease, heart failure, or infusion abnormalities), cerebrovascular disease, patients with a condition that can lead to hypotension (dehydration, reduce blood flow, and patients treating with high blood pressure, or patients with high blood pressure or patients with hypertension, or patient with high blood pressure, or patient with high blood pressure, or patient with high blood pressure, or patient with hypertension, or patient with high blood pressure, or patient with high blood pressure, or patient with high blood pressure or patients with hypertension Calculate.
Cases of patients with venous thrombosis (VTE) have been recorded as related to the use of anti -psychotic drugs.
Due to patients treated with anti -psychotic drugs, it is easy to have a risk of venous thrombolytic embolism, pay attention to all risk factors before and during treatment with Aripiprazol, and take preventive measures.
Conductive abnormalities:
Late movement disorders:
Malignant Neuropoly Syndrome (NMS):
NMS is a complex syndrome that is likely to cause death related to psychotic drugs.
In clinical trials in patients treated with Aripiprazole, there are very few cases of NMS. The clinical manifestation of malignant neurolithic syndrome is high fever, stiffness, mental change and a spontaneous instability (uneven circuit or unstable blood pressure, fast heartbeat, sweating and arrhythmia).
Other signs include increased creatin phosphokinas, muscle pilot and acute renal failure.
However, the phenomenon of increased creatin phosphokinase and muscle -based creatin may not be completely related to NMS syndrome. If the patient shows signs and symptoms of NMS syndrome, or has a high fever of unknown reasons but does not accompany the clinical manifestations of NMS syndrome, it is necessary to stop treating with anti -psychotic drugs including Aripiprazol. epilepsy: Clinical trials have recorded a few cases that are not common during treatment with Aripiprazol. Therefore, it is necessary to be cautious when using Aripiprazol in patients with a history of mental disorders or capable of epilepsy.
Elderly patients with mental disorders:
Increased mortality rate:
Of the three control tests with placebo (n = 938; at the age of 56-99 years, average age: 82.4 years old) in elderly patients with mental disorders associated with Alzheimer's disease, a group of patients treated with Aripiprazol is at higher risk of death than the place of placebo.
The mortality rate in patients treated with Aripiprazol is 3.5% compared to the placebo group with a placebo of 1.7%. Although the cause of death is usually different, most of the deaths are caused by cardiovascular disease (such as heart failure, sudden death) or natural infectious disease (such as pneumonia).
Stroke:
Also in these tests, cases of stroke (such as stroke, transient ischemic attacks), including deaths, have been told in elderly patients (average age: 84; age: 78-88 years old).
In general, 1.3% of patients treated with Aripiprazol recorded stroke, compared to 0.6% of patients with placebo. This difference has no statistical significance.
However, in one of these tests, a fixed dose test, which has recorded a significant relationship between the dose response to cerebral vascular accident in patients treated with Aripiprazol.
Aripiprazol is not indicated for treatment of mental disorders associated with dementia.
Hyperglycemia and diabetes:
Hyperglycemia, in some cases of bad evolution and leads to infection of acid or coma or death due to diabetic hyperglycemia syndrome that have been recorded in patients treated with non -typical anti -sedative drugs, including Aripiprazol.
Risk factors may cause patients to have serious complications including obesity and family history of people with diabetes.
Clinical experiments in patients using Aripiprazol shows that the unwanted effect rate is related to hyperglycemia (including diabetes) or the results of abnormal blood sugar tests are not significant than the placebo group.
There is no comparison results that estimate the exact risk of unwanted effects related to hyperglycemia in patients treated with Aripiprazol and other typical anti -psychotic drugs.
Patients treated with any anti -psychotic drugs, including Aripiprazol, should be monitored with signs and symptoms of hyperglycemia (such as hunger, more urinating and feeling tired) and patients with diabetes or risk of diabetes should also be monitored regularly to control blood glucose in blood.
Hypersensitivity: Like with other pharmaceuticals, hypersensitivity reactions, characterized by allergy symptoms, can occur with Aripiprazol.
Weight gain: Weight gain is often seen in schizophrenia and bipolar mental patients, because when suffering from these diseases, users of anti -psychotic drugs will have the phenomenon of weight gain, less alert, and can lead to serious complications.
After Aripiprazol was put into use on the market, there was a recording of weight gain in patients prescribed drugs.
Weight gain usually occurs in patients with risk factors such as a history of diabetes, thyroid disorders or pituitary adenoma. In clinical trials, Aripiprazol has been shown to cause no clinical weight gain.
Difficulty swallowing: Treatment with anti -psychotic drugs, including Aripiprazol, can cause esophageal movement disorders and difficulty breathing.
Be careful when using Aripiprazol and other anti -psychotic active ingredients in patients at risk of choking pneumonia.
Pathological gambling addiction: post -circulating reports on pathological gambling addiction have been recorded in patients who are appointed to use Aripiprazol, regardless of whether these patients have a history of gambling.
Patients with a history of medical gambling addiction may be at higher risk and need to be closely monitored.
Integrity: Aripiprazol tablets contain lactose. Patients with rare genetic problems are galactose tolerance, lactase deficiency or difficulty absorption of glucose-galactose should not use Aripiprazol tablets.
affects the ability to drive and operate machinery
Patients need to be cautious when driving or operating machinery and drugs that can cause dizziness, drowsiness, headache, fatigue, blurred vision.
Women during pregnancy and lactation
do not have adequate and strictly controlled tests on the effects of Aripiprazol Anti -Pedica for pregnant women.
The phenomenon of gene mutations has been recorded, however, there is no official conclusion due to the effect of Aripiprazol.
Animal studies cannot exclude the ability to develop the toxin of the drug in humans. Patients need to notify the doctor if they are pregnant or plan to give birth during treatment.
Due to the lack of adequate information about the safety level of the drug for the human body and concerns through the research results performed for animal reproductive systems, this drug is not used for pregnant women unless considering the level of patients higher than potential risk risks for the fetus.
The fetus is exposed to anti -psychotic drugs (including Aripiprazol) in the last three months of pregnancy, there will be an risk of unwanted effects that include foreign tower syndrome and/or symptoms of drug addiction and the level of impact will be more serious and prolonged after birth.
There have been reports on symptoms of restless psychology, increasing tone, reducing tone, tremor, drowsiness, respiratory failure, or disorders in eating. Therefore, it is necessary to closely monitor the symptoms of infant.
Aripiprazol is excreted in the milk of the mother mouse breastfeeding after taking the drug.
Aripiprazol is excreted in human milk in humans or not has not been determined. Patients should be warned not to breastfeed if being treated with Aripiprazol.
Drug interaction
drug interactions may affect the activity of the drug or cause side effects. Should notify the doctor or pharmacist a list of drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.
Due to the al-commenergic receptor resistance, Aripiprazol has the ability to enhance the effects of some antihypertensive drugs.
Due to the main effects of Aripiprazol, it has an impact on the central nervous system, need to be cautious when using Aripiprazol combined with alcoholic beverages or other central nerve treatments such as painkillers to avoid unwanted effects overlapping.
Be careful when using Aripiprazol simultaneously with drugs that cause prolonged QT or an insomnia of electrolytes.
Other pharmaceuticals are able to interact with Aripiprazol:
The drug that prevents the secretion of acid in the stomach, H2 Famotidin antagonists will reduce Aripiprazol's absorption rate but this effect is considered to be clinically unrelated.
Aripiprazol is metabolized by many roads including CYP2D6 and CYP3A4 enzymes but does not include CYP1A enzymes. Therefore, there is no need to adjust the dose for those who have a habit of smoking.
In a clinical trial in healthy people, a strong inhibitor of CYP2D6 (quinidin) increases the area under the concentration - time (AUC) curve (AUC) of Aripiprazol to 107%, but does not increase the concentration of the drug in plasma (CMAX). Dehydro-kariprazol's and CMAX, active substance of Aripiprazol, decreased by 32% and 47% respectively.
Needs to reduce the dose of Aripiprazol to about half of the dose prescribed when treating aripiprazol with quinidine.
Other strong inhibitors of CYP2D6, such as fluoxetin and paroxetin, may have the same effect and thus the same dose reduction.
In a clinical trial in a healthy person, a strong inhibitor of CYP3A4 (Ketoconazole) increases Aripiprazol's CMAX and CMAX to 63% and 37% respectively. Dehydro-kariprazole's scour and CMAX increased by 77% and 43% respectively.
In people with poor metabolic genotype CYP2D6, when using simultaneously Aripiprazol with strong inhibitors of CYP3A4 can lead to higher aripiprazol levels in plasma than those with normal metabolic genotypes CYP2D6.
When performing a combination of ketoconazole or strong CYP3A4 inhibitors, other than Aripiprazol, only combined therapy if it is considered to be potentially greater than potential risks for patients. When using Ketoconazole simultaneously with Aripiprazol, the dose of
Aripiprazole should be reduced by about half compared to the specified dose.
Other strong inhibitors of CYP3A4, such as iTraconazole and protease inhibitors used in HIV treatment, can cause similar effects, so the dose reduction is required.
After stopping using CYP2D6 or CYP3A4 inhibitors, Aripiprazol's dosage should be increased by the level before starting combined treatment.
When the weak inhibitors of CYP3A4 (for example, diltiazem or escitalopram) or CYP2D6 are used simultaneously with Aripiprazol, which can lead to a slight increase in Aripiprazol levels.
After simultaneously used with carbamazepine, a strong touch substance of CYP3A4, the average nucleus index of CMAX and Aripiprazol's scope respectively approximately 68% and 73% lower than when only treated with Aripiprazol (30 mg). Similarly, the average of CMAX and AUC's AUC of Dehydro-Kariprazol after combining simultaneously with carbamazepine is approximately equal to 69% and 71% lower than when only treated with Aripiprazol.
Need to increase the dose of Aripiprazol doubled when using simultaneously Aripiprazol with carbamazepin.
Other strong induction drugs of CYP3A4 (such as Rifampin, Rifabutin, Phenytoin, Phenobarbital, Primidon, Efavirenz, Nevirapin and St. John Wort) can have similar effects so that the increase in the dose of Aripiprazol.
After stopping the drug causing a powerful CYP3A4 induction, it is recommended to reduce the dosage of Aripiprazol to the recommended dose.
When using Valproat or Lithi simultaneously with Aripiprazol, the level of Aripiprazol has not changed significantly in terms of clinical.
Aripiprazol's ability to act on other pharmaceuticals:
In clinical studies, Aripiprazol doses of 10-30 mg/day for use of one-time use have no significant impact on the metabolism of the substrates of CYP2D6 (Dextromethorphan/3-Methoxyorphinan ratio), 2C9 (Warfarin), 2C19 (Omeprazol), and 3A4 (Dextromethrphan).In addition, Aripiprazol and Dehydro-KiPiprazol do not show the potential to change the metabolism through CYP1A2 In Vitro intermediaries. Therefore, inability to cause serious drug interactions, clinical intermediaries are intermediaries by these enzymes.
When using simultaneously Aripiprazol with valproear, lithium or abuse, there is no clinical change in clinical changes in the level of valproat, lithi or lamotrigin.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
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