Mirastad 30 Stella tablets treat depression, maintain mental balance (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Mirtazapine

Ingredient

Composition information	Content
Mirtazapine	30mg

Uses

Indications

drugs Mirastad 30 are indicated for treatment of major depression.

Pharmacokic

Mirtazapine is an antidepressant that can be used to treat large depression. The presence of symptoms such as melancholy, mental inhibition, sleep disorders (early awake) and weight loss will increase the chance to respond positively. Other symptoms such as indifference, suicide thoughts and temperament change (better evening than morning). In general, Mirtazapine starts to work after 1-2 weeks of treatment.

Mirtazapine is an α2 antagonistic drug that has centralized activity, increasing nerve transmission through Noradrenalin intermediaries and central serotonin. The enhancement of neurotransmitter through serotonin intermediaries only through specific receptors 5 - HT1, because receptors 5 - HT2 and 5 - HT3 are blocked by Mirtazapine. Both mirtazapine images are thought to be involved in antidepressant activity, implantoma S (+) receptor blocker α2 and 5 - HT2, and optical isomers R ( -) receptor blockers 5 - HT3. Mirtazapine H1 H1 antagonism is related to the sedative characteristics of the drug. Mirtazapine is usually very well tolerated. The drug has almost no anti -cholinergic activity and with the dose of treatment almost no effect on the cardiovascular system.

pharmacokinetics

After taking Mirtazapine, the active ingredient is absorbed quickly and well (bio -used 50%), reaching the peak concentration in plasma after about 2 hours. About 85% Mirtazapine is attached to plasma proteins. Mirtazapine is strongly metabolized through the liver by CYP2D6, CYP1A2, CYP3A4. Mirtazapine is eliminated through urine (75%) and in feces (15%). The average disposal time is from 20 - 40 hours; Occasionally recording longer -selling time, up to 65 hours and shorter waste time is often seen in young men. Such sale time is enough to take medicine at a dose 1 time a day. The concentration of the drug reaches a stable state after 3-4 days, then does not accumulate. In the recommended dose, Mirtazapine has linear pharmacokinetic properties. Mirtazapine is strongly metabolized and excreted in urine and stool for a few days. The main biological change is methyl and oxidation, followed by a conjugated reaction. Methyl metabolites have pharmacological activity and proved to have the same pharmacokinetic characteristics such as mother compound. Mirtazapine clearance may be reduced due to renal failure or liver failure.

Before taking Mirastad 30 Stella tablets treat depression, maintain mental balance (2 blisters x 14 tablets)

How to use

Mirastad 30 drugs for oral.

Take the tablet with a glass of water.

Dosage

Adults

Start treatment at a dose of 15 or 30 mg/day. Usually the dose is usually needed to achieve optimal clinical response. The effective daily dose is usually 15 - 45mg.

Mirtazapine usually starts effective after 1-2 weeks of treatment. Usually the dose increases (minimum after 1-2 weeks) to achieve optimal clinical response. A sufficient dosage treatment will have a positive response within 2-4 weeks. With incomplete response, there is a maximum increase. If there is still no response within 2-4 weeks, should stop treatment.

Patients with depression should be fully treated for at least 6 months to ensure no more symptoms.

At the end of Mirtazapine treatment, it should be stopped slowly to avoid the symptoms of stopping drugs.

Elderly

recommended dose as for adults. In elderly patients, increasing the dose should be closely monitored to find satisfactory and safety response.

Children

Do not use mirtazapine for children and teenagers under 18 years of age because the effect is not proven in two short -term clinical trials and for safety.

In patients with kidney failure and liver failure

Mirtazapine's clearance may be reduced in medium to severe renal failure (creatinine clearance

Mirtazapine's waste sale time is 20-40 hours, so it is suitable for using mirtazapine once a day, so drink only at night before going to bed. Mirtazapine dose can also be divided into 2 times (once and at night, higher doses should be taken in the evening).

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?

Symptoms

The existing experience of an individually overdose shows mild symptoms. Inhibiting the central nervous system with long -term disorientation and sedation has been reported, as well as tachycardia, hypertension or mild blood pressure. However, there may be more serious consequences (including death) at a much higher dosage than treatment, especially mixed overdose. In these cases, the interval of QT and twisted nails has been reported.

Handling

Cases of overdose should be treated with symptoms and support appropriately survival functions. Should monitor the electrocardiogram. Using activated carbon or gastric lavage should also be considered.

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

What to do when forgetting a 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 the drug, you may experience unwanted effects (ADR).

Patients with depression have some symptoms that are accompanied by the disease. Therefore, it is sometimes difficult to be sure of any symptoms that are the consequences of the disease and the symptoms are the result of treatment with mirtazapine.

Very common (1/10 ≤ ADR)

Metabolism and nutrition: weight gain, increased appetite.

Nervous system: drowsiness, sedation, headache

Mental: Abnormal dreams, confusion, anxiety, insomnia. Back.

Mental: nightmares, manic, agitation, hallucinations, mental restlessness (including lying, sitting restless, hyperactive). 1/1000)

Mental: aggressive.

Nervous system: Mechanical machine.

Warnings

Before using Mirastad 30, you need to read the instructions for use and refer to the information below.

Contraindicated

Mirastad 30 contraindicated drug in the following cases:

Hypersensitivity to mirtazapine or any ingredients of the drug.

Be cautious when using

Depression becomes worse and/or revealing suicidal thoughts and behaviors or having abnormal changes in behavior in both adults and children with large depression disorders or other mental disorders whether they are taking antidepressants or not. This risk may still exist until there is an important clinical relief. Suicide is the known risk of depression and some other mental disorders, which are the most obvious predictions of suicide action. However, there is a long -standing association that antidepressants can play a worse job than depression and suicide thoughts in some patients in the first stage of treatment.

Do not use mirtazapine to treat children and teenagers under 18 years old. In clinical studies, behaviors related to suicide (suicide or suicide thought) and opposition attitude (mostly aggressive behaviors, husbands and anger) are more common in children and young people treated with antidepressants compared to placebo -treated children. However, based on clinical needs, if the decision to treat, should carefully monitor the appearance of suicide symptoms in patients. In addition, there is a lack of information on long -term safety in children and young people related to growth, maturity, understanding and behavioral development.

Bone marrow inhibitor, often manifested by decreased or loss of granulocytes, has been reported during treatment with mirtazapine. Loss of granulocytes can be recovered as a rare situation in clinical studies with Mirtazapine. In the period after bringing Mirtazapine to the market, it is very rare for the case of grain leukemia to be reported, most of them recovered, but there are several deaths. The majority of deaths related to patients over 65 years old. Must report to the doctor about symptoms such as fever, sore throat, stomatitis or other signs of infection; When such symptoms occur should stop treatment and blood tests.

Need to take medicine carefully as well as regular monitoring for patients:

Epilepsy and physical brain syndrome: Clinical experience shows that these lesions rarely occur in patients treated with Mirtazapine. The average plasma concentration of Mirtazapine increased by about 55%. Mirtazapine's average plasma concentration increased by about 55% in medium and 115% renal failure patients in patients with severe renal impairment. There is no significant difference in patients with mild renal impairment (Creatinine clearance as well as other antidepressants, need to be cautious for patients:

Disorders of urination such as prostate hypertrophy (although this problem is rarely found because Mirtazapine has only very weak cholinergic anti -activity). skin.

In addition, as for other antidepressants, it should be noted:

Mental symptoms may be worse when taking antidepressants for schizophrenia or other mental disorders; The thought that the paranoid is more serious. When circulating on the market, it shows sudden stop treatment after a long time of taking the drug that can cause symptoms of stopping drugs. Most of the reactions stopped light and self -limited. Among the symptoms of suspension of drugs that are reported dizziness, agitation, anxiety, headache and nausea are the most common. Despite being reported as symptoms of stopping drugs, it is aware that these symptoms may be related to the disease. It is recommended to stop treating mirtazapine slowly. Most appears within the first few weeks of treatment, in patients developing these symptoms, increasing the dose may be harmful. Be cautious when prescribing mirtazapine for patients with cardiovascular disease or a family history of a QT extension, and when used with the drug that causes a long -term QT.

Rarely the condition of hypoglycemia is reported when using mirtazapine. Should be cautious with patients at risk, such as the elderly or when treated simultaneously with drugs that cause sodium hypoglycemia.

Serotonin syndrome can occur when selective Serotonin re -income inhibitors (SSRIs) are used simultaneously with other serotonergic activity substances. Should be cautious and clinically closely monitored when these active substances are combined with mirtazapine.

Elderly patients are often more sensitive, especially with the side effects of antidepressants. In clinical research with mirtazapine, on elderly illness, no side effects are reported more than other age groups; However, so far there is still little experience on this issue.

The drug contains lactose. This drug should not be used for patients with rare genetic problems galactose intolerance, total lactase enzyme deficiency or glucose - galactose.

Weight gain: 7% of body weight has been reported in 7.5% of patients treated with mirtazapine compared to 0% placebo and 5.9% amitriptylin use. In a study in the US, including many long -term patients, open longan treatment, 8% of patients using Mirtazapine stopped gaining weight. A clinical trial in children in 8 weeks of long -term treatment with a dose of 15 - 45mg/day, 49% of patients treated with Mirtazapine weight gain at least 7% compared to 5.7% of placebo patients.

Increase cholesterol and triglycerides: In the controlled studies in the US, random cholesterol increases up to ≥ 20% above the upper limit of normal is observed in 15% of patients treated with Mirtazapine compared to 7% of placebo patients and 8% amitriptylin use. In similar studies, random triglycerides> 500mg/dl are observed in 6% of patients treated with mirtazapine compared to 3% of patients using placebo and 3% amitriptylin.

Increased liver enzyme: Liver enzyme increase (ALT) significantly clinically (≥ 3 times the upper limit of normal levels) has been observed in 2.0% of patients in contact with Mirtazapine in short -term tests controlled in the US, compared to 0.3% of placebo patients and 2.0% of patients taking amitriptylin. Most patients with ALT increases do not show signs or symptoms related to liver function damage. While some patients have stopped increasing ALT, in another case, the enzyme level returns to normal despite being treated with Mirtazapine. Mirtazapine should be used carefully in patients with liver function.

Vertical hypotension: Mirtazapine is combined with significant hypotension that has been recorded regularly in clinical trials with depression patients.

The ability to drive and operate machinery

Mirastad 30 medicine can reduce the ability to concentrate and alertness. Patients treated with antidepressants should avoid doing dangerous jobs that need alertness and focus well, such as driving or operating machinery.

Pregnant women

have no complete and well -controlled research in pregnant women. Because animal reproductive studies cannot always be met in humans, so they should only use drugs during pregnancy if they are really necessary.

breastfeeding women

because a little mirtazapine can be secreted into breast milk, need to be cautious when using mirtazapine for nursing women.

Medicinal interaction

mirtazapine may increase the central nervous inhibition effect of alcohol, so it is recommended that patients abstain from alcohol during treatment with mirtazapine.

Do not use mirtazapine simultaneously with Mao inhibitors or within 2 weeks after stopping treatment with these drugs.

Mirtazapine may increase the sedative of benzodiazepine and other sedatives (especially anti -psychotic drugs, H1 antihistamines, opioids), need to be cautious when prescribing these drugs with mirtazapine.

Use mirtazapine at a dose of 30mg x 1 time/day causing slight increase but significant in terms of international normalization index (INR) in those who are treated with warfarin. Because it is not possible to exclude a more obvious effect when using a higher dosage of mirtazapine, the Inr index should be monitored in the case of simultaneous treatment of Warfarin with Mirtazapine.

The risk of extending the range of QT and/or ventricular arrhythmias (such as torsion) may increase when used simultaneously with drugs that extend QTC (such as some anti -psychotic and antibiotic drugs).

Enzyme inhibitors of metabolic metabolic enzymes CYP3A4, CYP2D6 and CYP1A2 (cimetidin, antifungal Azol conductors, HIV protease drugs, erythromycin) increase blood levels and can increase the toxicity of mirtazapine. In contrast, carbamazepine and some other CYP3A4 induction drugs increase the clearance of mirtazapine and may need to increase the dose of mirtazapine when used with these drugs.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

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