Dobdia Savi medicine treats severe depression (10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Mirtazapin
Ingredient Savi

Ingredient

Composition informationContent
Mirtazapin30mg

Uses

Indications

Dobdia drug indicated to treat severe depression.

Pharmacokological

Mirtazapin is a receptor inhibitor α2 of the centralized Synap money, increasing the neurotransmitter of Noradrenergic and Serotonergic. Serotonergic's nerve surgery is only through specific 5-HT1 receptors, due to the 5-HT2 and 5-HT3 receptors blocked by Mirtazapin. Both optical contrast substances of
Mirtazapin are thought to have antidepressant activity, S (+) receptor inhibitor α2 and 5-HT2 while isomer R (-) inhibit receptor 5-HT3.

Mirtazapin's H1 H1 antagonistic activity is associated with the sedative of the drug. The drug has almost no anti -cholinergic activity and has no effect on the cardiovascular system when used at the dose of treatment.

pharmacokinetic

absorption

After drinking, Mirtazapin is quickly absorbed with bioavailability about 50%, reaching the peak concentration in plasma after about 2 hours. Food does not affect the pharmacokinetics of mirtazapin.

Distribution

mirtazapin is associated with plasma protein at about 85%

Metabolism

The conversion is mainly methyl, oxidation and then combined. According to the in vitro research data in the liver microsom of the person, the enzymes of Cytochrom P450.

CYP2D6 and CYPIA2 involved the formation of mirtazapin 8-hydroxy metabolites, while CYP3A4 is thought to be involved in the formation of N-Demethyl and N-Oxyd metabolites. Methyl metabolites have reasonable activity and pharmacokinetic properties similar to mirtazapin.

Elimination

Mirtazapin is metabolized and excreted mainly through urine and stool within a few days. The average selling time is 20 - 40 hours, the sale time can be up to 65 hours longer. In young men, the sale time may be shorter. The drug concentration reaches a stable state after about 3-4 days and then there is no additional accumulation.

Mirtazapin's elimination decreases in people with kidney failure and liver failure.

linear

In the recommended dose range, Mirtazapin's pharmacokinetics are linear.

Before taking Dobdia Savi medicine treats severe depression (10 tablets)

How to use

Mirtazapin's waste sale time is quite long, about 20 to 40 hours so just use dobdia once a day. Should be taken every night before going to bed, can also be divided into 2 drinks (1 time in the morning, 1 time in the evening, higher dose than willow in the morning).

Used orally, during or outside meals. Drink whole tablets with water, do not chew, crush pills.

For a dose of 15 mg and 45 mg, it is possible to break the tablet in half the horizontal line on the tablet.

Dosage

recommended oil starting dose is 15 - 30 mg, effective dose is 15 - 45 g/day.

Mirtazapin shows effects after about 1-2 weeks of treatment.

Treatment with appropriate doses will give positive response within 2-4 weeks. When the response is incomplete, it may increase the dark dose. If after 2-4 weeks without response, it should be stopped.

Patients with depression should be treated for at least 6 months to ensure the symptoms completely.

When stopping treatment, it is advisable to stop slowly to avoid the symptoms of quitting.

Elderly

The recommended dose is similar to adults. When increasing the dose in elderly, closely monitor.

Renal failure

Mirtazapin's clearance may decrease in severe renal failure (creatinine clearance

People with liver failure

Mirtazapin's clearance may be reduced in people with liver failure. Be cautious when using Dobdia in people with liver failure, especially people with severe liver failure.

Children

Do not use Dobdia in children under 18 years old because they have not seen the effectiveness through two short -term clinical trials and concerns about the safety of drugs for children.

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? The central neurological inhibition symptoms such as disorientation and prolonged sedation have been reported, in addition to symptoms such as tachycardia, lowering or mild hypertension.

However, when taking the dose exceeding the treatment dose can cause serious consequences (including death), the symptoms have been reported including the peak twist, extending the QT.

Treatment: appropriate symptomatic treatment and therapies to support living function. Should monitor the electrocardiogram. Can remove drugs with activated carbon or gastric lavage.

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

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 Dobdia often has unwanted effects (ADR) such as:

Very common, ADR ≥ 1/10

  • Metabolism and nutrition: weight gain, increased appetite.
  • Mental: Abnormal dreams, anxiety, confusion, insomnia. Other: peripheral edema, fainting.
  • Mental: Meeting nightmares, revival, agitation, hallucinations, stimulating motor nerves.
  • Mental: aggressive.
  • blood and hematopoietic system: bone marrow failure (granulocytosis, leukopenia, anemia, platelet reduction), acidic hyperactivity. Serotonin, abnormal sensation in the mouth, hard to say. Set.
  • Warnings

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

    Contraindicated

    Contraindications Dobdia in the following cases:

  • Hypersensitivity to mirtazapin or any ingredients of the drug.

    Precautions when using

    Children

    Do not use mirtazapin for children under 18.

    There has been clinical reports related to behavior, suicide intentions and aggressive attitude when using mirtazapin for children in antidepressant treatment compared to the placebo group.

    In case of mandatory use, the patient must be closely monitored. There is no sufficient data on safety related to physical development, gender, and perception of children when using long -term mirtazapin.

    The intention to commit suicide or deteriorating events

    Depression is associated with an increase in the risk of suicide and painful intentions. After a few weeks of treatment, if there is no improvement, the patient must be closely monitored, the risk of suicide often occurs when starting to use Mirtazapin.

    Patients with a history of incidents related to self -organs or suicide before starting to use mirtazapin are people who have a high risk of self -intentions from using Mirtazapin. Therefore, this object must be closely monitored during the treatment process.

    About the risk of suicide, especially when starting treatment, only low -dose patients should be used.

    bone marrow inhibition

    bone marrow inhibitor, often showing signs of reduction or loss of granulocytes, has been reported during treatment with mirtazapin. In clinical studies with Mirtazapin
    granulocytes that can be recovered as a rare situation, some cases of grain leukopenia can lead to death and almost deaths are related to patients over 65 years old.

    Must report to the doctor about symptoms such as fever, sore throat, stomatitis or other infections. When such symptoms occur should be stopped and blood tests should be discontinued.

    jaundice

    Should stop taking the drug if the skin appears.

    Cases to monitor

    Need to take medicine carefully as well as regular monitoring for patients with the following conditions:

    Epilepsy and physical brain syndrome: The bright experience shows that these lesions rarely occur in patients treated with Mirtazapin. Use
    mirtazapin carefully for people with a history of epilepsy.

    Stop using the drug if the patient has epilepsy or increases the frequency of seizures.

    Hepatic failure: For solitary willow 15 mg Mirtazapin, the clearance of mirtazapin is reduced by about 35% in mild and moderate liver failure compared to normal people. Mirtazapin's average concentration increased by about 55%.

    Renal failure: For a single dose of 15 mg Mirtazapin, the clearance of Mirtazapin is reduced by about 30% in medium renal failure (creatinine clearance Heart disease such as transmission disorders, angina and recent myocardial infarction: These cases are often cautious and careful when used with other drugs.

    Low blood pressure.

    Diabetes: Antidepressants can affect blood sugar control effects, so insulin dose adjustments or oral anti -diabetic drugs and patients must be monitored closely.

    Like other antidepressants, need to be cautious for patients

    Mental symptoms may be worse when taking antidepressants for schizophrenia or other mental disorders: paranoid thoughts (paranoids) may be more serious.

    When starting to treat in the depression of bipolar disorder, the disease can turn to the revival stage. Patients with a history of mental disorders, Hung Cam must be closely monitored. Mirtazapin should be stopped in any patient who has the stage of being revived.

    Although antidepressants are not addictive, sudden stopping the drug after a long time of taking the drug may cause symptoms of quitting including dizziness, agitation, headache and nausea. These symptoms are usually mild and self -out. Although these symptoms are reported by sudden stopping drugs, wiring is still a sign of hidden diseases. When stopping the drug should gradually reduce the dose.

    Be cautious when using mirtazapin in people who hypertrophy of prostate or increased glaucoma of angle or increased internal pressure (this is rarely occurring with mirtazapin, because of the weak cholinergic activity of the drug is very weak).

    Symptoms of not sitting/restlessness: The use of antidepressants is associated with the development of non -sitting syndrome, characterized by unpleasant restlessness, sadness and causing patients to move continuously. This may occur in the first few weeks of treatment. In patients with these symptoms, increasing the dose may cause disadvantages.

    Cases of extending the QT, twisting, ventricular or stroke have been reported when using mirtazapin. These reports are mainly cases of overdose in patients with risk factors of the QT range, such as taking other drugs that extend the QT range. Be cautious when using mirtazapin in people with cardiovascular disease or a history of extension of QT and use in combination with other drugs that extend the QT range.

    hypoglycatry blood

    It could be due to the inappropriate anti -hormone secretion syndrome (SIADH), which was reported to rarely use Mirtazapin. Precautions need to be used when taking drugs in patients at risk such as elderly patients or patients with the form of treatment simultaneously with drugs that can cause hematuria.

    Serotonin syndrome

    Interaction with serotonin agreements: Serotonin syndrome can occur when combining SSRIs with serotonin movements. Serotonin syndrome symptoms may be hyperthermia, restlessness, hallucinations, loss of coordination, tachycardia, nausea, vomiting, diarrhea, headache, muscle convulsions, weakness, abdominal pain, anxiety, convulsions, coma. Caution should be closely monitored and must be closely monitored when using serotonin shipping owners with mirtazapin. When these symptoms occur, Mirtazapin should be stopped immediately and have appropriate supportive treatments.

    Elderly people

    Elderly, more sensitive to the side effects of depression treatment.

    excipients

    Due to the presence of lactose in preparations, cautious when used in patients with genetic problems such as galactose intolerance, lactase deficiency or glucose-galactose.

    Using drugs for women during pregnancy and lactation

    Pregnancy

    The limited data of the use of mirtazapin in pregnant women does not show an increased risk of birth defects.

    Animal studies do not show any teratogenic effects, but toxicity has been observed.

    Epidemiological data shows that the common SSRI during pregnancy, especially the end of pregnancy, may increase the risk of continuous pulmonary hypertension in newborns (PPH: Persistent Pulmonary Hypertension). Although no research has evaluated the relationship between PPHN and Mirtazapin, this risk should not be excluded due to the similar mechanism of operation between mirtazapin and SSRI (all increases serotonin levels).

    Be cautious when using Dobdia in pregnant women. If used during pregnancy and before birth, it is necessary to monitor signs of unwanted reactions in babies.

    Breastfeeding period

    Animal studies and limited data on humans show that mirtazapin secretes milk in small amounts.

    Only use Dobdia in breastfeeding women if the effect is superior to risk.

    The effect of the drug on driving and operating machinery

    Mirtazapin has a slight or moderate effect on driving and operating machinery. Mirtazapin can affect concentration and alertness (especially in the first stage of treatment). Therefore, patients should avoid driving and operating machinery when using this drug.

    Drug interaction

    Pharmacological interaction

    Avoid combining mirtazapin and capillary inhibitors, avoiding mirtazapin within 2 weeks after stopping using Mao inhibitors. In contrast,
    is not used with Mao inhibitors within 2 weeks after stopping using mirtazapin.

    Serotonin agreements (L-tryptophan, Triptan, Tramadol, Linezolid, Green Methylen, SSRI, Venlafaxin, Lithi and St. John's Herbal) when used in combination with Mirtazapin can cause serotonin syndrome. Precautions when using this combination and must monitor the patient closely.

    Mirtazapin can increase the sedative effects of benzodiazepine and other sedatives (especially anti -psychotic drugs, H1 antihistamines, opioid analgesic).

    Mirtazapin may increase the inhibition effect of alcohol. Therefore, alcohol should be avoided when drinking mirtazapin.

    Mirtazapin at 30 mg/day can cause Inr (International Normalized Ratio) in those who are being treated with warfarin. Should monitor the infected person's INR
    in this case of combination.

    The risk of extending the QT or torsion will increase when used with drugs that extend QT (such as some anti -psychotic and antibiotic drugs).

    Mobile interaction

    CYP3A4 induction substances such as carbamazepin and phenytoin can cause increased mirtazapin clearance to 2 times, causing reduction in the average concentration of mirtazapin in plasma is 60% and 45%. When sharing carbamazepine or liver enzyme induction (like rifampicin) with mirtazapin, mirtazapin dose is needed. When
    stops treating with liver enzyme induction, mirtazapin dose is reduced.

    Used in combination with CYP3A4 inhibitors increases the adhesion of mirtazapin to about 40% and AUC to about 50%.

    Use Cimetidine combination (weak inhibitor CYPIA2, CYP2D6 and CYP3A4) with IIRTAZAPIN will cause the concentration of mirtazapin in plasma to more than 50%.

    Be cautious when using this combination and should reduce the dose of mirtazapin when used in combination with CYP3A4 inhibitors, HIV Protease inhibitors, Azol antifungal drugs, erythromycin, cimetidine or ne Fazadon.

    Medicine interactive studies do not indicate any pharmacokinetic interactions of mirtazapin combinations with paroxetin, amitriptylin, risperidon or lithium.

  • Storage

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

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