Remeron 30mg Tablets Organon treats severe depression (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Mirtazapine

Ingredient

Composition information	Content
Mirtazapine	30mg

Uses

indicated

Treatment of severe depression.

Pharmacokic

Pharmacological classification: Antidepressants, ATC code: N06AX11.

Mirtazapine is a receptor antagonist α2 of the central effect, increasing the nerve transmission of Noradrenergic and Central Serotonergic. The increase in Serotonergic neurotransmitter is through specific intermediate 5-HT1 receptors, and by Mirtazapine, blocking 5-HT2 and 5-HT3 receptors. Both implants of Mirtazapine photos are thought to contribute to the antidepressant activity, copper of the image s (+) receptor blocker α2 and 5-HT2 and the isomer R (-) receptor blocker 5-HT3.

Mirtazapine's H1 antihistamine anti -H1 activity is related to the sedative characteristics of the drug. In fact, the drug has no anti -cholinergic anti -therapy activity, the drug has only very little effect (for example: lower hypotension) to the cardiovascular system.

Children:

Two random, double -blinded, controlled studies in children from 7 to 18 years old with depression (n = 259) use flexible dose for the first 4 weeks (15 - 45 mg Mirtazapine), then use the fixed dose (15, 30 or 45 mg Mirtazapine) for 4 other weeks, do not see significant differences between Mirtazapine and placebo in main criteria and extra criteria. Significant weight gain (≥ 7%) was observed in 48.8% of patients treated by Remeron compared to 5.7% of patients using placebo. Urticaria (11.8% compared to 6.8%) and increased blood triglycerides (2.9% and 0%) are also often recorded.

pharmacokinetics

absorption:

After using Remeron, the active ingredient Mirtazapine is well absorbed and fast (bioavailability is approximately 50%), reaching the peak concentration in plasma after about two hours. Food does not affect the pharmacokinetics of mirtazapine.

Distribution:

Mirtazapine ratio is attached to plasma proteins about 85%.

Metabolism:

The main biological changes are methyl and oxidation, then combined. In vitro data on human liver microsome shows that cytochrome P450 enzymes include CYP2D6 and CYP1A2 involved in the formation of Mirtazapine 8-hydroxy metabolites, while CYP3A4 is believed to be involved in the formation of N-Demethyl and N-Oxide metabolites. Demethyl metabolites have pharmacological activity and have the same pharmacokinetic properties with mother compound.

Era:

Mirtazapine is metabolized widely and eliminated through urine and stool for a few days. The average disposal time is 20 - 40 hours; Sometimes it records longer waste time, up to 65 hours, and in young men, they also observed shorter selling time. Sales time is sufficient to take the drug once a day. The stable concentration is achieved after 3-4 days, then does not accumulate.

Linear/nonlinear pharmacokinetics:

Mirtazapine has linear pharmacokinetics within the recommended dose limits.

Special population group:

Mirtazapine clearance may be reduced due to liver failure or renal failure.

Before taking Remeron 30mg Tablets Organon treats severe depression (3 blisters x 10 tablets)

How to use

Take oral use.

Dosage

Adults

Effective daily dose is usually about 15 to 45 mg; The starting dose is 15 or 30 mg. Overall, Mirtazapine began to work after 1-2 weeks of treatment. Treatment of adequate dose will create positive response for 2-4 weeks. If there is no adequate response, it may increase to the maximum dose. If there is still no response in the next 2-4 weeks, should stop treatment.

Elderly

recommended doses like adults. In elderly patients, they must be closely monitored when increasing the dose to get safe and desired response.

Children and teenagers under 18 years old

Do not use Remeron for children and teenagers under 18 years of age (see the "Warning and Caution") section because the effectiveness of the drug has not been proven in two short -term clinical studies (see the section "Pharmacological characteristics") and due to the relevance of the safety of the drug (see the section "Warning and caution when using the drug", the "Unwanted effect").

kidney failure

Mirtazapine clearance may be reduced in patients with average to severe renal failure (creatinine clearance

Hepatic failure

Mirtazapine clearance may be reduced in patients with liver failure. It should be considered that when prescribing Remeron for this group of patients, especially severe liver failure due to no studies in patients with severe liver failure (see the "Warning and cautious use when using the drug").

Mirtazapine's waste time is 20-40 hours and therefore Remeron is suitable for drinking once a day. It is best to take a single dose at night before going to bed. It is also possible to divide the remeron into two small doses (one morning and one evening dose, higher dose should be taken in the evening).

Should use oral tablets, with water, and swallow without chewing.

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

should stop treating mirtazapine slowly to avoid cessation syndrome (see the section "Warning and caution when using the drug").

What do

do when overdose? There has been a report on the inhibition of the central nervous system with prolonged orientation and sedation, along with tachycardia and increased mild blood pressure. However, there may be more serious consequences (including death) when taking much higher doses, especially overdose of many drugs at the same time. In these cases, there are also reports on long -lasting QT and torsion (Torsade de Pointes).

Cases of overdose should be treated and treated with appropriate symptoms for survival functions. Need to monitor the electrocardiogram. Also consider using activated carbon or gastreasing.

What to do when forgetting a dose?

Side Effects

Patients with depression have many symptoms that come with the disease. Therefore, sometimes it is difficult to determine any symptoms of the disease and any symptoms caused by remeron treatment.

The most common adultery reactions are recorded,> 5% of patients treated with remeron in random trials are controlled with placebo (see below) are drowsiness, sedation, dry mouth, weight gain, appetite, dizziness and fatigue.

All random tests that are controlled with placebo (including indications other than severe severe depression) are evaluated by Remeron's adultery reaction. General analysis of 20 tests, with an expected treatment time of up to 12 weeks, with 1501 patients (134 people - year (Person Years) using Mirtazapine doses up to 60 mg and 850 patients (79 people - year) use placebo. The expansion phase of these tests has been excluded to ensure the ability to be comparable to placebo therapy.

Table 1 shows the proportion of adverse effects classified in clinical trials that appear more often with statistical significance in the treatment of remeron compared to placebo, along with the adverse effects in spontaneous reports are calculated based on the rate of reporting these events in clinical studies. The frequency of adultery in spontaneous reports is based on the rate of reporting these events in clinical studies. The frequency of side effects in spontaneous reports without observing in patients in patients involved in random tests is controlled with placebo, classified as ‘unknown’ group

Table 1. Remeron's adultery effect

Agency system

is very common (≥1/10)

Common (≥1/100 to

Less (≥1/100 to 100)

(≥1/10000 to

Unknown frequency plateletic blood reduction).

- Nothing hypergonia

Endocrine disorders Nursing

- Weight gain 1

- Increase appetite 1

- Confusion

- Lo 2,5

- Insomnia 3

- Nightness 2

- Hung Cam

- restless 2

- Illusion

- Motor mental disorders (including restless sitting, increasing movement).

- Correspondent

- suicide thoughts 6

- Behavior 6

- Bleeing

- An Than1,4

- Headache 2

- Sleep1

- Dizziness

- Run

- Perception 2

- Unmarried leg

- Faint

- Mechanical shock

- convulsions (injury)

- Serotonin syndrome

- Perception in the mouth

- Language disorder

circuit disorders - Hypotension (posture) - Hypotension 2 mouth

- Nausea3

- diarrhea 2

- vomiting 2

- Constipation 1

- Perceptions in the mouth

- Pancreatitis - Supporting mouth

- Increase salivation

Liver disorders Ban2

- Dermatitis

- polymorphic erythema

- toxic skin necrosis

- Muscle pain

- Back pain 1

- Mechanical pepper 7 Vocational

- Tired

- Local edema

Testing

Treatment time with remeron compared to placebo.

2 In clinical trials, these side effects occur during placebo treatment more often than Remeron, but there is no statistical significance.

3 In clinical trials, these side effects occur during placebo treatment more often than Remeron.

4 notes: generally reducing the dose does not reduce drowsiness/sedation but may cause loss of treatment effect.

5 In general, depending on the antidepressants used during treatment, anxiety and insomnia (may be symptoms of depression) may appear or become worse. When treated with mirtazapine, there was a report on the appearance or worse development of anxiety and insomnia.

6 has reported cases with suicide thoughts and suicide behaviors during Mirtazapine treatment or when the medication is stopped (see the "Warning and Caution when using the drug").

7 has reported the case of muscle pattern related to serotonin syndrome and overdose. In the second case (overdose), it is impossible to firmly identify the causes related to mirtazapine.

Subclinical tests in clinical trials have shown a slight increase in enzyme transaminase and gamma-glutamyltransferase (however adultery effects related to the use of remeron are not reported more statistically than placebo).

Children:

Unwanted effects are often observed in children's clinical studies including: weight gain, urticaria and blood triglyceride (also viewed "Pharmacological characteristics")

Notice to the doctor or pharmacist the harmful reactions encountered when using the drug.

Warnings

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

Contraindicated

Hypersensitivity to the main active ingredient or any excipients of the drug.

Concomitance mirtazapine use with enzyme inhibitors Monoamine oxidase (monoamine oxidase-mao) (see the "Drug interaction" section).

Be cautious when using

used in children and teenagers under 18 years old

Do not use Remeron in the treatment of children and teenagers under 18 years old. In clinical trials, behaviors related to suicide (suicide intentions and suicidal thoughts), and hostile (mainly aggressive, anti -opposition and anger) in children and teenagers are treated with antidepressants are more frequent than placebo -treated children. However, based on clinical needs, if the decision to treat patients, they must be careful to monitor the appearance of suicide symptoms. In addition, there is no enough long -term safety data related to growth, maturity and development of behavior and awareness of children and teenagers.

suicide/ suicide thoughts or more severe clinical symptoms

Depression is associated with the risk of increasing suicide thoughts, self -injuries and suicidal actions (events related to suicide). This risk lasts until the disease is significantly reduced. Because the disease may not be relieved in the first weeks of treatment, the patient should be closely monitored until that significant remission is achieved. Clinical experience in general shows the risk of suicide that can increase in the initial recovery stages.

Patients with a history of suicidal events or patients who express suicide thoughts with clear levels before the beginning of treatment are known to have a higher risk of suicide or suicide thoughts, and should be closely monitored during the treatment process. A synthetic analysis (meta - analysis) Clinical trials for control of antidepressant drugs in adult patients with mental disorders showing the risk of suicide behavior in the group using antidepressants increased compared to the place of placebo patients at the age of 25.

Should closely monitor patients, especially patients at high risk when treated with antidepressants, especially in the early stages of treatment and the stage after the dose changes. The patient (and patient care) should be warned that the need to monitor any clinical symptoms becomes serious, the thoughts or suicidal behaviors and abnormal changes in behavior and should consult a doctor as soon as those symptoms appear.

For suicide risk, especially when starting treatment, only giving patients the smallest amount of Remeron film tablets in combination with good patient management, to reduce the risk of overdose.

Bone marrow failure

There has been a bone marrow failure report when treated with remeron, which is usually a grain leukopenia or granulocytosis. The recovery of the recovery of recovery has been reported with very rare frequency in clinical studies with Remeron. In the periodic report after circulation of remeron drugs, granulocytic loss is also very rare, mostly can recover, but some cases lead to death. Cases of death are largely related to patients over 65 years old. Doctors need to be alert for millions of eggs such as sauce, sore throat, stomatitis or other signs of infection; When these symptoms appear, treatment should be stopped and tested for blood formula.

jaundice

Should stop treatment if jaundice appears.

Conditions that need to be monitored

Need to use carefully in combination with regular and strict monitoring in patients:

Epilepsy and physical brain syndrome: Although clinical experience shows that epilepsy rarely occurs during Mirtazapine treatment, like other antidepressants, should be used for patients with a history of epilepsy. Treatment should be stopped in patients with seizures or epilepsy increases. The average plasma concentration of mirtazapine increased by about 55%. The average level of plasma mirtazapine increased by 55% and 115% respectively. There is no significant difference found in patients with mild renal impairment (40 ml/min ≤ Creatinine clearance

Like other antidepressants, it should be noted:

Symptoms of psychosis may be worse when taking antidepressants for schizophrenia or other mental disorders; Paranoid disease may be more serious. It is necessary to closely monitor patients with a history of mild mania/mild mania. Mirtazapine should be stopped in any patient who started to appear Hung Cam Pha. Most of the cessation reactions are light and self -limited. Among the different symptoms of cessation have been reported, the most common is dizziness, restlessness, fear, headache and nausea. Although these symptoms have been reported as symptoms of quitting, they may also be related to other potential diseases. Mirtazapine dose should be discontinued slowly as recommended in the "Usage, Dosage" section. Dynamic: The use of antidepressants associated with the development of sitting, restless, characterized by uncomfortable restlessness or anxiety subjective and need to exercise, often accompanied by the inability to sit still or stand still. This symptom often occurs in the first weeks of treatment. In patients with these symptoms, increasing the dose can be harmful to the patient. This test shows that both the dose of 45 mg (treatment dose) and the dose of 75 mg (on the treatment dose) do not affect the QTC range to the level of clinical significance. When using mirtazapine during after -sales period, there were reports on cases of prolonged QT, Torsades de Pointes), ventricular tachycardia and sudden death. The majority of reports occur related to overdose or in patients with other risk factors in the extended QT interval, including simultaneous use with drugs that extend the QTC range (see the "drug interaction" and the "overdose" section). Be careful when prescribing Remeron for patients who have known to have cardiovascular disease or family history with extended QT interval and simultaneously used with drugs that are thought to extend QTC.

Hematrum hypoclines

There have been a report on sodium hypoglycemia when using mirtazapine with very rare frequency. Caution should be cautious in patients at risk, such as elderly patients or patients treated simultaneously with drugs known to cause sodium hypothermia.

Serotonin syndrome

Interaction with serotonergic activity: Serotonin syndrome can occur when using simultaneously selective Serotonin reabsorption inhibitors (Selective Serotonin Reuptake Inhitors (SSRIs) with other serotonergic activity (see the "drug interaction" section). Serotonin syndrome symptoms may be hyperthermia, stiffness, muscle vibration, nervous instability with the ability to quickly fluctuate the signs of survival, mental changes including confusion, irritability and restlessness that leads to delusion and coma. Should be cautious and clinically closely monitored when combining these drugs with mirtazapine. Remember should be stopped if these syndrome occurs and setting up symptomatic treatment support therapy. Experience after circulation shows that Serotonin syndrome rarely occurs in patients treated only with Remeron (see the "unwanted effect").

Elderly patients

Elderly patients are often more sensitive, especially with the unwanted effects of antidepressants. In the process of clinical research with Remeron, unwanted effects on elderly patients were reported not more than other age groups.

lactose

This drug contains lactose. Patients with rare genetic diseases in tolerance Galactose, Lapp Lactase Loss or Glucose - Galactose should not use this drug.

The effect of the drug on driving and operating machinery

Remeron has a slight or medium impact on the ability to drive and operate machinery. Remeron can reduce concentration and alertness (especially in the first stage of treatment). Patients should avoid jobs that are likely to be dangerous due to the need for alertness and good concentration such as motor vehicles or operating machinery at any time affected.

Use drugs for women during pregnancy and lactation

Pregnant women:

Mirtazapine limited data in pregnant women does not show an increased risk of birth defects. Animal studies also do not show the clinical monster effects, but have observed toxicity on development (see the section "Pre -clinical safety data"). Should be cautious when prescribing pregnant women. If using Remeron until birth, or in a short time right before birth, should monitor babies after birth to treat the effects of stopping drugs may occur.

breastfeeding women:

Animal studies and limited data on humans show that mirtazapine is secreted into breast milk in very small amounts. Decide to continue/stop breastfeeding or continue/stop treatment with Remeron, so it is based on the benefit of breastfeeding for the child and the mother's benefits when treated with Remeron.

Drug interaction

Pharmacological interaction:

- Do not use mirtazapine simultaneously with Mao inhibitors or within two weeks of stopping using Mao inhibitors. In contrast, in patients who have been treated with mirtazapine, Mirtazapine should be stopped about two weeks before treatment with Mao inhibitors (see the "Contraindications" section).

In addition, like SSRIs, simultaneous use of active substances on other Serotonergic systems (L -Tryptophan, Triptans, Tramadol, Linezolid, Methylen, SSRI, Venlafaxine, Lithium and St. John’s World - Hypericum Perforatum) products can lead to ratio of related effects related to losers. (Serotonin syndrome: Please see the "Warning and Caution when using the drug").

Mirtazapine may increase the sedative characteristics of benzodiazepine and other sedatives (especially most anti -psychotic drugs, antihistamine H1, opioids). Be cautious when prescribing these drug preparations with mirtazapine. Therefore, these patients should avoid alcohol -containing drinks during Mirtazapine treatment. Because it is not possible to eliminate the more powerful effects when using the higher Mirtazapine dose, it is necessary to monitor the Inr in case of simultaneous use of Warfarin and Mirtazapine. Mirtazapine.

pharmacokinetic interaction:

Carbamazepine and Phenytoin, CYP3A4 induction substances increase Mirtazapine clearance about twice, leading to a decrease in plasma mirtazapine levels average, equivalent to 60% and 45%. When carbamazepine or any other liver metabolic substance (such as rifampicin) is used with mirtazapine therapy, mirtazapine dose may be increased. When stopping these drugs, mirtazapine dose may be reduced. CYP3A4) With Mirtazapine, the average plasma concentration of mirtazapine can increase by over 50%. Should be cautious and may have to reduce the dose when using mirtazapine simultaneously with substances capable of inhibiting CYP3A4, HIV protease inhibitors, antifungal drugs of Azole, erythromycin, Cimetidine or Nefazodone. Amitriptyline, Risperidone or Lithium.

Storage

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

To be out of reach of children, read the instructions carefully before use.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.