Remeron 30mg MSD medicine for severe depression (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Mirtazapine

Ingredient

Composition information	Content
Mirtazapine	30mg

Uses

indications

30 mg remeron drugs are indicated for treatment of severe depression.

Pharmacokology

Mirtazapine is an α2 antagonist α2 antagonist with central effects, increasing Noradrenergic and Serotonergic neurotransmitter. 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.

pharmacokinetic

absorption

After drinking, 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's 8-hydroxy metabolites, while CYP3A4 is said 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.

Elimination

Mirtazapine is metabolized widely and eliminated through urine and feces for a few days.

Average disposal time 20 - 40 hours; Sometimes it has recorded longer waste time, up to 65 hours, and in young men, they also observed shorter selling time.

Sales time is sufficient to take medicine once a day.

Stable concentration is achieved after 3-4 days, then no more accumulation.

Before taking Remeron 30mg MSD medicine for severe depression (1 blister x 10 tablets)

How to use

Mirtazapine's waste sale 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 take oral tablets, with water and swallow without chewing. Depression patients should be treated for at least 6 months to ensure no symptoms.

Should stop treating mirtazapine slowly to avoid cessation syndrome.

Patients use the appropriate dosage form with the specified dose.

Dosage

Adults

Effective daily dose is usually about 15 - 45 mg.

The starting dose is 15 - 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 for the next 2-4 weeks, it is advisable to stop treatment.

Elderly

recommended doses like adults. In elderly patients, closely monitor 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 due to the effectiveness of the drug has not been proven in two short -term clinical studies and due to the safety of the drug's safety.

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 when prescribing Remeron for this group of patients, especially severe liver failure due to no research on this patient group.

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? There have been reports on the inhibition of the central nervous system with prolonged orientation and sedation, along with tachycardia and mild hypertension.

However, more serious consequences (including death) may occur when taking much higher doses, especially overdose of many drugs at the same time. In these cases, there are also reports on prolonged QT intervals 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 you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Remeron drug, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Metabolism and nutrition: weight gain, appetite increase. fertilizer.

Mental system: nightmares, revival, restlessness, mental disorders (restless sitting, increased movement). ADR

Mental system: aggressive.

blood and lymphatic system: bone marrow failure (granulocytosis, granulocytosis, platelet anemia), eosinophilia. Du. pattern.

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

Remeron drugs contraindicated in the following cases:

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

Concomitant use of mirtazapine with enzyme inhibitors monoamine oxidase (monoamine oxidase-mao).

Caution when using

used in children and teenagers under 18 years old

Do not use remeron to treat children and teenagers under 18 years old. In clinical trials, acts related to suicide (suicide intentions and suicide thoughts) and hostility (mainly causing aggression, opposition and anger) in children and teenagers are treated with antidepressants are more frequent than the placebo group.

Despite this, based on clinical needs, if the decision to treat patients, it is careful to monitor the appearance of suicide symptoms.

In addition, there is currently no 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 show 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 treatment.

A meta-analysis) Clinical trials for control of antidepressant drugs in adult patients with mental disorders show the risk of suicide behavior in the group using antidepressants increased compared to placebo patients at the age of 25.

should closely monitor patients, especially patients at high risk when treating with antidepressants, especially in the early stages of treatment and the stage after the dose changes.

warns patients and patients to take care of patients about the need to monitor any clinical symptoms become serious, suicidal thoughts or behaviors and abnormal changes in behavior and should consult a doctor as soon as those symptoms appear.

Đối với nguy cơ tự tử, đặc biệt là khi bắt đầu điều trị, chỉ đưa cho bệnh nhân một lượng nhỏ nhất viên nén bao phim Remeron kết hợp với quản lý tốt bệnh nhân, để giảm nguy cơ quá liều.

Bone marrow failure

There has been a report on bone marrow failure when treated with remeron, which is usually a grain leukemia or granulocyte loss.

Recovery grain leukemia has been reported with very rare frequency in clinical studies with Remeron.

In the periodic reporting after circulation of remeron drugs, granulocytic loss is also very rare, mostly can recover, but some cases lead to death.

Cases of death is largely related to patients over 65 years old.

Doctors need to be alert with symptoms such as fever, sore throat, stomatitis or other signs of infection; When these symptoms appear, it is advisable to stop treating and testing for blood counts.

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 seizures rarely occur 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 increase the frequency of epilepsy.

Hepatic failure: After taking a dose of mirtazapine 15 mg, Mirtazapine clearance decreases about 35% in patients with mild to moderate liver failure, compared to patients with normal liver function. The average plasma concentration of Mirtazapine increased by about 55%.

Renal failure: After taking a dose of mirtazapine 15 mg, on patients with medium renal impairment (10 ml/minute 5 degrees of creatinine clearance The average plasma mirtazapine concentration increased by 55% and 115%.

There is no significant difference found in patients with mild renal failure (40 ml/min ≤ Creatinine clearance

Heart disease such as transmission disorders, angina and myocardial infarction occur, which are often cautious when used and when used with other drugs.

Hypotension.

Diabetes: In patients with diabetes, antidepressants can change blood sugar control. The dose of insulin and/or oral hypoglycemic drugs should be adjusted and strictly controlled

Like other antidepressants, it is necessary to pay attention to

Psychotic symptoms may be worse when taking antidepressants for schizophrenia or other mental disorders; Paranoid disease can be more serious.

When treating depression of bipolar disorder, depression can be transformed into a manual phase. It is necessary to closely monitor patients with a history of mild mania/mild mania. Mirtazapine should be stopped in any patient who starts to appear.

Although remeron is not addictive, the post -circulation experience shows that stopping treatment suddenly after a long time of taking the drug can sometimes cause symptoms of quitting. 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. Treatment should be stopped by reducing the dose of mirtazapine slowly as recommended in the "Usage, dosage" section. Precautions should be careful with patients with urination disorders such as prostate hypertrophy and patients with glaucoma narrowed angle and increased intraocular pressure (although the lesions rarely occur due to the weak anti -cholinergic activity).

Sitting, restless/mental disorders: The use of antidepressants associated with the development of sitting, restless, characterized by an 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. 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 in an overdose or in patients with other risk factors in terms of prolonged QT, including simultaneous use with drugs that extend QTC. Be careful when prescribing Remeron for patients who have known to have cardiovascular disease or family history with prolonged QT and simultaneous use with drugs that are thought to extend QTC.

Hematrum hypoclines

There have been reports of hypoglycet hypoclines when using mirtazapine with very rare frequency. Be cautious in patients at risk, such as elderly patients or patients treated simultaneously with drugs known to cause hypoglycatrological reduction.

Serotonin syndrome

Interaction with serotonergic activity: Serotonin syndrome may occur when using simultaneously selective Serotonin reabsorption inhibitors (Selective Serotonin Reeptake Inhitors-Ssris) with other serotonergic activity. 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 only treated with Remeron.

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 are galactose intolerance, lactase lactase deficiency or glucose-galactose should not take this drug.

The ability to drive and operate 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 driving or operating machinery at any time affected.

Pregnancy

Restricted data on the use of mirtazapine in pregnant women does not show increased risk of birth defects. Animal studies also do not show the clinical -related teratogenic effects, but have observed toxicity on development.

Should be cautious when prescribing for 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 period

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 simultaneously use mirtazapine 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.

In addition, like SSRIs, simultaneous use with other active substances on other Serotonergic systems (L -TRYPTOPHAN, TRIPTANS, TRAMADOL, LINEZOLID, METYLEN, SSRI, VENLAFAXINE, Lithium and St. John's Worldum Perforatum) products can lead to related effects on Serotonin (Serotonin -related effects. Serotonin).

Mirtazapine can increase the sedative characteristics of benzodiazepine and other sedatives (especially most anti -psychotic drugs, H1 antagonists, opioids). Be cautious when prescribing these medicinal preparations with mirtazapine.

Mirtazapine may increase the central nervous inhibition effect of alcohol. Therefore, these patients should avoid alcohol -containing drinks during mirtazapine treatment.

Dosage Mirtazapine 30 mg/day/day increases slightly but significant Inr statistical significance (International Normalized Ratio) in patients who are being treated with Warfarin. Because it is not possible to eliminate the more powerful effects when using the higher Mirtazapine dose, the Inr should be monitored in case of simultaneous use of Warfarin and Mirtazapine.

The risk of prolonged QT and/or ventricular arrhythmias (for example, torsion) may increase when used simultaneously with drugs that extend the QTC range (for example, some anti -psychotic and antibiotic drugs) and in the case of Mirtazapine overdose.

Pharmacokinetic interaction

Carbamazepine and Phenytoin, CYP3A4 induction substances increase Mirtazapine clearance about twice, resulting in reduced plasma mirtazapine concentrations 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.

Concentrated with ketoconazole, the substance capable of inhibiting CYP3A4, will increase the peak concentration in plasma and the area under the AUC curve of Mirtazapine, respectively about 40% and 50%.

When used with cimetidine (weak inhibitor CYP1A2, CYP2D6 and 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.

Interactive studies do not see any dynamic effects related to simultaneous treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium.

Storage

Remeron should be stored below 30 ° C. Store in the original packaging to avoid light and wet.

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.