Mirzentac 30mg (Mirtazapine)

Adult dosage

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose should be administered whenever possible. 1. Adults The initial dose of mirtazapine is 15mg daily, and the dose should be increased until an appropriate clinical response is achieved. The usual effective daily dose is 15∼45 mg of this medicine. 2. Administration in special populations 1) Patients with renal impairment Clearance of this medicine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); use caution when prescribing. 2) Patients with hepatic impairment Clearance of this medicine may be decreased in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing because patients with severe hepatic impairment have not been studied. 3) Older adults The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe response. 3. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor to treat a psychiatric disorder. 4. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment may be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue, or for 24 hours after the last dose, whichever occurs first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this medicine at a dose of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. Because the half-life of this medicine is 20∼40 hours, once-daily dosing is sufficient, preferably at a consistent time in the evening before bedtime. The daily dose may also be divided into equal doses taken once in the morning and once in the evening. To allow sufficient time to assess the therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1～2 weeks. At an appropriate dose, a therapeutic response occurs within 2～4 weeks. If the response is inadequate, the dose may be increased up to the maximum dose. If there is no response after continuing treatment for an additional 2～4 weeks, discontinue treatment. Treatment should continue for at least 4∼6 months until the patient's symptoms have completely resolved. Thereafter, gradual discontinuation is recommended to avoid withdrawal symptoms. Take this medicine orally with water. Swallow without chewing.

Children's dosage

Children and adolescents under 18 years of age: Do not use this medicine.

This drug should be used cautiously in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, as it may increase the risk of suicidal thoughts or behaviors. During treatment with this medication, agranulocytosis, a serious blood abnormality, may rarely occur, so if symptoms such as fever or sore throat appear, consult a doctor immediately. Patients with impaired liver or kidney function, patients with epilepsy or heart disease, and diabetic patients should exercise additional caution when using this medication. This drug can commonly cause side effects such as drowsiness, dizziness, increased appetite, and weight gain, so care should be taken when performing activities requiring attention, such as driving or operating machinery. In particular, this drug can cause a serious condition known as serotonin syndrome, so caution is advised when used together with other serotonergic medications, and any abnormal symptoms should be reported to medical personnel immediately. Taking this medication with alcohol may enhance central nervous system depressant effects, so alcohol consumption should be avoided. Women who are pregnant or may become pregnant, as well as nursing mothers, should consult a doctor before taking this medication, and it should not be administered to children and adolescents under 18 years of age. Suddenly discontinuing this medication can cause withdrawal symptoms such as dizziness, anxiety, headache, and nausea, so dosage should be gradually reduced according to a doctor's instructions. This medication should not be administered to patients with certain genetic disorders, and it may interact with other drugs, so inform the doctor of all medications being taken. In case of overdose, loss of consciousness or serious side effects may occur, so prescribed dosages must be strictly followed, and emergency assistance should be sought if any abnormal symptoms appear. Store out of reach of children, and be careful not to transfer to other containers.

• Drowsiness
• nausea
• increased appetite
• weight gain
• dizziness
• weakness
• flu-like symptoms
• back pain
• dry mouth
• constipation

This medication should be protected from air, light, and moisture, so it is important to store it in a tightly sealed container. Additionally, it should be kept in a cool place between 2 to 30 degrees Celsius to maintain its effectiveness.

Appearance

Reddish-brown oval film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, for export - 30 tablets/bottle, for export - 100 tablets/bottle, for export - 30 tablets/box [(10 tablets/PTP × 3)]