Mirzentak Tablet 15mg (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 in children and adolescents under 18 years of age because its efficacy has not been established in two short-term clinical trials and there are safety concerns.

This medication is an antidepressant used to treat symptoms related to depression. This medication may increase the risk of suicidal thoughts or behaviors, especially in young patients aged 18 to 24, so careful assessment by a physician and close monitoring of the patient is required when administered to this age group. During the course of treatment, a serious side effect known as agranulocytosis, which involves a decrease in white blood cell count, may occur rarely. If symptoms of infection appear, such as a sore throat or fever, immediate consultation with a physician is necessary. Patients with poor liver or kidney function, epilepsy, diabetes, or heart disease, as well as those with hypotension, should use this medication with special caution. Drowsiness or dizziness may frequently occur while taking this medication, thus caution is advised when performing hazardous tasks such as driving or operating machinery. It is also recommended to avoid alcohol consumption. This medication may cause increased appetite and weight gain, so it is important to monitor weight changes regularly. This medication may interact with other drugs; therefore, patients should inform their physician of any medications they are currently taking. Women who are pregnant or planning to become pregnant, as well as breastfeeding mothers, should consult with a physician before taking this medication. This medication is generally not prescribed to children or adolescents, as its safety and efficacy have not been established in this population. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, headaches, or nausea; therefore, dosage should be gradually reduced under a physician's guidance when discontinuing treatment. In case of overdose, immediate medical attention should be sought for appropriate treatment, as there is no specific antidote and symptomatic treatment will be necessary. This medication should be kept out of reach of children and should not be transferred to another container.

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

This medication should be stored in a tightly closed container to protect it from air, light, and moisture. It is best to maintain the storage temperature between 2 and 30 degrees Celsius. Proper storage ensures the safe retention of the medication's effectiveness.

Appearance

Pale yellow oval film-coated tablet

Package unit

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