Mirzentak ODT 15 mg (Mirtazapine)

Adult dosage

The therapeutic dose of this medicine should be adjusted according to the patient’s clinical condition, and the lowest effective dose possible should be administered. Adults: The initial dose of mirtazapine is 15 mg once daily. The dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose is 15～45 mg. Patients with renal impairment: Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance <40 mL/min); therefore, use caution when prescribing. Patients with hepatic impairment: Clearance of this medicine may be reduced in patients with hepatic impairment; therefore, use caution when prescribing. In particular, this medicine has not been studied in patients with severe hepatic impairment, so use caution when prescribing. 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. Switching from MAO inhibitors used to treat psychiatric disorders: If treatment with an MAO inhibitor for a psychiatric disorder is discontinued and treatment with this medicine is started, an interval of at least 14 days must be allowed. Conversely, if treatment with an MAO inhibitor for a psychiatric disorder is to be started, at least 14 days must have elapsed since discontinuation of this medicine. Other MAO inhibitors, such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization and other interventional procedures, consider administering treatment. If linezolid or intravenous methylene blue must be urgently administered to a patient already receiving this medicine, and no alternative to linezolid or intravenous methylene blue is available, and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. The half-life of this medicine is 20∼40 hours, so once-daily dosing is sufficient. If possible, take it 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. Do not change the dose at intervals of less than 1～2 weeks, to allow sufficient time to assess the therapeutic response to the dose. With an appropriate dose, a therapeutic effect appears within 2～4 weeks. If the effect is insufficient, the dose may be increased up to the maximum dose. If there is no effect after continuing treatment for a further 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. Remove this medicine and place it on the tongue. It dissolves rapidly on the tongue and can be swallowed without water. To prevent this medicine from breaking, do not press the tablets through the packaging (Figure 1). Each package contains 10 tablets, separated by perforations. As shown in Figures 2 and 3, bend the package along the perforations to separate and remove one tablet. As shown in Figures 4 and 5, hold the marked area on the back and carefully peel off the backing in the direction of the arrow. With dry hands, remove the tablet and place it on the tongue.

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 was not established in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Children and Adolescents under Precautions for Use).

This medication is an antidepressant used to treat depression, and there is an increased risk of suicidal thoughts or actions, particularly in younger populations. Therefore, the physician must carefully weigh the benefits and risks of treatment. While taking this drug, behavioral changes such as suicidal tendencies, aggressiveness, and anxiety should be closely monitored, and family members or caregivers should also closely observe the patient's condition. Rarely, agranulocytosis may occur, resulting in a rapid decrease in white blood cell count. If symptoms like sore throat, fever, or signs of infection arise, consult a doctor immediately. Patients with impaired liver or kidney functions may have increased levels of this medication, so special caution is needed when prescribed. This drug may cause drowsiness and dizziness, so caution is needed when performing tasks requiring alertness, such as driving or operating machinery. Weight gain and increased appetite can occur frequently, so it's advisable to check weight periodically. Drug interactions may occur when taken with other medications, so inform your doctor or pharmacist of any medications being taken. Especially, it should not be taken in conjunction with MAO inhibitors, as this may lead to life-threatening serotonin syndrome. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it should only be used during pregnancy when absolutely necessary. It is recommended not to use this drug in children and adolescents as safety and efficacy have not been established. In case of overdose, serious side effects may occur, so the prescribed dosage must be strictly adhered to, and if overdose is suspected, seek medical attention immediately. When storing, keep the medication out of reach of children, and do not transfer it to another container. It is advisable to avoid alcohol consumption during treatment, and do not stop taking the medication abruptly; taper off according to your doctor's instructions. If symptoms such as anxiety, agitation, insomnia, or aggression arise during treatment, consult a doctor immediately. This medication should be administered with caution to patients with heart diseases or those at risk of QT interval prolongation, and regular cardiac monitoring may be necessary.

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

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is best stored in a cool place below 30 degrees Celsius. This will help maintain the drug's effectiveness and prevent deterioration.

Appearance

White, round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP x 3)