Myungmoon Mirtazapine 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 possible should be administered. Adults: The initial dose of mirtazapine is 15 mg per day, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose is 15～45 mg of this medicine. Since the clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance<40 mL/min), use caution when prescribing. Since the clearance of this medicine may be reduced in patients with hepatic impairment, use caution when prescribing. In particular, this medicine has not been studied in patients with severe hepatic impairment, so use caution when prescribing. Elderly patients: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe effect. When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring other interventional procedures, including hospitalization, or treatment of a more urgent psychiatric condition, consider administration. 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. 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 injection 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. Because the half-life of this medicine is 20∼40 hours, once-daily dosing is sufficient, and it should be taken at a consistent time in the evening before bedtime, if possible. The daily dose of this medicine may also be divided into equal doses taken once in the morning and once in the evening. To allow sufficient time to evaluate the therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1～2 weeks. With an appropriate dose, a therapeutic effect appears within 2～4 weeks; if the effect is inadequate, the dose may be increased up to the maximum dose. If there is no effect 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. 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 package (Figure 1). Each package contains 6 tablets, separated by perforations. Bend the package along the perforations as shown in Figures 2 and 3 to separate the tablets, and detach 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. Remove the tablet with dry hands and place it on the tongue.

Children's dosage

Pediatric patients and adolescents under 18 years of age: Do not use this medicine in pediatric patients or adolescents under 18 years of age because its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Administration to Pediatric Patients and Adolescents under Precautions for Use).

This medication is an antidepressant used to treat psychiatric disorders such as major depression. The risk of suicidal thoughts or behaviors may increase during treatment, particularly in young adults and adolescents aged 18 to 24; thus, the physician should carefully evaluate the benefits and risks of treatment. During administration, it is important to closely monitor the patient for worsening depressive symptoms or abnormal behavioral changes such as suicidal tendencies or aggression, and family members or caregivers should also be vigilant and consult a doctor immediately if any concerning signs occur. This medication can cause agranulocytosis, a rare but serious blood disorder, so if symptoms of infection, sore throat, or fever appear within 4 to 6 weeks after taking this medication, it should be stopped immediately and a blood test should be performed. Patients with poor liver or kidney function, epilepsy, heart disease, or hypotension should take special precautions when using this medication. Drowsiness and dizziness are common side effects, so activities requiring concentration such as driving or operating machinery should be avoided until the patient's condition stabilizes after taking this medication. This drug may cause increased appetite and weight gain, making it important to periodically monitor weight changes. It can interact with other medications, so it is essential to inform the physician of all medications currently being taken, especially that MAO inhibitors should not be used in conjunction with this drug. Women who are pregnant or planning to become pregnant, as well as breastfeeding women, must consult their doctor before taking this medication. Safety and efficacy have not been established for children and adolescents, so it is generally not administered to these populations. In case of overdose, immediate medical attention is required, as there is no antidote for this medication and symptomatic treatment is necessary. This medication should be stored out of reach of children and should not be transferred to other containers.

• 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 sealed container to prevent air or moisture from entering, and it is advised to keep it in a cool place below 30 degrees Celsius. This way of storage can help maintain the drug's effectiveness for a longer period.

Appearance

White round tablet with an orange scent

Package unit

30 tablets (10 tablets/PTP X 3)