Mirtazapine 7.5 mg Tablets

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. The initial dose of mirtazapine is 15 mg per day, and the dose should be increased until an appropriate clinical effect is achieved. The effective daily dose is usually 15～45 mg of this medicine. Because the clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance<40 mL/min), caution should be exercised when prescribing it. Because the clearance of this medicine may be reduced in patients with hepatic impairment, caution should be exercised when prescribing it. In particular, this medicine has not been studied in patients with severe hepatic impairment, so caution should be exercised when prescribing it. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is necessary to achieve a satisfactory and safe effect. When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. Treatment should be considered for patients who require other interventions, including hospitalization, or treatment for a more urgent psychiatric condition. 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 discontinued 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 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 a non-intravenous route (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. Because the half-life of this medicine is 20∼40 hours, once-daily administration is sufficient; if possible, take it at a consistent time in the evening before going to bed. This medicine may also be taken in two equal doses, once in the morning and once in the evening. To allow sufficient time to evaluate the treatment response to the dose of this medicine, the dose should not be changed at intervals of less than 1～2 weeks. At an appropriate dose, a therapeutic effect appears within 2～4 weeks. If the therapeutic 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 disappeared. Thereafter, gradual discontinuation of treatment 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 in the package (Figure 1). Each package contains 10 tablets, separated by perforations. As shown in Figures 2 and 3, bend the package along the perforation to separate each tablet, and remove one tablet. As shown in Figures 4 and 5, hold the marked area on the back and carefully peel off the backing of the tablet 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: The efficacy of this drug has not been established in two short-term clinical trials, and due to safety concerns, it should not be used in children or adolescents under 18 years of age (see sections 4. Adverse Reactions and 8. Use in Children and Adolescents under Precautions for Use).

This drug may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, so a doctor should carefully assess the benefits and risks of treatment. While taking this medication, a serious side effect known as agranulocytosis, which is a decrease in white blood cells, may rarely occur. If symptoms such as sore throat, fever, or signs of infection appear, seek medical advice immediately. There is insufficient experience with concurrent electroconvulsive therapy, so caution is needed, and if jaundice occurs, this medication should be discontinued. The artificial sweetener aspartame contained in this medication may be harmful to patients with a genetic disorder called phenylketonuria and should not be administered. It is contraindicated in patients with hypersensitivity to this drug, those taking MAO inhibitors, and certain sugar-intolerant patients. Patients with impaired liver or kidney function, epilepsy, diabetes, heart disease, or hypotension should exercise caution when using this medication. Common side effects such as drowsiness, dizziness, increased appetite, and weight gain may occur, so caution is advised when driving or operating hazardous machinery. This medication may interact with other drugs, so it is essential to inform your doctor if you are taking any other medications, particularly that MAO inhibitors should not be combined with this drug. Pregnant or breastfeeding women should consult a doctor before taking this medication, and it is generally not administered to children and adolescents. Serious side effects may occur in cases of overdose, so it is crucial to adhere to the prescribed dosage and store it out of the reach of children.

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

This medication should be stored in a tightly sealed container to prevent air and moisture from entering and is best kept in a cool place below 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a longer time.

Appearance

White round orally disintegrating tablet

Package unit

100 tablets (10 tablets/PTP ×10)