Medication info
Mirtazapine Tablet 15 mg (Mirtazapine)

Mirtazapine Tablet 15 mg (Mirtazapine)

Prescription medicationOrally disintegrating Tablet
Ingredient · strength
Mirtazapine›15mg / 1 tablet
Manufacturer / importer
Myungin Pharmaceuticals Co., Ltd.
Appearance
White, round orally dissolving tablet
Packaging
100 tablets (10 tablets/PTP x 10)
Approval status
Active

MFDS item code 201405634 · Approved 2014.11.28 · Insurance code 651904110

Summary

Main use
Treatment of major depressive disorder
Who uses it
Adults · Children
Adult dosage
The therapeutic dose of this drug 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 once daily, and the dose may need to be increased until an appropriate clinical effect is achieved. The usual effective daily dose of this drug is 15~45 mg. Because the clearance of this drug 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 drug may be reduced in patients with hepatic impairment, caution should be exercised when prescribing it. In particular, as it has not been studied in patients with severe hepatic impairment, caution should be exercised when prescribing it. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is needed to ensure a satisfactory and safe effect. At least 14 days should elapse between discontinuation of an MAO inhibitor for the treatment of psychiatric disorders and initiation of treatment with this drug. Conversely, at least 14 days should elapse after discontinuing this drug before starting an MAO inhibitor for the treatment of psychiatric disorders. Treatment with this drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment with this drug should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue 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 drug may be discontinued immediately and linezolid or intravenous methylene blue may be 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 drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection), or with intravenous administration of this drug 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 drug is 20∼40 hours, once-daily dosing is sufficient; if possible, take it at a consistent time in the evening before bedtime. The daily dose of this drug 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 drug, do not change the dose 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 inadequate, 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 of treatment is recommended to avoid withdrawal symptoms. Remove this drug and place it on the tongue. It dissolves rapidly on the tongue and can be swallowed without water. To prevent this drug from breaking, do not press the tablet through 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 the tablets, 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
Do not use this drug in children or adolescents under 18 years of age.

Ingredients

Manufacturer
Myungin Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This medication is used to alleviate symptoms of mood disorders such as major depression.

Dosage and Administration

Adult dosage

The therapeutic dose of this drug 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 once daily, and the dose may need to be increased until an appropriate clinical effect is achieved. The usual effective daily dose of this drug is 15~45 mg. Because the clearance of this drug 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 drug may be reduced in patients with hepatic impairment, caution should be exercised when prescribing it. In particular, as it has not been studied in patients with severe hepatic impairment, caution should be exercised when prescribing it. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is needed to ensure a satisfactory and safe effect. At least 14 days should elapse between discontinuation of an MAO inhibitor for the treatment of psychiatric disorders and initiation of treatment with this drug. Conversely, at least 14 days should elapse after discontinuing this drug before starting an MAO inhibitor for the treatment of psychiatric disorders. Treatment with this drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment with this drug should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue 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 drug may be discontinued immediately and linezolid or intravenous methylene blue may be 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 drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection), or with intravenous administration of this drug 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 drug is 20∼40 hours, once-daily dosing is sufficient; if possible, take it at a consistent time in the evening before bedtime. The daily dose of this drug 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 drug, do not change the dose 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 inadequate, 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 of treatment is recommended to avoid withdrawal symptoms. Remove this drug and place it on the tongue. It dissolves rapidly on the tongue and can be swallowed without water. To prevent this drug from breaking, do not press the tablet through 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 the tablets, 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

Do not use this drug in children or adolescents under 18 years of age.

Precautions

This medication is an antidepressant used to treat major depression. It may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults, so it should be administered with caution, especially to patients aged 18 to 24. Patients of all ages should be closely monitored for worsening depression symptoms, suicidal tendencies, aggression, anger, and other abnormal behavior changes, and family members or caregivers should also keep a close watch on the patient. This medication is not approved for use in children and adolescents, so it is generally avoided. This medication can rarely cause a serious blood disorder called agranulocytosis, so if you experience a sore throat, fever, or symptoms of infection while taking this medication, consult a doctor immediately. Special caution is needed for patients with poor liver or kidney function, epilepsy, heart disease, diabetes, and low blood pressure. Common side effects include drowsiness, dizziness, increased appetite, and weight gain, so caution is required when driving or operating machinery. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as use during pregnancy, especially in late stages, can affect the newborn. This medication may interact with other drugs, so be sure to inform your doctor about any medications you are currently taking, especially that MAO inhibitors should not be taken together with it. Severe side effects may occur in case of overdose, so this medication must be taken exactly as prescribed, and if in doubt, consult medical personnel immediately. This medication should be kept out of reach of children and should not be transferred to another container for safety.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • fatigue
  • influenza-like syndrome
  • low back pain
  • dry mouth
  • constipation
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  • peripheral edema
  • edema
  • myalgia
  • abnormal dreams
  • unusual thoughts
  • tremors
  • confusion
  • shortness of breath
  • increased urination
  • lethargy
  • abdominal pain
  • acute abdominal syndrome
  • chills
  • fever
  • facial edema
  • ulcer
  • photosensitivity reaction
  • neck stiffness
  • neck pain
  • abdominal distension
  • soft tissue inflammation
  • chest pain below the sternum
  • hypertension
  • vasodilation
  • angina
  • myocardial infarction
  • bradycardia
  • ventricular extrasystole
  • syncope
  • migraine
  • hypotension
  • atrial dysrhythmia
  • ectopic heartbeat
  • vascular headache
  • pulmonary embolism
  • cerebral ischemia
  • cardiomegaly
  • phlebitis
  • left heart failure
  • vomiting
  • loss of appetite
  • belching
  • glossitis
  • cholecystitis
  • gum bleeding
  • stomatitis
  • colitis
  • abnormal liver function tests
  • tongue discoloration
  • ulcerative stomatitis
  • salivary gland hypertrophy
  • excessive saliva secretion
  • intestinal obstruction
  • pancreatitis
  • aphthous stomatitis
  • liver cirrhosis
  • gastritis
  • gastroenteritis
  • oral candidiasis
  • tongue edema
  • goiter
  • hypothyroidism
  • lymphadenopathy
  • leukopenia
  • petechiae
  • anemia
  • thrombocytopenia
  • lymphocytosis
  • pancytopenia
  • thirst
  • dehydration
  • weight loss
  • gout
  • elevated AST
  • abnormal healing
  • increased acid phosphatase
  • elevated ALT
  • diabetes
  • hyponatremia
  • myasthenia
  • arthralgia
  • arthritis
  • tendinitis
  • pathological fractures
  • osteoporotic fractures
  • bone pain
  • myositis
  • tendon rupture
  • osteoarthritis
  • bursitis
  • sensory loss
  • apathy
  • depression
  • decreased motor function
  • dizziness
  • single contraction
  • agitation
  • anxiety
  • amnesia
  • hyperactivity
  • paresthesia
  • ataxia
  • delirium
  • delusion
  • loss of self-esteem
  • movement disorders
  • extrapyramidal syndrome
  • increased libido
  • impaired coordination
  • stuttering
  • hallucinations
  • manic reactions
  • neurosis
  • muscle tone abnormalities
  • hostility
  • increased reflexes
  • emotional instability
  • relief
  • paranoid reactions
  • aphasia
  • nystagmus
  • akathisia
  • confusion
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • grand mal seizure
  • muscle hypotonia
  • toxic epidermal necrolysis
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory loss
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs syndrome
  • oral sensory disturbance
  • aggression
  • suicidal tendencies
  • suicidal impulses
  • suicidal behavior
  • hostility
  • aggression
  • anger
  • insomnia
  • agitation
  • panic disorder
  • excitement
  • impulsivity
  • akathisia
  • mania
  • hypomania
  • withdrawal symptoms
  • disorientation
  • memory impairment
  • tachycardia
  • coma
  • seizures
  • QT prolongation
  • tosylate deponte arrhythmia
  • ventricular tachycardia
  • sudden death

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is recommended to keep it in a cool place below 30 degrees. Storing it this way helps maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

White, round orally dissolving tablet

Package unit

100 tablets (10 tablets/PTP x 10)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.