Medication info
Mirtax 15 mg (Mirtazapine)

Mirtax 15 mg (Mirtazapine)

Prescription medicationOrally disintegrating Tablet
Ingredient · strength
Mirtazapine›15mg / 1 tablet
Manufacturer / importer
Samil Pharm. Co., Ltd.
Appearance
Flat white round orally disintegrating tablet with a characteristic smell on both sides.
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 200901546 · Approved 2009.02.27 · Insurance code 643903960

Summary

Main use
Treatment of major depressive disorder
Who uses it
Adults · Children
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 effective daily dose is usually 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), caution should be exercised when prescribing it. Since the clearance of this medicine may be reduced in patients with hepatic impairment, caution should be exercised when prescribing it. In particular, caution should be exercised because it has not been studied in patients with severe hepatic impairment. Elderly patients: The recommended dose is the same as that for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe response. Children and adolescents under 18 years of age: This medicine should not be used in children or adolescents under 18 years of age, as its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns. When discontinuing MAO inhibitors for the treatment of psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting MAO inhibitor treatment for a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. Treatment with this medicine should not be started in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients who require treatment of a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this medicine. 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 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 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. Since the half-life of this medicine 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 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, the dose should not be changed at intervals of less than 1~2 weeks. With treatment at an appropriate dose, a therapeutic effect appears within 2~4 weeks; if the therapeutic effect is insufficient, the dose may be increased 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 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.
Children's dosage
Children and adolescents under 18 years of age: The efficacy of this drug was not demonstrated in two short-term clinical trials, and due to safety concerns, it should not be used in children and adolescents under 18 years of age.

Ingredients

Importer
Samil Pharm. Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depressive disorder
View approved original text

This medication is used for the treatment of major depressive disorder. Major depressive disorder is a condition characterized by a persistently low mood that interferes with daily life, and this medication helps improve symptoms and support recovery to a normal life.

Dosage and Administration

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 effective daily dose is usually 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), caution should be exercised when prescribing it. Since the clearance of this medicine may be reduced in patients with hepatic impairment, caution should be exercised when prescribing it. In particular, caution should be exercised because it has not been studied in patients with severe hepatic impairment. Elderly patients: The recommended dose is the same as that for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe response. Children and adolescents under 18 years of age: This medicine should not be used in children or adolescents under 18 years of age, as its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns. When discontinuing MAO inhibitors for the treatment of psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting MAO inhibitor treatment for a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. Treatment with this medicine should not be started in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients who require treatment of a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this medicine. 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 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 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. Since the half-life of this medicine 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 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, the dose should not be changed at intervals of less than 1~2 weeks. With treatment at an appropriate dose, a therapeutic effect appears within 2~4 weeks; if the therapeutic effect is insufficient, the dose may be increased 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 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.

Children's dosage

Children and adolescents under 18 years of age: The efficacy of this drug was not demonstrated in two short-term clinical trials, and due to safety concerns, it should not be used in children and adolescents under 18 years of age.

Precautions

This medication is an antidepressant used to treat major depressive disorder and psychiatric conditions. During treatment with this medication, the risk of suicidal thoughts or behaviors may increase, particularly in children, adolescents, and young adults, so symptoms should be closely monitored during the initial period of treatment. Additionally, this medication can rarely cause a serious blood condition called agranulocytosis, so if fever or signs of infection occur, consult a physician immediately. Patients with compromised liver or kidney function, cardiovascular disease, diabetes, and others should exercise special caution when using this medication. Common side effects include drowsiness, dizziness, increased appetite, and weight gain, so caution is advised for activities requiring alertness such as driving or operating machinery. This medication may interact with other drugs, so inform your physician if you are taking other medications. Women who are pregnant or breastfeeding should consult healthcare professionals before taking this medication, and its use in children and adolescents under 18 is not recommended. In case of overdose, seek medical attention immediately for appropriate treatment, and store this medication out of reach of children. Finally, taking this medication with alcohol can increase central nervous system depressant effects, so it is advisable to avoid alcohol when taking this medication.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • weakness
  • flu-like syndrome
  • low back pain
  • dry mouth
  • constipation
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  • peripheral edema
  • myalgia
  • abnormal dreams
  • abnormal behavior
  • tremors
  • confusion
  • respiratory distress
  • frequent urination
  • fatigue
  • abdominal pain
  • acute abdomen syndrome
  • chills
  • fever
  • facial swelling
  • ulcers
  • photosensitivity reaction
  • neck stiffness
  • neck pain
  • abdominal distention
  • soft tissue infection
  • chest pain under the sternum
  • hypertension
  • vasodilation
  • angina pectoris
  • myocardial infarction
  • bradycardia
  • ectopic beats
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • bigeminy
  • 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 test
  • tongue discoloration
  • ulcerative stomatitis
  • salivary gland enlargement
  • excessive salivation
  • intestinal obstruction
  • pancreatitis
  • aphthous stomatitis
  • liver cirrhosis
  • gastritis
  • gastroenteritis
  • oral candidiasis
  • tongue swelling
  • goiter
  • hypothyroidism
  • lymphadenopathy
  • leukopenia
  • petechiae
  • anemia
  • thrombocytopenia
  • lymphocytosis
  • pancytopenia
  • thirst
  • dehydration
  • weight loss
  • gout
  • elevated AST
  • abnormal healing
  • elevated acid phosphatase
  • elevated ALT
  • diabetes
  • hyponatremia
  • myasthenia gravis
  • joint pain
  • arthritis
  • tendinitis
  • pathological fracture
  • osteoporotic fracture
  • bone pain
  • myositis
  • tendon rupture
  • arthrosis
  • bursitis
  • sensory loss
  • apathy
  • depression
  • reduced motor function
  • dizziness
  • single contraction
  • agitation
  • anxiety
  • amnesia
  • hyperactivity
  • sensory abnormalities
  • ataxia
  • delirium
  • delirium
  • ego loss
  • motor disorders
  • extrapyramidal syndrome
  • increased libido
  • abnormal coordination
  • stuttering
  • hallucinations
  • manic reactions
  • neurosis
  • muscle tension disorder
  • hostility
  • hyperreflexia
  • emotional instability
  • reassurance
  • paranoid reaction
  • aphasia
  • nystagmus
  • inability to sit still
  • confusion
  • dementia
  • diplopia
  • drug dependency
  • paralysis
  • grand mal seizure
  • muscle hypotonia
  • hepatic myoclonus
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased cough
  • sinusitis
  • nosebleed
  • bronchitis
  • asthma
  • pneumonia
  • asphyxia
  • laryngitis
  • pneumothorax
  • hiccups
  • itching
  • rash
  • acne
  • exfoliative dermatitis
  • dry skin
  • herpes simplex
  • hair loss
  • urticaria
  • shingles
  • skin hypertrophy
  • seborrhea
  • skin ulcer
  • ocular pain
  • abnormal eye accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • incontinence
  • glaucoma
  • auditory hyperreactivity
  • ear pain
  • eyelid inflammation
  • transient hearing loss
  • otitis media
  • loss of taste
  • abnormal smell
  • urinary tract infection
  • kidney stones
  • cystitis
  • dysuria
  • incontinence
  • urinary retention
  • vaginitis
  • hematuria
  • breast pain
  • amenorrhea
  • menstrual pain
  • leukorrhea
  • erectile dysfunction
  • polyuria
  • urethritis
  • uterine bleeding
  • menorrhagia
  • abnormal ejaculation
  • breast engorgement
  • breast enlargement
  • urgent urination
  • forgetfulness
  • facial tremors
  • fatigue
  • tinnitus
  • skin mucosal syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory loss
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs syndrome
  • oral sensory abnormalities
  • aggression
  • excessive sedation
  • memory impairment
  • tachycardia
  • loss of direction sense

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 exposure to air or moisture. Additionally, it is important to store it in a cool place at or below 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Flat white round orally disintegrating tablet with a characteristic smell on both sides.

Package unit

30 tablets (10 tablets/PTP x 3)

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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.