Medication info
Mirtax 15mg Tablets (Mirtazapine)

Mirtax 15mg Tablets (Mirtazapine)

Prescription medicationTablet
Ingredient · strength
Mirtazapine›15mg / 1 tablet
Manufacturer / importer
Samil Pharm. Co., Ltd.
Appearance
Yellow, rectangular, film-coated tablet with a score line on one side
Packaging
30 tablets (10 tablets/PTP x 3 packs), 120 tablets/bottle,
Approval status
Active

MFDS item code 200804995 · Approved 2008.04.30 · Insurance code 643903950

Summary

Main use
Treatment of major depressive disorder
Who uses it
Adults · Children
Adult dosage
The therapeutic dose of this medication 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, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose of this medication is 15~45 mg. Because clearance of this medication may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min), caution should be exercised when prescribing it. Clearance of this medication may be reduced in patients with hepatic impairment; therefore, caution should be exercised when prescribing it. In particular, it 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. At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication. Conversely, at least 14 days should elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients who require treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to administer linezolid or intravenous methylene blue urgently to a patient already receiving this medication. 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 medication may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this medication 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 medication 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. To allow sufficient time to evaluate the therapeutic response to the dose of this medication, 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 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. Take this medication orally with water. Swallow it whole without chewing.
Children's dosage
Children and adolescents under 18 years of age This medicine should not be used in children and adolescents under 18 years of age because its efficacy has not been demonstrated 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).

Ingredients

Importer
Samil Pharm. Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This medication is used to relieve symptoms related to major depression. Major depression is characterized by symptoms such as low mood, loss of motivation, and decreased concentration, and this medication is taken to improve these symptoms. It helps stabilize the patient's mood and allows for smoother daily functioning.

Dosage and Administration

Adult dosage

The therapeutic dose of this medication 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, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose of this medication is 15~45 mg. Because clearance of this medication may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min), caution should be exercised when prescribing it. Clearance of this medication may be reduced in patients with hepatic impairment; therefore, caution should be exercised when prescribing it. In particular, it 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. At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication. Conversely, at least 14 days should elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients who require treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to administer linezolid or intravenous methylene blue urgently to a patient already receiving this medication. 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 medication may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this medication 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 medication 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. To allow sufficient time to evaluate the therapeutic response to the dose of this medication, 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 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. Take this medication orally with water. Swallow it whole without chewing.

Children's dosage

Children and adolescents under 18 years of age This medicine should not be used in children and adolescents under 18 years of age because its efficacy has not been demonstrated 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).

Precautions

This medication is used to treat depression and mental disorders, and careful use is required, particularly in children, adolescents, and young adults, as the risk of suicidal thoughts or behaviors may increase. During treatment with this medication, if any symptoms of fever, sore throat, or infection occur, you should consult a doctor immediately, as this could indicate agranulocytosis, a serious and rare blood disorder. There is a need for special caution in patients with impaired liver or kidney function, patients with heart disease, and those with diabetes when taking this medication. Common side effects include drowsiness, dizziness, increased appetite, and weight gain; therefore, caution is advised when driving or operating hazardous machinery. This medication can interact with other drugs, so you must inform your doctor if you are taking or plan to take any other medications. Women who are pregnant or breastfeeding should consult a healthcare professional before taking this medication, and it is generally not used in children and adolescents. In the event of an overdose, serious side effects may occur, so the medication should be taken strictly according to the prescribed dosage and method, and it should be stored out of the reach of children. If symptoms of worsening depression, suicidal thoughts, or abnormal behavioral changes occur while taking this medication, appropriate measures should be sought by informing a healthcare professional immediately. Additionally, taking this medication with alcohol can intensify drowsiness and cognitive impairment, so it is advisable to avoid alcohol consumption. During treatment, symptoms such as anxiety, restlessness, aggression, and insomnia may occur; therefore, close monitoring is necessary, and family members or caregivers should keep a close watch on the patient.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • asthenia
  • flu-like syndrome
  • low back pain
  • dry mouth
  • constipation
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  • peripheral edema
  • myalgia
  • abnormal dreams
  • abnormal behavior
  • trembling
  • confusion
  • shortness of breath
  • frequent urination
  • fatigue
  • abdominal pain
  • acute abdomen 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 premature contractions
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • ectopic beats
  • 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 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
  • increased acid phosphatase
  • elevated ALT
  • diabetes
  • hyponatremia
  • myasthenia
  • arthralgia
  • arthritis
  • tendinitis
  • pathological fractures
  • osteoporotic fractures
  • bone pain
  • myositis
  • tendon rupture
  • arthrosis
  • bursitis
  • sensory impairment
  • apathy
  • depression
  • decreased motor function
  • dizziness
  • single contraction
  • agitation
  • anxiety
  • amnesia
  • hyperkinesia
  • sensory abnormalities
  • ataxia
  • delirium
  • delirium
  • ego loss
  • dyskinesia
  • extrapyramidal syndrome
  • increased libido
  • coordination abnormalities
  • stuttering
  • hallucinations
  • manic reactions
  • neurosis
  • muscle tone abnormalities
  • hostility
  • hyperreflexia
  • emotional instability
  • relief
  • paranoid reactions
  • aphasia
  • nystagmus
  • inability to sit still
  • confusion
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • grand mal seizures
  • decreased muscle tone
  • collagen-related muscle spasms
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased cough
  • sinusitis
  • epistaxis
  • bronchitis
  • asthma
  • pneumonia
  • asphyxiation
  • laryngitis
  • pneumothorax
  • hiccups
  • itching
  • rash
  • acne
  • exfoliative dermatitis
  • dry skin
  • herpes simplex
  • hair loss
  • urticaria
  • shingles
  • skin hypertrophy
  • seborrhea
  • skin ulcers
  • ocular pain
  • abnormal eye accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • overflow disorder
  • glaucoma
  • auditory hypersensitivity
  • ear pain
  • blepharitis
  • temporary partial deafness
  • otitis media
  • taste loss
  • olfactory abnormalities
  • urinary tract infection
  • kidney stones
  • cystitis
  • dysuria
  • urinary incontinence
  • urinary retention
  • vaginitis
  • hematuria
  • mastalgia
  • amenorrhea
  • dysmenorrhea
  • white vaginal discharge
  • erectile dysfunction
  • polyuria
  • urethritis
  • uterine bleeding
  • menorrhagia
  • abnormal ejaculation
  • breast engorgement
  • breast enlargement
  • urgency
  • forgetfulness
  • facial tremor
  • fatigue
  • tinnitus
  • skin mucous membrane syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • increased creatine kinase in the blood
  • rhabdomyolysis
  • oral sensory impairment
  • lip edema
  • bone marrow depression
  • granulocytopenia
  • agranulocytosis
  • aplastic anemia
  • eosinophilia
  • restless legs syndrome
  • oral sensory disturbances
  • aggression
  • excessive sedation

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

Storage

This medication should be stored in a tightly sealed container to protect it from air, light, and moisture. It is recommended to maintain the storage temperature between 2 to 30 degrees Celsius at room temperature to preserve the drug's efficacy and safety over time.

Appearance and packaging

Appearance

Yellow, rectangular, film-coated tablet with a score line on one side

Package unit

30 tablets (10 tablets/PTP x 3 packs), 120 tablets/bottle,

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.