Medication info
Mirtazapine Tablet 30 mg

Mirtazapine Tablet 30 mg

Prescription medicationOrally disintegrating Tablet
Ingredient · strength
Mirtazapine›30mg / 1 tablet
Manufacturer / importer
Myungin Pharmaceutical Co., Ltd.
Appearance
White, round orodispersible tablet
Packaging
100 tablets (10 tablets/PTP x 10)
Approval status
Active

MFDS item code 201405633 · Approved 2014.11.28 · Insurance code 651904120

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 should be administered whenever possible. Adults: The initial dose of mirtazapine is 15 mg per day, and the dose may need to be increased until an appropriate clinical effect is achieved. The effective daily dose is usually 15~45 mg of this drug. Patients with renal impairment: Clearance of this drug may be reduced in patients with moderate to severe renal impairment (creatinine clearance <40 mL/min); use caution when prescribing. Patients with hepatic impairment: Clearance of this drug may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, because this drug has not been studied in patients with severe hepatic impairment, use caution when prescribing. Elderly patients: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is necessary to achieve a satisfactory and safe effect. Pediatrics and adolescents younger than 18 years: Do not use this drug in children or adolescents younger than 18 years because its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Pediatric and Adolescent Patients under Precautions for Use). When discontinuing an MAO inhibitor used to treat psychiatric disorders and initiating treatment with this drug, an interval of at least 14 days must be allowed. Conversely, at least 14 days must elapse after discontinuing this drug before initiating an MAO inhibitor to treat psychiatric disorders. Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring other interventions, 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 drug. 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, discontinue this drug immediately and administer linezolid or intravenous methylene blue. 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 occurs first. Treatment with this drug 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 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 such use. Because the half-life of this drug is 20∼40 hours, once-daily administration 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 each in the morning and evening. Do not change the dose at intervals shorter than 1~2 weeks, to allow sufficient time to evaluate the therapeutic response to the dose. With an appropriate dose, a therapeutic effect appears within 2~4 weeks. If the effect is insufficient, the dose may be increased to the maximum dose. If there is no effect after continuing treatment for another 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 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 packaging (Figure 1). Each package contains 10 tablets, separated by perforations. Bend the package along the perforations as shown in Figures 2 and 3 to separate 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
Pediatrics and adolescents younger than 18 years: Do not use this drug in children or adolescents younger than 18 years because its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Pediatric and Adolescent Patients under Precautions for Use).

Ingredients

Manufacturer
Myungin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This medication is used for 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 should be administered whenever possible. Adults: The initial dose of mirtazapine is 15 mg per day, and the dose may need to be increased until an appropriate clinical effect is achieved. The effective daily dose is usually 15~45 mg of this drug. Patients with renal impairment: Clearance of this drug may be reduced in patients with moderate to severe renal impairment (creatinine clearance <40 mL/min); use caution when prescribing. Patients with hepatic impairment: Clearance of this drug may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, because this drug has not been studied in patients with severe hepatic impairment, use caution when prescribing. Elderly patients: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is necessary to achieve a satisfactory and safe effect. Pediatrics and adolescents younger than 18 years: Do not use this drug in children or adolescents younger than 18 years because its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Pediatric and Adolescent Patients under Precautions for Use). When discontinuing an MAO inhibitor used to treat psychiatric disorders and initiating treatment with this drug, an interval of at least 14 days must be allowed. Conversely, at least 14 days must elapse after discontinuing this drug before initiating an MAO inhibitor to treat psychiatric disorders. Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring other interventions, 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 drug. 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, discontinue this drug immediately and administer linezolid or intravenous methylene blue. 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 occurs first. Treatment with this drug 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 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 such use. Because the half-life of this drug is 20∼40 hours, once-daily administration 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 each in the morning and evening. Do not change the dose at intervals shorter than 1~2 weeks, to allow sufficient time to evaluate the therapeutic response to the dose. With an appropriate dose, a therapeutic effect appears within 2~4 weeks. If the effect is insufficient, the dose may be increased to the maximum dose. If there is no effect after continuing treatment for another 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 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 packaging (Figure 1). Each package contains 10 tablets, separated by perforations. Bend the package along the perforations as shown in Figures 2 and 3 to separate 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

Pediatrics and adolescents younger than 18 years: Do not use this drug in children or adolescents younger than 18 years because its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Pediatric and Adolescent Patients under Precautions for Use).

Precautions

This medication is an antidepressant used in the treatment of major depressive disorder. This medication may particularly increase the risk of suicidal thoughts and behaviors in young adults and adolescents aged 18 to 24, so it should be used with caution and after adequate consultation with a doctor. During treatment, changes in the patient's mental condition should be closely monitored, and family members or guardians should observe for abnormal behaviors and report any issues to the doctor immediately. This medication can, although rarely, cause agranulocytosis, which is a sudden drop in white blood cell count, so if symptoms of infection such as sore throat or fever occur, immediate medical attention should be sought. Patients with liver or kidney dysfunction, epilepsy, or cardiovascular diseases, as well as diabetics, require special caution when using this medication. Drowsiness and dizziness are common side effects, so attention is needed when driving or operating hazardous machinery, and alcohol consumption should be avoided. Weight gain and increased appetite may occur, so regular monitoring of weight changes is necessary. This medication should not be administered to patients with certain genetic disorders, and it has many drug interactions, so inform your doctor of any other medications being taken. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it should not be given to children or adolescents under 18. In the case of overdose, serious side effects can occur, so the prescribed dose must be strictly followed, and any side effects or abnormal symptoms should be reported to healthcare professionals immediately.

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
  • edema
  • myalgia
  • abnormal dreams
  • unusual thoughts
  • tremor
  • confusion
  • dyspnea
  • increased urination
  • lethargy
  • abdominal pain
  • acute abdomen syndrome
  • chills
  • fever
  • facial edema
  • ulcer
  • photosensitivity reactions
  • neck stiffness
  • neck pain
  • abdominal distention
  • soft tissue inflammation
  • chest pain under the sternum
  • hypertension
  • vasodilation
  • angina pectoris
  • myocardial infarction
  • bradycardia
  • premature ventricular contraction
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • alternative pulse
  • vascular headache
  • pulmonary embolism
  • cerebral ischemia
  • cardiac hypertrophy
  • 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
  • hypersalivation
  • 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 alkaline phosphatase
  • elevated ALT
  • diabetes mellitus
  • hyponatremia
  • myasthenia gravis
  • arthralgia
  • arthritis
  • tendinitis
  • pathological fracture
  • osteoporosis fracture
  • bone pain
  • myositis
  • tendon rupture
  • osteoarthritis
  • bursitis
  • sensory impairment
  • apathy
  • depression
  • decreased motor function
  • dizziness
  • single contraction
  • anxiety
  • unease
  • amnesia
  • hyperactivity
  • sensory abnormalities
  • ataxia
  • delirium
  • hallucination
  • loss of sense of self
  • dyskinesia
  • extrapyramidal syndrome
  • increased libido
  • abnormal coordination
  • stuttering
  • hallucination
  • manic reaction
  • neurosis
  • muscle tone abnormalities
  • hostility
  • increased reflexes
  • emotional instability
  • relief
  • paranoid reaction
  • aphasia
  • nystagmus
  • inability to sit still
  • lethargy
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • generalized seizure
  • decreased muscle tone
  • liver failure myoclonus
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased coughing
  • sinusitis
  • nosebleed
  • bronchitis
  • asthma
  • pneumonia
  • asphyxiation
  • laryngitis
  • pneumothorax
  • hiccups
  • itching
  • rash
  • acne
  • exfoliative dermatitis
  • dry skin
  • herpes simplex
  • hair loss
  • urticaria
  • herpes zoster
  • skin thickening
  • seborrhea
  • skin ulcer
  • eye pain
  • abnormal eye accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • overflow incontinence
  • glaucoma
  • auditory hypersensitivity
  • ear pain
  • eye inflammation
  • temporary hearing loss in part
  • otitis media
  • loss of taste
  • abnormal olfaction
  • urinary tract infection
  • kidney stones
  • cystitis
  • dysuria
  • urinary incontinence
  • urinary retention
  • vaginitis
  • hematuria
  • mastalgia
  • amenorrhea
  • dysmenorrhea
  • white discharge
  • erectile dysfunction
  • polyuria
  • urethritis
  • uterine bleeding
  • menorrhagia
  • abnormal ejaculation
  • breast engorgement
  • breast enlargement
  • urgency
  • excessive sedation
  • forgetfulness
  • facial tremor
  • fatigue
  • tinnitus
  • mucocutaneous syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory impairment
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs syndrome
  • oral sensory abnormalities
  • aggression
  • suicidal tendencies
  • suicidal impulses
  • suicidal behavior

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 and moisture and kept in a cool place below 30 degrees Celsius. Storing it this way preserves its effectiveness and quality.

Appearance and packaging

Appearance

White, round orodispersible 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.

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.