Medication info
Mirtazapine 30 mg (Mirtazapine)

Mirtazapine 30 mg (Mirtazapine)

Prescription medicationTablet
Ingredient · strength
Mirtazapine›30mg / 1 tablet
Manufacturer / importer
MyungIn Pharmaceutical Co., Ltd.
Appearance
Brownish-red oval film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 201404690 · Approved 2014.10.13 · Insurance code 651904090

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 15mg per day, and the dose may need to be increased until an appropriate clinical effect is achieved. The usual effective daily dose of this medicine is 15 ~ 45 mg. Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); use caution when prescribing. Clearance of this medicine may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as they have not been studied. Older adults: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is needed to obtain a satisfactory and safe effect. The half-life of this medicine is 20 ∼ 40 hours, so once-daily administration is sufficient; if possible, take it at a consistent time in the evening before bedtime. This medicine may also be taken as the daily dose divided equally into two doses, one in the morning and one in the evening. To allow sufficient time to evaluate the therapeutic response to the dose, do not change the dose at intervals of less than 1 ∼ 2 weeks. With an appropriate dose, a therapeutic effect appears within 2∼ 4 weeks. If the effect is insufficient, the dose may be increased up 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 is recommended to avoid withdrawal symptoms. Take this medicine orally with water. Swallow it without chewing.
Children's dosage
Children and adolescents under 18 years: Do not use this medicine in children or adolescents under 18 years of age, because its efficacy has not been established in two short-term clinical trials and there are safety concerns.

Ingredients

Manufacturer
MyungIn Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depressive disorder
View approved original text

This medication is used for major depressive disorder. Major depressive disorder is characterized by persistent feelings of sadness and decreased motivation. This medication helps relieve symptoms and improves the daily life of patients.

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 15mg per day, and the dose may need to be increased until an appropriate clinical effect is achieved. The usual effective daily dose of this medicine is 15 ~ 45 mg. Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); use caution when prescribing. Clearance of this medicine may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as they have not been studied. Older adults: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is needed to obtain a satisfactory and safe effect. The half-life of this medicine is 20 ∼ 40 hours, so once-daily administration is sufficient; if possible, take it at a consistent time in the evening before bedtime. This medicine may also be taken as the daily dose divided equally into two doses, one in the morning and one in the evening. To allow sufficient time to evaluate the therapeutic response to the dose, do not change the dose at intervals of less than 1 ∼ 2 weeks. With an appropriate dose, a therapeutic effect appears within 2∼ 4 weeks. If the effect is insufficient, the dose may be increased up 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 is recommended to avoid withdrawal symptoms. Take this medicine orally with water. Swallow it without chewing.

Children's dosage

Children and adolescents under 18 years: Do not use this medicine in children or adolescents under 18 years of age, because its efficacy has not been established in two short-term clinical trials and there are safety concerns.

Precautions

This medication is an antidepressant used to treat major depressive disorder. When taking this medication, there may be an increased risk of suicidal thoughts or behavior, particularly in young adults and adolescents aged 18 to 24, who should be monitored closely. This medication may reduce the number of granulocytes in the blood, increasing the risk of infection; therefore, immediate consultation with a doctor is needed if any symptoms such as a sore throat or fever occur. Patients with impaired liver or kidney function may require dose adjustment and careful monitoring when taking this medication. Drowsiness or dizziness can frequently occur during treatment, so caution should be exercised when driving or operating machinery. This medication may lead to increased appetite and weight gain, so it is advisable to regularly monitor weight changes. Abnormalities may appear on liver function tests, so regular liver function testing is necessary. Care should be taken when using this medication in conjunction with other serotonergic drugs, as it may result in life-threatening serotonin syndrome. Pregnant or breastfeeding women are strongly advised to consult a physician before taking this medication. It is not recommended for use in children and adolescents as the safety and efficacy have not been adequately established. Severe side effects can occur with overdose, so the prescribed dosage must be strictly adhered to. Many medications can interact with this drug, so if you are taking other medications, be sure to inform your physician. If symptoms such as anxiety, agitation, aggression, or insomnia occur during treatment, immediate consultation with a physician is necessary.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • weakness
  • influenza-like syndrome
  • low back pain
  • dry mouth
  • constipation
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  • peripheral edema
  • swelling
  • myalgia
  • abnormal dreams
  • hallucinations
  • tremors
  • confusion
  • dyspnea
  • frequent urination
  • lethargy
  • abdominal pain
  • acute abdominal syndrome
  • chills
  • fever
  • facial edema
  • ulcers
  • photosensitivity reaction
  • neck stiffness
  • neck pain
  • abdominal distension
  • soft tissue inflammation
  • chest pain below the sternum
  • hypertension
  • vasodilation
  • angina
  • myocardial infarction
  • bradycardia
  • premature ventricular contractions
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • bigeminy
  • vascular headache
  • pulmonary embolism
  • cerebral ischemia
  • cardiomegaly
  • phlebitis
  • left-sided heart failure
  • vomiting
  • loss of appetite
  • belching
  • glossitis
  • cholecystitis
  • gum bleeding
  • stomatitis
  • colitis
  • abnormal liver function tests
  • tongue discoloration
  • ulcerative stomatitis
  • salivary gland hypertrophy
  • 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
  • increased AST
  • abnormal healing
  • increased acid phosphatase
  • increased 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
  • vertigo
  • single contraction
  • agitation
  • anxiety
  • amnesia
  • hyperactivity
  • sensory abnormalities
  • ataxia
  • delirium
  • delusion
  • loss of self-esteem
  • abnormal motor function
  • extrapyramidal syndrome
  • increased libido
  • cooperation abnormalities
  • stuttering
  • hallucinations
  • manic response
  • neurosis
  • muscle tone abnormalities
  • hostility
  • increased reflexes
  • emotional instability
  • relief
  • paranoid response
  • aphasia
  • nystagmus
  • inability to sit still
  • confusion
  • dementia
  • double vision
  • drug dependence
  • paralysis
  • grand mal seizure
  • decreased muscle tone
  • muscle fasciculation
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased cough
  • sinusitis
  • nosebleed
  • bronchitis
  • asthma
  • pneumonia
  • asphyxia
  • laryngitis
  • pneumothorax
  • hiccups
  • itching
  • rash
  • acne
  • dermatitis exfoliativa
  • skin dryness
  • herpes simplex
  • alopecia
  • urticaria
  • herpes zoster
  • skin hypertrophy
  • seborrhea
  • skin ulcer
  • ocular pain
  • abnormal eye accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • urinary incontinence
  • glaucoma
  • auditory hypersensitivity
  • ear pain
  • eye inflammation
  • temporary hearing loss
  • otitis media
  • loss of taste
  • abnormal smell
  • urinary tract infection
  • kidney stones
  • cystitis
  • dysuria
  • urinary incontinence
  • urinary retention
  • vaginitis
  • hematuria
  • breast pain
  • amenorrhea
  • dysmenorrhea
  • white vaginal discharge
  • erectile dysfunction
  • polyuria
  • urethritis
  • uterine bleeding
  • menorrhagia
  • abnormal ejaculation
  • breast engorgement
  • breast enlargement
  • urgency
  • excessive sedation
  • forgetfulness
  • facial tremors
  • fatigue
  • tinnitus
  • skin and mucous membrane syndrome
  • Stevens-Johnson syndrome
  • bullous dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • LHIEL syndrome
  • elevated serum creatine kinase
  • rhabdomyolysis
  • oral sensory loss
  • lip swelling
  • bone marrow suppression
  • agranulocytosis
  • granulocytopenia
  • aplastic anemia
  • eosinophilia
  • restless legs syndrome
  • oral sensory abnormalities
  • aggression
  • insomnia
  • agitation
  • panic disorder
  • excitement
  • impulsivity
  • inability to sit still
  • mania
  • bipolar disorder
  • seizures
  • hyponatremia
  • serotonin syndrome
  • suicidal tendencies
  • suicidal impulse
  • suicidal behavior
  • hostility
  • aggression
  • anger
  • anxiety
  • headache
  • memory impairment
  • tachycardia
  • disorientation

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

Storage

This medication should be stored in a tightly closed container protected from light and air, and kept at a cool temperature between 2°C and 30°C, avoiding humid areas. By storing it this way, the effectiveness of the medication can be safely maintained.

Appearance and packaging

Appearance

Brownish-red oval film-coated tablet

Package unit

30 tablets/bottle, 200 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.