Medication info
Remeron 30 mg Tablet (Mirtazapine)

Remeron 30 mg Tablet (Mirtazapine)

Prescription medicationTablet
Ingredient · strength
Mirtazapine›30mg / 1 tablet
Manufacturer / importer
Organon Korea Co., Ltd.
Appearance
Brownish-red film-coated oval tablet
Packaging
30 tablets (10 tablets/PTP x 3 PTP)
Approval status
Active

MFDS item code 200808414 · Notified 2008.08.06 · Insurance code 073100330

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 once daily, and the dose may need to be increased until an appropriate clinical response is achieved. The usual effective daily dose is 15~45 mg of this medicine. Clearance of this medicine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); therefore, caution should be exercised when prescribing it. Clearance of this medicine may be decreased in patients with hepatic impairment; therefore, caution should be exercised when prescribing it. In particular, this medicine has not been studied in patients with severe hepatic impairment, so caution should be exercised when prescribing it. Elderly: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is necessary to achieve a satisfactory and safe effect. When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require other interventions, including hospitalization, or treatment for a more urgent psychiatric condition, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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 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 occurs first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. 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 going to bed. This medicine may also be taken in two equal doses, 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 shorter 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 to the maximum dose. If there is no effect after continuing treatment for an additional 2~4 weeks, treatment should be discontinued. Treatment should be continued for at least 4∼6 months, until the patient's symptoms have completely resolved. Thereafter, gradual discontinuation is recommended to avoid withdrawal symptoms. This medicine is taken orally. Swallow it with water without chewing.
Children's dosage
Children and adolescents under 18 years of age: Do not use this medicine in children or adolescents under 18 years of age, as its efficacy has not been demonstrated in two short-term clinical trials and there are safety concerns.

Ingredients

Importer
Organon Korea Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This drug is used for the treatment of major depression.

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 once daily, and the dose may need to be increased until an appropriate clinical response is achieved. The usual effective daily dose is 15~45 mg of this medicine. Clearance of this medicine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); therefore, caution should be exercised when prescribing it. Clearance of this medicine may be decreased in patients with hepatic impairment; therefore, caution should be exercised when prescribing it. In particular, this medicine has not been studied in patients with severe hepatic impairment, so caution should be exercised when prescribing it. Elderly: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is necessary to achieve a satisfactory and safe effect. When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require other interventions, including hospitalization, or treatment for a more urgent psychiatric condition, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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 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 occurs first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. 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 going to bed. This medicine may also be taken in two equal doses, 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 shorter 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 to the maximum dose. If there is no effect after continuing treatment for an additional 2~4 weeks, treatment should be discontinued. Treatment should be continued for at least 4∼6 months, until the patient's symptoms have completely resolved. Thereafter, gradual discontinuation is recommended to avoid withdrawal symptoms. This medicine is taken orally. Swallow it with water without chewing.

Children's dosage

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

Precautions

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depression or other psychiatric disorders. Careful assessment and monitoring are necessary when prescribing to patients in this age group. During treatment with this medication, there may be a decrease in white blood cell count, making patients more susceptible to infections. If accompanied by a sore throat or fever, medical attention should be sought immediately. In patients with impaired liver or kidney function, the drug concentration may increase, requiring dose adjustment and careful monitoring. Serious side effects may occur when taken with specific medications, so inform your doctor or pharmacist of any other medications you are taking. Drowsiness and dizziness may occur at the beginning of treatment; caution is advised when driving or operating hazardous machinery. This medication may cause weight gain and increased appetite, so it is advisable to regularly monitor weight changes during long-term use. Pregnant or breastfeeding women should consult their doctor before taking this drug, and must inform healthcare professionals immediately if they plan to become pregnant or find out they are pregnant. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, anxiety, headache, and nausea; therefore, the dose should be gradually reduced according to your doctor's instructions. Elderly patients may be more sensitive to this medication. Careful monitoring for side effects should be conducted when administering to elderly patients. Overdose can cause serious side effects, so strictly adhere to the prescribed dosage and do not change the dosage without medical guidance. Taking this medication with alcohol may enhance central nervous system depressive effects, so it is advisable to avoid alcohol during treatment. If abnormal behavioral changes such as suicidal thoughts, aggression, or anxiety occur while using this medication, consult your doctor immediately, and family members or caregivers should closely monitor the patient's condition.

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
  • muscle pain
  • abnormal dreams
  • hallucinations
  • tremors
  • confusion
  • shortness of breath
  • frequent urination
  • lethargy
  • abdominal pain
  • acute abdominal syndrome
  • chills
  • fever
  • facial swelling
  • ulcer
  • photosensitivity reaction
  • neck stiffness
  • neck pain
  • abdominal distension
  • soft tissue inflammation
  • chest pain under the sternum
  • hypertension
  • vasodilation
  • angina
  • myocardial infarction
  • bradycardia
  • ventricular ectopic beats
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • ectopic pulse
  • 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 salivation
  • bowel obstruction
  • pancreatitis
  • aphthous stomatitis
  • liver cirrhosis
  • gastritis
  • gastroenteritis
  • oral candidiasis
  • tongue swelling
  • goiter
  • hypothyroidism
  • lymphadenopathy
  • leukopenia
  • petechiae
  • anemia
  • thrombocytopenia
  • lymphocytosis
  • pan-cytopenia
  • thirst
  • dehydration
  • weight loss
  • gout
  • elevated AST
  • abnormal healing
  • increased acid phosphatase enzyme
  • elevated ALT
  • diabetes
  • hyponatremia
  • myasthenia gravis
  • arthralgia
  • arthritis
  • tendinitis
  • pathological fractures
  • osteoporotic fractures
  • 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
  • delusions
  • loss of self-esteem
  • movement disorders
  • extrapyramidal syndrome
  • increased libido
  • adherence issues
  • stuttering
  • hallucinations
  • manic reactions
  • neurosis
  • muscle tone disorders
  • hostility
  • increased reflexes
  • emotional instability
  • relief
  • paranoid reactions
  • aphasia
  • nystagmus
  • inability to sit still
  • confusion
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • grand mal seizures
  • reduced muscle tone
  • hepatic myoclonus
  • psychotic depression
  • withdrawal symptoms
  • 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
  • eye pain
  • abnormal eye control function
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • urinary incontinence
  • glaucoma
  • auditory hypersensitivity
  • ear pain
  • eye inflammation
  • transient partial hearing loss
  • otitis media
  • loss of taste
  • abnormal sense of smell
  • urinary tract infection
  • kidney stones
  • cystitis
  • dysuria
  • incontinence
  • urinary retention
  • vaginitis
  • hematuria
  • breast pain
  • amenorrhea
  • dysmenorrhea
  • white discharge
  • erectile dysfunction
  • polyuria
  • urethritis
  • uterine bleeding
  • menorrhagia
  • abnormal ejaculation
  • breast congestion
  • breast enlargement
  • urgency
  • excessive sedation
  • forgetfulness
  • facial tremors
  • fatigue
  • tinnitus
  • skin and mucous membrane syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • eosinophilia
  • drug reaction with systemic eosinophilia
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory loss
  • lip swelling
  • bone marrow depression
  • eosinophilia
  • restless legs syndrome
  • oral sensory disturbance
  • aggression
  • hyperprolactinemia
  • sleepwalking
  • priapism

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

Storage

Store this medication in a tightly sealed container to protect it from air, light, and moisture. It is best kept in a cool place between 2°C and 30°C.

Appearance and packaging

Appearance

Brownish-red film-coated oval tablet

Package unit

30 tablets (10 tablets/PTP x 3 PTP)

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.