Medication info
Youngjin Mirtazapine Tablets 15 mg

Youngjin Mirtazapine Tablets 15 mg

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Mirtazapine›15.51mg / 1 tablet
Manufacturer / importer
Youngjin Pharmaceutical Co., Ltd.
Appearance
Pale yellow oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201701437 · Approved 2017.03.27 · Insurance code 642404190

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 possible should be administered. Adults: The initial dose of mirtazapine is 15mg per day, and the dose should be increased until an appropriate clinical response is achieved. The usual effective daily dose is 15~45 mg of this drug. Clearance of this drug may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); therefore, use caution when prescribing. Clearance of this drug may be reduced in patients with hepatic impairment; therefore, use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as these patients have not been studied. 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. When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuation of this drug. This drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection) or intravenous injection 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 of this drug may also be divided into equal doses taken once in the morning and once in the evening. To allow sufficient time to assess the therapeutic response to the dose of this drug, 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 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 of treatment is recommended to avoid withdrawal symptoms. This drug is taken orally. Swallow it with water without chewing.
Children's dosage
Children and adolescents under 18 years of age: Do not use this drug in children or adolescents under 18 years of age, because its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns.

Ingredients

Manufacturer
Youngjin 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 possible should be administered. Adults: The initial dose of mirtazapine is 15mg per day, and the dose should be increased until an appropriate clinical response is achieved. The usual effective daily dose is 15~45 mg of this drug. Clearance of this drug may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); therefore, use caution when prescribing. Clearance of this drug may be reduced in patients with hepatic impairment; therefore, use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as these patients have not been studied. 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. When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuation of this drug. This drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection) or intravenous injection 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 of this drug may also be divided into equal doses taken once in the morning and once in the evening. To allow sufficient time to assess the therapeutic response to the dose of this drug, 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 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 of treatment is recommended to avoid withdrawal symptoms. This drug is taken orally. Swallow it with water without chewing.

Children's dosage

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

Precautions

This drug is an antidepressant primarily used to treat symptoms related to depression. While taking this drug, there may be an increased risk of suicidal thoughts or behaviors, especially in young patients aged 18 to 24, who should be monitored closely. During the initial period of treatment or after a dosage change, there may be a worsening of depression symptoms or unusual behaviors such as suicidal impulses, aggression, or anger, necessitating careful observation by family members or guardians. This drug may rarely cause agranulocytosis, which is a sudden decrease in white blood cell counts; if symptoms like sore throat, fever, or signs of infection occur, the patient should consult a doctor immediately. Patients with impaired liver or kidney function should take care when using this drug, and if liver dysfunction or jaundice symptoms appear, the medication should be discontinued. This drug contains the artificial sweetener aspartame and should not be taken by patients with certain genetic disorders, such as phenylketonuria. This medication should not be taken with certain other medications, especially MAO inhibitors, as this combination may lead to the risk of serious side effects such as serotonin syndrome. Drowsiness or dizziness may occur frequently during treatment; therefore, caution is advised when driving or operating hazardous machinery. Increased appetite and weight gain may commonly occur, so periodic weight monitoring is recommended. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it is not recommended for pediatric patients or adolescents. Serious side effects may occur in the case of overdose, so prescribed dosages must be adhered to, and immediate emergency actions should be taken if an overdose is suspected. When storing this medication, it should be kept in a safe place out of reach of children and should not be transferred to other containers.

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
  • unusual incidents
  • tremors
  • confusion
  • dyspnea
  • increased urination
  • lethargy
  • abdominal pain
  • acute abdominal 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
  • premature ventricular contractions
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • ectopic beats
  • vascular headache
  • pulmonary embolism
  • cerebral ischemia
  • cardiomegaly
  • phlebitis
  • left heart failure
  • vomiting
  • loss of appetite
  • belching
  • stomatitis
  • cholecystitis
  • gum bleeding
  • oral mucositis
  • colitis
  • abnormal liver function tests
  • tongue depigmentation
  • ulcerative stomatitis
  • salivary gland enlargement
  • excessive salivation
  • intestinal obstruction
  • pancreatitis
  • aphthous stomatitis
  • 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 disturbance
  • ataxia
  • delirium
  • hallucinations
  • loss of self
  • dyskinesia
  • extrapyramidal syndrome
  • increased libido
  • abnormal cooperation
  • stuttering
  • hallucinations
  • manic reaction
  • neurosis
  • muscle tone abnormalities
  • hostility
  • increased reflexes
  • emotional instability
  • relief
  • paranoid reaction
  • aphasia
  • nystagmus
  • inability to sit still
  • confusion
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • grand mal seizure
  • decreased muscle tone
  • metabolic muscle spasms
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased coughing
  • sinusitis
  • nosebleeds
  • 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 accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • overflow incontinence
  • glaucoma
  • hypersensitivity to sound
  • ear pain
  • eyelid inflammation
  • temporary hearing loss in part
  • otitis media
  • loss of taste
  • olfactory dysfunction
  • 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
  • urinary urgency
  • forgetfulness
  • facial tremors
  • fatigue
  • tinnitus
  • skin mucosal syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • elevated serum creatine kinase
  • rhabdomyolysis
  • oral sensory impairment
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs syndrome
  • oral sensory disturbances
  • aggression
  • excessive sedation

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

Storage

This drug should be stored in a container that blocks light and allows air circulation. Additionally, avoid damp places, and it is important to maintain a temperature between 2 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablets

Package unit

30 tablets/bottle, 100 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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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.