Medication info
Mirtazapine 7.5 mg Tablets (Mirtazapine)

Mirtazapine 7.5 mg Tablets (Mirtazapine)

Prescription medicationTablet
Ingredient · strength
Mirtazapine›7.5mg / 1 tablet
Manufacturer / importer
Hyundai Pharmaceutical Co., Ltd.
Appearance
Blue oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201205974 · Approved 2012.06.29 · Insurance code 642003110

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 minimum effective dose should be administered whenever possible. The initial dose of mirtazapine is 15mg per day, and the dose may need to be increased until an appropriate clinical response is achieved. The usual effective daily dose of this medicine is 15~45 mg. Use caution when prescribing this medicine to patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min), as its clearance may be reduced. Use caution when prescribing this medicine to patients with hepatic impairment, as its clearance may be reduced. In particular, use caution when prescribing it to patients with severe hepatic impairment, as it has not been studied in this population. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe effect. Allow an interval of at least 14 days between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of psychiatric disorders. 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear. As the half-life of this medicine is 20∼40 hours, 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 assess the response to treatment at the prescribed dose, do not adjust the dose at intervals of less than 1~2 weeks. At an appropriate dose, a therapeutic effect is seen within 2~4 weeks. If the response is insufficient, the dose may be increased up to the maximum dose. If there is no response 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. This medicine is for oral use. Swallow it with water without chewing.
Children's dosage
Children and adolescents under 18 years: The efficacy of this medicine has not been established in two short-term clinical trials, and there are safety concerns; therefore, do not use this medicine in children or adolescents under 18 years of age.

Ingredients

Manufacturer
Hyundai Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This medication 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 minimum effective dose should be administered whenever possible. The initial dose of mirtazapine is 15mg per day, and the dose may need to be increased until an appropriate clinical response is achieved. The usual effective daily dose of this medicine is 15~45 mg. Use caution when prescribing this medicine to patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min), as its clearance may be reduced. Use caution when prescribing this medicine to patients with hepatic impairment, as its clearance may be reduced. In particular, use caution when prescribing it to patients with severe hepatic impairment, as it has not been studied in this population. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe effect. Allow an interval of at least 14 days between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of psychiatric disorders. 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear. As the half-life of this medicine is 20∼40 hours, 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 assess the response to treatment at the prescribed dose, do not adjust the dose at intervals of less than 1~2 weeks. At an appropriate dose, a therapeutic effect is seen within 2~4 weeks. If the response is insufficient, the dose may be increased up to the maximum dose. If there is no response 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. This medicine is for oral use. Swallow it with water without chewing.

Children's dosage

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

Precautions

This medication is an antidepressant used to treat psychiatric disorders such as major depression. Caution is needed as the risk of suicidal thoughts or behaviors may increase when administered to children, adolescents, and young adults. Rare blood disorders such as agranulocytosis may occur during treatment; consult a physician if symptoms of infection such as fever or sore throat appear. Patients with impaired liver or kidney function, epilepsy, diabetes, and heart disease require caution when using this drug. Drowsiness or dizziness may commonly occur during treatment, so care should be taken when driving or operating machinery. Additionally, increased appetite and weight gain may occur, so it is advisable to regularly monitor weight changes. This drug may interact with other medications; therefore, it is essential to inform the doctor of any other medications being taken. Alcohol consumption should be avoided as it may exacerbate the side effects of this medication. Women who are pregnant or planning to become pregnant, as well as those who are breastfeeding, must consult a doctor. In cases of overdose, memory impairment, drowsiness, and irregular heartbeats may occur, requiring immediate medical attention. Finally, this medication should be stored out of reach of children, and it is crucial not to discontinue use arbitrarily but to follow the doctor's instructions.

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
  • unusual experiences
  • tremors
  • confusion
  • dyspnea
  • frequent urination
  • fatigue
  • abdominal pain
  • acute abdomen syndrome
  • chills
  • fever
  • facial swelling
  • ulcers
  • photosensitivity reaction
  • neck stiffness
  • neck pain
  • abdominal distension
  • soft tissue inflammation
  • pain in the chest below the sternum
  • hypertension
  • vasodilation
  • angina
  • myocardial infarction
  • bradycardia
  • premature ventricular contractions
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • bigeminy
  • vascular headache
  • pulmonary embolism
  • cerebral ischemia
  • cardiac hypertrophy
  • phlebitis
  • left heart failure
  • vomiting
  • decreased appetite
  • belching
  • glossitis
  • cholecystitis
  • gum bleeding
  • stomatitis
  • colitis
  • abnormal liver function tests
  • tongue discoloration
  • ulcerative stomatitis
  • salivary gland enlargement
  • excessive salivation
  • bowel 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 loss
  • apathy
  • depression
  • reduced motor function
  • dizziness
  • single contraction
  • anxiety
  • worry
  • amnesia
  • hyperactivity
  • sensory abnormalities
  • ataxia
  • delirium
  • delusion
  • loss of self
  • movement disorders
  • extrapyramidal syndrome
  • increased libido
  • coordination disorders
  • stuttering
  • hallucinations
  • manic response
  • neurosis
  • muscle tension abnormalities
  • hostility
  • reflex increase
  • emotional instability
  • sense of well-being
  • paranoid response
  • aphasia
  • nystagmus
  • inability to sit still
  • stupor
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • tonic-clonic seizure
  • decreased muscle tone
  • toxic myopathy
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased cough
  • sinusitis
  • epistaxis
  • bronchitis
  • asthma
  • pneumonia
  • asphyxia
  • 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
  • episcleritis
  • overflow incontinence
  • glaucoma
  • auditory hypersensitivity
  • earache
  • conjunctival inflammation
  • temporary hearing loss in part
  • otitis media
  • taste loss
  • olfactory disturbance
  • 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
  • excessive sedation
  • forgetfulness
  • facial tremor
  • fatigue
  • tinnitus
  • skin and mucous membrane syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • increased creatine kinase in the blood
  • rhabdomyolysis
  • oral sensory loss
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs syndrome
  • oral sensory disturbances
  • aggression
  • suicidal tendencies
  • suicidal impulses
  • suicidal behavior
  • hostility
  • aggression
  • anger
  • insomnia
  • anxiety
  • panic disorder
  • agitation
  • impulsivity
  • inability to sit still
  • hypomania
  • mania
  • mania/hypomania
  • seizures
  • hyponatremia
  • serotonin syndrome
  • loss of sense of direction
  • memory impairment
  • tachycardia
  • QT prolongation
  • Torsades de Pointes arrhythmia

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

Storage

This medication should be stored in a light- and air-protected, tightly sealed container. It is also important to avoid humid areas and to store it at a cool temperature between 2 degrees and 30 degrees Celsius.

Appearance and packaging

Appearance

Blue 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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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.