Medication info
Mirzentak ODT 7.5 mg (Mirtazapine)

Mirzentak ODT 7.5 mg (Mirtazapine)

Prescription medicationOrally disintegrating TabletOral · Intravenous injection
Ingredient · strength
Mirtazapine›7.5mg / 1 tablet
Manufacturer / importer
Hanin Pharmaceutical Co., Ltd.
Appearance
White round orodispersible tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 202009438 · Approved 2020.12.31 · Insurance code 657203750

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. The initial dose of mirtazapine is 15mg/day, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose of this medicine is 15~45 mg. Clearance of this medicine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); use caution when prescribing. Clearance of this medicine may be decreased in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as these patients have not been studied. The recommended dose is the same as that for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe response. 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 for the treatment of psychiatric disorders, at least 14 days should elapse after discontinuing this medicine. Because the half-life of this medicine is 20∼40 hours, once-daily administration is sufficient; if possible, take it at a consistent time in the evening before bedtime. Alternatively, the daily dose may be divided into equal doses taken once in the morning and once 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. Treatment at an appropriate dose produces a therapeutic effect 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. Remove this medicine and place it on the tongue. It dissolves rapidly on the tongue and can be swallowed without water.
Children's dosage
Children and adolescents under 18 years of age: 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
Hanin 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 medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. The initial dose of mirtazapine is 15mg/day, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose of this medicine is 15~45 mg. Clearance of this medicine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); use caution when prescribing. Clearance of this medicine may be decreased in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as these patients have not been studied. The recommended dose is the same as that for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe response. 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 for the treatment of psychiatric disorders, at least 14 days should elapse after discontinuing this medicine. Because the half-life of this medicine is 20∼40 hours, once-daily administration is sufficient; if possible, take it at a consistent time in the evening before bedtime. Alternatively, the daily dose may be divided into equal doses taken once in the morning and once 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. Treatment at an appropriate dose produces a therapeutic effect 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. Remove this medicine and place it on the tongue. It dissolves rapidly on the tongue and can be swallowed without water.

Children's dosage

Children and adolescents under 18 years of age: 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 for treating psychiatric disorders such as major depression. Particularly, it may increase the risk of suicidal thoughts or behaviors in young patients aged 18 to 24 years, so doctors should carefully assess the risks and benefits when prescribing this medication. During treatment, changes in the patient's mental state should be closely monitored, and family members or caregivers should also observe any changes in behavior, consulting a doctor immediately if problems arise. Rarely, this medication can cause severe blood abnormalities such as agranulocytosis, so if symptoms of infection or fever occur within 4 to 6 weeks after administration, blood tests should be conducted immediately. Patients with poor liver or kidney function, those with heart disease, diabetes, or epilepsy require special caution when using this medication. Drowsiness or dizziness may frequently occur during treatment, so caution is especially required when performing activities that require alertness, such as driving or operating machinery. This medication may cause increased appetite and weight gain, so it's advisable to regularly check for changes in weight. Combining with alcohol may enhance the central nervous system depressant effects, so avoiding alcohol during treatment is safe. Women who are pregnant, planning to become pregnant, or breastfeeding should consult a doctor, and this medication is not to be administered to children and adolescents. Additionally, this medication can interact with other drugs, so it is essential to inform the doctor of any medications currently being taken, especially those that are MAO inhibitors and should not be used simultaneously. In case of overdose, symptoms like severe drowsiness, memory impairment, and arrhythmia may appear, so the prescribed dosage should be strictly adhered to, following the doctor's instructions. Finally, this medication should be kept out of reach of children, and it should not be discontinued abruptly but rather tapered off gradually according to the doctor's advice.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • weakness
  • flu-like syndrome
  • back pain
  • dry mouth
  • constipation
Show 234 more
  • peripheral edema
  • muscle pain
  • abnormal dreams
  • unusual incidents
  • tremors
  • confusion
  • shortness of breath
  • increased urination
  • fatigue
  • abdominal pain
  • acute abdomen syndrome
  • chills
  • fever
  • facial swelling
  • ulcers
  • photosensitivity reaction
  • neck stiffness
  • neck pain
  • abdominal distension
  • soft tissue inflammation
  • chest pain under the sternum
  • hypertension
  • vasodilation
  • angina
  • myocardial infarction
  • bradycardia
  • ventricular ectopy
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • dual rhythm
  • vascular headaches
  • 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
  • hypersalivation
  • 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 activity
  • elevated ALT
  • diabetes
  • hyponatremia
  • myasthenia
  • joint pain
  • arthritis
  • tendinitis
  • pathologic fractures
  • osteoporotic fractures
  • bone pain
  • myositis
  • tendon rupture
  • arthropathy
  • bursitis
  • sensory impairment
  • apathy
  • depression
  • decreased motor function
  • dizziness
  • single contraction
  • anxiety
  • unease
  • amnesia
  • hyperactivity
  • sensory abnormalities
  • ataxia
  • delirium
  • hallucination
  • loss of self-esteem
  • dyskinesia
  • extrapyramidal syndrome
  • increased libido
  • coordination abnormalities
  • stuttering
  • hallucinations
  • manic reactions
  • neurosis
  • muscle tension abnormalities
  • hostility
  • increased reflexes
  • emotional instability
  • relief
  • paranoid reactions
  • aphasia
  • nystagmus
  • inability to sit still
  • confusion
  • dementia
  • double vision
  • drug dependence
  • paralysis
  • grand mal seizure
  • decreased muscle tone
  • clonic muscular spasms
  • psychotic depression
  • withdrawal syndrome
  • 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
  • herpes zoster
  • skin thickening
  • seborrhea
  • skin ulcers
  • ocular pain
  • abnormal eye accommodation function
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • overflow disorder
  • glaucoma
  • auditory hypersensitivity
  • ear pain
  • eyelid inflammation
  • temporary hearing loss in parts
  • otitis media
  • loss of taste
  • olfactory abnormalities
  • 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
  • mucocutaneous syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory impairment
  • lip swelling
  • bone marrow depression
  • eosinophilia
  • restless legs
  • oral sensory abnormalities
  • aggression
  • hyperprolactinemia
  • sleepwalking
  • disorientation
  • memory impairment
  • tachycardia
  • coma
  • seizure
  • insomnia
  • agitation
  • headache
  • nausea
  • anxiety
  • unease
  • panic disorder
  • hostility
  • aggression
  • impulsivity
  • inability to sit still
  • hypomania
  • mania
  • suicidal tendency
  • suicidal impulse
  • suicidal behavior
  • animosity
  • aggression
  • defiant behavior
  • anger

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and kept in a cool place at or below 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a long time.

Appearance and packaging

Appearance

White round orodispersible tablet

Package unit

30 tablets (10 tablets/PTP x 3)

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.