Medication info
Mirzentaq 7.5 mg (Mirtazapine)

Mirzentaq 7.5 mg (Mirtazapine)

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Mirtazapine›7.5mg / 1 tablet
Manufacturer / importer
Hanin Pharmaceutical Co., Ltd.
Appearance
Blue oval film-coated tablets
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/bottle, For export - 100 tablets/bottle
Approval status
Active

MFDS item code 201707056 · Approved 2017.09.12 · Insurance code 657203510

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 should be administered whenever possible. The initial dose of mirtazapine is 15mg daily, and the dose should 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); 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 because patients with severe hepatic impairment have not been studied. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe response. Because the half-life of this medicine is 20∼40 hours, once-daily dosing is sufficient, preferably 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 therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1~2 weeks. At an appropriate dose, a therapeutic response occurs within 2~4 weeks. If the response is inadequate, the dose may be increased up to the maximum dose. If there is no response 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 without chewing.
Children's dosage
Children and adolescents under 18 years of age: The efficacy of this drug has not been demonstrated in two short-term clinical trials, and because of safety concerns, this drug should not be used in children and adolescents under 18 years of age.

Ingredients

Manufacturer
Hanin 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.

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 should be administered whenever possible. The initial dose of mirtazapine is 15mg daily, and the dose should 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); 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 because patients with severe hepatic impairment have not been studied. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe response. Because the half-life of this medicine is 20∼40 hours, once-daily dosing is sufficient, preferably 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 therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1~2 weeks. At an appropriate dose, a therapeutic response occurs within 2~4 weeks. If the response is inadequate, the dose may be increased up to the maximum dose. If there is no response 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 without chewing.

Children's dosage

Children and adolescents under 18 years of age: The efficacy of this drug has not been demonstrated in two short-term clinical trials, and because of safety concerns, this drug should not be used in children and adolescents under 18 years of age.

Precautions

This drug is used to treat depression and other psychiatric disorders, and caution is needed as it may increase the risk of suicidal thoughts or behaviors, especially in young individuals. During the course of medication, there is a rare possibility of agranulocytosis, which is a sudden drop in white blood cell count. If symptoms of infection such as sore throat or fever occur, it is essential to consult a doctor immediately. Patients with impaired liver or kidney function, epilepsy, diabetes, heart disease, etc. should be especially cautious when using this drug. Common side effects may include drowsiness, dizziness, increased appetite, and weight gain, so caution is needed when driving or operating machinery. Additionally, this drug may interact with other medications, so it is crucial to inform your doctor or pharmacist about any other medications you are taking, especially avoiding concurrent use with MAO inhibitors. Women who are pregnant or breastfeeding should consult a physician before taking this medication. It is not recommended for children or adolescents as its safety and efficacy have not been established. This drug may cause withdrawal symptoms if suddenly discontinued, so the dosage should be gradually reduced under the guidance of a physician when discontinuing. In the event of an overdose, serious side effects may occur, so it is crucial to strictly adhere to the prescribed dosage, and if an overdose is suspected, immediate emergency treatment should be sought. Lastly, this medication should be stored out of the reach of children, and changing the container improperly should be avoided.

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
  • breathing difficulties
  • frequent urination
  • lethargy
  • abdominal pain
  • acute abdominal syndrome
  • chills
  • fever
  • facial edema
  • ulcers
  • photosensitivity reactions
  • neck rigidity
  • neck pain
  • abdominal distension
  • soft tissue inflammation
  • chest pain below the sternum
  • hypertension
  • vasodilation
  • angina pectoris
  • myocardial infarction
  • bradycardia
  • ventricular ectopic contractions
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmias
  • biphasic pulse
  • vascular headaches
  • pulmonary embolism
  • brain ischemia
  • cardiac hypertrophy
  • phlebitis
  • left heart failure
  • vomiting
  • anorexia
  • burping
  • glossitis
  • cholecystitis
  • gum bleeding
  • stomatitis
  • colitis
  • abnormal liver function tests
  • tongue depigmentation
  • 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
  • elevated AST
  • abnormal healing
  • elevated acidic phosphatase
  • elevated ALT
  • diabetes
  • hyponatremia
  • myasthenia gravis
  • arthralgia
  • arthritis
  • tendinitis
  • pathological fractures
  • osteoporotic fractures
  • bone pain
  • myositis
  • tendon rupture
  • arthrosis
  • bursitis
  • sensory impairment
  • apathy
  • depression
  • decreased motor function
  • dizziness
  • single contractions
  • agitation
  • anxiety
  • amnesia
  • hyperactivity
  • sensory abnormalities
  • ataxia
  • delirium
  • illusion
  • loss of self
  • dyskinesia
  • extrapyramidal syndrome
  • increased libido
  • coordination abnormalities
  • stuttering
  • hallucinations
  • manic reactions
  • neuroses
  • muscle tone abnormalities
  • hostility
  • increased reflexes
  • emotional instability
  • relief
  • paranoid reactions
  • aphasia
  • nystagmus
  • akathisia
  • confusion
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • grand mal seizures
  • decreased muscle tone
  • hepatic myoclonus
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased cough
  • sinusitis
  • nosebleeds
  • bronchitis
  • asthma
  • pneumonia
  • asphyxiation
  • laryngitis
  • pneumothorax
  • hiccups
  • itching
  • rash
  • acne
  • exfoliative dermatitis
  • skin dryness
  • herpes simplex
  • hair loss
  • urticaria
  • shingles
  • skin hypertrophy
  • seborrhea
  • skin ulcers
  • ocular pain
  • abnormal eye accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • overflow incontinence
  • glaucoma
  • auditory hypersensitivity
  • ear pain
  • ocular inflammation
  • temporary hearing loss
  • otitis media
  • loss of taste
  • olfactory disturbance
  • urinary tract infection
  • kidney stones
  • cystitis
  • dysuria
  • urinary incontinence
  • urinary retention
  • vaginitis
  • hematuria
  • breast pain
  • amenorrhea
  • menstrual pain
  • white vaginal discharge
  • erectile dysfunction
  • polyuria
  • urethritis
  • uterine bleeding
  • menorrhagia
  • abnormal ejaculation
  • breast engorgement
  • breast enlargement
  • urgency in urination
  • excessive sedation
  • forgetfulness
  • facial tremors
  • fatigue
  • tinnitus
  • skin and 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
  • suicidal tendencies
  • resentment
  • aggression
  • anger
  • insomnia
  • agitation
  • impulsivity
  • akathisia
  • mania
  • manic/hypomanic episodes
  • seizures
  • hyponatremia
  • serotonin syndrome
  • disorientation
  • 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 tightly sealed container to protect it from air, light, and moisture. It is recommended to maintain the temperature between 2 degrees and 30 degrees. Proper storage will help maintain the drug's efficacy for a long time.

Appearance and packaging

Appearance

Blue oval film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/bottle, For export - 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.