Medication info
Mirtax ODT 30 mg (Mirtazapine)

Mirtax ODT 30 mg (Mirtazapine)

Prescription medicationOrally disintegrating Tablet
Ingredient · strength
Mirtazapine›30mg / 1 tablet
Manufacturer / importer
Samil Pharm. Co., Ltd.
Appearance
White round orally disintegrating tablet with a flat double-sided shape and a distinctive odor
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 200803427 · Approved 2008.03.28 · Insurance code 643903940

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 15 mg per day, and the dose may need to be increased until an adequate clinical effect is achieved. The usual effective daily dose is 15~45 mg of this medicine. Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance<40 mL/min); use caution when prescribing. Clearance of this medicine may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as this population has not been studied. 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 medicine, allow an interval of at least 14 days. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of a psychiatric disorder. Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. In patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventions, consider treatment. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this medicine. If there are no alternative medicines 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 medicine 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 comes 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 a non-intravenous route (oral tablets or local injection), or 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. 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. 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 evaluate the therapeutic response to the dose, do not change the dose at intervals shorter than 1~2 weeks. At an appropriate dose, a therapeutic effect appears within 2~4 weeks. If the effect is insufficient, the dose may be increased up to the maximum dose. Discontinue treatment if there is no effect after continuing treatment for an additional 2~4 weeks. 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 quickly on the tongue and can be swallowed without water. To prevent this medicine from breaking, do not press the tablet in its packaging (Figure 1). Each package contains 10 tablets, separated by perforations. As shown in Figures 2 and 3, bend the package along the perforations to separate the tablets, and detach one tablet. As shown in Figures 4 and 5, hold the marked area on the back and carefully peel off the backing in the direction of the arrow. Remove the tablet with dry hands and place it on the tongue.
Children's dosage
Do not use this medicine in children and adolescents under 18 years of age.

Ingredients

Importer
Samil Pharm. Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depressive disorder
View approved original text

This medication is used for the treatment of major depressive disorder. Major depressive disorder is characterized by persistent feelings of sadness and loss of interest, and this medication helps alleviate these symptoms and improve the patient's daily functioning.

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 15 mg per day, and the dose may need to be increased until an adequate clinical effect is achieved. The usual effective daily dose is 15~45 mg of this medicine. Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance<40 mL/min); use caution when prescribing. Clearance of this medicine may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as this population has not been studied. 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 medicine, allow an interval of at least 14 days. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of a psychiatric disorder. Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. In patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventions, consider treatment. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this medicine. If there are no alternative medicines 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 medicine 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 comes 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 a non-intravenous route (oral tablets or local injection), or 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. 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. 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 evaluate the therapeutic response to the dose, do not change the dose at intervals shorter than 1~2 weeks. At an appropriate dose, a therapeutic effect appears within 2~4 weeks. If the effect is insufficient, the dose may be increased up to the maximum dose. Discontinue treatment if there is no effect after continuing treatment for an additional 2~4 weeks. 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 quickly on the tongue and can be swallowed without water. To prevent this medicine from breaking, do not press the tablet in its packaging (Figure 1). Each package contains 10 tablets, separated by perforations. As shown in Figures 2 and 3, bend the package along the perforations to separate the tablets, and detach one tablet. As shown in Figures 4 and 5, hold the marked area on the back and carefully peel off the backing in the direction of the arrow. Remove the tablet with dry hands and place it on the tongue.

Children's dosage

Do not use this medicine in children and adolescents under 18 years of age.

Precautions

This medication is primarily used for the treatment of depression. There may be an increase in suicidal thoughts or behaviors during treatment, so young patients, especially those between the ages of 18 and 24, should be closely monitored. Additionally, this medication can rarely cause a serious blood condition called agranulocytosis, so consult a doctor immediately if symptoms of infection, such as sore throat or fever, occur. This medication should be used cautiously in patients with poor liver or kidney function, and patients with heart diseases or low blood pressure should also be cautious. Drowsiness or dizziness may occur frequently during treatment, so care should be taken when driving or operating machinery. Increased appetite and weight gain may commonly occur, so it is advisable to check weight regularly. This medication is contraindicated in patients with certain genetic disorders and may interact with other medications, so patients should inform their doctor of any other medications they are taking. Women who are pregnant, planning to become pregnant, or breastfeeding must consult a doctor before taking this medication. Sudden discontinuation of this medication may cause withdrawal symptoms, so it should be tapered off gradually under a doctor’s supervision. In the event of overdose, serious side effects may occur, so it is important to adhere to the prescribed dosage and keep it out of reach of children.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • weakness
  • flu-like syndrome
  • lower back pain
  • dry mouth
  • constipation
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  • peripheral edema
  • myalgia
  • abnormal dreams
  • abnormal events
  • tremors
  • confusion
  • dyspnea
  • frequent urination
  • lethargy
  • abdominal pain
  • acute abdominal syndrome
  • chills
  • fever
  • facial edema
  • ulcers
  • photosensitivity reactions
  • 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
  • cardiac hypertrophy
  • phlebitis
  • left heart failure
  • vomiting
  • reduced appetite
  • belching
  • glossitis
  • cholecystitis
  • gum bleeding
  • stomatitis
  • colitis
  • abnormal liver function tests
  • tongue discoloration
  • 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
  • elevated alkaline phosphatase
  • elevated ALT
  • diabetes mellitus
  • 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
  • hyperactivity
  • sensory disturbances
  • ataxia
  • delirium
  • delusion
  • loss of self-identity
  • movement disorders
  • extrapyramidal syndrome
  • increased libido
  • impaired coordination
  • stuttering
  • hallucinations
  • manic reaction
  • neurosis
  • muscle rigidity
  • hostility
  • increased reflexes
  • emotional instability
  • euphoria
  • paranoid reaction
  • aphasia
  • nystagmus
  • inability to sit still
  • confusion
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • generalized seizures
  • reduced muscle tone
  • hypertrophic muscle cramps
  • 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
  • alopecia
  • urticaria
  • herpes zoster
  • dermal hypertrophy
  • seborrhea
  • skin ulcers
  • ocular pain
  • abnormal eye accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • overflow incontinence
  • glaucoma
  • hyperacusis
  • ear pain
  • blepharitis
  • temporary unilateral hearing loss
  • otitis media
  • loss of taste
  • abnormal olfaction
  • urinary tract infection
  • kidney stones
  • cystitis
  • dysuria
  • incontinence
  • urinary retention
  • vaginitis
  • hematuria
  • mastalgia
  • amenorrhea
  • dysmenorrhea
  • white vaginal discharge
  • erectile dysfunction
  • polyuria
  • urethritis
  • uterine bleeding
  • menorrhagia
  • abnormal ejaculation
  • breast congestion
  • breast enlargement
  • urgency
  • excessive sedation
  • forgetfulness
  • facial tremors
  • fatigue
  • tinnitus
  • Sjögren's syndrome
  • bullous dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory impairment
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs
  • oral sensory abnormalities
  • aggression
  • suicidal tendencies
  • insomnia
  • anxiety
  • agitation
  • panic disorder
  • excitement
  • hostility
  • aggression
  • impulsivity
  • inability to sit still
  • hypomania
  • mania
  • mania/hypomania
  • seizures
  • hyponatremia
  • serotonin syndrome
  • loss of spatial orientation
  • memory impairment
  • tachycardia
  • QT prolongation
  • Tolsad de Pointes arrhythmia

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is important to keep the temperature below 30 degrees Celsius. This will help maintain the medication's effectiveness and safety for a longer period.

Appearance and packaging

Appearance

White round orally disintegrating tablet with a flat double-sided shape and a distinctive odor

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

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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.