Medication info
Myeongmun Mirtaodi Tablets 30mg (Mirtazapine)

Myeongmun Mirtaodi Tablets 30mg (Mirtazapine)

Prescription medicationOrally disintegrating TabletOral · Intravenous injection
Ingredient · strength
Mirtazapine›30mg / 1 tablet
Manufacturer / importer
Myeongmun Pharmaceutical Co., Ltd.
Appearance
White round tablets with an orange flavor
Packaging
30 tablets (10 tablets/ PTP X 3)
Approval status
Active

MFDS item code 201800907 · Approved 2018.02.23 · Insurance code 649807290

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. Adults: The initial dose of mirtazapine is 15 mg daily, and the dose may be increased until an appropriate clinical effect is achieved. The usual effective daily dose of this medicine is 15~45 mg. Patients with renal impairment: Clearance of this medicine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 mL/min); use caution when prescribing. Patients with hepatic impairment: 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 this medicine has not been studied in these patients. Elderly patients: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe effect. Switching from MAO inhibitors used to treat psychiatric disorders: 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, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 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 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 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 of this medicine, do not change 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 effect is insufficient, the dose may be increased to the maximum dose. If there is no effect after continuing treatment for another 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. To prevent this medicine from breaking, do not push the tablet through the packaging (Figure 1). Each package contains 6 tablets, separated by perforations. As shown in Figures 2 and 3, bend the package along the perforation to separate each tablet, and remove 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. With dry hands, remove the tablet and place it on the tongue.
Children's dosage
Do not use this medicine in children and adolescents under 18 years of age because its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Children and Adolescents under Precautions for Use).

Ingredients

Manufacturer
Myeongmun Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This medication is used to treat major depression. Major depression is characterized by severe mood decline and loss of motivation, and this drug helps alleviate symptoms and assists in the recovery of the patient's daily life.

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. Adults: The initial dose of mirtazapine is 15 mg daily, and the dose may be increased until an appropriate clinical effect is achieved. The usual effective daily dose of this medicine is 15~45 mg. Patients with renal impairment: Clearance of this medicine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 mL/min); use caution when prescribing. Patients with hepatic impairment: 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 this medicine has not been studied in these patients. Elderly patients: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe effect. Switching from MAO inhibitors used to treat psychiatric disorders: 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, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 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 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 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 of this medicine, do not change 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 effect is insufficient, the dose may be increased to the maximum dose. If there is no effect after continuing treatment for another 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. To prevent this medicine from breaking, do not push the tablet through the packaging (Figure 1). Each package contains 6 tablets, separated by perforations. As shown in Figures 2 and 3, bend the package along the perforation to separate each tablet, and remove 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. With dry hands, remove the tablet and place it on the tongue.

Children's dosage

Do not use this medicine in children and adolescents under 18 years of age because its efficacy was not demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Children and Adolescents under Precautions for Use).

Precautions

This medication is an antidepressant used to treat psychiatric disorders such as depression. When taking this medication, the risk of suicidal thoughts or behaviors may be increased, particularly in young patients aged 18 to 24, so doctors and guardians should closely monitor the patient’s condition. A rare condition called agranulocytosis, characterized by a sudden drop in white blood cell count due to bone marrow suppression, may occur, and in this case, the patient should consult a doctor immediately if they experience a sore throat or fever. If jaundice symptoms appear due to liver dysfunction, the medication should be discontinued immediately. The artificial sweetener aspartame contained in this medication can be harmful to patients with a specific genetic disorder called phenylketonuria, so these patients should not take it. This medication is contraindicated for concurrent use with certain drugs, especially monoamine oxidase inhibitors (MAOIs), as it may lead to life-threatening serotonin syndrome, so it must be discussed with a physician. Patients with impaired liver or kidney function, heart disease, or diabetes should use this medication more cautiously. While taking this medication, common side effects such as drowsiness, dizziness, increased appetite, and weight gain may occur, thus caution is advised while driving or operating machinery. This medication should be administered cautiously to women who are pregnant or breastfeeding, and if pregnancy is planned or confirmed, it is essential to inform a doctor. The safety and efficacy in children and adolescents have not been established, so they are generally not administered this medication; however, if administration is necessary, careful observation for side effects, such as suicidal tendencies, is required. In elderly patients, the excretion of the drug may be reduced, necessitating caution during administration. In the event of overdose, decreased consciousness, drowsiness, and cardiac abnormalities may occur, requiring immediate treatment at a medical facility. This medication should be kept out of reach of children and should not be transferred to other containers. Alcohol consumption should be avoided while taking this medication, and the doctor should be informed if other medications are being taken. This medication may cause withdrawal symptoms like dizziness, anxiety, headache, and nausea with sudden discontinuation, so when stopping, it should be gradually reduced according to a doctor's guidance.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • weakness
  • flu-like syndrome
  • low back pain
  • dry mouth
  • constipation
Show 211 more
  • peripheral edema
  • swelling
  • myalgia
  • abnormal dreams
  • delusions
  • tremors
  • confusion
  • shortness of breath
  • frequent urination
  • lethargy
  • abdominal pain
  • acute abdomen syndrome
  • chills
  • fever
  • facial swelling
  • ulcers
  • photosensitivity reaction
  • neck stiffness
  • neck pain
  • abdominal distention
  • soft tissue inflammation
  • chest pain under the sternum
  • hypertension
  • vasodilation
  • angina
  • myocardial infarction
  • bradycardia
  • premature ventricular contractions
  • syncope
  • migraine
  • hypotension
  • atrial arrhythmia
  • ectopic heartbeat
  • vascular headache
  • pulmonary embolism
  • cerebral ischemia
  • cardiomegaly
  • phlebitis
  • left heart failure
  • vomiting
  • decreased appetite
  • belching
  • stomatitis
  • cholecystitis
  • gum bleeding
  • oral mucositis
  • colitis
  • abnormal liver function tests
  • tongue depigmentation
  • ulcerative stomatitis
  • salivary gland hypertrophy
  • excessive salivation
  • 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 alkaline phosphatase
  • elevated ALT
  • diabetes
  • hyponatremia
  • myasthenia
  • arthralgia
  • arthritis
  • tendinitis
  • pathological fractures
  • osteoporosis-related fractures
  • bone pain
  • myositis
  • tendon rupture
  • arthrosis
  • bursitis
  • sensory decrease
  • apathy
  • depression
  • decreased motor function
  • dizziness
  • single contraction
  • agitation
  • anxiety
  • amnesia
  • hyperkinesia
  • sensory abnormalities
  • ataxia
  • delirium
  • hallucinations
  • ego dissolution
  • movement disorders
  • extrapyramidal syndrome
  • increased libido
  • coordination abnormalities
  • stuttering
  • delusions
  • manic responses
  • neurosis
  • muscle tone abnormalities
  • hostility
  • hyperreflexia
  • emotional instability
  • euphoria
  • paranoid responses
  • aphasia
  • nystagmus
  • inability to sit still
  • confusion
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • tonic-clonic seizure
  • decreased muscle tone
  • toxic muscle spasms
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased cough
  • 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 ulcers
  • ocular pain
  • abnormal eye accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • lacrimal drainage disorder
  • glaucoma
  • auditory hyperreactivity
  • ear pain
  • eye inflammation
  • temporary hearing loss in one ear
  • otitis media
  • loss of taste
  • abnormal olfaction
  • 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 congestion
  • breast enlargement
  • urgent urination
  • excessive sedation
  • forgetfulness
  • facial tremors
  • fatigue
  • tinnitus
  • skin and mucous membrane syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory decrease
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs syndrome
  • oral sensory abnormalities
  • aggressiveness
  • suicidal tendencies
  • suicidal impulses
  • suicidal behavior

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 contact with air or moisture, and it is best kept in a cool place below 30 degrees Celsius. This storage method helps maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

White round tablets with an orange flavor

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.