Medication info
Parma Mirtazapine 7.5 mg (Mirtazapine)

Parma Mirtazapine 7.5 mg (Mirtazapine)

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

MFDS item code 202402771 · Approved 2024.11.25 · Insurance code 653007030

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 15mg daily, and the dose may need to be increased until an appropriate clinical effect is achieved. The usual effective daily dose is 15~45 mg of this medicine. 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 to patients with severe hepatic impairment, as this group has not been studied. Older adults: 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 psychiatric disorders 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 psychiatric disorders. Treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventions, consider administering this medicine. 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 considered 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at doses of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses. Since 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 evaluate the therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1~2 weeks. Treatment at an appropriate dose usually produces a therapeutic effect within 2~4 weeks. If the therapeutic effect is insufficient, the dose may be increased up to the maximum dose. If there is no effect after continuing treatment for a further 2~4 weeks, discontinue treatment. Treatment should be continued 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 medicine has not been demonstrated in two short-term clinical trials, and due to safety concerns, this medicine should not be used in children and adolescents under 18 years of age.

Ingredients

Manufacturer
Korea Pharma 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. Adults: The initial dose of mirtazapine is 15mg daily, and the dose may need to be increased until an appropriate clinical effect is achieved. The usual effective daily dose is 15~45 mg of this medicine. 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 to patients with severe hepatic impairment, as this group has not been studied. Older adults: 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 psychiatric disorders 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 psychiatric disorders. Treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventions, consider administering this medicine. 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 considered 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at doses of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses. Since 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 evaluate the therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1~2 weeks. Treatment at an appropriate dose usually produces a therapeutic effect within 2~4 weeks. If the therapeutic effect is insufficient, the dose may be increased up to the maximum dose. If there is no effect after continuing treatment for a further 2~4 weeks, discontinue treatment. Treatment should be continued 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 medicine has not been demonstrated in two short-term clinical trials, and due to safety concerns, this medicine should not be used in children and adolescents under 18 years of age.

Precautions

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so the physician must exercise caution in prescribing it. While taking this medication, careful observation for worsening depressive symptoms, suicidal tendencies, aggression, anger, and other abnormal behavioral changes should be performed, and family or guardians should also monitor the patient closely. This medication can cause serious blood disorders such as agranulocytosis, so if sore throat, fever, or signs of infection occur, consult a doctor immediately. If jaundice occurs, stop taking this medication. Contains an artificial sweetener called aspartame; therefore, patients with certain genetic disorders such as phenylketonuria should not take it. Serious side effects may occur if this medication is taken with certain drugs, especially MAO inhibitors, so it should not be administered concurrently. Patients with liver or kidney impairment, epilepsy, diabetes, heart disease, etc., should use this medication with special caution. Side effects such as drowsiness, dizziness, increased appetite, and weight gain may commonly occur, so caution should be exercised when driving or operating machinery. Taking this medication with alcohol may enhance the central nervous system depressant effects, so it is advisable to avoid alcohol consumption. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and its use is not recommended for children and adolescents. In case of overdose, symptoms such as disorientation, drowsiness, memory impairment, and heart rhythm abnormalities may occur; immediate medical attention is required. This medication should be kept out of reach of children and not transferred to other containers. While taking this medication, regular check-ups for adverse reactions or side effects should be conducted according to the physician's guidance.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • weakness
  • flu syndrome
  • lower back pain
  • dry mouth
  • constipation
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  • peripheral edema
  • edema
  • myalgia
  • abnormal dreams
  • hallucinations
  • tremors
  • confusion
  • dyspnea
  • frequent urination
  • lethargy
  • abdominal pain
  • acute abdomen syndrome
  • chills
  • fever
  • facial edema
  • ulcers
  • photosensitivity reaction
  • neck stiffness
  • neck pain
  • abdominal distension
  • soft tissue inflammation
  • chest pain beneath the sternum
  • hypertension
  • vasodilation
  • angina
  • myocardial infarction
  • bradycardia
  • ventricular ectopic beats
  • syncope
  • migraine
  • hypotension
  • atrial fibrillation
  • ectopic beats
  • vascular headache
  • 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 depigmentation
  • ulcerative stomatitis
  • salivary gland enlargement
  • 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
  • increased acid phosphatase
  • elevated ALT
  • diabetes
  • 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
  • restlessness
  • anxiety
  • amnesia
  • hyperactivity
  • sensory abnormalities
  • ataxia
  • delirium
  • delusions
  • loss of self-identity
  • movement disorders
  • extrapyramidal syndrome
  • increased libido
  • coordination disorders
  • stuttering
  • hallucinations
  • manic reaction
  • neurosis
  • muscle hypertonia
  • hostility
  • increased reflexes
  • emotional instability
  • a sense of fortune
  • paranoid responses
  • aphasia
  • nystagmus
  • sitting incapacity
  • stupor
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • tonic-clonic seizure
  • muscle hypotonia
  • clonic muscle spasms
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased cough
  • sinusitis
  • nosebleed
  • bronchitis
  • asthma
  • pneumonia
  • suffocation
  • 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
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • overflow incontinence
  • glaucoma
  • auditory hypersensitivity
  • ear pain
  • eye inflammation
  • temporary hearing loss in parts
  • otitis media
  • taste loss
  • abnormal smell
  • 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 congestion
  • breast enlargement
  • urgency to urinate
  • excessive sedation
  • forgetfulness
  • facial tremor
  • fatigue
  • tinnitus
  • skin-mucosal syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory loss
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs syndrome
  • oral sensory disturbances
  • aggression
  • 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 container that is protected from light and in a dry place. The appropriate storage temperature is between 2°C and 30°C.

Appearance and packaging

Appearance

Blue oval film-coated tablets

Package unit

100 tablets/bottle, 30 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.