Medication info
Remeron Tablets 15 mg (Mirtazapine)

Remeron Tablets 15 mg (Mirtazapine)

Prescription medicationTablet
Ingredient · strength
Mirtazapine›15mg / 1 tablet
Manufacturer / importer
Organon Korea Co., Ltd.
Appearance
Pale yellow film-coated oval tablet
Packaging
30 tablets (10 tablets/PTP x 3 PTP)
Approval status
Active

MFDS item code 200603875 · Notified 2006.03.27 · Insurance code 073100320

Summary

Main use
Treatment of major depressive disorder
Who uses it
Adults · Children
Adult dosage
The therapeutic dose of this medication should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. 1. Adults The initial dose of mirtazapine is 15mg per day, and the dose may need to be increased until an appropriate clinical response is achieved. The usual effective daily dose is 15~45 mg of this medication. 2. Administration in special populations 1) Patients with renal impairment Clearance of this medication may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); use caution when prescribing. 2) Patients with hepatic impairment Clearance of this medication may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, this medication has not been studied in patients with severe hepatic impairment, so use caution when prescribing. 3) 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 response. 3. Switching to or from MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication, allow an interval of at least 14 days. Conversely, at least 14 days must elapse after discontinuing this medication before starting an MAO inhibitor for the treatment of psychiatric disorders. 4. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medication because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medication 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 medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medication at doses of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses. Because this medication has a half-life of 20∼40 hours, once-daily administration is sufficient; if possible, take it at a regular time in the evening before bedtime. The daily dose may also be divided into equal doses taken once each in the morning and evening. To allow sufficient time to assess the therapeutic response to the dose of this medication, do not change the dose at intervals of less than 1~2 weeks. At an appropriate dose, a therapeutic effect is observed 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. This medication is taken orally. Swallow it with water without chewing.
Children's dosage
Children and adolescents under 18 years of age: Do not use this medicine in children and adolescents under 18 years of age

Ingredients

Importer
Organon Korea Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This medication is used for the treatment of major depression.

Dosage and Administration

Adult dosage

The therapeutic dose of this medication should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. 1. Adults The initial dose of mirtazapine is 15mg per day, and the dose may need to be increased until an appropriate clinical response is achieved. The usual effective daily dose is 15~45 mg of this medication. 2. Administration in special populations 1) Patients with renal impairment Clearance of this medication may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); use caution when prescribing. 2) Patients with hepatic impairment Clearance of this medication may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, this medication has not been studied in patients with severe hepatic impairment, so use caution when prescribing. 3) 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 response. 3. Switching to or from MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication, allow an interval of at least 14 days. Conversely, at least 14 days must elapse after discontinuing this medication before starting an MAO inhibitor for the treatment of psychiatric disorders. 4. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medication because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medication 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 medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medication at doses of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses. Because this medication has a half-life of 20∼40 hours, once-daily administration is sufficient; if possible, take it at a regular time in the evening before bedtime. The daily dose may also be divided into equal doses taken once each in the morning and evening. To allow sufficient time to assess the therapeutic response to the dose of this medication, do not change the dose at intervals of less than 1~2 weeks. At an appropriate dose, a therapeutic effect is observed 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. This medication is taken orally. Swallow it with water without chewing.

Children's dosage

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

Precautions

This medication is an antidepressant used for the treatment of major depression. Particularly in children, adolescents, and young adults, there may be an increased risk of suicidal thoughts or behaviors, so careful medical assessment and close monitoring are necessary for patients in these age groups. This medication can rarely cause serious blood abnormalities, such as agranulocytosis, so if symptoms of infection like fever or sore throat occur during treatment, you should consult a doctor immediately. Patients with diminished liver and kidney function, epilepsy, heart disease, or diabetes should be particularly cautious when using this medication. Drowsiness, dizziness, increased appetite, and weight gain are common side effects; hence, caution is required when engaging in potentially hazardous activities like driving or operating machinery. This medication may interact with other drugs, so if you are taking other medications, you must inform your doctor. It can be especially dangerous when combined with MAO inhibitors or serotonergic agents. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and its use is not recommended for children and adolescents under 18 years old. Overdosing can lead to serious side effects, so you must adhere strictly to the prescribed dosage, and in case of overdose, contact a medical facility immediately. This medication should be stored out of the reach of children, and transferring it to another container should be avoided.

Side effects

  • Drowsiness
  • nausea
  • increased appetite
  • weight gain
  • dizziness
  • weakness
  • flu-like syndrome
  • back pain
  • dry mouth
  • constipation
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  • peripheral edema
  • edema
  • muscle pain
  • abnormal dreams
  • unusual incidents
  • tremors
  • confusion
  • shortness of breath
  • frequent urination
  • lethargy
  • abdominal pain
  • acute abdomen syndrome
  • chills
  • fever
  • facial edema
  • ulcers
  • phototoxic reactions
  • neck stiffness
  • neck pain
  • abdominal distension
  • soft tissue infections
  • chest pain under the sternum
  • hypertension
  • vasodilation
  • angina
  • myocardial infarction
  • bradycardia
  • ventricular ectopy
  • fainting
  • migraine
  • hypotension
  • atrial arrhythmia
  • bigeminy
  • 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 discoloration
  • 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
  • elevated acid phosphatase
  • elevated ALT
  • diabetes
  • hyponatremia
  • myasthenia gravis
  • arthralgia
  • arthritis
  • tendinitis
  • pathologic fracture
  • osteoporotic fracture
  • bone pain
  • myositis
  • tendon rupture
  • osteoarthritis
  • bursitis
  • sensory loss
  • apathy
  • depression
  • diminished motor function
  • dizziness
  • single contraction
  • agitation
  • anxiety
  • amnesia
  • hyperactivity
  • sensory abnormalities
  • ataxia
  • delirium
  • delusions
  • loss of self-esteem
  • dyskinesia
  • extrapyramidal syndrome
  • increased libido
  • abnormal cooperation
  • stuttering
  • hallucinations
  • manic reactions
  • neurosis
  • muscle rigidity
  • hostility
  • increased reflexes
  • emotional instability
  • sense of relief
  • paranoid reactions
  • aphasia
  • nystagmus
  • akathisia
  • confusion
  • dementia
  • diplopia
  • drug dependence
  • paralysis
  • grand mal seizures
  • decreased muscle tone
  • myoclonic jerks
  • psychotic depression
  • withdrawal syndrome
  • serotonin syndrome
  • increased coughing
  • sinusitis
  • nosebleed
  • 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
  • eye pain
  • abnormal accommodation
  • conjunctivitis
  • hearing loss
  • keratoconjunctivitis
  • enuresis
  • glaucoma
  • auditory hypersensitivity
  • ear pain
  • blepharitis
  • temporary hearing loss in parts
  • otitis media
  • loss of taste
  • abnormal sense of smell
  • urinary tract infection
  • kidney stones
  • cystitis
  • dysuria
  • urinary incontinence
  • urinary retention
  • vaginitis
  • hematuria
  • breast pain
  • amenorrhea
  • dysmenorrhea
  • white discharge
  • erectile dysfunction
  • polyuria
  • urethritis
  • uterine bleeding
  • menorrhagia
  • abnormal ejaculation
  • breast engorgement
  • breast enlargement
  • urgency
  • excessive sedation
  • forgetfulness
  • facial tremors
  • fatigue
  • tinnitus
  • skin and mucous membrane syndrome
  • vesicular dermatitis
  • erythema multiforme
  • toxic epidermal necrolysis
  • eosinophilia
  • systemic drug reaction with eosinophilia
  • increased serum creatine kinase
  • rhabdomyolysis
  • oral sensory loss
  • lip swelling
  • bone marrow suppression
  • eosinophilia
  • restless legs syndrome
  • oral sensory abnormalities
  • aggression
  • hyperprolactinemia
  • sleepwalking
  • priapism

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, light, and moisture. In addition, it is important to store it at a cool temperature between 2 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Pale yellow film-coated oval tablet

Package unit

30 tablets (10 tablets/PTP x 3 PTP)

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.