Mirtazapine 45 mg Tablet

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 used. Adults: The initial dose of mirtazapine is 15mg daily, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose of this medicine is 15~45 mg. Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); therefore, caution should be exercised when prescribing it. Clearance of this medicine may be reduced in patients with hepatic impairment; therefore, caution should be exercised when prescribing it. In particular, caution is required when prescribing it to patients with severe hepatic impairment, as it has not been studied in this population. 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. When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. The half-life of this medicine is 20∼40 hours, so once-daily administration is sufficient; if possible, take it at a consistent time in the evening before bedtime. Alternatively, the daily dose of this medicine may 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. With an appropriate dose, a therapeutic effect is seen 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 a further 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. This medicine is taken orally. Swallow it with water without chewing it.

Children's dosage

Children and adolescents under 18 years of age: This medicine should not be used in children or adolescents under 18 years of age.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or psychiatric disorders, so it should be used with caution. Rarely, agranulocytosis, which is a decrease in white blood cell count, may occur during treatment with this medication; if symptoms such as sore throat, fever, or infection develop, consult a physician immediately. Patients with poor liver or kidney function should use caution while taking this medication, as the drug concentration may vary depending on liver and kidney function. This medication may cause drowsiness and dizziness; therefore, caution should be exercised while driving or operating machinery, especially during the early stages of treatment. Increased appetite and weight gain may commonly occur, so regular monitoring of weight changes is advisable. This medication may interact with other drugs, so if you are taking any other medications, you must inform your physician or pharmacist. Taking this medication with alcohol may enhance central nervous system depressant effects; therefore, it is advisable to avoid alcohol consumption while taking this medication. Women who are pregnant or may become pregnant, as well as those who are breastfeeding, should consult a physician before taking this medication. This medication is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not been established. Older adults may be more sensitive to this medication, so caution is required during use. Sudden discontinuation of this medication may result in withdrawal symptoms; therefore, the dosage should be gradually reduced according to a physician's instructions. If depressive symptoms worsen or abnormal behaviors such as suicidal thoughts, aggression, or anxiety occur while taking this medication, immediate consultation with medical personnel is required. In the case of overdose, symptoms such as loss of directional sense, drowsiness, and memory impairment may occur, and immediate medical intervention is necessary in emergencies. This medication should be kept out of reach of children, and it is advisable not to transfer it to another container.

Drowsiness, nausea, increased appetite, weight gain, dizziness, weakness, flu-like syndrome, low back pain, dry mouth, constipation, peripheral edema, myalgia, abnormal dreams, unusual behavior, tremor, confusion, shortness of breath, frequent urination, lethargy, abdominal pain, acute abdominal syndrome, chills, fever, facial swelling, ulcer, photosensitivity reaction, 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, bigeminy, vascular headache, pulmonary embolism, cerebral ischemia, cardiac hypertrophy, 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 saliva secretion, intestinal obstruction, pancreatitis, aphthous stomatitis, liver cirrhosis, gastritis, gastroenteritis, oral candidiasis, tongue swelling, goiter, hypothyroidism, lymphadenopathy, leukopenia, petechial hemorrhage, anemia, thrombocytopenia, lymphocytosis, pancytopenia, thirst, dehydration, weight loss, gout, elevated AST, abnormal healing, increased alkaline phosphatase, elevated ALT, diabetes, hyponatremia, myasthenia gravis, arthralgia, arthritis, tendinitis, pathological fractures, osteoporotic fractures, bone pain, myositis, tendon rupture, arthrosis, bursitis, sensory decrease, apathy, depression, reduced motor function, dizziness, single contraction, restlessness, anxiety, amnesia, hyperactivity, sensory abnormalities, ataxia, delirium, hallucinations, loss of self-image, movement disorders, extrapyramidal syndrome, increased libido, coordination abnormalities, stuttering, hallucinations, manic responses, neurosis, muscle tone abnormalities, hostility, increased reflexes, emotional instability, feelings of safety, paranoid reactions, aphasia, nystagmus, inability to sit still, confusion, dementia, double vision, drug dependence, paralysis, grand mal seizure, reduced muscle tone, glycosuria, psychotic depression, withdrawal syndrome, serotonin syndrome, increased coughing, sinus inflammation, nosebleeds, bronchitis, asthma, pneumonia, asphyxia, laryngitis, pneumothorax, hiccups, itching, rash, acne, exfoliative dermatitis, dry skin, herpes simplex, hair loss, hives, shingles, skin thickening, seborrhea, skin ulcer, ocular pain, abnormal eye accommodation, conjunctivitis, hearing loss, keratoconjunctivitis, overflow incontinence, glaucoma, auditory hyperreactivity, ear pain, blepharitis, temporary hearing loss in parts, 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 discharge, erectile dysfunction, polyuria, urethritis, uterine bleeding, menorrhagia, abnormal ejaculation, breast engorgement, breast enlargement, urgent urination, excessive sedation, forgetfulness, facial tremors, fatigue, tinnitus, mucocutaneous syndrome, bullous dermatitis, erythema multiforme, toxic epidermal necrolysis, increased eosinophils, systemic symptoms accompanying drug reactions, increased serum creatine kinase, rhabdomyolysis, oral sensory decrease, lip swelling, bone marrow suppression, eosinophilia, restless legs syndrome, oral sensory abnormalities, aggression, hyperprolactinemia, sleepwalking, priapism, loss of spatial orientation, memory impairment, tachycardia

This medication should be stored in a container that is not permeable to light and air, and it should be kept at a temperature between 2°C and 30°C while avoiding humid areas. Proper storage will help maintain the medication's effectiveness for a long time.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle