Medication info
Citalopram Capsule 20 mg (Fluoxetine Hydrochloride)

Citalopram Capsule 20 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Sears Pharmaceuticals Co., Ltd.
Appearance
A hard capsule with green upper part and yellowish lower part filled with white to grayish-white powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201908289 · Approved 2019.12.08

Summary

Main use
Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), bulimia nervosa, and premenstrual dysphoric disorder
Who uses it
Adults
Adult dosage
Adults 1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20~80mg daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks or longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but psychopharmacologists recognize that acute symptoms of depression require drug treatment for several months or longer. It is not known whether the amount of antidepressant required to relieve symptoms is the same as that required to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this drug daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug daily. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. 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 drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must have elapsed after discontinuing this drug. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. In patients who require more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available and, in a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 5 weeks after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this drug at doses of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Sears Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), bulimia nervosa, and premenstrual dysphoric disorder

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or retardation of psychomotor activity
  • loss of interest in daily life or decreased sexual desire
  • increased fatigue
  • feelings of guilt or worthlessness
  • slowing of thoughts or decreased concentration
  • suicidal attempts or thoughts
  • binging
  • purging behavior
  • obsession
View approved original text

This medication is used to treat various psychiatric symptoms such as depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. For patients with depression, therapeutic effects typically appear within 5 to 6 weeks, helping to improve symptoms such as persistent sadness, appetite, sleep, and concentration. In bulimia nervosa, it reduces binge-eating and purging behaviors. For patients with obsessive-compulsive disorder, it decreases obsessions and compulsions, alleviating difficulties in social functioning. In premenstrual dysphoric disorder, it contributes to reducing periodic depression, anxiety, and physical symptoms which enhances the quality of life. However, in all cases, the patient's condition should be regularly assessed during long-term administration. This drug is effectively used to treat these various symptoms.

Dosage and Administration

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20~80mg daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks or longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but psychopharmacologists recognize that acute symptoms of depression require drug treatment for several months or longer. It is not known whether the amount of antidepressant required to relieve symptoms is the same as that required to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this drug daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug daily. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. 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 drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must have elapsed after discontinuing this drug. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. In patients who require more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available and, in a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 5 weeks after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this drug at doses of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication is used for the treatment of major depression and psychiatric disorders, and particularly in children, adolescents, and young adults, there may be an increased risk of suicidal thoughts and behaviors; therefore, careful evaluation is required before administration. It should not be administered to patients with hypersensitivity, severe renal impairment, and those currently taking MAO inhibitors, as combining with MAO inhibitors can lead to serious side effects and is contraindicated. Caution should be exercised in patients with a history of seizures, and treatment should be discontinued immediately if seizures occur or worsen. Mental changes such as suicidal thoughts, aggression, anxiety, and mania may occur during treatment with this medication, and symptoms should be closely monitored by both the patient and their guardians. Patients with cardiovascular disease or those at risk of QT interval prolongation need an electrocardiogram (ECG) before administration, and should discontinue the drug immediately if abnormal signs appear. Dosage adjustment is required for patients with impaired liver or kidney function, and patients with diabetes should carefully monitor their blood glucose levels. This medication can cause pupil dilation and caution should be taken for patients at risk for increased intraocular pressure. Common side effects during treatment may include headache, nausea, insomnia, fatigue, and diarrhea, and rarely serious allergic reactions, bleeding, or liver dysfunction may occur. Suddenly discontinuing this medication can cause withdrawal symptoms such as dizziness, sensory disturbances, and sleep disorders, so it should be tapered according to the doctor's instructions. This medication may pose potential risks to the fetus during pregnancy, and pregnant women should consult their physician before administration; caution is also required during breastfeeding as it can be excreted in breast milk and affect the baby. The safety in children and adolescents has not been established, and it is ideally avoided; it should be administered with careful observation in the elderly. In cases of overdose, symptoms may include nausea, vomiting, seizures, and cardiac arrhythmia, necessitating immediate medical intervention. This medication can interact with other drugs, and all medications being taken should be reported to the doctor, with avoidance of alcohol consumption recommended. Additionally, caution should be exercised while driving vehicles or operating hazardous machinery while taking this medication. This drug should be kept out of reach of children and should not be transferred to other containers for safety.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, benign myoclonus, convulsions, inability to sit still, Bucco-Glossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, increased tendency for bruising, sweating, angioedema, petechiae, photosensitivity reaction, purpura, erythema multiforme, arthralgia, myalgia, frequency of urination, dysuria, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe skin, renal, hepatic, or pulmonary-related reactions, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive 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 exposure to air or moisture and kept at room temperature between 1 and 30 degrees Celsius. This helps to safely maintain the medication's effectiveness.

Appearance and packaging

Appearance

A hard capsule with green upper part and yellowish lower part filled with white to grayish-white powder.

Package unit

30 capsules/bottle, 300 capsules/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.

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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.