Medication info
Zerojak Capsule (Fluoxetine Hydrochloride)

Zerojak Capsule (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Korea PMG Pharmaceutical Co., Ltd.
Appearance
A hard capsule containing white to grayish-white powder with a yellowish-brown upper and lower part.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 200401412 · Notified 2004.09.09

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 the 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 the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine, but psychopharmacologists agree that acute episodes of depression require several months or longer of drug treatment. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as the amount needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this medicine daily. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with comorbid conditions: Administer a low dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from or to MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, at least 5 weeks must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of a psychiatric disorder. 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, other interventions should be considered. 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine 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 medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by nonintravenous routes (oral tablets or local injection) or with 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 these uses.

Ingredients

Manufacturer
Korea PMG Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Depression
  • discomfort
  • changes in appetite
  • changes in sleep
  • agitation
  • retardation
  • loss of interest
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowed thinking
View approved original text

This medication is used to treat various mental health issues such as depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. In patients with depression, symptoms usually improve within about 5-6 weeks, helping alleviate persistent feelings of sadness and a variety of physical and mental symptoms. In bulimia nervosa, it reduces binge eating and related symptoms, while it decreases obsessive thoughts and behaviors in patients with obsessive-compulsive disorder, thereby alleviating discomfort in daily life. It is also effective for premenstrual dysphoric disorder, helping relieve cyclical emotional instability and physical symptoms. However, it is important to regularly reassess its usefulness for individual patients during prolonged use. This medication is used to improve these 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 the 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 the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine, but psychopharmacologists agree that acute episodes of depression require several months or longer of drug treatment. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as the amount needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this medicine daily. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with comorbid conditions: Administer a low dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from or to MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, at least 5 weeks must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of a psychiatric disorder. 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, other interventions should be considered. 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine 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 medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by nonintravenous routes (oral tablets or local injection) or with 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 these uses.

Precautions

This medication is primarily used to treat psychiatric disorders such as depression. During the use of this medication, there may be an increase in suicidal thoughts or behaviors, particularly in young patients aged 18 to 24, who require close monitoring by a physician. This medication should not be used if there is a known allergy to it, severe renal impairment, or if currently taking certain medications (MAO inhibitors). Patients with a history of seizures or a high risk of suicide should use this medication with caution, and any changes in symptoms or unusual behavior during treatment should be reported to a physician immediately. Patients with heart disease or impaired liver function need to be careful when using this medication, and especially might require an electrocardiogram. Diabetic patients may be affected in their blood sugar management, so their blood sugar should be monitored regularly and medication adjustments made as needed. This medication can cause pupil dilation, so patients with high intraocular pressure or at risk of glaucoma should be cautious. Common side effects during treatment may include headaches, nausea, insomnia, fatigue, diarrhea, etc., and rarely severe allergic reactions, bleeding, or liver function abnormalities may occur. Suddenly stopping the treatment may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and tremors, so dosage should be gradually reduced according to a physician's instructions. This medication may interact with other medications, so patients should inform their doctor or pharmacist of any other medications they are taking, and alcohol consumption should be avoided. During pregnancy, there may be risks to the fetus, so it should only be used when absolutely necessary, and if breastfeeding, it is advised to consider discontinuing breastfeeding as the medication can be passed through breast milk. The safety for children and adolescents has not been established, so its use is not recommended. Elderly patients should also use this medication with caution, and in case of overdose, they should seek medical attention immediately. This medication should be kept out of the reach of children and should not be transferred to other containers.

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 disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorders, sexual desire disorders, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and actions, confusion, attention deficit, dizziness, taste disturbances, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, fasciculation, spasms, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, tendency for increased bruising, sweating, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased urinary frequency, dysuria, urinary retention, voiding dysfunction, gynecological bleeding, erectile dysfunction, ejaculatory dysfunction, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, weakness, restlessness, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe skin, kidney, liver, or pulmonary-related reactions, weight loss, growth delay, sexual maturity delay, sexual dysfunction, hyponatremia, platelet function changes, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, dyskinesia, 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, akathisia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the effectiveness of the medication.

Appearance and packaging

Appearance

A hard capsule containing white to grayish-white powder with a yellowish-brown upper and lower part.

Package unit

30 capsules/bottle, 100 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.