Medication info
Youngproctin Capsule 10 mg (Fluoxetine Hydrochloride)

Youngproctin Capsule 10 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Youngpoong Pharmaceutical Co., Ltd.
Appearance
A hard green capsule filled with white or grayish powder.
Packaging
30 capsules/bottle, 500 capsules/bottle
Approval status
Active

MFDS item code 201901937 · Approved 2019.03.29

Summary

Main use
Treatment of depressive and obsessive-compulsive disorders, premenstrual dysphoric disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
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 per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be administered twice daily (morning and noon), and the maximum dose of 80mg per day must 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 medication, but psychopharmacologists agree that acute signs of depression require drug treatment for several months or longer. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this medication per day. The daily dose must not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medication per day. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medication per day. Reassess the need for continued treatment after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with concomitant illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately 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 medication, allow an interval of at least 14 days. Conversely, at least 5 weeks must elapse after discontinuing this medication 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 must not start treatment with this medication because of the increased risk of serotonin syndrome. For patients who require more urgent treatment for a psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to administer linezolid or intravenous methylene blue urgently to a patient already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, this medication 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 medication 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 doses of this medication 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
Youngpoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of depressive and obsessive-compulsive disorders, premenstrual dysphoric disorder, and bulimia nervosa

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or psychomotor retardation
  • loss of interest in daily activities
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowed thinking
  • decreased concentration
  • suicide attempts
View approved original text

This medication is effective for the treatment of depression, generally showing symptom improvement within 5 to 6 weeks. Depression includes persistent sadness and various symptoms (changes in appetite and sleep, fatigue, guilt, decreased concentration, etc.), and this medication helps alleviate these symptoms. It is also used to reduce symptoms associated with bulimia nervosa and obsessive-compulsive disorder. This medication is used to relieve depression, anxiety, and physical symptoms associated with premenstrual dysphoric disorder. However, it is important to regularly reassess effectiveness for each patient during long-term treatment. In summary, this medication is used to treat depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

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 per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be administered twice daily (morning and noon), and the maximum dose of 80mg per day must 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 medication, but psychopharmacologists agree that acute signs of depression require drug treatment for several months or longer. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this medication per day. The daily dose must not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medication per day. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medication per day. Reassess the need for continued treatment after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with concomitant illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately 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 medication, allow an interval of at least 14 days. Conversely, at least 5 weeks must elapse after discontinuing this medication 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 must not start treatment with this medication because of the increased risk of serotonin syndrome. For patients who require more urgent treatment for a psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to administer linezolid or intravenous methylene blue urgently to a patient already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, this medication 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 medication 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 doses of this medication 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 mainly used to treat psychiatric disorders such as depression. During treatment, especially young patients between 18 and 24 years old, may have an increased risk of suicidal thoughts or behaviors, so doctors and families should closely monitor the patient's condition. This medication should not be given to certain patients, such as those who are allergic to this drug or its components, have significant renal impairment, or are taking specific other medications (MAO inhibitors). Patients with a history of seizures or a high risk of suicide, or those with bipolar disorder or heart disease, should use this medication cautiously and report any changes in symptoms to healthcare professionals immediately. Because this medication is metabolized and excreted by the liver and kidneys, dose adjustments may be needed for patients with impaired liver or kidney function. Diabetic patients may be affected in their blood sugar control and should regularly check their blood sugar levels. Patients with glaucoma who have increased pressure in the eyes should exercise caution when taking this medication. Common side effects such as headaches, nausea, insomnia, fatigue, and diarrhea may occur, and rarely serious side effects such as allergic reactions or cardiac arrhythmias can occur. Suddenly stopping the treatment can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to the doctor's instructions. This medication should only be used during pregnancy when the risks to the fetus are considered minimal. Caution is also necessary during breastfeeding, as this medication may be excreted in breast milk. Safety for children and adolescents has not been established, and it is generally not recommended for this age group. Taking this medication with other drugs or alcohol may result in interactions, so it is necessary to inform the doctor of any other medications being taken. Activities requiring attention, such as driving or operating machinery, may be affected as judgment or reaction times may be impaired after taking this medication. In cases of overdose, severe side effects may occur, and immediate medical attention is required; therefore, store this medication in a safe place out of reach of children.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste distortion, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, paroxysmal muscle cramps, seizures, inability to sit still, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, respiratory events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, itching, hyperhidrosis, increased tendency for bruising, clammy sweat, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequency of urination, dysuria, urinary retention, urination 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, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe skin, kidney, liver, or pulmonary reactions, suicidal ideation, suicidal behavior, hostility, manic reaction, growth retardation, decreased alkaline phosphatase levels, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hypoglycemia, immune-related hemolytic anemia, renal failure, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, petechiae, purpura, abnormal bleeding from the skin, hemorrhagic diarrhea, melena, gastric ulcer bleeding, Stevens-Johnson syndrome, toxic epidermal necrolysis, inability to sit still, psychomotor restlessness

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture. Additionally, avoid storing the medication in very hot or very cold locations, and it is safe to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

A hard green capsule filled with white or grayish powder.

Package unit

30 capsules/bottle, 500 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.