Medication info
Q-Cetin Capsule (Fluoxetine Hydrochloride)

Q-Cetin Capsule (Fluoxetine Hydrochloride)

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

MFDS item code 202106095 · Approved 2021.08.23

Summary

Main use
Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), premenstrual dysphoric disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
Adults 1. Depression 1) Initial treatment: The initial dose is 20 mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20–80 mg/day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg/day should be administered twice daily (morning and noon), and the maximum dose of 80 mg/day 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 medicine; however, psychopharmacologists recognize that acute episodes of depression require several months or more of drug treatment. 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 60 mg/day of this medicine. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg/day of this medicine. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg/day of this medicine. Reassess the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older patients, and patients with comorbid conditions: Use a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Nova M Healthcare Co., Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • psychomotor agitation
  • psychomotor retardation
  • lack of interest in daily life
  • decreased sexual desire
  • feelings of guilt
  • feelings of worthlessness
  • slowed thinking
  • decreased concentration
  • suicide attempts
View approved original text

This medication is used to treat depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. In cases of depression, it is effective for persistent depressive moods and various symptoms that interfere with daily functioning, with therapeutic effects appearing within 5-6 weeks. In bulimia nervosa, it effectively reduces binge eating and purging behaviors. In obsessive-compulsive disorder, it alleviates obsessions and compulsions, reducing difficulties in social and work life. It helps improve emotional symptoms such as depression and anxiety that occur periodically in patients with premenstrual dysphoric disorder and alleviates physical discomfort. However, when using this medication for long periods, it is necessary to regularly evaluate its efficacy for each patient. This medication is utilized to effectively improve the symptoms of these disorders.

Dosage and Administration

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20 mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20–80 mg/day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg/day should be administered twice daily (morning and noon), and the maximum dose of 80 mg/day 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 medicine; however, psychopharmacologists recognize that acute episodes of depression require several months or more of drug treatment. 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 60 mg/day of this medicine. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg/day of this medicine. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg/day of this medicine. Reassess the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older patients, and patients with comorbid conditions: Use a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication is an antidepressant used to treat psychiatric disorders like depression. Caution is especially warranted when administering it to children, adolescents, and young adults aged 18 to 24, as there is an increased risk of suicidal thoughts or behavior. When using this medication, the patient's condition should be carefully monitored, and if abnormal behaviors such as suicidal tendencies or aggression occur, healthcare personnel should be notified immediately. This medication should not be administered to certain patients, such as those with allergies to this drug or its ingredients, severe renal impairment, and those currently taking monoamine oxidase inhibitors. It should also not be given to patients with genetic issues like lactose intolerance. Patients with a history of seizures should exercise particular caution while using this medication and discontinue use if seizures occur or increase in frequency. Patients at risk of suicide require careful monitoring from the onset of treatment, and this medication should not be given to those presenting manic symptoms. Caution is also needed for patients with heart issues or impaired liver or kidney function. In patients with diabetes, blood sugar control may vary, necessitating careful monitoring of their blood sugar status. Common side effects of this medication may include headaches, nausea, insomnia, fatigue, and diarrhea, while rarer side effects may include allergic reactions, cardiac arrhythmias, bleeding, and skin rashes. Notably, abrupt cessation of the medication can lead to withdrawal symptoms like dizziness and sleep disturbances; therefore, dosage should be gradually reduced according to medical advice. This medication can interact with other drugs, so patients should always inform their doctor or pharmacist of any other medications they are taking, especially caution is needed when combined with monoamine oxidase inhibitors, anticoagulants, or cardiac medications. Women who are pregnant or breastfeeding should carefully consider the use of this medication due to potential effects on the fetus or newborn, and should discuss usage with healthcare professionals if needed. The safety and efficacy of this medication in children and adolescents have not been sufficiently established, so its use is not recommended. No special adverse reactions have been reported in elderly patients, but caution is advised based on other diseases or medications. Overdose of this medication can lead to severe symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias, thus strict adherence to dosing guidelines is essential, and immediate contact with medical facilities should be sought in case of overdose. Finally, this medication must be kept out of reach of children and should not be transferred to other containers to maintain the quality and safety of the medication.

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 disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention disorder, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, hypertonic muscle spasms, convulsions, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurry vision, dilated pupils, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency to bruise, cold sweats, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myalgia, frequent urination, dysuria, urine retention, urination disorders, gynecological bleeding, erectile dysfunction, orgasm 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 disorders, asthenia, agitation, anxiety, tremors, headache, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestasis 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 protect it from air and moisture. It is also recommended to store it at room temperature between 1 °C and 30 °C.

Appearance and packaging

Appearance

A hard capsule with a green upper part and a pale yellow 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.