Youngjin Paroxetine CR Tablet (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medication should be taken once daily, preferably in the morning, regardless of meals. Swallow this medication whole without chewing or crushing it. 1. Major depressive disorder 1) Starting dose: The recommended initial dose is 25 mg of paroxetine once daily. In clinical trials conducted to demonstrate the efficacy of this medication for the treatment of major depressive disorder, subjects received 25～62.5 mg. As with other medications for the treatment of major depressive disorder, the full effect may be delayed. For some patients who do not respond to 25 mg, the dose may be increased in increments of 12.5 mg up to a maximum of 62.5 mg once daily. Dose changes should be made at intervals of at least 1 week. 2) Maintenance therapy: Acute episodes of major depressive disorder require ongoing pharmacological treatment for several months or longer. It is not known whether the antidepressant dose needed to relieve symptoms is the same as the dose needed to maintain a stable condition. Systematic evaluation of the efficacy of paroxetine immediate-release tablets showed that efficacy was maintained when an average dose of 30 mg (equivalent to 37.5 mg of this medication based on relative bioavailability) was administered for 1 year. 2. Panic disorder 1) Starting dose: The starting dose is 12.5 mg of paroxetine once daily, increased by 12.5 mg each week. In clinical trials conducted to demonstrate the efficacy of this medication, patients received 12.5～75 mg daily. The daily dose should not exceed 75 mg. 2) Maintenance therapy: Long-term maintenance of the efficacy of paroxetine immediate-release tablets was demonstrated in a 3-month clinical trial for prevention of relapse. In this trial, the relapse rate among patients with panic disorder taking paroxetine immediate-release tablets was lower than that among patients taking placebo. Because panic disorder is a chronic condition, it is advisable to continue treatment in patients who respond. The dose of this medication should be adjusted to the minimum effective dose for the patient, and patients should be reassessed periodically to determine whether continued treatment is needed. 3. Social anxiety disorder/social phobia 1) Starting dose: The recommended starting dose is 12.5 mg of paroxetine once daily. In clinical trials conducted to demonstrate the efficacy of this medication for the treatment of social anxiety disorder, patients received 12.5～37.5 mg daily. If the dose is increased, increase it by 12.5 mg at intervals of at least 7 days, up to a maximum dose of 37.5 mg once daily. 2) Maintenance therapy: There is no useful evidence regarding how long this medication should be taken. In placebo-controlled clinical trials for social anxiety disorder, the efficacy of this medication was not evaluated beyond 12 weeks; however, as social anxiety disorder is recognized as a chronic condition, it is advisable to continue treatment in patients who respond. The dose should be adjusted to the minimum effective dose for the patient, and patients should be reassessed periodically to determine whether continued treatment is needed. 4. Premenstrual dysphoric disorder 1) Starting dose: Depending on the physician's assessment, this medication may be taken throughout the entire menstrual cycle or limited to the luteal phase of the menstrual cycle. The recommended starting dose is 12.5 mg of paroxetine once daily. In clinical trials, both 12.5 mg and 25 mg daily were effective. Dose changes should be made at intervals of at least 1 week. 2) Maintenance therapy: In placebo-controlled trials, the efficacy of this medication was not systematically evaluated for periods exceeding 3 menstrual cycles. However, it is generally reported that symptoms worsen with age until menopause begins and the symptoms resolve. Therefore, it is advisable to continue treatment in patients who respond. Patients should be reassessed periodically to determine whether continued treatment is needed. ○ Elderly patients and patients with severe renal/hepatic impairment: The recommended starting dose of this medication for elderly patients and patients with severe renal/hepatic impairment is 12.5 mg of paroxetine once daily. The dose may be increased if necessary, but should not exceed 50 mg daily. ○ Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days must have elapsed after discontinuing this medication. ○ Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a 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 medication. If there is no alternative to linezolid or intravenous methylene blue, and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this medication may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 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 administration of methylene blue by nonintravenous routes (oral tablets or local injection), or intravenous administration of this medication 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. ○ Discontinuation of this medication Symptoms associated with discontinuation of paroxetine immediate-release tablets have been reported. These symptoms should be monitored when discontinuing treatment, regardless of the indication for which it was prescribed. Gradual dose reduction is recommended rather than abrupt discontinuation. If symptoms that cannot be controlled occur during dose reduction or discontinuation of this medication, resuming the previously taken dose should be considered. The physician may then continue reducing the dose at a more gradual rate.

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions. Therefore, when administering to patients in this age group, the physician must carefully assess the risks and benefits. This medication should never be administered to patients who are taking certain medications, particularly MAO inhibitors, as this may lead to severe side effects. Additionally, it should not be given to those with hypersensitivity to this medication or individuals with certain heart conditions, lactose intolerance, etc. Patients on neuroleptics, anticoagulants, those with epilepsy, heart disease, diabetes, etc., should exercise special caution when taking this medication, and the occurrence of side effects should be closely monitored. This medication can cause various adverse reactions, especially during the early stages of administration, including dizziness, nausea, drowsiness, insomnia, and sexual dysfunction. Abrupt discontinuation of the medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced as directed by a physician. This medication is not recommended to be taken with alcohol, and due to the high potential for drug interactions, all medications being taken must be reported to the physician. Women who are pregnant or nursing should consult their physician prior to use to determine potential effects on the fetus or newborn. The safety and efficacy of this medication have not been established in children and adolescents under the age of 18, so it is recommended not to use it in this age group. In cases of overdose, symptoms may include nausea, tremors, drowsiness, and changes in blood pressure. There is no specific antidote, so immediate medical treatment is required. Finally, keep this medication out of the reach of children and take care not to transfer it to another container.

Tachycardia, temporary increase or decrease in blood pressure, orthostatic hypotension, bradycardia, increase in cholesterol levels, decreased appetite, hyponatremia, blurred vision, pupil dilation, acute glaucoma, nausea, constipation, diarrhea, vomiting, thirst, gastrointestinal bleeding, weight gain, weakness, peripheral edema, increase in liver enzymes, liver disease, dizziness, tremors, headaches, extrapyramidal disorders, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, agitation, derealization, panic attacks, suicidal thoughts and suicidal behaviors, urinary retention, incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse reactions, urticaria, photosensitivity reactions, unusual bleeding of the skin and mucous membranes, thrombocytopenia, pancytopenia, agranulocytosis, leukopenia, severe allergic reactions, syndrome of inappropriate antidiuretic hormone secretion, yawning, tinnitus, joint pain, myalgia, dizziness, sensory disturbances, sleep disorders, agitation, anxiety, confusion, sweating, diarrhea, palpitations, emotional instability, irritability, visual disturbances, emotional instability, neuroticism, abdominal pain, hyperactivity, hostility, rigidity, headaches, dysuria, urinary disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disturbances, flush, weight loss, weight gain, fatigue, chest pain, seizures, delayed electrical seizure therapy-induced seizure, secondary seizures, anxiety disorders, psychomotor agitation, hypomania, mania, fractures, serotonin syndrome, blood pressure changes, involuntary muscle contractions, fever, coma, changes in electrocardiogram, death

This medication must be stored in a tightly closed container that blocks light, and the temperature must be kept below 25 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance

Yellow, round enteric-coated film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle