Paxetil CR Tablets (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medication should be taken once daily, usually in the morning, with or without food. Swallow this medication whole; do not chew or crush 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 treatments for major depressive disorder, a sufficient response may be delayed. For some patients who do not respond to 25 mg, the dose may be increased in 12.5 mg increments 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: The acute episode of major depressive disorder requires a period of continuous pharmacological treatment lasting several months or longer. It is not known whether the dose of an antidepressant needed to relieve symptoms is the same as the dose needed to maintain a stable condition. Systematic evaluation of the efficacy of immediate-release paroxetine 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 once daily. The daily dose should not exceed 75 mg. 2) Maintenance therapy: The long-term maintenance of the efficacy of immediate-release paroxetine tablets was demonstrated in a 3-month clinical trial for the prevention of relapse. In this trial, the relapse rate among patients with panic disorder taking immediate-release paroxetine tablets was lower than 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 the need for continued treatment. 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 once daily. If the dose is increased, increase it by 12.5 mg at intervals of at least 7 days; the maximum dose is 37.5 mg once daily. 2) Maintenance therapy: There is no useful evidence regarding how long this medication should be taken. Although the efficacy of this medication was not evaluated beyond 12 weeks in placebo-controlled clinical trials of social anxiety disorder, social anxiety disorder is recognized as a chronic condition, so 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 the need for continued treatment. 4. Premenstrual dysphoric disorder 1) Starting dose: Based on the physician's assessment, this medication may be administered 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 once 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 the need for continued treatment. ○ 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 once 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 to treat 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 treatment with this medication because of the increased risk of serotonin syndrome. For patients who require 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 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, discontinue this medication immediately and administer linezolid or intravenous methylene blue. 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 methylene blue administered by a non-intravenous route (oral tablets or local injection), or with 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 such use. ○ Discontinuation of this medication Symptoms associated with discontinuation of immediate-release paroxetine tablets have been reported. These symptoms should be monitored when treatment is discontinued, regardless of the indication for which it was prescribed. Gradual dose reduction is recommended rather than abrupt discontinuation. If intolerable symptoms occur following dose reduction or discontinuation of this medication, consider resuming the previously prescribed dose. The physician may then continue reducing the dose at a more gradual rate.

This medication is primarily an antidepressant used to treat depression and psychiatric disorders. There may be an increased risk of suicidal thoughts or behaviors during treatment; therefore, close monitoring by a physician is necessary, especially for young patients aged 18 to 24. This medication should not be taken with certain drugs, such as MAO inhibitors, due to the potential for serious side effects. Patients with heart diseases or a history of QT interval prolongation should use this drug cautiously, as interactions with some drugs may increase the risk of side effects. This medication contains lactose and should not be taken by patients with lactose intolerance or certain genetic metabolic disorders. During treatment, various side effects may occur, including changes in blood pressure, dizziness, nausea, drowsiness, insomnia, weight changes, and sexual dysfunction. If severe abnormal symptoms occur, immediate consultation with a healthcare professional is necessary. It is particularly important to taper off the medication gradually instead of stopping suddenly, as withdrawal symptoms like dizziness, anxiety, and sleep disturbances may occur. Women who are pregnant or planning to become pregnant should consult a physician, as taking this medication may increase the risk of cardiovascular malformations or other complications in the fetus. Lactating mothers should consider the potential risk to the newborn, as this medication can be excreted in breast milk. The safety and efficacy of this medication have not been established in children and adolescents, so it is not recommended for this age group. In the event of an overdose, symptoms such as nausea, tremors, drowsiness, and changes in blood pressure may occur, requiring urgent treatment and supportive care. Store in a location out of reach of children, and avoid transferring to another container. Caution is needed when driving or operating machinery during treatment, and the use of alcohol is not recommended. Additionally, there may be an increased tendency to bleed while taking this medication, so caution is warranted when used with other drugs that increase bleeding risk. Finally, this medication may interact with various drugs; therefore, inform your physician or pharmacist of any other medications you are currently taking.

Tachycardia, transient elevation or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, decreased appetite, hyponatremia, blurred vision, pupil dilation, acute glaucoma, nausea, constipation, diarrhea, vomiting, polydipsia, gastrointestinal bleeding, weight gain, asthenia, peripheral edema, elevated liver enzymes, liver disease, dizziness, tremor, headache, extrapyramidal disorder, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, agitation, abnormal dreams, confusion, hallucinations, mania, anxiety, depersonalization, panic attacks, suicidal thoughts and behaviors, urinary retention, incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse reactions, urticaria, photosensitivity reactions, abnormal bleeding of skin and mucous membranes, thrombocytopenia, pancytopenia, agranulocytosis, leukopenia, severe allergic reactions, syndrome of inappropriate antidiuretic hormone secretion, yawning, tinnitus, arthralgia, myalgia, dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, hyperactivity, visual disturbances, emotional instability, irritability, abdominal pain, hyperkinesia, hostility, rigidity, dysuria, urinary dysfunction, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disorders, flushing, weight loss, weight gain, fatigue, chest pain, polydipsia, hypersensitivity, fever, blood pressure changes, involuntary muscle contractions, agitation, anxiety, tachycardia, coma, electrocardiogram changes

This medication should be stored in a tightly closed container protected from light, and it is important to maintain a temperature below 25 degrees Celsius. Proper storage will help preserve the medication's composition and effectiveness.

Appearance

Yellow, round, enteric-coated film tablets

Package unit

30 tablets/bottle, 100 tablets/bottle