Parox C R Tablet 12.5 mg (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medication should be taken once daily, usually 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 in 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 by 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: Acute episodes of major depressive disorder require continuous pharmacological treatment for 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 state. Systematic evaluation of the efficacy of immediate-release paroxetine tablets showed that efficacy was maintained with an average dose of 30 mg (equivalent to 37.5 mg of this medication based on relative bioavailability) 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: Long-term maintenance of the efficacy of immediate-release paroxetine tablets was demonstrated in a 3-month clinical trial for relapse prevention. In this trial, the relapse rate among patients with panic disorder taking immediate-release paroxetine tablets was lower than that among patients taking placebo. Since panic disorder is a chronic condition, it is advisable to continue treatment in patients who respond. Adjust the dose of this medication to the minimum effective dose for the patient, and periodically reassess patients 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 in 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. The efficacy of this medication in social anxiety disorder was not evaluated beyond 12 weeks in placebo-controlled clinical trials. However, since social anxiety disorder is recognized as a chronic condition, it is advisable to continue treatment in patients who respond. Adjust the dose to the minimum effective dose for the patient, and periodically reassess patients 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 restricted 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: The efficacy of this medication has not been systematically evaluated for periods exceeding 3 menstrual cycles in placebo-controlled trials. 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 periodically reassessed 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 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 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, this medication may be stopped immediately and linezolid or intravenous methylene blue administered. The patient 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks 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, are 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 immediate-release paroxetine 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 intolerable symptoms occur following dose reduction or discontinuation of this medication, resuming the previously prescribed dose may be considered. The physician may then continue reducing the dose at a more gradual rate.

This medication is an antidepressant used to treat psychiatric disorders such as major depressive disorder. This medication may increase the risk of suicidal thoughts or behavior, particularly in young adults aged 18 to 24; hence, care should be taken when prescribing it to patients in this age group, and risks versus benefits should be carefully evaluated by the physician. This medication can be dangerous when taken with certain medications, especially with MAO inhibitors or drugs that can prolong the QT interval, and therefore should not be administered to patients currently taking these medications. Additionally, this medication contains lactose, so patients with lactose intolerance or related genetic disorders should avoid taking it. Patients with cardiac disease, liver or kidney dysfunction, tendency to bleed, diabetes, or a history of mania should exercise caution when using this medication. While taking this medication, various side effects such as dizziness, headache, nausea, drowsiness, insomnia, sexual dysfunction, etc., may occur, thus symptoms should be monitored closely. Particularly, discontinuing this medication abruptly can lead to withdrawal symptoms such as dizziness, anxiety, sleep disturbances; therefore, the dosage should be tapered off gradually under medical supervision. Caution is advised while driving or operating machinery, and co-administration with alcohol is not recommended. Pregnant women or those planning to become pregnant should consult their physician as this medication may affect the fetus; breastfeeding women should also consider its impact on the newborn before deciding to take it. This medication has not been sufficiently proven safe and effective for children and adolescents, so it is not recommended for these groups. In case of overdose, symptoms such as nausea, dilated pupils, tremors, and drowsiness may occur, and in severe cases, immediate medical attention may be required. Finally, this medication should be kept out of the reach of children, and it should not be transferred to other containers.

Tachycardia, transient increase or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, decreased appetite, hyponatremia, blurred vision, pupil dilation, acute glaucoma, nausea, constipation, diarrhea, vomiting, thirst, gastrointestinal bleeding, weight gain, asthenia, peripheral edema, increased liver enzymes, liver disease, dizziness, tremor, headache, extrapyramidal symptoms, akathisia, seizure, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, anxiety, derealization, panic attacks, suicidal ideation and behavior, 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 disorders, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, hyperactivity, visual impairment, emotional instability, irritability, abdominal pain, hyperactivity, hostility, rigidity, dysuria, urinary disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disorders, flushing, weight loss, weight gain, fatigue, chest pain, thirst, hypersensitivity, fever, blood pressure changes, involuntary muscle contractions, anxiety, tachycardia, coma, electrocardiogram changes

This medication is sensitive to light; therefore, it should be stored in a container that prevents light exposure. It is also recommended to store it at a cool temperature below 25 degrees Celsius.

Appearance

Yellow, round enteric-coated tablet

Package unit

100 tablets/box [10 tablets/PTP x 10], 30 tablets/bottle, 200 tablets/bottle