Parox CR Tablets 25 mg (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medication should be taken once daily, usually in the morning, regardless of meals. 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 in the treatment of major depressive disorder, subjects received 25～62.5 mg. As with other treatments for major depressive disorder, an adequate 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 onset of major depressive disorder requires continuous 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. A 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: Long-term maintenance of the efficacy of immediate-release paroxetine tablets was demonstrated in a 3-month relapse-prevention trial. 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 lowest effective dose for the patient, and patients should be periodically reassessed 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. Although the efficacy of this medication was not evaluated beyond 12 weeks in placebo-controlled clinical trials of social anxiety disorder, the condition is recognized as chronic, so it is advisable to continue treatment in patients who respond. The dose should be adjusted to the lowest effective dose for the patient, and patients should be periodically reassessed to determine the need for continued treatment. 4. Premenstrual dysphoric disorder 1) Starting dose: Depending on the physician's assessment, this medication may be administered throughout the entire menstrual cycle or only during 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 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 for the treatment of psychiatric disorders, at least 14 days must have elapsed since 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 requiring 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 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 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 comes first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medication at doses 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 immediate-release paroxetine tablets have been reported. Patients should be monitored for these symptoms when treatment is discontinued, 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 prescribed dose should be considered. The physician may then continue reducing the dose at a more gradual rate.

This drug is an antidepressant used to treat psychiatric disorders such as depression. While taking this medication, the risk of suicidal thoughts or behaviors may increase, especially in young patients aged 18 to 24, who require close observation by their physician. This drug should not be taken with certain medications; for example, serious side effects can occur when used in combination with MAO inhibitors or certain heart medications. Patients with allergies to any ingredient in this medication or specific genetic metabolic issues should not be administered this drug. Patients with heart disease, liver or kidney dysfunction, bleeding tendencies, and patients with diabetes should take special precautions when using this medication. During treatment, various side effects such as dizziness, headache, digestive disturbances, drowsiness, insomnia, sexual dysfunction, and skin rash may occur; if symptoms are severe, consultation with a physician is required. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to the physician's advice. Women who are pregnant or breastfeeding should consult their physician as this medication may affect the fetus or newborn. The safety and efficacy of this medication in children and adolescents have not been sufficiently established, hence use is not recommended. In case of overdose, symptoms such as nausea, tremors, and changes in blood pressure may occur, and immediate medical attention should be sought. This medication should be stored out of reach of children and transferring it to other containers should be avoided. Caution is needed when driving or operating machinery during treatment, and concomitant use with alcohol is not recommended. If new symptoms arise or existing symptoms worsen during treatment, consultation with a physician is required immediately.

Tachycardia, temporary rise or fall 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, asthenia, peripheral edema, increase in 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 ideation and suicidal behavior, urinary retention, incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin reactions, urticaria, photosensitivity reactions, abnormal bleeding of the 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, agitation, anxiety, confusion, sweating, palpitations, emotional instability, irritability, vision impairment, emotional instability, nervousness, abdominal pain, hyperactivity, hostility, rigidity, headache, dysuria, voiding disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disturbances, flushing, weight loss, weight gain, fatigue, chest pain, thirst, hypersensitivity, fever, blood pressure changes, involuntary muscle contractions, agitation, anxiety, tachycardia

This drug is sensitive to light and should be stored in a special container that does not allow light in. Moreover, it is important to store it in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance

Pink round enteric-coated film-coated tablets

Package unit

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