Paroxetine CR Tablets 12.5 mg (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medicine should be taken once daily, usually in the morning, with or without food. Swallow this medicine 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 medicine for the treatment of major depressive disorder, subjects received 25～62.5 mg. As with other treatments for major depressive disorder, adequate effects 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: Acute episodes of major depressive disorder require continued 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. 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 medicine based on relative bioavailability) was given 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 medicine, 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 prevention of relapse. In this trial, the relapse rate among patients with panic disorder taking immediate-release paroxetine 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 medicine should be adjusted to the minimum 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 medicine 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, up to a maximum dose of 37.5 mg once daily. 2) Maintenance therapy: There is no useful evidence on how long this medicine should be taken. Although the efficacy of this medicine was not evaluated beyond 12 weeks in placebo-controlled clinical trials for social anxiety disorder, social anxiety disorder is considered 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 periodically reassessed to determine the need for continued treatment. 4. Premenstrual dysphoric disorder 1) Starting dose: Based on the physician's assessment, this medicine 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 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 medicine was not systematically evaluated for periods exceeding 3 menstrual cycles. However, it is commonly 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 medicine for elderly patients and patients with severe renal/hepatic impairment is 12.5 mg of paroxetine once daily. The dose may be increased if needed, 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 medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. ○ Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine 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 medicine. 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 medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medicine 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 medicine 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 symptoms that cannot be controlled occur following dose reduction or discontinuation of this medicine, resumption of the previously prescribed dose should be considered. The physician may then continue reducing the dose at a more gradual rate.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric illnesses, so the physician must assess carefully before administration. This medication should not be administered to patients with an allergy to this drug or its components, or those taking certain types of drugs like MAO inhibitors. Patients with heart-related diseases or those taking specific medications, as well as those with bleeding tendencies or issues with liver or kidney function, should be especially cautious when taking this medication. Various side effects such as dizziness, nausea, drowsiness, insomnia, and sexual dysfunction may occur during use; if symptoms worsen or abnormal behavior is observed, consult a physician immediately. Abruptly discontinuing this medication may cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage must be gradually reduced according to the physician's instructions. This medication may interact with other drugs, particularly heart-related drugs, anticoagulants, and some psychiatric medications, so caution is needed when taken together. Pregnant or breastfeeding women should consult a physician before taking this medication due to potential effects on the fetus or newborn. It is preferable not to administer this medication to children and adolescents under 18 years of age as its safety and efficacy have not been sufficiently demonstrated. In case of overdose, symptoms such as vomiting, dizziness, and blood pressure changes may occur, so strictly adhere to the prescribed dose and visit a medical facility immediately in case of overdose. This medication should be stored out of reach of children, and it is safer to not transfer it to other containers.

Tachycardia, temporary increase or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, decreased appetite, hyponatremia, blurred vision, pupillary dilation, acute glaucoma, nausea, constipation, diarrhea, vomiting, dry mouth, gastrointestinal bleeding, weight gain, weakness, peripheral edema, increased 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, excessive lactation, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse reactions, urticaria, photosensitivity reactions, abnormal bleeding from 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, irritability, vision disturbances, emotional instability, nervousness, abdominal pain, hyperactivity, hostility, rigidity, dysuria, urinary disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disorders, flush, weight loss, weight gain, fatigue, chest pain, dry mouth, hypersensitivity, fever, blood pressure changes, involuntary muscle contractions, tachycardia

This medication is sensitive to light, so it should be stored in a container that does not allow light exposure. Additionally, it is important to store it at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow round enteric-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle