Paxil CR Tablet 12.5 mg (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medicine should be taken once daily, mainly in the morning, with or without food. Swallow this medicine whole. Do not chew or crush it. 1. Major depressive disorder 1) Initial dosage: The recommended initial dosage is 25 mg of paroxetine once daily. In clinical trials conducted to demonstrate the efficacy of this medicine in treating major depressive disorder, subjects received 25～62.5 mg. As with other medicines for major depressive disorder, a sufficient response may be delayed. For some patients who do not respond to 25 mg, the dosage may be increased in 12.5 mg increments, up to a maximum of 62.5 mg once daily. Allow at least 1 week between dosage changes. 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 dosage of an antidepressant needed to relieve symptoms is the same as the dosage needed to maintain a stable state. A 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 medicine based on relative bioavailability) was administered for 1 year. 2. Panic disorder 1) Initial dosage: The initial dosage 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 dosage should not exceed 75 mg. 2) Maintenance therapy: The long-term maintenance of efficacy of paroxetine immediate-release 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 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. Adjust the dosage of this medicine to the lowest effective dose for the patient, and periodically reassess patients to determine whether continued treatment is necessary. 3. Social anxiety disorder/social phobia 1) Initial dosage: The recommended initial dosage is 12.5 mg of paroxetine once daily. In clinical trials conducted to demonstrate the efficacy of this medicine in treating social anxiety disorder, patients received 12.5～37.5 mg once daily. If the dosage is increased, increase it by 12.5 mg at intervals of 7 days or longer; the maximum dosage is 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 of social anxiety disorder, social anxiety disorder is recognized as a chronic condition, so it is advisable to continue treatment in patients who respond. Adjust the dosage to the lowest effective dose for the patient, and periodically reassess patients to determine whether continued treatment is necessary. 4. Premenstrual dysphoric disorder 1) Initial dosage: Based on the physician's assessment, this medicine may be administered throughout the entire menstrual cycle or restricted to the luteal phase of the menstrual cycle. The recommended initial dosage is 12.5 mg of paroxetine once daily. In clinical trials, both 12.5 mg and 25 mg once daily were effective. Allow at least 1 week between dosage changes. 2) Maintenance therapy: In placebo-controlled trials, the efficacy of this medicine has not been 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. Periodically reassess patients to determine whether continued treatment is necessary. ○ Elderly patients and patients with severe renal/hepatic impairment: The recommended initial dosage of this medicine for elderly patients and patients with severe renal/hepatic impairment is 12.5 mg of paroxetine once daily. The dosage may be increased if necessary, but should not exceed 50 mg once daily. ○ Switching from or to MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed since discontinuing this medicine. ○ Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine 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 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. Monitor the patient 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks 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 are 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 paroxetine immediate-release tablets have been reported. Monitor for these symptoms 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 medicine, consider restarting the previously prescribed dose. The physician may then continue reducing the dosage at a more gradual rate.

This medication may increase the risk of suicidal thoughts and behaviors in young patients with major depressive disorder or other psychiatric disorders, particularly in children, adolescents, and young adults aged 18 to 24. Therefore, extreme caution is advised when using this medication. Concomitant use with certain medications can be dangerous. In particular, it is absolutely prohibited to take this medication with monoamine oxidase (MAO) inhibitors or to start MAO inhibitors within 14 days of discontinuing this medication. Patients with certain heart diseases or taking medications that can prolong the QT interval should not use this medication. Patients with genetic issues such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption should not take this medication. Special caution should be exercised when administering this medication to patients with a history of seizures, heart disease, diabetes, mania, bleeding tendencies, narrow-angle glaucoma, severe liver impairment, and renal impairment. Various side effects such as dizziness, nausea, headache, drowsiness, insomnia, sexual dysfunction, and skin rash may occur during the course of treatment. If any unusual symptoms persist, consult your physician. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, the dosage should be gradually reduced under medical supervision. It is not recommended to take this medication with alcohol, and you must inform your doctor of all medications you are currently taking due to the possibility of drug interactions. Women who are pregnant or planning to become pregnant should consult their physician before taking this medication, and caution is necessary as the drug may be transmitted through breast milk while breastfeeding. Finally, this medication has not been established for safety and efficacy in children and adolescents under 18 years of age, and it is advisable not to use it in this population. If symptoms of suicidal thoughts, worsening depression, or abnormal behavioral changes occur during treatment, consult your physician immediately, and family members or caregivers should closely monitor the patient’s condition.

Tachycardia, temporary elevation or decrease of 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 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 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, palpitations, emotional instability, irritability, visual impairment, emotional instability, irritability, abdominal pain, hyperactivity, hostility, rigidity, headache, 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, drowsiness, coma, ECG changes, death

This medication is sensitive to light; therefore, it should be stored in a container that does not allow light to enter. It is also advisable to store it at a cool temperature below 25 degrees Celsius.

Appearance

Yellow, round, biconvex, film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)