Paroxetin Tablets 10 mg (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medication should preferably be taken once daily with breakfast. Swallow it whole without chewing. In general, treatment is recommended for a sufficient period to allow symptoms to resolve. After the first satisfactory response occurs following initiation of treatment, continued administration may prevent relapse. For depressive disorders, treatment should be continued for at least 4～6 months after symptoms resolve; for obsessive-compulsive disorder and panic disorder, treatment may be continued for a longer period. As with other psychoactive drugs, treatment should not be stopped abruptly (see Adverse Reactions). As with other antidepressants, the dose should be reviewed within 2～3 weeks after starting treatment and appropriately adjusted if necessary; thereafter, it should be adjusted as clinically appropriate. If this medication is used long term, the need for continued long-term use should be reassessed regularly for each patient. Major depressive disorder: The recommended oral dose is 20 mg of paroxetine once daily. Some patients may require an increase in dose; in such cases, increase the dose gradually by 10 mg according to the patient's response. The maximum daily dose is 50 mg. Obsessive-compulsive disorder: The recommended oral dose is 40 mg of paroxetine once daily. Start treatment at 20 mg once daily; the dose may be increased by 10 mg each week. The maximum daily dose is 60 mg. Panic disorder: The recommended oral dose is 40 mg of paroxetine once daily. Start treatment at 10 mg once daily; the dose may be increased by 10 mg each week according to the patient's response. Some patients may require an increase in the daily dose to a maximum of 60 mg. Since symptoms of panic disorder are known to possibly worsen at the start of treatment, a low initial dose is recommended. Generalized anxiety disorder (GAD): The recommended oral dose is 20 mg of paroxetine once daily. Patients who do not respond to this dose may have their daily dose increased gradually by 10 mg each week, up to a maximum of 50 mg. Post-traumatic stress disorder (PTSD): The recommended oral dose is 20 mg of paroxetine once daily. For patients who do not respond to this dose, the dose may be increased by 10 mg as needed, up to a maximum of 50 mg. In placebo-controlled trials of post-traumatic stress disorder, the efficacy of this medication was not evaluated beyond 12 weeks. Social anxiety disorder/social phobia: The recommended oral dose is 20 mg of paroxetine once daily. For patients who do not respond to this dose after at least 2 weeks, the daily dose may be increased to a maximum of 50 mg. Depending on the patient's response, increase the dose by 10 mg at intervals of at least 1 week. The efficacy of this medication for social anxiety disorder/social phobia was demonstrated in 12-week placebo-controlled trials; however, data on use beyond 12 weeks are limited. Elderly patients: Blood concentrations of this medication may be higher in elderly patients. The recommended initial dose is 10mg/day; increase the dose gradually by 10 mg per week according to the patient's response. The maximum daily dose is 40 mg. Patients with renal or hepatic impairment: Blood concentrations of this medication may be higher in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or hepatic impairment. The recommended dose is 20 mg once daily. If an increase is necessary, the dose should be limited to the lowest dose. 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, 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 after discontinuing this medication. Other MAO inhibitors such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue must not start this medication because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization or other interventions, treatment should be considered. If linezolid or intravenous methylene blue must be administered urgently to a patient already receiving this medication, and 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 in a particular patient, this medication may be stopped 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 occurs first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous 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.

Children's dosage

Use of this medicine is not recommended in children because its efficacy and safety have not been established.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders, so careful observation is needed during use. This medication should not be given to patients with an allergy to any component of this drug or those taking monoamine oxidase inhibitors (MAOIs). Caution is advised when using this drug in patients with heart disease or impaired liver or kidney function, those with a tendency to bleed, or those taking certain medications. Various side effects such as dizziness, nausea, headache, drowsiness, insomnia, weight changes, etc., may occur with this medication, so changes in symptoms need to be carefully monitored. Especially abrupt discontinuation of this medication may result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, dosage should be reduced gradually under the guidance of a physician. Co-administration with alcohol is not recommended, and potential drug interactions should be communicated if the patient is taking other medications. Women who are pregnant or planning to become pregnant should consult a physician due to potential risks to the fetus from this medication. It is best not to use this medication in children and adolescents under 18 years of age due to the lack of established safety and efficacy. In case of overdose, symptoms such as nausea, dilated pupils, tremors, and anxiety may occur, so the prescribed dosage should be strictly followed, and immediate medical consultation should be sought in case of any abnormalities. This medication should be stored out of the reach of children, and transferring it to another container should be avoided.

Tachycardia, temporary rise or fall 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, weakness, peripheral edema, elevated liver enzymes, liver disease, dizziness, tremors, headache, extrapyramidal symptoms, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, anxiety, depersonalization, panic attacks, suicidal thoughts and behaviors, urinary retention, urinary incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse 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 disturbances, anxiety, restlessness, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances, emotional instability, irritability, abdominal pain, hyperactivity, hostility, rigidity, dysuria, urination 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, tachycardia, coma, electrocardiogram changes

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is best to keep it at room temperature between 1°C and 30°C. By doing so, the effectiveness of the medication can be maintained for a longer period.

Appearance

Yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle