Paroxetine 10 mg Tablet (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medication should preferably be taken once daily with breakfast. Swallow it 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 continue 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 medications, 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 adjusted as appropriate if necessary, and thereafter adjusted as considered clinically appropriate. When this medication is used long term, its long-term use should be reassessed regularly for each individual patient. 1. 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, the dose should be increased gradually in 10 mg increments according to the patient's response. The maximum daily dose is 50 mg. 2. Obsessive-compulsive disorder The recommended oral dose is 40 mg of paroxetine once daily. Treatment may be initiated at 20 mg daily and increased by 10 mg each week. The maximum daily dose is 60 mg. 3. Panic disorder The recommended oral dose is 40 mg of paroxetine once daily. Treatment may be initiated at 10 mg daily and 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. As panic disorder is generally known to have the potential for worsening symptoms early in treatment, a low initial dose is recommended. 4. 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 gradually increased by 10mg each week, up to a maximum of 50mg. 5. Post-traumatic stress disorder (PTSD) The recommended oral dose is 20 mg of paroxetine once daily. Patients who do not respond to this dose may have their dose increased by 10 mg as needed, up to a maximum of 50 mg. The efficacy of this medication for post-traumatic stress disorder has not been evaluated beyond 12 weeks in placebo-controlled trials. 6. Social anxiety disorder/social phobia The recommended oral dose is 20 mg of paroxetine once daily. Patients who do not respond to this dose after at least 2 weeks may have their daily dose increased to a maximum of 50 mg. Dose changes should be made in 10 mg increments at intervals of at least 1 week, according to the patient's response. The efficacy of this medication for social anxiety disorder/social phobia was demonstrated in 12-week placebo-controlled trials; however, data on use for more than 12 weeks are limited. ○ Elderly patients: Blood concentrations of this medication may be higher in elderly patients. The recommended initial dose is 10mg/day, which may be increased 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 daily. If an increase is necessary, the dose should be limited to the lowest dose. ○ Switching from MAO inhibitors used to treat psychiatric disorders At least 14 days should elapse after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this medication. Conversely, at least 14 days should elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. ○ Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or an intravenous methylene blue product 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 or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue product to a patient already receiving this medication. If no alternative to linezolid or an intravenous methylene blue product is available and, in a particular patient, the benefits of treatment with linezolid or an intravenous methylene blue product are judged to outweigh the risk of serotonin syndrome, this medication may be stopped immediately and linezolid or an intravenous methylene blue product administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or an intravenous methylene blue product, or until 24 hours after the last dose, whichever occurs first. Treatment with this medication may be resumed 24 hours after the last dose of linezolid or an intravenous methylene blue product. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medication at a dose 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

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

This medication is an antidepressant used for the treatment of major depressive disorder and other psychiatric conditions. During the use of this medication, there may be an increase in suicidal thoughts or behavior, so careful judgment and continuous monitoring by a physician is required, especially for young patients aged between 18 and 24. It should not be used by those who are allergic to this medication or those taking certain medications, especially MAO inhibitors. Patients with a history of heart disease or QT interval prolongation, bleeding tendencies, and those with severely impaired liver or kidney functions should exercise special caution when using this medication. Various side effects may occur from this medication, such as neurological symptoms, gastrointestinal disorders, weight changes, sexual dysfunction, and skin rashes, so if any abnormal symptoms appear, consult a physician immediately. Especially, sudden discontinuation of this medication may lead to withdrawal symptoms like dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced upon discontinuation as directed by a physician. This medication can interact with other drugs, so it is essential to inform your physician or pharmacist about any other medications you are taking. Pregnant or breastfeeding women should consult their physician before taking this medication, and particular caution is necessary during the early and late stages of pregnancy. It is recommended not to use this medication in children and adolescents as safety and efficacy have not been established. In case of overdose, symptoms such as nausea, dilated pupils, tremors, anxiety, sweating, drowsiness may appear, and in severe cases, immediate medical attention is required. This medication should be kept out of the reach of children and should not be transferred to another container. Care should be taken when driving or operating machinery during the use of this medication, and if there are changes in mental status or abnormal behavior, medical consultation should be sought immediately.

Tachycardia, temporary 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 disorder, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, unease, depersonalization, panic attacks, suicidal thoughts and behaviors, urinary retention, incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, serious 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 disorders, anxiety, confusion, sweating, palpitations, emotional instability, irritability, vision disturbances, emotional instability, irritability, abdominal pain, hyperactivity, hostility, rigidity, headache, 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, anxiety, tachycardia

This medication should be kept in a tightly closed container to prevent air and moisture from entering and should be stored at room temperature between 1 to 30 degrees Celsius. Storing in this manner will help maintain the medication's efficacy for a longer period.

Appearance

Biconvex yellow film-coated tablets with a rectangular shape

Package unit

30 tablets/bottle, 100 tablets/bottle