Paroxetine 10mg Tablets (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medicine 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 is achieved following initiation of treatment, continuing treatment may prevent relapse. For depressive disorders, treatment should continue for at least 4～6 months after symptoms have resolved; for obsessive-compulsive disorder and panic disorder, treatment may be continued for a longer period. As with other psychoactive medicines, 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 needed; thereafter, it should be adjusted as considered clinically appropriate. When this medicine is used long term, its long-term use should be periodically reassessed for each individual patient. 1. Major depressive disorder The recommended oral dose is 20 mg of paroxetine once daily. Some patients may require a dose increase; in such cases, increase the dose in increments of 10 mg 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. Start treatment at 20 mg once daily and increase 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. Start treatment at 10 mg once daily and increase 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 may worsen at the beginning of treatment for panic disorder, it is generally recommended to start with a low dose. 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 increased in increments of 10 mg each week, up to a maximum of 50 mg. 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 in increments of 10 mg as needed, up to a maximum of 50 mg. The efficacy of this medicine 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 increments of 10 mg at intervals of at least 1 week, according to the patient's response. The efficacy of this medicine for social anxiety disorder/social phobia has been demonstrated in 12-week placebo-controlled trials; however, data on use beyond 12 weeks are limited. Blood concentrations of this medicine may be elevated in elderly patients. The recommended initial dose is 10mg/day, which may be increased in increments of 10 mg per week according to the patient's response. The maximum daily dose is 40 mg. Blood concentrations of this medicine may be elevated 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 needed, the dose should be limited to the lowest dose necessary. When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, 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 after discontinuing this medicine. Treatment with this medicine must not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventional procedures, treatment 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 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 occurs first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a nonintravenous route (oral tablets or local injection) or with intravenous administration of this medicine 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 such use.

Children's dosage

The efficacy and safety of this medication have not been established in children; therefore, its use is not recommended.

Caution is required when administering this drug to children, adolescents, and young adults (ages 18-24) with major depressive disorder or other psychiatric disorders because of the increased risk of suicidal thoughts or behavior. Before taking this medication, one should not have any allergic reactions or combine it with specific drugs, especially MAO inhibitors, as this may increase the risk of serotonin syndrome, a serious side effect. Patients with a history of heart disease or QT interval prolongation, diabetes, bleeding tendencies, and severely impaired liver or kidney function should be cautious when using this medication. During treatment, one must closely observe for exacerbation of depressive symptoms, suicidal impulses, aggression, anxiety, insomnia, and other mental symptoms, and families or caregivers should also monitor the patient's condition. This drug can cause various side effects, with common ones including nausea, headaches, drowsiness, insomnia, weight changes, and sexual dysfunction. Rarely, liver function abnormalities, cardiac arrhythmias, and serious skin reactions may occur. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, the dosage should be gradually reduced according to the physician's instructions. Taking this medication with alcohol is not recommended, and there is a high possibility of interactions with other medications. If other medications are being taken, it is essential to consult a doctor or pharmacist. Pregnant or breastfeeding women should consult healthcare professionals before taking this medication, as it may affect the fetus or newborn, and it is advisable to avoid usage during breastfeeding. The safety and efficacy of this medication have not been established for children and adolescents, therefore it is preferable not to administer it to individuals under 18 years of age. In case of an overdose, symptoms such as nausea, tremors, drowsiness, and blood pressure changes may occur, hence immediate contact with healthcare facilities is necessary, as there is no specific antidote and appropriate treatment based on the symptoms is needed. Keep this medication out of reach of children and avoid transferring it to other containers. Be cautious when engaging in activities requiring alertness, such as driving or operating machinery when taking this medication.

Tachycardia, transient increase or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, decreased appetite, hyponatremia, blurred vision, dilation of the pupils, acute glaucoma, nausea, constipation, diarrhea, vomiting, thirst, gastrointestinal bleeding, weight gain, asthenia, peripheral edema, increased liver enzymes, liver disease, dizziness, tremors, headaches, 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 rashes, itching, severe cutaneous 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, agitation, anxiety, confusion, sweating, headaches, diarrhea, palpitations, emotional instability, hyperreactivity, visual disturbances, emotional instability, irritability, abdominal pain, hyperactivity, hostility, rigidity, dysuria, urinary disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disorders, flushing, weight loss, weight gain, fatigue, chest pain, thirst, hyperreactivity, fever, blood pressure changes, involuntary muscle contraction, anxiety, tachycardia

This medication should be kept in a sealed container that does not allow air to pass through, stored at room temperature between 1°C and 30°C. This will help maintain the effectiveness and prevent degradation of the medication.

Appearance

Yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle