Paroxetine 20 mg Tablet (Paroxetine Hydrochloride Hydrate)

Adult dosage

This medication should preferably be taken once daily with breakfast. It should be swallowed whole without chewing. In general, treatment should be continued 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; thereafter, it should be adjusted as clinically appropriate. When this medication is used long term, the need for continued long-term use should be periodically reassessed for each individual patient. ○ Adults: 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, the dose may be increased gradually 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. Treatment may be started at 20 mg once 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 started at 10 mg once daily and increased by 10 mg each week according to the patient's response. Some patients may require an increase to a maximum daily dose of 60 mg. Because panic disorder is generally known to have the potential for worsening of 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. In patients who do not respond to this dose, the daily dose may be increased gradually by 10mg each week to a maximum of 50mg. 5. Post-traumatic stress disorder (PTSD) The recommended oral dose is 20 mg of paroxetine once daily. In 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 for post-traumatic stress disorder, the efficacy of this medication was not evaluated beyond 12 weeks. 6. Social anxiety disorder/social phobia The recommended oral dose is 20 mg of paroxetine once daily. In 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. Dose adjustments 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 medication for social anxiety disorder/social phobia was demonstrated in 12-week placebo-controlled trials, but 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; the dose may be increased gradually by 10 mg per week according to the patient's response, up to a maximum daily dose of 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 a psychiatric disorder and starting treatment with this medication, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor for the treatment of a psychiatric disorder, 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 should not start treatment with this medication because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. 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 medication may be stopped immediately and linezolid or intravenous methylene blue administered. The patient 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 comes first. Treatment with this medication 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 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

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

This medication is primarily used as an antidepressant to treat psychiatric disorders such as depression. It is not recommended for children and adolescents under 18 years old, as its safety and efficacy have not been fully established. Patients and caregivers should closely monitor for any abnormal behavior changes such as suicidal thoughts or actions, anxiety, or aggression during treatment. Particularly, an increased risk of suicidal tendencies has been reported in young adults aged 18 to 24, thus physicians should carefully assess the necessity and risks of treatment. This medication should not be administered to patients with allergies to this drug or its components, or those currently taking MAO inhibitors. Patients taking cardiac medications, or with a history of heart disease or QT interval prolongation should also be cautious when using this drug. Since this medication can affect blood coagulation, patients who are on anticoagulants or medications that increase bleeding risk must be careful regarding bleeding. Additionally, patients with severely impaired liver or kidney function, angle-closure glaucoma, or a history of suicidal impulses should use this medication cautiously. Various side effects such as dizziness, headaches, nausea, drowsiness, insomnia, weight changes, and sexual dysfunction may arise, and some of these side effects may diminish over time. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to the physician’s instructions. Pregnant or breastfeeding women should consult with their physician to determine whether to take this medication, as it can affect the fetus or newborn. This medication may interact with other drugs, so it is essential to inform your physician or pharmacist about any other medications you are taking. Finally, this medication should be kept out of reach of children, and you should not arbitrarily stop or change the dosage.

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, elevated liver enzymes, liver disease, dizziness, tremors, headache, extrapyramidal disorder, akathisia, seizures, restless leg syndrome, serotonin syndrome, drowsiness, insomnia, agitation, abnormal dreams, confusion, hallucinations, mania, anxiety, depersonalization, panic attacks, suicidal thoughts and suicidal 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 disorders, agitation, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, hyperactivity, vision impairment, emotional instability, irritability, abdominal pain, hyperkinesia, 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, agitation, anxiety, tachycardia

This medication should be stored in a tightly sealed container to prevent air from entering, at room temperature between 1 and 30 degrees Celsius. Storing it this way will maintain the drug’s efficacy and prevent deterioration.

Appearance

Biconvex white film-coated tablet in a rectangular shape

Package unit

30 tablets/bottle, 100 tablets/bottle