Hwanin Paroxetine Tablet 20 mg (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 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 psychotropic medicines, treatment should not be stopped abruptly (see Adverse Reactions). As with other antidepressants, the dosage should be reviewed within 2～3 weeks after starting treatment and adjusted appropriately if necessary; thereafter, it should be adjusted as clinically appropriate. For long-term use of this medicine, each patient should be regularly reassessed regarding the continued need for long-term treatment with this medicine. ○ Adults: 1. Major depressive disorder The recommended oral dosage is 20 mg of paroxetine once daily. Some patients may require an increase in dosage; in such cases, increase the dose gradually by 10 mg according to the patient's response. The maximum daily dose is 50 mg. 2. Obsessive-compulsive disorder The recommended oral dosage is 40 mg of paroxetine once daily. Treatment may be started at 20 mg daily and increased by 10 mg each week. The maximum daily dose is 60 mg. 3. Panic disorder The recommended oral dosage is 40 mg of paroxetine once daily. Treatment may be started 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 up to a maximum of 60 mg. Since symptoms of panic disorder are known to possibly worsen early in treatment, a low initial dose is recommended. 4. Generalized anxiety disorder (GAD) The recommended oral dosage 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. 5. Post-traumatic stress disorder (PTSD) The recommended oral dosage is 20 mg of paroxetine once daily. Patients who do not respond to this dose may have their dosage increased by 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 dosage 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 up to a maximum of 50 mg. Dosage 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 medicine 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: Plasma concentrations of this medicine may be higher in elderly patients. The recommended initial dose is 10mg/day; increase 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: Plasma concentrations of this medicine 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, it should be limited to the lowest dose increment. ○ Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should 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. ○ Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a 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 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. 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 risks associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with 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.

Children's dosage

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

This medication is primarily used to treat psychiatric conditions such as depression. When taking this medication, there may be an increased risk of suicidal thoughts or behavior, particularly in children, adolescents, and young adults, so physicians should carefully evaluate the need for treatment and potential risks. This medication should not be taken with certain drugs, especially monoamine oxidase inhibitors (MAOIs), as there is a high risk of serious side effects known as serotonin syndrome. Additionally, it may be dangerous to take this medication with other drugs that can prolong the QT interval. Specific patient populations, such as those on antipsychotics, anticoagulants, patients with epilepsy, heart disease, diabetes, a tendency to bleed, and the elderly, should use this medication with caution, and dosage adjustments or special monitoring may be necessary. While taking this medication, various side effects such as dizziness, nausea, drowsiness, insomnia, sexual dysfunction, and skin rashes may occur, so symptoms should be closely monitored. Sudden discontinuation of treatment may result in withdrawal symptoms like dizziness, anxiety, and headache, so dosage should be gradually reduced after consulting with a physician. Pregnant or breastfeeding women should consult a physician before taking this medication as it may affect the fetus or newborn. Additionally, this medication is not recommended for children and adolescents under the age of 18. It is advisable to avoid consuming alcohol while taking this medication, and patients should inform their physician of any other medications they are taking. Store the medication out of the reach of children and do not transfer it to other containers for safety. Finally, caution is needed when driving or operating machinery, and if any adverse reactions or changes in mental status occur during treatment, patients should immediately consult healthcare providers.

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, increased liver enzymes, liver disease, dizziness, tremors, headaches, extrapyramidal disorders, akathisia, seizures, restless leg 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 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, 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, irritability, fever, blood pressure changes, involuntary muscle contractions, tachycardia

This medication should be stored in an airtight, sealed container, preferably in a temperature range of 1 to 30 degrees Celsius at room temperature. This helps to maintain its efficacy and prevent deterioration.

Appearance

White, double convex, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 30 tablets (10 tablets/PTP × 3) (for export)