Parosenin Tablet 20 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 continue for at least 4～6 months after symptoms have resolved; for obsessive-compulsive disorder and panic disorder, treatment may continue for a longer period. As with other psychoactive medications, treatment should not be discontinued 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 reassessed regularly for each 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, 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 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 to a maximum daily dose of 60 mg. Because symptoms of panic disorder are generally known to have the potential to worsen 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. For patients who do not respond to this dose, the daily dose may be increased gradually 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. 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 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. For patients who do not respond to this dose after at least 2 weeks, the daily dose may be increased up to a maximum of 50 mg. Dose changes should be made in 10 mg increments at intervals of at least 1 week, depending on 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 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, 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 necessary, dose increases 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 a psychiatric disorder and starting treatment with this medication, an interval of at least 14 days must be observed. Conversely, when starting an MAO inhibitor to treat 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 this medication because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventions 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, discontinue this medication immediately and administer linezolid or intravenous methylene blue. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after starting 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 methylene blue administered 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 potential for 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 an antidepressant used for treating psychiatric disorders such as major depressive disorder. First, this medication may increase the risk of suicidal thoughts and behaviors, especially in children, adolescents, and young adults aged 18 to 24, so it must be administered with extreme caution. It should not be used by anyone allergic to this medication or its components, or who are taking certain medications, especially MAO inhibitors. Also, special caution is required for patients with a history of cardiac disease or with prolonged QT interval, and in patients with severely impaired liver or kidney function. While taking this medication, various side effects such as dizziness, drowsiness, nausea, headache, dyspepsia, sweating, sexual dysfunction, etc. may occur, and particularly at the beginning of treatment or when changing the dose, mental changes such as suicidal thoughts, aggression, and anxiety may occur, so careful monitoring is necessary. Abruptly stopping this medication may result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, it is essential to taper the dose gradually following the doctor's instructions. This medication may pose a serious side effect risk of serotonin syndrome when taken with other serotonergic agents, so caution is advised during co-administration. Women who are pregnant or planning to become pregnant should consult thoroughly with their doctor as the use of this medication may increase the risk of cardiovascular malformations in the fetus. For breastfeeding mothers, it is also important to consult with a doctor because this medication is secreted in small amounts in breast milk and may affect the newborn. The safety and efficacy of this medication have not been established in children and adolescents, so its usage is not recommended in these age groups. In case of overdose, symptoms such as nausea, tremors, drowsiness, and blood pressure changes may appear, and in severe cases, immediate medical attention should be sought. Finally, this medication should be stored out of the reach of children, and it is advisable not to change the container arbitrarily.

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, lethargy, peripheral edema, increase in liver enzymes, liver disease, dizziness, tremors, headache, extrapyramidal syndrome, 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, excessive milk secretion, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin 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 disturbance, sleep disturbances, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, vision impairment, 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, anxiety, tachycardia, coma, electrocardiogram changes

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication.

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle