Handok Sertraline Tablets 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 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 continue for a longer period. As with other psychoactive 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. If this medicine is used long term, the need for continued long-term use should be reassessed regularly for each individual patient. ○ Adults: 1. Major depressive disorder The recommended oral dose is 20 mg of paroxetine once daily. Depending on the patient, a dose increase may be needed; 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. 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 dose 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. In some patients, the daily dose may need to be increased to a maximum of 60 mg. Because symptoms of panic disorder are generally known to possibly worsen at the beginning of 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 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. 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 medicine 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 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 was demonstrated in 12-week placebo-controlled trials; however, data on use for more than 12 weeks are limited. ○ Elderly patients: Plasma concentrations of this medicine may be higher in elderly patients. The recommended initial dose is 10mg/day; depending on the patient's response, it may be increased gradually by 10 mg per week. 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 a dose increase is needed, 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 a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must elapse 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 interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and, in 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 starting 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 administration of methylene blue by nonintravenous routes (oral tablets or local injection) or 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

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

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so caution is needed. In particular, patients aged 18 to 24 should carefully consider the risks and benefits when taking this medication. This medication should not be administered to patients who are allergic to it or its components, those taking MAO inhibitors, or those taking certain heart-related medications. Additionally, careful observation and management are required for patients with neuromuscular disorders, those on oral anticoagulants, patients with epilepsy, those with heart disease, diabetes, a history of mania, susceptibility to bleeding, narrow-angle glaucoma, severe liver disease, and kidney disease, those with a history of suicidal thoughts, the elderly, and others. This medication can cause various side effects, with common side effects including nausea, weight gain, drowsiness, headaches, dizziness, and sexual dysfunction. Rarely, severe liver disease, serotonin syndrome, and severe dermatological reactions may occur, so if any abnormal symptoms appear, immediate consultation with healthcare professionals is necessary. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and headaches, therefore the dosage should be gradually reduced according to a physician's instructions. It is not recommended to take this medication with alcohol, and due to numerous drug interactions, it is essential to inform healthcare personnel of any other medications being taken. During pregnancy or breastfeeding, the use of this medication may affect the fetus or newborn, so the decision to use it should be made after sufficient consultation with a physician. The safety and efficacy of this medication have not been established in children and adolescents, so it is generally not used. In the case of overdose, symptoms such as nausea, tremors, drowsiness, and changes in blood pressure may occur, and immediate medical action is required. This medication should be kept out of reach of children and it is recommended not to transfer it to other containers.

Tachycardia, temporary increase or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, decreased appetite, hyponatremia, blurred vision, mydriasis, acute glaucoma, nausea, constipation, diarrhea, vomiting, thirst, gastrointestinal bleeding, weight gain, asthenia, peripheral edema, increased liver enzymes, liver disease, dizziness, tremor, headache, extrapyramidal syndrome, 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, urinary incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse reactions, urticaria, phototoxic 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, nausea, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances, emotional instability, nervousness, 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, hypersensitivity, fever, blood pressure changes, involuntary muscle contractions, drowsiness, blood pressure changes, coma, electrocardiogram changes, death, suicidal impulses, suicide attempts, self-harm, mood swings, crying, thoughts of suicide, increased suicidal tendencies

This medication should be stored in a tightly sealed container to prevent exposure to air, and it is advisable to store it at room temperature, avoiding excessively hot or cold conditions. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

Biconvex, white, rectangular film-coated tablets

Package unit

30 tablets/bottle