Handok Sertraline Tablets 10 Milligrams (Paroxetine Hydrochloride Hemihydrate)

Adult dosage

This medicine should preferably be taken once daily with breakfast. Swallow it whole without chewing. In general, treatment should continue 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 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 appropriately adjusted if necessary; thereafter, it should be adjusted as considered clinically appropriate. For long-term use of this medicine, the need for continued long-term treatment should be regularly reassessed for each individual patient. ○ Adults: 1. Major depressive disorder The recommended oral dose is 20 mg of paroxetine once daily. Depending on the patient, an increase in the dose may be necessary. In this case, 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 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 should be started at 10 mg once daily, and the dose may be increased by 10 mg each week according to the patient's response. Depending on the patient, the daily dose may need to be increased to a maximum of 60 mg. Since panic disorder is generally known to have the potential for worsening symptoms 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. 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 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 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 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: Blood concentrations of this medicine may be higher in elderly patients. The recommended initial dose is 10mg/day, which may be 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 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 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 who require treatment for 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 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 risk associated with administration of methylene blue by non-intravenous 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 these uses.

Children's dosage

○ Pediatrics: Efficacy and safety have not been established in children; therefore, use of this medicine is not recommended.

This drug is an antidepressant used to treat psychiatric conditions such as major depressive disorder. There may be an increase in suicidal thoughts or behaviors during the use of this medication, so young patients, especially those aged 18 to 24, should be observed more closely. Patients with allergies to this drug or its ingredients or those currently taking certain medications known as MAO inhibitors should not use this drug. Additionally, patients taking certain medications that may affect heart rhythm should avoid this drug. Special caution is required for patients on antipsychotics, anticoagulants, those with epilepsy, cardiac conditions, diabetes, and those at risk of bleeding. There may be an exacerbation of depressive symptoms or the emergence of abnormal behaviors such as suicidal thoughts, aggression, and anxiety during the initial administration or dosage changes, so symptoms should be closely monitored by patients and caregivers. Various side effects may occur, including dizziness, drowsiness, headache, nausea, changes in weight, blurred vision, sexual dysfunction, and more. Abrupt cessation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, one should gradually taper the dosage under a doctor's guidance. Women who are pregnant or planning to become pregnant should consult a doctor as this medication may affect the fetus. If breastfeeding, caution must be exercised, as this drug may be secreted in breast milk and could affect the newborn. This medication may interact with other drugs; therefore, all medications being taken should be reported to a doctor, particularly when combined with serotonergic drugs, anticoagulants, or certain antipsychotics. It is advisable to avoid alcohol while taking this medication and exercise caution when driving or operating machinery, as dizziness or drowsiness may occur. In case of overdose, symptoms such as nausea, tremors, drowsiness, and changes in blood pressure may emerge, so it is essential to adhere strictly to the dosage and consult medical professionals for any unusual symptoms. This medication is not recommended for use in children and adolescents as safety and effectiveness have not been established. It should be stored out of reach of children and should not be transferred to other containers.

Tachycardia, temporary elevation 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, increased liver enzymes, liver disease, dizziness, tremor, headache, extrapyramidal syndrome, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, agitation, depersonalization, panic attacks, suicidal thoughts and behavior, urinary retention, urinary incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse reactions, urticaria, photosensitivity reactions, abnormal bleeding from 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, palpitations, emotional instability, irritability, visual disturbances, emotional instability, irritability, abdominal pain, hyperactivity, aggression, rigidity, dysuria, urinary disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disorders, flushing, weight loss, weight gain, fatigue, chest pain, thirst, sensitivity, fever, blood pressure changes, involuntary muscle contractions, anxiety, tachycardia, coma, electrocardiogram changes

This medication should be stored in a tightly closed container to protect it from air, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer period.

Appearance

Yellow, oval-shaped, film-coated tablets with a bulging shape on both sides

Package unit

30 tablets/bottle