Paroxetine Tablets (Paroxetine Hydrochloride Hemihydrate)

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 is achieved following initiation of treatment, continuing treatment 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 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, increase the dose gradually in 10 mg increments 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. Start treatment at 20 mg daily, and the dose may be 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. Start treatment at 10 mg daily, and the dose may be increased by 10 mg each week according to the patient's response. Some patients may require an increase in the daily dose to a maximum of 60 mg. Because symptoms of panic disorder may 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. 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 effects of this medication were 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, 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. ○ Older adults: Blood concentrations of this medication may be higher in older adults. The recommended initial dose is 10mg/day. Depending on the patient's response, the dose may be increased gradually by 10 mg per week. 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 below 30 mL/min) or hepatic impairment. The recommended dose is 20 mg 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 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 must 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 and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is 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 until 2 weeks after starting linezolid or intravenous methylene blue, or 24 hours after the last dose, whichever occurs first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (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 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 as an antidepressant to treat psychiatric conditions like depression. There may be an increased risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so careful assessment by a doctor is necessary when using this medication. This medication must not be used if there is an allergy to it or if it is taken with certain drugs, particularly MAO inhibitors. Patients with heart disease or impaired liver or kidney function, as well as those with bleeding tendencies, should exercise caution when using this medication. This drug can cause various side effects, with common symptoms including nausea, headache, drowsiness, insomnia, and weight changes; in rare cases, severe liver disease and serotonin syndrome may occur. Sudden discontinuation of treatment may result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to a doctor's instructions. This medication may interact with other drugs, so it is important to inform the doctor or pharmacist of any other medications being taken. Pregnant or breastfeeding women should consult healthcare professionals, as using this medication may affect the fetus or newborn. Caution is needed while driving or operating machinery, as drowsiness or dizziness may occur. Safety and efficacy have not been established in children and adolescents, so use in this age group is not recommended. Severe symptoms may occur in case of overdose, so it is crucial to adhere strictly to the prescribed dosage and seek immediate medical attention if any abnormal symptoms occur. Store this medication out of reach of children, and it is best to keep it in its original container.

Tachycardia, transient 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, malaise, peripheral edema, increased liver enzymes, liver disease, dizziness, tremors, headache, extrapyramidal disorders, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, agitation, abnormal dreams, confusion, hallucinations, mania, anxiety, depersonalization, panic attacks, suicidal ideation, suicidal behavior, 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, palpitations, emotional instability, irritability, vision disturbances, emotional instability, nervousness, abdominal pain, hyperactivity, hostility, rigidity, dysuria, urination disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disturbances, flushing, weight loss, weight gain, fatigue, chest pain, thirst, hypersensitivity, fever, blood pressure changes, headache, involuntary muscle contractions, agitation, anxiety, tachycardia, coma, electrocardiogram changes

This medication should be stored in a sealed container to protect it from air and moisture. It is also recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle