Paxetil Tablets (Paroxetine Hydrochloride Hydrate)

Adult dosage

This drug is preferably taken once daily with breakfast. Swallow it without chewing. In general, treatment is recommended for a sufficient period to allow symptoms to resolve. Once a satisfactory response is first achieved after starting treatment, continued administration may prevent relapse. For depressive disorders, administer 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 psychoactive drugs, treatment must not be stopped abruptly (see Adverse Reactions). As with other antidepressants, review the dose within 2～3 weeks after starting treatment and adjust it appropriately if necessary; thereafter, adjust it as considered clinically appropriate. When this drug is used long term, regularly reassess the long-term use of this drug for each individual patient. ○ Adults: 1. Major depressive disorder The recommended oral dose is 20 mg of paroxetine per day. An increase may be necessary depending on the patient; in this case, 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 per day. Start treatment at 20 mg per day and increase by 10 mg each week. The maximum daily dose is 60 mg. 3. Panic disorder The recommended oral dose is 40 mg of paroxetine per day. Start treatment at 10 mg per day and increase by 10 mg each week according to the patient's response. For some patients, the daily dose may need to be increased to a maximum of 60 mg. Because symptoms of panic disorder are known to possibly worsen at the start of treatment, a low initial dose is recommended. 4. Generalized anxiety disorder (GAD) The recommended oral dose is 20 mg of paroxetine per day. For patients who do not respond to this dose, increase the dose gradually by 10mg each week, up to a maximum daily dose of 50mg. 5. Post-traumatic stress disorder (PTSD) The recommended oral dose is 20 mg of paroxetine per day. For patients who do not respond to this dose, increase the dose by 10 mg as necessary, up to a maximum of 50 mg. In placebo-controlled trials for post-traumatic stress disorder, the efficacy of this drug was not evaluated beyond 12 weeks. 6. Social anxiety disorder/social phobia The recommended oral dose is 20 mg of paroxetine per day. For 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. Adjust the dose according to the patient's response, increasing by 10 mg at intervals of at least 1 week. The efficacy of this drug for social anxiety disorder/social phobia was demonstrated in 12-week placebo-controlled trials, but data on use beyond 12 weeks are limited. ○ Elderly patients: Blood concentrations of this drug 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: Blood concentrations of this drug 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 per day. If necessary, limit dose increases to the minimum.

Children's dosage

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

This medication is primarily used as an antidepressant for the treatment of psychiatric disorders such as depression. It may increase the risk of suicidal thoughts or behaviors in young patients, particularly those aged 18 to 24; therefore, careful consideration of risks and benefits by a physician is required when prescribing to patients in this age group. This medication should not be taken with certain other drugs, particularly MAO inhibitors, as this can increase the risk of serious side effects such as serotonin syndrome. Patients with heart conditions or prolonged QT intervals, those taking specific medications, or those with lactose intolerance should be assessed for caution or avoid taking this medication. Patients should be closely monitored for worsening depressive symptoms, suicidal impulses, aggression, anxiety, insomnia, and other changes in mental state, and family members or caregivers should observe changes in patient behavior and consult with a physician. When discontinuing this medication, it should not be stopped abruptly, but rather should be tapered down according to a physician's instructions to avoid withdrawal symptoms such as dizziness, anxiety, and sleeping disorders. This medication can cause drowsiness or dizziness, so caution is advised while driving or operating machinery. Women who are pregnant or planning to become pregnant should consult with their physician before taking this medication, as it can affect the fetus or newborn in early or late pregnancy. Breastfeeding women should also decide whether to take this medication after consulting with their doctor, as it may be excreted in breast milk. Co-administration with alcohol is not recommended, and one should report any other medications they are taking to their physician or pharmacist to avoid potential interactions. Overdose may lead to symptoms such as nausea, tremors, drowsiness, and changes in blood pressure; in such cases, immediate medical attention is necessary. This medication is not recommended for children and adolescents as safety and efficacy have not been established. Finally, this medication should be stored out of reach of children and should not be transferred to other containers.

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, dry mouth, gastrointestinal bleeding, weight gain, asthenia, peripheral edema, increased liver enzymes, liver disease, dizziness, tremors, headache, extrapyramidal disorder, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, anxiety, depersonalization, panic attacks, suicidal thoughts and behaviors, urinary retention, urinary incontinence, sexual dysfunction, hyperprolactinemia, excessive milk secretion, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rashes, itching, severe skin adverse reactions, hives, 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 disorders, anxiety, confusion, sweating, palpitations, emotional instability, irritability, visual disturbances, emotional instability, irritability, abdominal pain, hyperkinesia, hostility, rigidity, headache, dysuria, urinary disorders, edema, decreased libido, dyspepsia, tinnitus, facial edema, neurosis, gastrointestinal disorders, flushing, weight loss, weight gain, fatigue, chest pain, dry mouth, irritability, fever, changes in blood pressure, involuntary muscle contractions, anxiety, tachycardia

This medication should be stored in a tightly sealed container to prevent air exposure, and it is best kept at room temperature between 1 to 30 degrees Celsius. Storing it in this manner will help maintain its effectiveness for a longer period.

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle