Parmaparoxetine Tablets 10mg (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 duration 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, this medication should not be discontinued 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 considered clinically appropriate. If this medication is used long term, its continued use should be periodically reassessed for each individual patient. ○ Adults: 1. Major depressive disorder The recommended oral dosage is 20 mg of paroxetine once daily. Some patients may require an increase in dosage; in such cases, increase the dosage gradually in increments of 10 mg according to the patient's response. The maximum daily dosage is 50 mg. 2. Obsessive-compulsive disorder The recommended oral dosage 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 dosage is 60 mg. 3. Panic disorder The recommended oral dosage 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 in the daily dosage to a maximum of 60 mg. Since symptoms of panic disorder are known to potentially worsen at the beginning of treatment, a low initial dosage is recommended. 4. Generalized anxiety disorder (GAD) The recommended oral dosage is 20 mg of paroxetine once daily. For patients who do not respond to this dosage, the daily dosage may be increased gradually by 10mg each week, up to a maximum of 50mg. 5. Post-traumatic stress disorder (PTSD) The recommended oral dosage is 20 mg of paroxetine once daily. For patients who do not respond to this dosage, the dosage may be increased by 10 mg as needed, up to a maximum of 50 mg. The efficacy of this medication for post-traumatic stress disorder has not been evaluated beyond 12 weeks in placebo-controlled trials. 6. Social anxiety disorder/social phobia The recommended oral dosage is 20 mg of paroxetine once daily. For patients who do not respond to this dosage after at least 2 weeks, the daily dosage may be increased to a maximum of 50 mg. Dosage 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 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 dosage is 10mg/day, which may be increased gradually by 10 mg per week according to the patient's response. The maximum daily dosage 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 dosage is 20 mg daily. If an increase is necessary, the dosage should be limited to the lowest possible dose. ○ Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must elapse 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 more urgent treatment for a 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 there is no alternative to linezolid or intravenous methylene blue, and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in 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 administration of linezolid or intravenous methylene blue, or for 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 administration of methylene blue 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 such use.

Children's dosage

○ Pediatric patients: Use of this medicine is not recommended in pediatric patients because its efficacy and safety have not been established.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depression or other psychiatric disorders; thus, when administering to patients in this age range, physicians must carefully evaluate the necessity and risks. This medication may be dangerous when taken with certain drugs, especially MAO inhibitors or medications that can prolong the QT interval, and should not be used in patients taking these agents. This drug should be administered cautiously to patients with certain conditions or who are on medication, such as those taking neuroleptics, anticoagulants, with epilepsy, heart disease, diabetes, etc., and their condition should be closely monitored during treatment. This medication can cause various adverse reactions, especially dizziness, nausea, drowsiness, insomnia, and sexual dysfunction may occur at the beginning of treatment or during dosage changes; caution is necessary. Abruptly discontinuing this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and headaches; therefore, dosage should be gradually reduced according to the doctor's instructions. Concurrent use of this medication with alcohol is not recommended, and serotonergic drugs should be used with caution as they can lead to serotonin syndrome, a potentially life-threatening condition. Use during pregnancy, especially in the early and late stages, may pose risks to the fetus; therefore, women who are pregnant or planning to become pregnant should consult a physician. Caution is also necessary for breastfeeding women as small amounts may be transmitted to the baby through breast milk, making the decision to administer while breastfeeding important. Safety and efficacy have not been established in children and adolescents, so it is advisable not to administer this medication to this age group. In case of overdose, symptoms may include nausea, tremors, drowsiness, and changes in blood pressure; immediate medical treatment is required as there are no specific antidotes. This medication should be stored out of reach of children, and transferring it to another container is not recommended to maintain quality.

Tachycardia, transient elevation or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, decreased appetite, hyponatremia, blurred vision, pupillary dilation, acute glaucoma, nausea, constipation, diarrhea, vomiting, thirst, gastrointestinal bleeding, weight gain, asthenia, peripheral edema, increased liver enzymes, liver disease, dizziness, tremor, headache, extrapyramidal disorders, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, agitation, abnormal dreams, confusion, hallucinations, mania, anxiety, derealization, panic attacks, suicidal thoughts and behaviors, urinary retention, incontinence, sexual dysfunction, hyperprolactinemia, galactorrhea, 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 disturbances, sleep disorders, agitation, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances, nervousness, hyperactivity, hostility, emotional instability, crying, emotional fluctuations, self-harm, suicidal thoughts and suicide attempts, rigidity, headache, 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, agitation, 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°C and 30°C. Proper storage will help maintain the efficacy and safety of the drug.

Appearance

Biconvex yellow film-coated tablets, rectangular shape

Package unit

30 tablets/bottle, 100 tablets/bottle