Sandoz Paroxetine Tablets (Paroxetine Hydrochloride Anhydrous)

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 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 be continued for a longer period. As with other psychoactive medications, 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 as appropriate if necessary, and thereafter adjusted as clinically appropriate. When this medication is used long term, its long-term use should be regularly 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 a dose increase; in such cases, 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 dosage is 40 mg of paroxetine once daily. Treatment may be initiated 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 dosage is 40 mg of paroxetine once daily. Treatment may be initiated at 10 mg once 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. Since symptoms of panic disorder are known to have the potential to worsen during the early stages of treatment, a low initial dose 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 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 dosage 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 of post-traumatic stress disorder, the efficacy of this medication was not evaluated beyond 12 weeks. 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 dose after at least 2 weeks, the daily dose may be increased 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; however, data on use for more than 12 weeks are limited. ○ Elderly patients : Blood concentrations of this medication may be elevated in elderly patients. The recommended initial dose is 10mg/day; the dose 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 medication may be elevated in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or hepatic impairment. The recommended dose is 20 mg once 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 should 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 should not start this medication because of the increased risk of serotonin syndrome. For patients who require treatment of a more urgent psychiatric condition, including hospitalization or 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 there is no alternative to linezolid or intravenous methylene blue 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 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 medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this medication at a dose of 1mg/kg or less are 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 an antidepressant used to treat depression and psychiatric disorders. This drug may increase the risk of suicidal thoughts or behaviors, particularly in children, adolescents, and young adults aged 18 to 24, thus careful consideration by a physician is necessary when prescribing to patients in this age group. This drug may be hazardous when taken with certain medications, hence should not be combined with MAO inhibitors or drugs that can prolong the QT interval. Patients with specific health conditions, such as those taking neuroleptics or anticoagulants, heart disease, diabetes, bleeding tendencies, liver disorders, or kidney disorders, should be cautious when taking this drug. During treatment, a range of side effects may occur such as dizziness, nausea, drowsiness, insomnia, sexual dysfunction, changes in blood pressure, liver function abnormalities, etc., and if the symptoms are severe or persistent, consult a doctor immediately. Rapid discontinuation of this medication may result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, therefore it is essential to gradually reduce the dosage according to a physician's instructions. This drug may increase the risk of cardiovascular malformations in the fetus when taken during pregnancy, particularly in the first three months, and complications such as respiratory distress and seizures can occur in newborns during the latter stages of pregnancy, so women who are pregnant or planning to become pregnant should always consult a physician. During breastfeeding, this drug may be secreted in small amounts in breast milk, thus careful consideration of the risks and benefits of drug use and breastfeeding is necessary. The safety and efficacy of this drug have not been established in children and adolescents, therefore its use is not recommended. In case of overdose, symptoms such as nausea, tremors, drowsiness, and blood pressure changes may occur, and in severe cases, immediate medical attention should be sought. This medication should be kept out of reach of children and should not be transferred to other containers. Caution is needed when driving or operating machinery while taking this drug, and concomitant use with alcohol is not recommended. Additionally, this drug may interact with other medications, so you must inform your doctor or pharmacist about all medications currently being taken.

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, increase in liver enzymes, liver disease, dizziness, tremor, headache, extrapyramidal disorder, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, agitation, derealization, panic attacks, suicidal thoughts and behaviors, urinary retention, incontinence, sexual dysfunction, hyperprolactinemia, hypersecretion of milk, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse 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 disturbances, agitation, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, vision impairment, emotional instability, irritability, 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, anxiety, tachycardia

This drug should be kept in a tightly sealed container to prevent air exposure and stored at a temperature between 1 degree and 30 degrees Celsius at room temperature. This method helps maintain the drug's effectiveness for a longer duration.

Appearance

Round tablet with a cutting line and inscribed PX20, white in color

Package unit

30 tablets/bottle, 100 tablets/bottle