Paxelontin Extended Release Tablet 25 mg (Paroxetine Hydrochloride Hydrate)

Adult dosage

This drug should be taken once daily, preferably in the morning, with or without food. Swallow this drug whole without chewing or crushing it. 1. Major depressive disorder 1) Starting dose: The recommended initial dose is 25 mg of paroxetine daily. In clinical trials evaluating the efficacy of this drug for the treatment of major depressive disorder, subjects received 25～62.5 mg. As with other treatments for major depressive disorder, an adequate response may be delayed. For some patients who do not respond to 25 mg, the dose may be increased in increments of 12.5 mg, up to a maximum of 62.5 mg daily. Allow an interval of at least 1 week between dose changes. 2) Maintenance therapy: Acute episodes of major depressive disorder require continuous pharmacological treatment for several months or longer. It is not known whether the dose of an antidepressant needed to relieve symptoms is the same as the dose needed to maintain remission. Systematic evaluation of the efficacy of immediate-release paroxetine showed that its effect was maintained during 1 year of treatment at an average dose of 30 mg (equivalent to 37.5 mg of this drug based on relative bioavailability). 2. Panic disorder 1) Starting dose: The starting dose is 12.5 mg of paroxetine daily, increased by 12.5 mg each week. In clinical trials evaluating the efficacy of this drug, patients received 12.5～75 mg daily. Do not exceed 75 mg daily. 2) Maintenance therapy: Long-term maintenance of the efficacy of immediate-release paroxetine was demonstrated in a 3-month clinical trial for prevention of recurrence. In this trial, recurrence rates among patients with panic disorder taking immediate-release paroxetine were lower than among patients taking placebo. Panic disorder is a chronic condition; therefore, continuation of treatment is appropriate in patients who respond. Adjust the dose of this drug to the minimum effective dose for the patient, and periodically reassess patients to determine whether continued treatment is necessary. 3. Social anxiety disorder/social phobia 1) Starting dose: The recommended starting dose is 12.5 mg of paroxetine daily. In clinical trials evaluating the efficacy of this drug for social anxiety disorder, patients received 12.5～37.5 mg daily. If the dose is increased, increase it by 12.5 mg at intervals of at least 7 days; the maximum dose is 37.5 mg daily. 2) Maintenance therapy: There is no useful evidence regarding how long this drug should be taken. Although the efficacy of this drug in placebo-controlled clinical trials for social anxiety disorder was not evaluated beyond 12 weeks, social anxiety disorder is considered a chronic condition, and continuation of treatment is appropriate in patients who respond. Adjust the dose to the minimum effective dose for the patient, and periodically reassess patients to determine whether continued treatment is necessary. 4. Premenstrual dysphoric disorder 1) Starting dose: Based on the physician's assessment, this drug may be administered throughout the menstrual cycle or restricted to the luteal phase of the menstrual cycle. The recommended starting dose is 12.5 mg of paroxetine daily. In clinical trials, both 12.5 mg and 25 mg daily were effective. Allow an interval of at least 1 week between dose changes. 2) Maintenance therapy: The efficacy of this drug in placebo-controlled trials was not systematically evaluated for periods exceeding 3 menstrual cycles. However, it is generally reported that symptoms worsen with age until menopause begins and symptoms resolve. Therefore, continuation of treatment is appropriate in patients who respond. Periodically reassess patients to determine whether continued treatment is necessary. ○ Elderly patients and patients with severe renal/hepatic impairment: The recommended starting dose of this drug is 12.5 mg of paroxetine daily in elderly patients and patients with severe renal/hepatic impairment. The dose may be increased if necessary, but should not exceed 50 mg daily.

This medication is an antidepressant used in the treatment of psychiatric disorders such as major depressive disorder. During the course of taking this medication, there may be an increase in suicidal thoughts or behavior, so close observation by a physician is necessary, especially for young patients between the ages of 18 and 24. It should not be used in patients with hypersensitivity or in combination with certain medications, particularly MAO inhibitors. Patients with heart disease, epilepsy, or bleeding tendencies need to consult a physician before administration. This medication may cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances if suddenly stopped, thus dosage should be gradually reduced according to the physician's instructions. During treatment, various side effects such as drowsiness, headache, dyspepsia, weight changes, and sexual dysfunction may occur. Any abnormal symptoms should be reported to a healthcare provider immediately. Women who are pregnant or breastfeeding should consult a physician before taking this medication, as it may affect the fetus or newborn, necessitating caution. This medication may interact with other drugs, so it is important to disclose any other medications being taken, particularly anticoagulants, anticonvulsants, and heart-related medications. The concurrent use of alcohol is not recommended, and caution is advised when driving or operating machinery. This medication has not been established for safety and efficacy in children and adolescents, so its use is not recommended. In case of overdose, symptoms such as nausea, tremor, and blood pressure changes may occur, and immediate medical attention should be sought in emergencies. When stored, keep it out of the reach of children, and ensure that the container is not changed arbitrarily.

Tachycardia, temporary increase or decrease in blood pressure, orthostatic hypotension, bradycardia, increased cholesterol levels, reduced 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 disorder, akathisia, seizures, restless leg syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, anxiety, depersonalization, panic attacks, suicidal ideation, suicidal behavior, urinary retention, urinary incontinence, sexual dysfunction, hyperprolactinemia, excessive lactation, menstrual disorders, priapism, postpartum hemorrhage, sweating, skin rash, itching, severe skin adverse reactions, hives, photosensitivity reactions, abnormal bleeding of skin and mucous membranes, thrombocytopenia, pancytopenia, agranulocytosis, leukopenia, severe allergic reactions, inappropriate secretion of antidiuretic hormone syndrome, yawning, tinnitus, arthralgia, myalgia, dizziness, sensory disturbances, sleep disturbances, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances, emotional instability, nervousness, abdominal pain, hyperactivity, hostility, rigidity, dysuria, urinary disorder, 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 medication is sensitive to light and should be stored in a dark container that does not allow light in. Also, it is important to store it at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

Pink round enteric-coated extended-release tablets

Package unit

30 tablets/bottle