Ajat CR Tablets 25 mg (Paroxetine Hydrochloride Hemihydrate)

Adult dosage

1. Major Depressive Disorder 1) Starting dose: The initial recommended dose is 25 mg of paroxetine once daily. In clinical trials conducted to demonstrate the efficacy of this drug in the treatment of major depressive disorder, subjects received 25～62.5 mg. As with other treatments for major depressive disorder, the full effect may be delayed. For some patients who do not respond to 25 mg, the dose may be increased by 12.5 mg increments, up to a maximum of 62.5 mg once daily. Dose changes should be made at intervals of at least 1 week. 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 a stable state. Systematic evaluation of the efficacy of paroxetine immediate-release tablets showed that efficacy was maintained when an average dose of 30 mg (equivalent to 37.5 mg of this drug based on relative bioavailability) was administered for 1 year. 2. Panic Disorder 1) Starting dose: The starting dose is 12.5 mg of paroxetine once daily, increased by 12.5 mg each week. In clinical trials conducted to demonstrate the efficacy of this drug, patients received 12.5～75 mg once daily. The daily dose should not exceed 75 mg. 2) Maintenance therapy: Long-term maintenance of the efficacy of paroxetine immediate-release tablets was demonstrated in a 3-month clinical trial for relapse prevention. In this trial, the relapse rate among patients with panic disorder who took paroxetine immediate-release tablets was lower than that among patients who took placebo. Because panic disorder is a chronic condition, it is advisable to continue treatment in patients who respond. The dose of this drug should be adjusted to the minimum effective dose for the patient, and patients should be periodically reassessed to determine the need for continued treatment. 3. Social Anxiety Disorder/Social Phobia 1) Starting dose: The recommended starting dose is 12.5 mg of paroxetine once daily. In clinical trials conducted to demonstrate the efficacy of this drug in the treatment of social anxiety disorder, patients received 12.5～37.5 mg once daily. If the dose is increased, increase by 12.5 mg at intervals of at least 7 days, up to a maximum dose of 37.5 mg once daily. 2) Maintenance therapy: There is no useful evidence regarding how long this drug should be taken. Although the efficacy of this drug was not evaluated beyond 12 weeks in placebo-controlled clinical trials for social anxiety disorder, social anxiety disorder is recognized as a chronic condition, so it is advisable to continue treatment in patients who respond. The dose should be adjusted to the minimum effective dose for the patient, and patients should be periodically reassessed to determine the need for continued treatment. 4. Premenstrual Dysphoric Disorder 1) Starting dose: Based on the physician's assessment, this drug may be administered throughout the menstrual cycle or only during the luteal phase of the menstrual cycle. The recommended starting dose is 12.5 mg of paroxetine once daily. In clinical trials, both 12.5 mg and 25 mg once daily were effective. Dose changes should be made at intervals of at least 1 week. 2) Maintenance therapy: In placebo-controlled trials, the efficacy of this drug was not systematically evaluated for periods exceeding 3 menstrual cycles. However, it is generally reported that symptoms worsen with age until menopause begins and the symptoms resolve. Therefore, it is advisable to continue treatment in patients who respond. Patients should be periodically reassessed to determine the need for continued treatment. ○ Elderly patients and patients with severe renal/hepatic impairment: The recommended starting dose of this drug for elderly patients and patients with severe renal/hepatic impairment is 12.5 mg of paroxetine once daily. The dose may be increased if needed, but should not exceed 50 mg once daily. ○ Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed since discontinuation of this drug. ○ Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent 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 drug. If there are no alternative drugs 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, this drug may be stopped immediately and linezolid or intravenous methylene blue administered. Patients 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 drug 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 drug 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. ○ Discontinuation of this drug Symptoms associated with discontinuation of paroxetine immediate-release tablets have been reported. These symptoms should be monitored when discontinuing treatment, regardless of the indication for which it was prescribed. Gradual dose reduction is recommended rather than abrupt discontinuation. If symptoms that cannot be controlled occur during dose reduction or discontinuation of this drug, consideration should be given to resuming the previously prescribed dose. Thereafter, the physician may continue reducing the dose at a more gradual rate.

This drug is an antidepressant used to treat mental health issues such as depression. When taking this medication, there may be an increased risk of suicidal thoughts or behaviors, particularly in young people aged 18 to 24, hence close monitoring by a physician is required. This medication may cause various side effects in different body systems including the nervous, digestive, cardiovascular, liver, and kidney systems; hence, consult a healthcare professional immediately if symptoms occur. Particularly, sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should be tapered gradually as directed by a physician. Severe interactions may occur if this medication is used with certain other drugs, so if you are taking other medications, you must inform your healthcare provider. Women who are pregnant or breastfeeding should consult their physician before taking this medication, as it may affect the fetus or newborn. Furthermore, this medication is not recommended for children and adolescents and should generally be avoided unless specific circumstances apply. Finally, this medication must be kept out of reach of children, and one should not arbitrarily discontinue or change the dosage.

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, polydipsia, gastrointestinal bleeding, weight gain, asthenia, peripheral edema, increased liver enzymes, liver disease, dizziness, tremor, headache, extrapyramidal symptoms, akathisia, seizures, restless legs syndrome, serotonin syndrome, drowsiness, insomnia, anxiety, abnormal dreams, confusion, hallucinations, mania, anxiety, depersonalization, panic attacks, suicidal thoughts, 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 of skin and mucous membranes, thrombocytopenia, pancytopenia, agranulocytosis, leukopenia, severe allergic reactions, syndrome of inappropriate antidiuretic hormone secretion, yawning, tinnitus, arthralgia, myalgia, dizziness, sensory disturbance, sleep disorder, anxiety, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual impairment, emotional instability, irritability, abdominal pain, hyperactivity, hostility, rigidity, dysuria, urinary disorders, edema, decreased libido, dyspepsia, tinnitus, facial swelling, neurosis, gastrointestinal disorders, flush, weight loss, weight gain, fatigue, chest pain, polydipsia, irritability, fever, blood pressure changes, involuntary muscle contractions, anxiety, tachycardia

This medication is sensitive to light and should be stored in a container that does not allow light exposure. Additionally, it is best stored at a cool temperature below 25 degrees.

Appearance

Pink round enteric-coated tablets

Package unit

30 tablets/bottle