Product Details
{Trade Name} {Common Name} Indian Abiraterone {English Name} [Product Price]/Tablet Inquiry Telephone Number [Character] This product is white to off-white, with one side of the oval tablet concave. [Function and Indications] Combination with prednisone is suitable for the treatment of patients with metastatic castration-resistant prostate cancer who have received previous docetaxel-containing chemotherapy. [Specifications]/tablet/bottle [Usage and Dosage] The recommended dosage is oral administration once a day in combination with oral administration of prednisone once a day. It must be administered on an empty stomach. Food should not be consumed for at least 1 hour before and 1 hour after taking. Tablets should be swallowed whole with water. [Adverse Reactions] It may cause fetal harm when administered to pregnant women. Abiraterone is contraindicated in women who are pregnant or may become pregnant. If the drug is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be counseled about the potential hazard to the fetus. [Contraindications] [Precautions] Use with caution in patients with a history of cardiovascular disease, hypertension, hypokalemia, and fluid retention due to excess mineralocorticoids. Hypertension, hypokalemia, and fluid retention due to increased mineralocorticoid levels may occur as a result of the inhibitory effects [see Adverse Reactions and Clinical Pharmacology]. Coadministration of corticosteroids suppresses adrenocorticotropic hormone drive, resulting in a reduction in the incidence and severity of these adverse reactions. It must be used with caution when the patient is being treated for a medical condition that may be compromised by increased blood pressure, hypokalemia, or fluid retention, such as in patients with heart failure, recent myocardial infarction, or ventricular arrhythmias. Safety has not been established in patients with left ventricular ejection fraction < or Category 1 or heart failure because these patients were excluded from randomized clinical trials. Monitor patients for hypertension, hypokalemia, and fluid retention at least monthly for abiraterone efficacy. Use to control hypertension and correct hypokalemia before and during treatment. Adrenocortical Insufficiency Adrenocortical insufficiency has been reported in clinical trials in patients receiving concomitant prednisone, after discontinuation of daily steroids and/or with current infection or stress []. Use caution and monitor for signs and symptoms of adrenocortical insufficiency especially if the patient withdraws prednisone, has a prednisone dose reduction, or experiences unusual stress. Adverse effects seen in patients treated with mineralocorticoid overdose may mask symptoms and signs of adrenocortical insufficiency. If clinically indicated, perform appropriate testing to confirm the diagnosis of adrenocortical insufficiency. Increased corticosteroid dosage may be indicated before, during, and after stressful situations [see Warnings and Precautions]. Hepatotoxicity has occurred with significant increases in liver enzymes leading to discontinuation of the drug or dose adjustment [see Adverse Reactions]. Serum transaminase and bilirubin levels were measured before initiating treatment, weekly for the first three months of treatment, and monthly thereafter. How much does abiraterone cost? In patients with baseline severe hepatic impairment who received a reduced dose, bilirubin and bilirubin were measured weekly before initiating treatment, weekly for the first month of treatment, weekly for the first month of treatment, and monthly thereafter. If clinical symptoms and signs suggest the occurrence of hepatotoxicity, measure serum total bilirubin promptly. ,, or an increase in bilirubin from the patient's baseline should prompt more frequent monitoring, and. If at any time the rise is greater than fivefold, or if bilirubin is increased greater than threefold, interrupt treatment and monitor liver function closely. Retreatment at a reduced dose level may be initiated only after liver function tests return to the patient's baseline or to and below or equal to × and total bilirubin is below or equal to × [see Dosage and Administration]. The safety of retreatment in patients who develop ≥× and/or bilirubin ≥≥× is unknown. Food effects must be taken on an empty stomach. Abiraterone should not be consumed with food for at least hours before and at least hours after taking the dose. When a single dose of abiraterone acetate is administered with a meal, abiraterone and ∞ exposures increase by up to and -fold, respectively, when compared to the fasting state. The safety of these increased exposures when abiraterone acetate is administered multiple times with food has not been evaluated [see Dosage and Administration and Clinical Pharmacology]. [Storage] Store at a temperature allowed to go out to a temperature of ℃ [see room temperature control]. [Packaging] High-density polyethylene bottles, tablets [Manufacturer] Indian company
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