Product Introduction
Abretone 250mg Tablets are a highly specific oral anticancer agent used in the management of advanced prostate cancer. The active ingredient is Abiraterone Acetate, a potent androgen biosynthesis inhibitor. This medication is vital for treatment regimens aimed at decreasing the production of androgens, which are hormones that stimulate the growth of prostate cancer cells. Abretone 250mg is supplied as part of a comprehensive therapeutic strategy for oncology specialists.
Uses of Abretone 250mg TabletsAbretone 250mg Tablets, in combination with a low-dose corticosteroid (typically prednisone or prednisolone), are indicated for the treatment of:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC): Prostate cancer that has spread to other parts of the body and has progressed despite standard hormonal (castration) therapy.
- Metastatic High-Risk Castration-Sensitive Prostate Cancer (mHSPC): Newly diagnosed patients with high-risk, metastatic prostate cancer, used in conjunction with Androgen Deprivation Therapy (ADT) and a corticosteroid.
- Special Dosage Indication: The 250mg strength is specifically noted for use as a reduced starting dose in patients with baseline moderate hepatic impairment (Child-Pugh Class B) to achieve comparable drug exposure to the standard 1000mg dose in patients with normal liver function.
Benefits of Abretone 250mg Tablets Abretone 250mg Tablets offer significant advantages in cancer therapy:
- Effective Hormone Deprivation: It provides a highly effective method of suppressing androgen production from all three sources: the testes, the adrenal glands, and the tumor tissue itself, leading to profound testosterone reduction.
- Extended Survival: Clinical data support its role in prolonging overall survival and progression-free survival in men with advanced prostate cancer.
- Dose Flexibility for Impaired Liver Function: The 250mg tablet size provides necessary flexibility for physicians to safely initiate treatment at a reduced dose for patients with moderate liver impairment, an important clinical consideration.
Side Effects of Abretone 250mg TabletsWhile critical for treatment, Abretone 250mg Tablets can cause side effects.
- Common Side Effects: Fatigue, joint pain (arthralgia), hypertension (high blood pressure), peripheral edema (swelling of ankles or feet), hypokalemia (low blood potassium), hot flashes, diarrhea, and nausea.
- Serious Side Effects (requires immediate attention): Hepatotoxicity (liver injury, indicated by yellowing of skin/eyes, dark urine, or severe right upper quadrant pain), severe hypertension, severe hypokalemia, and signs of adrenocortical insufficiency (e.g., severe fatigue, nausea, vomiting, dizziness).
Disclaimer: This is not an exhaustive list. Medical professionals must be consulted for complete risk assessment and patient counseling.
How to Use Abretone 250mg Tablets
- Standard Dosage: The full dose is 1,000 mg (four 250mg tablets) taken orally once daily, in combination with prednisone 5 mg (or equivalent) orally twice daily.
- Administration: The tablets must be swallowed whole with water and should not be crushed, chewed, or broken. It must be taken on an empty stomach. Patients should not consume food for at least two hours before and for at least one hour after taking the dose.
- Hepatic Impairment Dosage: For patients with moderate hepatic impairment, the recommended starting dose is 250 mg (one 250mg tablet) once daily.
- Co-treatment: Abretone therapy is typically continued alongside a GnRH analog (or post-orchiectomy) to maintain castrate testosterone levels.
How Abretone 250mg Tablets WorksAbretone contains Abiraterone Acetate, a pro-drug that is converted to the active compound Abiraterone in the body. Abiraterone is a selective, non-steroidal inhibitor of the enzyme CYP17 (17α-hydroxylase/C17,20-lyase). This enzyme is essential for the biosynthesis of androgens (like testosterone) in the testes, adrenal glands, and prostate tumor tissue. By blocking CYP17, Abretone significantly reduces the systemic level of androgens. This powerful hormonal deprivation starves the prostate cancer cells of the necessary growth stimulus, thereby inhibiting their proliferation and slowing disease progression.
- Strict Monitoring: Frequent monitoring of blood pressure, serum potassium levels, and liver function tests (ALT, AST, bilirubin) is mandatory during treatment, especially in the initial months.
- Cardiovascular Risk: Use with caution in patients with a history of cardiovascular disease, heart failure (NYHA Class II-IV), or uncontrolled hypertension.
- Hepatic Impairment: Patients with liver problems require specialized dosing (250mg once daily for moderate impairment) and intensified monitoring.
- Pregnancy Warning: This drug is only for men. It must not be used by women, particularly those who are pregnant or may become pregnant, due to the risk of fetal harm. Women should not handle broken tablets without protective gloves.
- Drug Interactions: Avoid co-administration with strong CYP3A4 inducers (e.g., Rifampicin, Carbamazepine, Phenytoin) and exercise caution with CYP2D6 substrates (e.g., Metoprolol, Codeine) with a narrow therapeutic index.
What if You Forget to Take Abretone 250mg Tablets? If a dose is missed, the patient should skip the missed dose and resume treatment the following day with the regularly scheduled dose. Do not take extra tablets to make up for the missed dose, as this could increase the risk of side effects.
Quick Tips
- Crucial Empty Stomach: Emphasize the strict requirement to take the tablet on an empty stomach to ensure correct drug exposure.
- Never Adjust Steroid Dose: Patients should not stop or change the dose of the concomitant corticosteroid (prednisone/prednisolone) without medical advice.
- Report Symptoms: Counsel patients to report symptoms of liver issues (jaundice) or mineralocorticoid excess (swelling, muscle weakness, rapid heartbeat) immediately.
- Professional Use: This medication must only be initiated and monitored by a physician experienced in oncology and the treatment of prostate cancer.
FAQs
Q1: What is the benefit of stocking the 250mg strength for bulk buyers? A: The 250mg strength, while requiring four tablets for the standard daily dose, is essential for dose flexibility. It is the mandatory starting dose for patients with moderate baseline hepatic impairment (Child-Pugh Class B), making it a clinically indispensable product for comprehensive inventory.
Q2: What quality assurance documentation is provided with bulk shipments of Abretone 250mg Tablets? A: UnnatiPharmax ensures all bulk orders are accompanied by comprehensive quality documentation, including the Certificate of Analysis (CoA), Certificate of Origin, and detailed shipping documents, confirming the product’s pharmaceutical grade and compliance with international standards for supply to Australia, Germany, Singapore, the UK, the US, and the Philippines.
Q3: Is Abretone 250mg Tablet stable for international shipping to diverse climates? A: Abretone 250mg Tablets are highly stable under typical room temperature storage conditions (below ). Our logistics protocols for international shipping are designed to protect the integrity of the product from extreme temperature and moisture variations, ensuring safe transit to all destinations.
Q4: Is the dosing regimen the same for all prostate cancer indications? A: While the full daily dose is of Abiraterone Acetate for both mCRPC and mHSPC, the required co-administration of the corticosteroid (prednisone/prednisolone) may differ. Furthermore, the starting dose is reduced to once daily for patients with moderate hepatic impairment, making careful patient assessment essential.
Q5: What packaging is typical for Abretone 250mg Tablets bulk supply? A: Abretone 250mg Tablets are commonly supplied in HDPE (High-Density Polyethylene) bottles with child-resistant closures, typically containing 60 or 120 tablets, sealed to protect against moisture and light. Bulk quantities are shipped in master cartons adhering to international pharmaceutical packaging standards.
Q6: What is the most critical safety point for dispensing pharmacists regarding Abretone?A: Pharmacists must strictly enforce the “empty stomach” rule for administration (2 hours before or 1 hour after food). They must also counsel patients regarding the required co-administration with a steroid and the necessity of immediate medical contact for symptoms of liver issues, severe swelling, or unusual fatigue/weakness.
A Note to Our Bulk Buyers: UnnatiPharmax guarantees a secure supply of pharmaceutical-grade Abretone 250mg Tablets, manufactured to the highest international standards. This critical oncology medication is available for reliable and compliant bulk international shipping to our partners in Australia, Germany, Singapore, the UK, the US, and the Philippines.
References:-
- U.S. Food and Drug Administration (FDA)
- Abiraterone Acetate (Zytiga) drug label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202379lbl.pdf
- European Medicines Agency (EMA)
- Zytiga (brand name Abiraterone Acetate) EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zytiga
- National Institutes of Health (NIH)
- National Cancer Institute (NCI) definition: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/abiraterone-acetate
- PubMed Central (PMC) – Example research paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6018245/
- ClinicalTrials.gov
- Example clinical trial for Abiraterone Acetate: https://clinicaltrials.gov/study/NCT00887198
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