INTRODUCTION
ABURA 250 TABLET contains Abiraterone which belongs to a group of medicines called Androgen biosynthesis inhibitors. ABURA 250 TABLET is used with prednisone/prednisolone in adult men to treat prostate cancer that has spread to other parts of the body.
ABURA 250 TABLET is also to treat early stage of prostate cancer when used with androgen deprivation therapy (treatment that lowers testosterone hormone) and prednisone/prednisolone (medication) in affected individuals.
ABURA 250 TABLET is not recommended for use in patients allergic to abiraterone. It is also not recommended for use in patients suffering from severe liver disease.
Before taking ABURA 250 TABLET, inform your doctor if you have high blood pressure, any other blood vessel problems (such as blood pressure, stroke), swelling in the feet/ankles/legs, diabetes, lung problems (such as shortness of breath), heart problems (such as heart failure, irregular/rapid heart rate), kidney, and/or liver problems.
ABURA 250 TABLET is not recommended for use in pregnant and breastfeeding women since it is intended to be used only in male patients.
ABURA 250 TABLET is also not recommended for use in children and adolescents (aged below 18 years) and is advised to be used with caution in elderly patients (aged 75 years/above) after consulting the doctor.
The most common side effects of taking ABURA 250 TABLET are swelling in legs/feet, high blood pressure, urinary tract infection, diarrhea, indigestion, chest pain, irregular heartbeat, and/or rash. Contact your doctor if any of the symptoms worsen.
USES OF ABURA 250 TABLET
With prednisone/prednisolone:
Treats prostate cancer that has spread to other parts of the body
Treats early stage of prostate cancer when used with androgen deprivation therapy (treatment that lowers testosterone hormone) in affected individuals
HOW ABURA 250 TABLET WORKS
ABURA 250 TABLET is an androgen biosynthesis inhibitor which works by inhibiting the production of 17?-hydroxylase (CYP17) enzyme needed to produce testosterone (male sex hormone) which enables the growth of cancer cells in the prostate gland. Since ABURA 250 TABLET suppresses the production of testosterone, the cancer cells in the prostate gland won?t be able to grow thus preventing its effects on the gland in affected individuals.
DIRECTIONS FOR USE
Take ABURA 250 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Avoid taking the medicine with food. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF ABURA 250 TABLET
COMMON
Swelling in legs/feet
Signs of hypokalemia (low potassium level in blood) such as muscle twitches, muscle cramps, faintness
High blood pressure
Urinary tract infection
Diarrhea, indigestion
Chest pain, irregular heartbeat, rapid heart rate
Severe infections such as sepsis (life-threatening complication of an infection)
Bone fractures
Blood in urine
Rash
UNCOMMON
Adrenal insufficiency (disorder in which the adrenal glands won?t be able to produce enough hormones)
Abnormal heart rhythm
Muscle weakness/pain
RARE
Lung irritation (allergic alveolitis)
Signs of acute liver failure such as stomach pain, nausea, vomiting, yellowing of the skin/white of the eyes
Stop taking ABURA 250 TABLET and contact your doctor if you experience any of the following side effects:
Signs of low potassium levels in the blood such as muscle weakness, muscle twitches, and/or pounding heartbeat
HOW TO MANAGE SIDE EFFECTS
Diarrhoea:
Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.
Indigestion:
Try to reduce consumption of tea, coffee, cola or alcohol and lose weight if you are obsese. Avoid smoking and do not eat three to four hours before going to bed. Consult your doctor if the symptom gets worse.
Rashes:
Do not scratch the affected area. Wear protective clothing while going outdoors. Regularly moisturize your skin. Consult and inform your doctor if the symptom gets worse.
WARNING & PRECAUTIONS
PREGNANCY
ABURA 250 TABLET is not recommended for use in pregnant women since it is intended to be used only in male patients. Men while having sex with pregnant women or women of childbearing potential should use condom/other effective birth control methods to prevent pregnancy or harm to the unborn child during pregnancy. ?
BREASTFEEDING
ABURA 250 TABLET is not recommended for use in breastfeeding women since it is intended to be used only in male patients. ?
DRIVING AND USING MACHINES
ABURA 250 TABLET is unlikely to affect your ability to drive or operate machines. Consult your doctor before taking ABURA 250 TABLET.
KIDNEY
ABURA 250 TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking ABURA 250 TABLET.
LIVER
ABURA 250 TABLET is not recommended for use in patients with severe liver damage. It should be used with caution in patients with other liver diseases. Consult your doctor before taking ABURA 250 TABLET.
ALLERGY
Do not take ABURA 250 TABLET if you allergic to abiraterone, and/or any other ingredients of this medicine.
LUNGS
ABURA 250 TABLET should be used with caution in patients with lung problems such as shortness of breath. Consult your doctor before taking ABURA 250 TABLET.
HEART DISEASE
ABURA 250 TABLET should be used with caution in patients with heart problems such as heart failure, irregular/rapid heart rate, and/or heart rhythm problem. Consult your doctor before taking ABURA 250 TABLET.
OTHERS
Before taking ABURA 250 TABLET, inform your doctor if you:
Have high blood pressure
Have signs of low potassium level in blood such as constipation, muscle damage, fatigue, and/or numbness
Have any other blood vessel problems such as blood pressure, stroke
Have gained weight rapidly
Have swelling in the feet, ankles, and/or legs
Have possible side effects on your bone
Have diabetes
Are intolerant to certain sugars such as lactose
Use in Pediatrics:
ABURA 250 TABLET is not recommended for use in children and adolescents (aged below 18 years). Consult your doctor before taking ABURA 250 TABLET.
Use in Geriatrics:
ABURA 250 TABLET should be used with caution in elderly patients (aged 75 years/above). Consult your doctor before taking ABURA 250 TABLET.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking ABURA 250 TABLET, inform your doctor, if you are taking any of the following medicine:
Tranquillizers (medicines used to treat fear, agitation, anxiety, tension and related states of mental disturbance) Ex. diazepam, lorazepam, chlordiazepoxide?
Medicines used to treat diabetes (Ex. metformin, insulin, pramlintide)
St John?s wort (herbal medicine used to treat depression)
Ketoconazole (medicine used to treat skin infections such as athlete?s foot, jock itch, ringworm, and certain kinds of dandruff)
Ra-223 (radioactive drug used to treat prostate cancer)
Quinidine, procainamide, amiodarone and sotalol (medicines used to treat irregular heartbeat)
Medicines used in androgen deprivation treatment to treat prostate cancer (Ex. leuprolide, goserelin, triptorelin, histrelin)
Methadone (medicine used for pain relief and part of drug deaddiction therapy)
Moxifloxacin (antibiotic used to treat bacterial infections)
Antipsychotics (used for serious mental illnesses) Ex. aripiprazole,?asenapine, cariprazine
B. Drug-Food Interactions:
ABURA 250 TABLET should not be taken with grapefruit juice since it may increase the risks of side effects.
Overdosage:
If you or anyone else accidentally takes too much of ABURA 250 TABLET, contact your doctor immediately or go to a hospital straight away.
SYNOPSIS
Drug :?? Abiraterone
Pharmacological Category :?? Androgen biosynthesis inhibitors
Therapeutic Indication :?? Prostate cancer? ? ? ? ?
Dosage Forms :?? Tablet, Injection
MORE INFORMATION
Keep ABURA 250 TABLET out of reach in children
Store ABURA 250 TABLET at room temperature
?
FAQs ABOUT ABURA 250 TABLET
What is ABURA 250 TABLET used for?
ABURA 250 TABLET is used with prednisone/prednisolone in adult men to treat prostate cancer that has spread to other parts of the body. It is also to treat early stage of prostate cancer when used with androgen deprivation therapy (treatment that lowers testosterone hormone) and prednisone/prednisolone (medication) in affected individuals.
Can ABURA 250 TABLET be taken along with food?
No. ABURA 250 TABLET should not be taken along with food since it may increase the absorption of this medicine and can increase the risk of side effects. Take this medicine one hour before or after two hours of eating the food. Consult your doctor before taking the medicine.
What are the side effects of ABURA 250 TABLET?
The most common side effects of taking ABURA 250 TABLET are swelling in legs/feet, high blood pressure, urinary tract infection, diarrhea, indigestion, chest pain, irregular heartbeat, and/or rash. Contact your doctor if any of the symptoms worsen.
Is ABURA 250 TABLET safe to use in children?
No, ABURA 250 TABLET is not recommended for use in children and adolescents (aged below 18 years). If ABURA 250 TABLET is accidentally ingested by a child or adolescent, go to the hospital immediately and consult the doctor for further management.
Can ABURA 250 TABLET be taken by a diabetes pateint?
ABURA 250 TABLET should be used with caution in patients with high blood sugar. Consult your doctor before taking ABURA 250 TABLET who may advise you to check your blood sugar level before ABURA 250 TABLET is advised to be taken.
REFERENCES
1. Beverly Moy, Richard J. Lee and Mathew Smith. Natural products in cancer chemotherapy: Hormones and related drugs. Goodman & Gilman?s: The pharmacological basics of therapeutics. 12th Edition. New York MC Graw Hill Medical 2011. Page ? 1767.
2. Yasser Rehman, Jonathan E Rosenberg. Abiraterone acetate: oral androgen biosynthesis inhibitor for treatment of castration-resistant prostate cancer. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. 2012. [Accessed on 26th April 2022]?https://pubmed.ncbi.nlm.nih.gov/22291466/
3. Matthew R Smith, Dana E Rathkopf, Peter F A Mulders, Joan Carles, Hendrik Van Poppel, Jinhui Li, Thian Kheoh, Thomas W Griffin, Arturo Molina, Charles J Ryan. Efficacy and Safety of Abiraterone Acetate in Elderly (75 Years or Older) Chemotherapy Na?ve Patients with Metastatic Castration Resistant Prostate Cancer. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. November 2015. [Accessed on 26th April 2022]?https://pubmed.ncbi.nlm.nih.gov/26151676/
4. Merckle GmbH. Health Products Regulatory Authority (HPRA). [Revised in May 2022] [Accessed on 26th April 2022]?http://www.hpra.ie/img/uploaded/swedocuments/80fd6aa1-a8b2-4f60-92bf-ac7a2e96c6a4.pdf
5. Biocon Biologics India Limited. ABSTET. [Revised in July 2019] [Accessed on 26th April 2022]?https://www.biocon.com/docs/domestic-market-pi/onco/ABSTET%20PI.pdf
6. Azista Industries Private Limited. Abiraterone acetate 250mg tablets. [Accessed on 26th April 2022]?https://www.azistaindustries.com/abiraterone-acetate-tablets-exporters/
USEFUL DIAGNOSTIC TESTS
Prostate Specific Antigen (Free) PSA
Prostate Specific Antigen (Total) PSA
PRODUCT DETAILS
Country Of Origin
India
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