ABISAM 250mg Tablet 30’s

INTRODUCTION

ABISAM 250MG TABLET contains Abiraterone which belongs to a group of medicines called Androgen biosynthesis inhibitors. ABISAM 250MG TABLET is used with prednisone/prednisolone in adult men to treat prostate cancer that has spread to other parts of the body.

ABISAM 250MG 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.

ABISAM 250MG 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 ABISAM 250MG 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.

ABISAM 250MG TABLET is not recommended for use in pregnant and breastfeeding women since it is intended to be used only in male patients.

ABISAM 250MG 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 ABISAM 250MG 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 ABISAM 250MG 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 ABISAM 250MG TABLET WORKS

ABISAM 250MG TABLET is an androgen biosynthesis inhibitor which works by inhibiting the production of 17α-hydroxylase (CYP17) enzyme needed to produce testosterone (male sex hormone) which enables the growth of cancer cells in the prostate gland. Since ABISAM 250MG 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 ABISAM 250MG 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 ABISAM 250MG 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 ABISAM 250MG 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

ABISAM 250MG 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

ABISAM 250MG TABLET is not recommended for use in breastfeeding women since it is intended to be used only in male patients.  

DRIVING AND USING MACHINES

ABISAM 250MG TABLET is unlikely to affect your ability to drive or operate machines. Consult your doctor before taking ABISAM 250MG TABLET.

KIDNEY

ABISAM 250MG TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking ABISAM 250MG TABLET.

LIVER

ABISAM 250MG 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 ABISAM 250MG TABLET.

ALLERGY

Do not take ABISAM 250MG TABLET if you allergic to abiraterone, and/or any other ingredients of this medicine.

LUNGS

ABISAM 250MG TABLET should be used with caution in patients with lung problems such as shortness of breath. Consult your doctor before taking ABISAM 250MG TABLET.

HEART DISEASE

ABISAM 250MG 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 ABISAM 250MG TABLET.

OTHERS

Before taking ABISAM 250MG 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:

ABISAM 250MG TABLET is not recommended for use in children and adolescents (aged below 18 years). Consult your doctor before taking ABISAM 250MG TABLET.

Use in Geriatrics:

ABISAM 250MG TABLET should be used with caution in elderly patients (aged 75 years/above). Consult your doctor before taking ABISAM 250MG TABLET.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking ABISAM 250MG 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:

ABISAM 250MG 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 ABISAM 250MG 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 ABISAM 250MG TABLET out of reach in children
Store ABISAM 250MG TABLET at room temperature

FAQs ABOUT ABISAM 250MG TABLET

What is ABISAM 250MG TABLET used for?

ABISAM 250MG 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 ABISAM 250MG TABLET be taken along with food?

No. ABISAM 250MG 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 ABISAM 250MG TABLET?

The most common side effects of taking ABISAM 250MG 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 ABISAM 250MG TABLET safe to use in children?

No, ABISAM 250MG TABLET is not recommended for use in children and adolescents (aged below 18 years). If ABISAM 250MG TABLET is accidentally ingested by a child or adolescent, go to the hospital immediately and consult the doctor for further management.

Can ABISAM 250MG TABLET be taken by a diabetes pateint?

ABISAM 250MG TABLET should be used with caution in patients with high blood sugar. Consult your doctor before taking ABISAM 250MG TABLET who may advise you to check your blood sugar level before ABISAM 250MG 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 Naïve 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