INTRODUCTION
SAMTICA 250MG TABLET contains Abiraterone which belongs to a group of medicines called Androgen biosynthesis inhibitors. SAMTICA 250MG TABLET is used with prednisone/prednisolone in adult men to treat prostate cancer that has spread to other parts of the body.
SAMTICA 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.
SAMTICA 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 SAMTICA 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.
SAMTICA 250MG TABLET is not recommended for use in pregnant and breastfeeding women since it is intended to be used only in male patients.
SAMTICA 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 SAMTICA 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 SAMTICA 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 SAMTICA 250MG TABLET WORKS
SAMTICA 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 SAMTICA 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 SAMTICA 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 SAMTICA 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 SAMTICA 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
SAMTICA 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
SAMTICA 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
SAMTICA 250MG TABLET is unlikely to affect your ability to drive or operate machines. Consult your doctor before taking SAMTICA 250MG TABLET.
KIDNEY
SAMTICA 250MG TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking SAMTICA 250MG TABLET.
LIVER
SAMTICA 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 SAMTICA 250MG TABLET.
ALLERGY
Do not take SAMTICA 250MG TABLET if you allergic to abiraterone, and/or any other ingredients of this medicine.
LUNGS
SAMTICA 250MG TABLET should be used with caution in patients with lung problems such as shortness of breath. Consult your doctor before taking SAMTICA 250MG TABLET.
HEART DISEASE
SAMTICA 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 SAMTICA 250MG TABLET.
OTHERS
Before taking SAMTICA 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:
SAMTICA 250MG TABLET is not recommended for use in children and adolescents (aged below 18 years). Consult your doctor before taking SAMTICA 250MG TABLET.
Use in Geriatrics:
SAMTICA 250MG TABLET should be used with caution in elderly patients (aged 75 years/above). Consult your doctor before taking SAMTICA 250MG TABLET.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking SAMTICA 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:
SAMTICA 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 SAMTICA 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 SAMTICA 250MG TABLET out of reach in children
- Store SAMTICA 250MG TABLET at room temperature
FAQs ABOUT SAMTICA 250MG TABLET
What is SAMTICA 250MG TABLET used for?
SAMTICA 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 SAMTICA 250MG TABLET be taken along with food?
No. SAMTICA 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 SAMTICA 250MG TABLET?
The most common side effects of taking SAMTICA 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 SAMTICA 250MG TABLET safe to use in children?
No, SAMTICA 250MG TABLET is not recommended for use in children and adolescents (aged below 18 years). If SAMTICA 250MG TABLET is accidentally ingested by a child or adolescent, go to the hospital immediately and consult the doctor for further management.
Can SAMTICA 250MG TABLET be taken by a diabetes pateint?
SAMTICA 250MG TABLET should be used with caution in patients with high blood sugar. Consult your doctor before taking SAMTICA 250MG TABLET who may advise you to check your blood sugar level before SAMTICA 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
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