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CALURED Tablet 10's

Cancer Oncology
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    Introduction About CALURED TABLET

    CALURED TABLET contains Bicalutamide, which belongs to a group of medicines called Anti-androgens. It is used in the management of prostate cancer in adult male patients. Prostate cancer is a type of slow-growing cancer that occurs in the cells of the prostate gland (a small walnut-shaped gland that provides nourishment to sperm in males) that grows out of control and spreads to other parts of the body.

    Prostate cancer is characterized by symptoms such as troubled urination, blood in urine, the urge to urinate frequently at night, blood in semen, bone pain, losing weight without trying, pain while sitting, and erectile dysfunction. During management with CALURED TABLET, your doctor may perform blood tests to check for any changes to your blood.

    Avoid direct exposure to excessive sunlight or UV light while you are taking CALURED TABLET. Before taking CALURED TABLET, inform your doctor if you have any liver or heart problems or diabetes. CALURED TABLET is not recommended for use in women, including pregnant women or mothers who are breast-feeding their babies.

    CALURED TABLET is also not recommended for use in children and adolescents (less than 18 years of age). The most common side effects of taking CALURED TABLET are skin rash, breast swelling or tenderness, weakness, loss of appetite, dizziness, sleepiness, nausea, etc. Call your doctor if any of the symptoms get worse over time.

    Uses Of CALURED TABLET

    • To manage prostate cancer in adult male patients

    How CALURED TABLET Works

    CALURED TABLET inhibits cell growth and manages the spread of cancer cells from the prostate gland to other parts of the body by selectively blocking proteins responsible for the growth and development of the prostate gland (androgen receptors), which reduces the effect of androgen (the male sex hormone) in the prostate gland.

    How to use CALURED TABLET

    Take CALURED TABLET as advised by your physician. Swallow it with a glass of water, and do not chew or crush it. Your doctor will decide the correct dose and duration of CALURED TABLET management for you depending upon your age, body weight, and disease condition. Do not stop taking CALURED TABLET unless your doctor advises you to stop.

    Side Effects Of CALURED TABLET

    Common

    • skin rash, dry skin, itching
    • swollen and tender breast tissue
    • feeling weak, tired, and pale due to anemia (a decrease in red blood cells).
    • reduced appetite, sex drive, and fertility
    • depression
    • dizziness, sleepiness
    • hot flushes, constipation, indigestion, wind, nausea
    • hair loss or increased hair growth on the body
    • impotence
    • chest pain, heart attack, reduced heart function
    • swelling
    • weight gain

    Rare

    • increased skin sensitivity to sunlight

    Stop taking CALURED TABLET and contact your doctor if you experience any of the following side effects:

    • signs of allergic reactions (rash, itching, or hives on the skin; swelling of the face, lips, tongue, throat, or other parts of the body; shortness of breath; wheezing or trouble breathing)
    • signs of liver disease (yellowing of the skin or whites of your eyes, also called jaundice)
    • stomach pain
    • blood in your urine
    • signs of interstitial lung disease (serious shortness of breath with or without a cough or fever)
    • changes in ECG (QT prolongation)

    How To Manage Side Effects

    Constipation

    Try to eat more high-fiber foods such as fresh fruit, vegetables, and cereals, drink plenty of water, and exercise regularly. If this does not help, inform your doctor about receiving alternate managements for constipation.

    Dizziness Or Drowsiness

    When you feel dizzy, lie down, or sit down immediately. Lie down in a dark and quiet place with your eyes closed. Vehicle driving should be avoided if you experience frequent dizziness without warning. If the symptom persists, contact your doctor.

    Nausea And Vomiting

     Try to take CALURED TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oily or spicy food. Drink ice-cold drinks. Try to avoid sugary snacks and drinks. Avoid drinking too much liquid along with your meals, drink slowly in between meals. If the symptom persists, contact your doctor.

    Warning & Precautions

    Pregnancy

    Contraindicated

    CALURED TABLET is not recommended for use by pregnant women. Patients and their partners should use birth control while taking CALURED TABLET and for 130 days after stopping the> management. Consult your doctor before taking it.

    Breastfeeding

    Contraindicated

    CALURED TABLET is not recommended for use by breastfeeding women. Consult your doctor before taking it.

    Driving and Using Machines

    Use with Caution

    Do not drive or operate any machines if you feel sleepy after taking CALURED TABLET.

    Alcohol

    Consult your doctor

    Avoid consumption of alcohol while taking CALURED TABLET.

    Kidney

    Contraindicated

    No dosage adjustment of CALURED TABLET is necessary for patients with kidney impairment. Consult your doctor before taking it.

    Liver

    Use with Caution

    CALURED TABLET should be used with caution in patients with liver problems. Consult your doctor before taking it.

    Allergy

    Consult your doctor

    Do not take CALURED TABLET if you are allergic to Bicalutamide or any of the other ingredients of this medicine.

    Heart Disease

    Consult your doctor

    CALURED TABLET should be used with caution in patients having any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or who are being managed with medicines for these conditions. Consult your doctor before taking it.

    Use In Pediatrics

    Contraindicated

    CALURED TABLET is not recommended for use in children and adolescents (below 18 years of age). Consult your child’s doctor for advice.

    Use In Geriatrics

    Consult your doctor

    CALURED TABLET can be used in elderly patients (aged 70 years or older) only if the life expectancy exceeds 10 years. Consult your doctor before taking it.

    Others

    CALURED TABLET is not recommended for use if you:

    • are a woman

    Before taking CALURED TABLET, inform your doctor if you:

    • have diabetes

    Interactions

    A. Drug- Drug Interactions:

    Before taking CALURED TABLET, inform your doctor if you are taking any of the following medicines:

    • cisapride (used for stomach disorders)
    • terfenadine, astemizole (medicines used for hay fever or allergies)
    • medicines used to manage heart rhythm problems (Ex. quinidine, procainamide, amiodarone, and sotalol)
    • methadone (medicine used for pain relief and drug addiction detoxification)
    • moxifloxacin (an antibiotic used in infections)
    • medicines used for serious mental illnesses (Ex. clozapine, cariprazine)
    • medicines used to manage blood clots (Ex. warfarin, heparin)
    • ciclosporin (medicine used to suppress your immune system to manage rejection of a transplanted organ or bone marrow)
    • certain medicines used to manage high blood pressure or other heart conditions (Ex. amlodipine, nifedipine)
    • cimetidine (used to manage stomach ulcers)
    • ketoconazole (used to manage fungal infections of the skin and nails)
    • medicines used in certain cancer managements (Ex. buserelin, leuprorelin, and triptorelin)

    Overdosage:

    If you or anyone else accidentally takes too much of CALURED TABLET, contact your doctor immediately or go to a hospital right away.

    Synopsis

    Drug :   Bicalutamide
    Pharmacological Category :   Non-Steriodal anti androgens
    Therapeutic Indication :   Metastatic Prostrate Cancer
    Dosage Forms :   Tablet

    More Information

    • Keep CALURED TABLET out of reach of children
    • Store CALURED TABLET between 20-25°C

    FAQs About CALURED TABLET

    Q: Can CALURED TABLET affect male fertility?

    A: Yes. CALURED TABLET may influence male fertility, which could be reversible. Patients and their partners should use birth control while taking CALURED TABLET and for 130 days after stopping the management. Consult your doctor for further queries.

    Q: What if I miss a dose of CALURED TABLET?

    A: If you miss a dose of CALURED TABLET, take it as soon as you remember. However, skip that dose if it's almost time for the next one. Do not take CALURED TABLET two times to make up for the missed dose.

    Q: Can I go out in the sun while taking CALURED TABLET?

    A: Avoid direct exposure to excessive sunlight or UV light while you are taking CALURED TABLET, as it can increase your skin’s sensitivity to sunlight. Discuss with your doctor how you can protect your skin from the sun during management with CALURED TABLET.

    Q: Can CALURED TABLET be taken during pregnancy?

    A: CALURED TABLET is strictly for use in men and is not recommended for use in women, including pregnant women. If you are pregnant, think you may be pregnant, or are planning to have a child, consult your doctor before taking it.

    Q: Can CALURED TABLET be taken by a diabetes patient?

    A: CALURED TABLET should be used with caution in patients with diabetes (high blood sugar levels). Consult your doctor before taking it. Your doctor may advise you to check your blood sugar level before and during CALURED TABLET management.

    References

    1. KD. Tripathi. Androgens and Related Drugs, Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Eighth edition. 2019. Page – 326.

    2. AstraZeneca. Casodex 150-mg Compassionate Use Trial for Subjects with Prostate Cancer. NIH U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in June 2008] [Accessed on 2nd May 2022]. https://clinicaltrials.gov/ct2/show/NCT00636259

    3. Jesco Pfitzenmaier and Jens E. Altwein. Hormonal Therapy in the Elderly Prostate Cancer Patient. NIH National Library of Medicine. National center for biotechnology information. PubMed Central. April 2009. [Accessed on 2nd May 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2689585/

    4. Zhao J, Stockwell T, Roemer A, Chikritzhs T. Is alcohol consumption a risk factor for prostate cancer? A systematic review and meta-analysis. NIH National Library of Medicine. National center for biotechnology information. Pubmed.gov. November 2016. [Accessed on 2nd May 2022]. https://pubmed.ncbi.nlm.nih.gov/27842506/

    5. Accord Healthcare Limited. Electronic medicines compendium (EMC). [Revised in January 2021] [Accessed on 2nd May 2022]. https://www.medicines.org.uk/emc/files/pil.9687.pdf

    6. Accord Healthcare Limited. Electronic medicines compendium (EMC). [Revised in February 2020] [Accessed on 2nd May 2022]. https://www.medicines.org.uk/emc/files/pil.6038.pdf

    7. Corden Pharma GmbH. U.S. Food and Drug Administration (USFDA). [Revised in October 2017] [Accessed on 2nd May 2022]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf

    User Feedback

    • Prostate Specific Antigen (Free) PSA
    • Prostate Specific Antigen (Total) PSA
    • Liver function tests
    • Complete Blood Count

    Author Details

    Written By Dr. N. Sai Swaroop - Pharm.D
    Reviewed For Accuracy By Dr. Rajnikant - MBBS, MD (Physiology)
    Last updated on 02 Nov 2023 | 11:11 AM(IST)
    Lab updated