Dimalan tablets

Dimalan

  • Active Ingredient: Bicalutamide
  • 50 mg
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What is Dimalan?

The active ingredient of Dimalan brand is bicalutamide. Bicalutamide is an anti-androgen. It works in the body by preventing the actions of androgens (male hormones). Bicalutamide has a molecular weight of 430.37. The pKa' is approximately 12. Bicalutamide is a fine white to off-white powder which is practically insoluble in water at 37В°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran. Bicalutamide is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of Bicalutamide; the S-enantiomer is essentially inactive. The inactive ingredients of Bicalutamide tablets, USP are lactose monohydrate, magnesium stearate, hypromellose E5, polyethylene glycol 400, povidone K 30, sodium starch glycolate, and titanium dioxide. Bicalutamide tablets, USP 50 mg meets USP Dissolution Test 2.

Used for

Dimalan is used to treat diseases such as: Prostate Cancer.

Side Effect

Possible side effects of Dimalan include: fever; chest pain or discomfort; blindness; nervousness; weight gain; chills; pain or tenderness around the eyes and cheekbones; painful or difficult urination.

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General side effects from Dimalan (Casodex®)
  • May caused liver injury. Call your doctor immediately if you notice yellowing of the skin or eyes
  • Can cause swelling of breast tissue and breast pain when used at high doses (150 mg) - known as gynecomastia
  • Patients commonly experience hot flashes while receiving therapy with Dimalan
  • May cause weakness, drowsiness, and flu-like symptoms
  • Can cause back or joint pain
  • Some patients may experience impotence (loss of sexual function)
  • May cause abdominal pain, constipation, or diarrhea
  • May cause high blood pressure
  • Can cause trouble controlling bladder, bladder infection, or blood in the urine
  • Sore throat
  • Rash
  • Weight gain
  • Inflammation of lung airways
  • Shortness of breath
  • Click on the Dimalan (Casodex®) package insert below for reported side effects and possible drug interactions

Bicalutam >The recommended dose for Dimalan therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that Dimalan be taken at the same time each day. Treatment with Dimalan should be started at the same time as treatment with an LHRH analog. If a dose of Dimalan is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Taking Dimalan tablets

Dimalan comes as tablets you can take at home. Your nurse or doctor will talk to you about your treatment plan.

You usually take Dimalan once a day. Always take the tablets exactly as explained. This is important to make sure they work as well as possible for you. Make sure you:

  • swallow them whole with a glass of water
  • take them at the same time every day.

If you forget to take the tablets, you should take the missed dose as soon as possible within the same day. If a full day has passed, let your doctor or nurse know. Do not take a double dose unless your doctor tells you to.

Other things to remember about your tablets:

  • Keep them in the original package and at room temperature, away from heat and direct sunlight.
  • Keep them safe and out of sight and reach of children.
  • If you are sick just after taking the tablets, contact your healthcare team. Do not take another dose.
  • Get a new prescription before you run out of tablets, and make sure you have plenty for holidays.
  • If your treatment is stopped, return any unused tablets to the pharmacist.

Your nurse or pharmacist may also give you other medicines to take home. Take all your medicines exactly as they have been explained to you. Do not stop taking any of your medicines unless your doctor tells you to.

What should I avoid while taking Dimalan (Casodex)?

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Dimalan can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Dimalan

An oral non-steroidal antiandrogenic used to manage prostate cancer and hirsutism.

Adverse effectsBreast tenderness, gynaecomastia, hot flushes, gastrointestinal disorders, diarrhoea, nausea, elevated transaminases, jaundice, asthenia, pruritus.

Bicalutam >

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Dimalan is usually taken once per day in the morning or evening. You may take the medicine with or without food. Try to take the medication at the same time each day.

Dimalan is given as part of a combination prostate cancer treatment with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. These medicines prevent the testicles from producing testosterone.

Treatment with Dimalan and LHRH is usually started at the same time. Follow your doctor's instructions.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor's instructions.

You should not stop using Dimalan unless your doctor tells you to.

While using Dimalan, you may need frequent blood tests.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

Copyright 1996-2019 Cerner Multum, Inc.

Latest Update: 11/9/2018, Version: 5.01

Find out what Dimalan is, how you have it and other important information about having Dimalan.

Dimalan is a cancer treatment drug and is also known by its brand name, Casodex.

It is a treatment for prostate cancer.

Bicalutam >About Dimalan
  • Before taking Dimalan
  • How to take Dimalan
  • Getting the most from your treatment
  • Can Dimalan cause problems?
  • How to store Dimalan
  • Important information about all medicines
  • What other information should I know?

    Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Dimalan.

    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    CASODEX is not indicated for use in pregnant women. There is no information available on the presence of Dimalan in human milk, or on the effects on the breastfed infant or on milk production. Dimalan has been detected in rat milk.

    Bicalutam >

    This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

    Avoid exposure to sunlight or tanning beds. Dimalan can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

    This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

    Other drugs may interact with Dimalan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

    References

    1. "Product Information. Casodex (Dimalan)." Zeneca Pharmaceuticals, Wilmington, DE.

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    In prostate cancer, the cancer cells need the male hormone testosterone to grow and multiply well. Hormone treatments like Dimalan block the effect of testosterone on prostate cancer cells. This slows down the growth of the cancer. Dimalan also helps to reduce symptom 'flares' and side-effects from other treatments which may be used for the cancer, or following surgery.

    Before taking Dimalan,

    • tell your doctor and pharmacist if you are allergic to Dimalan, any other medications, or any of the ingredients in Dimalan tablets. Ask your pharmacist for a list of the ingredients.
    • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); aripiprazole (Abilify); buspirone (Buspar); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), felodipine (Plendil), nifedipine (Adalat, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); chlorpheniramine; cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), lovastatin (Mevacor), and simvastatin (Zocor); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); diazepam (Valium); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir), and saquinavir (Invirase, Fortovase); methadone (Dolophine); midazolam (Versed); pimozide (Orap); quinidine (Quinidex, Quinaglute); quinine; sildenafil (Viagra); tacrolimus (Prograf); tamoxifen (Nolvadex); telithromycin (Ketek); trazodone (Desyrel); triazolam (Halcion); and vincristine (Vincasar). Many other medications may also interact with Dimalan, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
    • tell your doctor if you have or have ever had liver disease.
    • you should know that Dimalan is only for use in men. If taken by pregnant women, Dimalan can cause abnormalities in the fetus. Women who are or may become pregnant should not take Dimalan. If you take Dimalan while you are pregnant, call your doctor immediately.

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    Dimalan is a hormonal therapy drug used to treat prostate cancer. It is best to read this information with our general information about hormonal therapies and the type of cancer you have.

    Dimalan is given as tablets. Your cancer doctor, nurse or pharmacist will tell you how often you will have it.

    Like all cancer drugs, Dimalan can cause side effects. Some of the side effects can be serious, so it is important to read the detailed information below.

    Your healthcare team can give you advice on how to manage any side effects. Tell your doctor or nurse straight away if you feel unwell or have severe side effects, including any we do not mention here.

    Rarely, side effects may be life-threatening. Your cancer doctor or nurse can explain the risk of these side effects to you.

    If you need medical attention for any reason other than cancer, always tell the healthcare staff that you are having this treatment.

    Gynecomastia and Breast Pain

    In clinical trials with Dimalan 150 mg as a single agent for prostate cancer, gynecomastia and breast pain have been reported in up to 38% and 39% of patients, respectively.

    Interactions

    Drug-drug. Warfarin: increased Dimalan effects

    Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, cholesterol, BUN, creatinine: increased levels

    Hemoglobin, white blood cells: decreased values

    Contraindications

    Dimalan is contraindicated in:

    Dimalan is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet's components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported.

    Dimalan has no indication for women, and should not be used in this population.

    Bicalutam >Use in Specific Populations (8.1) ].

    Bicalutam > In a multi-center, double-blind, controlled clinical trial, 813 patients with previously untreated advanced prostate cancer were randomized to receive Dimalan 50 mg once daily (404 patients) or flutamide 250 mg (409 patients) three times a day, each in combination with LHRH analogs (either goserelin acetate implant or leuprolide acetate depot).

    In an analysis conducted after a median follow-up of 160 weeks was reached, 213 (52.7%) patients treated with Dimalan-LHRH analog therapy and 235 (57.5%) patients treated with flutamide-LHRH analog therapy had died. There was no significant difference in survival between treatment groups (see Figure 1). The hazard ratio for time to death (survival) was 0.87 (95% confidence interval 0.72 to 1.05).

    Figure 1 - The Kaplan-Meier probability of death for both antiandrogen treatment groups.


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