Bicaluplex tablets

Bicaluplex

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

The active ingredient of Bicaluplex 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

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

Side Effect

Possible side effects of Bicaluplex include: runny nose; painful or difficult urination; cough producing mucus; wrinkled skin; headache.

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Gynecomastia and Breast Pain

In clinical trials with Bicaluplex 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.

DRUG INTERACTIONS

Clinical studies have not shown any drug interactions between Bicaluplex and LHRH analogs (goserelin or leuprolide). There is no evidence that Bicaluplex induces hepatic enzymes.

In vitro studies have shown that R-Bicaluplex is an inhibitor of CYP 3A4 with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Clinical studies have shown that with co-administration of CASODEX, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5-fold (for Cmax) and 1.9-fold (for AUC). Hence, caution should be exercised when CASODEX is co-administered with CYP 3A4 substrates.

In vitro protein-binding studies have shown that Bicaluplex can displace coumarin anticoagulants from binding sites. Prothrombin times should be closely monitored in patients already receiving coumarin anticoagulants who are started on CASODEX and adjustment of the anticoagulant dose may be necessary.

Introduction

Bicaluplex is a nonsteroidal antiandrogen similar in structure to flutamide that is used widely in the therapy of prostate cancer and has been linked to rare instances of liver injury.

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  • Find out about the possible side effects of Bicaluplex and how to manage them

What should I avoid while taking Bicaluplex (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. Bicaluplex 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.

Renal Impairment

Renal impairment (as measured by creatinine clearance) had no significant effect on the elimination of total Bicaluplex or the active R-enantiomer.

Dosage Forms And Strength

CASODEX ® (Bicaluplex) 50 mg tablets for oral administration.

White, film-coated tablets (identified on one side with "CDX50" and on the reverse with the "CASODEX logo") are supplied in unit dose bottles of 30 tablets (0310-0705-30).

References

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

Drug Interactions

Clinical studies have not shown any drug interactions between Bicaluplex and LHRH analogs (goserelin or leuprolide). There is no evidence that Bicaluplex induces hepatic enzymes.

In vitro studies have shown that R-Bicalutam >max ) and 1.9 fold (for AUC). Hence, caution should be exercised when Bicaluplex is coadministered with CYP 3A4 substrates.

In vitro protein-binding studies have shown that Bicalutam > .

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What are the possible side effects of Bicaluplex (Casodex)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • breast pain or swelling;
  • blood in your urine;
  • fever, chills;
  • sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • liver problems--nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

  • hot flashes;
  • pain in your back, pelvis, or stomach;
  • swelling in your hands, ankles, or feet;
  • increased night-time urination;
  • weakness, dizziness; or
  • nausea, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Safety Data from Clinical Studies using Bicalutam > Bicaluplex 150 mg is not approved for use either alone or with other treatments.

Two identical multi-center, randomized, open-label trials comparing Bicaluplex 150 mg daily monotherapy to castration were conducted in patients that had locally advanced (T3-4, NX, M0) or metastatic (M1) prostate cancer.

Monotherapy — M1 Group

Bicaluplex 150 mg daily is not approved for use in patients with M1 cancer of the prostate. Based on an interim analysis of the two trials for survival, the Data Safety Monitoring Board recommended that Bicaluplex treatment be discontinued in the M1 patients because the risk of death was 25% (HR 1.25, 95% CI 0.87 to 1.81) and 31% (HR 1.31, 95% CI 0.97 to 1.77) higher in the Bicaluplex treated group compared to that in the castrated group, respectively.

Locally Advanced (T3-4, NX, M0) Group

In addition to the above two studies, there are three other ongoing clinical studies that provide additional safety information for Bicaluplex 150 mg, a dose that is not approved for use. These are three multi-center, randomized, double-blind, parallel group trials comparing Bicaluplex 150 mg daily monotherapy (adjuvant to previous therapy or under watchful waiting) with placebo, for death or time to disease progression, in a population of 8113 patients with localized or locally advanced prostate cancer.

Bicaluplex 150 mg daily is not approved for use as therapy for patients with localized prostate cancer who are candidates for watchful waiting. Data from a planned subgroup analysis of two of these trials in 1627 patients with localized prostate cancer who were under watchful waiting, revealed a trend toward decreased survival in the Bicaluplex arm after a median follow-up of 7.4 years. There were 294 (37.7%) deaths in the Bicaluplex treated patients versus 279 (32.9%) deaths in the placebo treated patients (localized watchful waiting group) for a hazard ratio of 1.16 (95% CI 0.99 to 1.37).

Lactation

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

Summary

Bicaluplex (Casodex) is a drug prescribed for the treatment of late stage prostate cancer. Side effects, drug interactions, and patient safety information should be reviewed prior to taking this medication.

Pediatric Use

The safety and effectiveness of CASODEX in pediatric patients have not been established.

CASODEX (Bicaluplex) orodispersible tablet was studied in combination with ARIMIDEX (anastrozole) orodispersible tablet in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of gonadotropin independent precocious puberty in boys with familial male-limited precocious puberty, also known as testotoxicosis. Patients were enrolled in the study if they had a baseline age ≥2 years and a diagnosis of testotoxicosis based on clinical features of progressive precocious puberty, symmetrical testicular enlargement, advanced bone age, pubertal levels of serum testosterone, prepubertal pattern of gonadotropin secretion following a GnRH stimulation test, and absence of other clinical and biochemical causes of testosterone excess. Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up). If central precocious puberty (CPP) developed, an LHRH analog was to be added. Four patients were diagnosed with CPP during the 12-month study and received LHRH analog treatment and 2 additional patients were diagnosed at the end of the 12 months and received treatment subsequently. Mean ± SD characteristics at baseline were as follows: chronological age: 3.9±1.9 years; bone age 8.8±2.5; bone age/chronological age ratio: 2.06±0.51; growth rate (cm/yr): 10.81±4.22; growth rate standard deviation score (SDS): 0.41±1.36.

The starting CASODEX dose was 12.5 mg. CASODEX was titrated in each patient until steady-state R-Bicaluplex (the active isomer of Bicaluplex) trough plasma concentration reached 5-15 mcg/mL, which is the range of therapeutic concentrations achieved in adults with prostate cancer following the administration of the currently approved CASODEX dose of 50 mg. The starting daily dose of anastrozole was 0.5 mg. Anastrozole was independently titrated in each patient until it reached at steady-state a serum estradiol concentration of

Table 2. Growth Rates

Total testosterone concentrations increased by a mean of 5 mmol/L over the 12 months of treatment from a baseline mean of 10 mmol/L. Estradiol concentrations were at or below the level of quantification (9.81 pmol/L) for 11 of 12 patients after 12 months of treatment. Six of the 12 patients started treatment at an estradiol concentration below the level of quantification.

There were no deaths, serious adverse events, or discontinuations due to adverse events during the study. Of the 14 patients exposed to study treatment, 13 (92.9%) experienced at least one adverse event. The most frequently reported (>3 patients) adverse events were gynecomastia (7/14, 50%), central precocious puberty (6/14, 43%), vomiting (5/14, 36%), headache (3/14, 21%), pyrexia (3/14, 21%), and upper respiratory tract infection (3/14, 21%). Adverse reactions considered possibly related to Bicaluplex by investigators included gynecomastia (6/14, 43%), central precocious puberty (2/14, 14%), breast tenderness (2/14, 14%), breast pain (1/14, 7%), asthenia (1/14, 7%), increased alanine aminotransferase (1/14, 7%), increased aspartate aminotransferase (1/14, 7%), and musculoskeletal chest pain (1/14, 7%). Headache was the only adverse reaction considered possibly related to anastrozole by investigators. For the patient who developed elevated ALT and AST, the elevation was

Interactions

Drug-drug. Warfarin: increased Bicaluplex effects

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

Hemoglobin, white blood cells: decreased values


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