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Bdenza

Bdenza (Enzalutamide )

Bdenza 40mg tablets are prescribing for; Metastatic or long lasting castration resistant prostate cancer

Feature
Brand name:
Bdenza
Active substance:
Enzalutamide 40mg
Manufacturer:
BD Pharma
Packaging:
28 Capsules
Product form:
Capsules
In stock
Active substance: Enzalutamide
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Description

DESCRIPTION

Enzalutamide is an active ingredient of Bdenza 40mg tablets available in the strength of 40mg. Bdenza 40mg tablets are used to treat the metastatic prostate cancer, in men. Bdenza 40mg is exhibits its action by stopping the advancement of tumor cells by blockade of androgen hormones especially testosterone.

Bdenza 40mg containing Enzalutamide is also categorized as an anti-androgen chemo medicine. Bdenza 40mg is not self medication; it is used under the knowledge of medical oncologist.

INDICATION

Bdenza 40mg tablets are prescribing for; Metastatic or long lasting castration resistant prostate cancer

MECHANISM OF ACTION

Bdenza 40mg containing anti-androgen agent like Enzalutamide, it expels an anti-tumor activity in different steps. Bdenza 40mg tablets are interfere in androgen receptor signaling pathway, which prohibiting androgen binding to androgen receptors leads to androgen receptor nuclear translocation inhibition and interact with DNA. The major metabolite of Bdenza 40mg is N-desmethyl Enzalutamide which is similar to Enzalutamide activity. The anti-tumor activity of Bdenza 40mg is exposed by depleting the multiplication and persuades cell lysis in prostate cancer cells.

PHARMACOKINETICS

The peak plasma concentration time of Bdenza 40mg occurs at 1 hour with the range of 0.5 to 3 hours). The steady state of Bdenza 40mg occurs in day 28. The volume of distribution occur after single dose of Bdenza 40mg is 110L Bdenza 40mg has highly bounds to the human plasma protein with the range of 97 to 98%.

The major metabolite of Enzalutamide is N-desmethyl Enzalutamide has 95% bound to human plasma protein. The most important isoenzymes responsible for the metabolism of Enzalutamide are CYP2C8 & CYP3A4. CYP2C8 is involved in the formation of an active metabolite N-desmethyl Enzalutamide. Bdenza 40mg is majorly excreted through liver metabolism, 71% of metabolite present in urine and 14% in feces. The terminal half life period of Bdenza 40mg tablet is occurs after a single dose at 5.8days and N-desmethyl Enzalutamide is taken 7.8 to 8.6 days.

DOSAGE MANAGEMENT

The usual recommended dosage of Bdenza 40mg is 160mg, but available strength of Bdenza 40mg Four tablets of Bdenza 40mg should be taken at a time as a single dose. Bdenza 40mg tablet should be administered with or without food.

Dosing alteration: In ≥ grade 3 toxicity or extreme side effects: Postpone the dose of Bdenza 40mg for 1 week or as far as symptoms progress to ≤ grade 2, continue at the same or reduced to 120mg or 80mg. Concurrent use with strong CYP2C8 inhibitors:

In case of combination with strong CYP2C8 inhibitors, diminish the dose of Bdenza 40mg to 80mg as a single dose. Concurrent use with strong CYP3A4 inducers: In case of combination with strong CYP3A4 inducers, increasing the dose of Bdenza 160mg to 240mg as a single dose.

BDENZA 40MG40MG TABLETS SAFETY PRECAUTIONS

The major adverse effect during the therapy of Bdenza 40mg tablets are;

The major adverse effect during the therapy of Bdenza 40mg tablets are;

SEIZURE
Seizure may produce during the treatment with Bdenza 40mg tablets, if seizure occurs the treatment should be discontinued until seizure resolved. To avoid this condition, patient should be counsel about the problems occurred during the therapy before starting the treatment. Seizure may leads to loss of consciousness.

POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME PRES
Patient who are all taking Bdenza 40mg tablets acquired PRES, is a neurological problem produce symptoms like headache, lethargy, confusion, loss of vision, other neurological problems related with hypertension. PRES diagnosed by MRI. If patient acquired with PRES, discontinue the Bdenza 40mg therapy

SIDE EFFECTS

BDENZA 40MG40MG TABLETS CAUSING SIDE EFFECT

Asthenia Peripheral edema Back pain, arthralgia Musculoskeletal pain Muscular weakness Musculoskeletal stiffness Diarrhea Hot flush Hypertension Headache Dizziness Spinal cord compression Caude equine syndrome Paresthesia Mental disorders Hypoesthesia Respiratory tract infections Insomnia Anxiety Hematuria Pollakiuria Non pathologic fractures Pruritus Dry skin Epistaxis

DRUG INTERACTION

Bdenza 40mg tablets concomitant with strong CYP2C8 inhibitors like gemfibrozil which may increase the plasma concentration time curve of Enzalutamide, so avoid this concomitant if possible. If required condition, the dose of Bdenza 40mgis reduced to 80mg. Bdenza 40mgtablet combined with CYP3A4 inducers, causes depletion of AUC of Enzalutamide and its active metabolite. CYP3A4 inducers like rifampicin, anti-convulsants, st. Johns wort. This combination should be avoided, in unavoidable condition the dose of Bdenza 40mg is increased up to 240mg. Bdenza 40mg with st. Johns wort causes depletion of Enzalutamide exposure.

Bdenza 40mg with CYP3A4 strong inducer, CYP2C9 & CYP2C19 moderate inducers; CYP3A4 strong inducer: Midazolam CYP2C9: warfarin CYP2C19: Omeprazole The concurrent use of Bdenza 40mg with these drugs may cause depletion of plasma exposure of these drugs. Drugs metabolized by CYP3A4 such as cyclosporine, dihydroergotamine, fentanyl, pimozide, quinidine, sirolimus etc combined with Bdenza 40mg causes decreasing the exposure of these drugs.

CONTRAINDICATIONS

Bdenza 40mg is contraindicated to pregnancy conditions, which may causes fetal harm Anaphylactic reactions occurs, if patients are contraindicated to the component occurred in Bdenza 40mg tablets

PREGNANCY & LACTATION

The pregnancy category of Bdenza 40mg tablet is X Bdenza 40mg tablets are contraindicated to pregnancy conditions; it may cause fetal harm even to death. Bdenza 40mg tablets are contraindicated in lactation period, breast feeding should not be recommended.

STORAGE 

The storage condition of Bdenza 40mg tablets container at 20°C to 25°C (68°F to 77°F). Container should be kept at dry and cool place.

OVER DOSAGE

In case of over dosage of Bdenza 40mg tablets, patients must provided with some supportive measures and discontinue the therapy. The half life of Bdenza 40mg is occurs for 5.8 days. Seizure is the major adverse effect occurred due to over dosage of Bdenza 40mg. Seizure is not described at ≤240mg daily; since three seizures occurs at 360mg, 480mg and 600mg daily.

MISSED DOSE

Bdenza 40mg is a chemo tablets, if patient fail to take the dose of Bdenza 40mg tablets must be consult with medical oncologist and take the dose within a time. In any other way the missed dose should be avoid and follow the regular dosing schedule.

 

Feature
Brand name
Bdenza
Active substance
Enzalutamide 40mg
Manufacturer
BD Pharma
Packaging
28 Capsules
Product form
Capsules
Strength
40mg
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