Bdenza 40mg capsules
DESCRIPTION
Bdenza is a hormonal therapy, for men who are all affected with prostate carcinoma in metastatic stage.Bdenza 40mg capsules are majorly indicated for prostate carcinoma, which contains Enzalutamide, as an active component considered as non steroidal anti-androgen medication. Bdenza 40mg capsule is involved in association with castration in the therapy of metastatic or long lasting castration resistant prostate cancer. Bdenza 40mg is a prescription medicine, the main ingredient which is used as enzalutamide, only prescribed by medical oncologist. |
| Bdenza 40mg capsule |
DOSING CONDITIONS AND ADMINISTRATION
The usual prescribed dosage of Bdenza is 160mg as a single dose by taking with or without food. Bdenza 40mg is available in the strength of 40mg; four capsules of Bdenza should be administered at a same time. Bdenza 40mg capsule should not crush, not chew taken with glass of water. Dose adjustment: In patients with ≥ grade III toxicity: Bdenza 40mg therapy should be refuse for one week or the symptoms should be reduced to grade II, then restart with same dose or decreased to 80mg or 120mg Strong CYP2C8 inhibitors: While combining with Bdenza 40mg capsule, the dosage should be modified by reducing to 80mg as a single dose or avoid this combination. Strong CYP3A4 inducers: Co administration of Bdenza 40mg with Strong CYP3A4 inducers, the dosage of Bdenza capsule increased up to 240mg or stop this combination.PHARMACOKINETICS
Absorption:After receiving 160mg of Bdenza 40mg capsule for mCRPC, from median time to attain peak plasma concentration time at 1 hour (variation with 0.5 to 3 hours). The steady state level of Bdenza 40mg is accomplished by day 28 Food does not cause any alteration in absorption of Bdenza capsules.
Distribution:
Volume of distribution 110L High plasma protein bounding capacity of Bdenza 40mg capsules is occurs as 97% to 98%
Metabolism:
Two most prominent cytochrome isoenzymes are involved in metabolism of Bdenza 40mg capsules; There are two isoenzymes i.e CYP2C8 & CYP3A4; in which CYP2C8 is vital for production of N-desmethyl Enzalutamide which is an active metabolite of Enzalutamide.
Excretion:
Bdenza 40mg capsules undergoes excretion by hepatic metabolism Major route of elimination; 71% in urine; 14% in feces The terminal half life period of Bdenza 40mg capsules is 5.8 days (range at 2.8 to 10.2 days); N-desmethyl Enzalutamide has half life period of relatively 7.8 to 8.6 days.
MECHANISM
An androgen which is a male hormone is used to develop prostate carcinoma. One of the major hormone secreted by testes and adrenal glands is known as testosterone. Bdenza 40mg containing Enzalutamide will interfere with testosterone production, causes tumor cell growth depletion. Bdenza interfere with androgen receptor signaling transduction and leads to cancer cell lysisDISTINCTLY IN
Pregnancy :Pregnancy category of Bdenza 40mg capsule is D Bdenza is contraindicated to pregnancy; it may cause fetal harm even to death.
Lactation :
Breast feeding is not suggested, Bdenza 40mg is contraindicated in lactation
WARNING AND PRECAUTIONS
During the treatment with Bdenza 40mg capsules, patient may suffer with some adverse effects like; Posterior reversible encephalopathy syndrome Seizures In PRES, some neurological disorders occur in patients. The condition can recovered by providing safety measures or discontinue the therapy as soon as possible. PRES is recognized by using MRI In seizures, Before starting the treatment patient must counsel about this adverse reaction and Stop the therapy if possible. Spermatogenesis occurs that may prohibit the male fertility leads to hypo spermatogenesis. In androgen decline the treatment, may have increase exposure of cardiovascular disease like worsening hypertension.MISSED DOSE
Bdenza 40mg is a chem. Drug, used in prostate cancer. Bdenza 40mg capsule should not be self medicated, used by the patients only after getting advice from the medical oncologist. If a single dose missed by patient, then must consult with the physician and follow the instructions as per the guidance of medical adviser, the missed dose should be taken within a time or avoid the missed dose and follow the regular schedule.CONTRAINDICATION
Bdenza 40mg capsules are contraindicated to pregnancy condition, which may cause fetal harm leads to death. An Anaphylactic reaction happens, if patients are contraindicated to the ingredient present in Bdenza 40mg capsules.SIDE EFFECTS
Some side effects during the therapy using with Bdenza 40mg; Back pain, Arthralgia, Muscular weakness, pain, Diarrhea, Hypertension & hot flush, Dizziness, headache, Asthenia conditions, Peripheral edema, Spinal cord compression, paresthesia, Mental impairment, Hypesthesia, Respiratory tract infections, Hematuria, Pollakiuria, Dry skin, Pruritus, Neutropenia, Thrombocytopenia, Increasing bilirubin level, Epistaxis, Infections like sepsis,Hallucinations , Fractures, joint injury, and hematomas (Fall associated injuries).Address:
Apartment No.304 A Wing,Shiva Sakthi chs lts,
JP Road, Near Apna Bazar,
Andheri(West),
Mumbai - 400058
Maharashtra.
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