Enzamide 40mg capsules
DESCRIPTION
Enzamide 40mg is a hormonal therapy, for men who are all affected with prostate carcinoma in metastatic stage.Enzamide 40mg capsule are majorly indicated for prostate carcinoma, which contains Enzalutamide, as an active component considered as non steroidal anti-androgen medication. Enzamide 40mg is involved in association with castration in the therapy of metastatic or long lasting castration resistant prostate cancer. Enzamide 40mg is a prescription medicine, the main ingredient which is used as Enzalutamide, only prescribed by medical oncologist. |
Enzamide 40mg capsule |
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CAPSULES INDICATIONS
The primary usage of Enzamide 40mg capsule is involved in the effective treatment of mCRPC (metastatic castration resistant prostate cancer), taken orally. The effect of anti-androgen viewing by obstruct the testosterone production by inhibiting androgen synthesis, the hormone which is require for cancer cell growth.Enzamide 40mg is majorly used to treat prostate cancer in men.MECHANISM
The primary usage of Enzamide 40mg capsule is involved in the effective treatment of mCRPC (metastatic castration resistant prostate cancer), taken orally. The effect of anti-androgen viewing by obstruct the testosterone production by inhibiting androgen synthesis, the hormone which is require for cancer cell growth.Enzamide 40mg is majorly used to treat prostate cancer in men.PHARMACOKINETICS
Absorption:After receiving 160mg of Enzamide 40mg 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 Enzamide is accomplished by day 28 Food does not cause any alteration in absorption of Enzamide 40mg capsule.
Distribution:
Volume of distribution 110L High plasma protein bounding capacity of Enzamide 40mg capsule is occurs as 97% to 98%
Metabolism:
Two most prominent cytochrome isoenzymes are involved in metabolism of Enzamide 40mg ; 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:
Enzamide 40mg undergoes excretion by hepatic metabolism Major route of elimination; 71% in urine; 14% in feces The terminal half life period of Enzamide 40mg 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.
DOSAGE
The usual prescribed dosage of Enzamide 40mg is 160mg as a single dose by taking with or without food.Enzamide is available in the strength of 40mg; four tablets of Enzamide should be administered at a same time. Enzamide 40mg capsule should not crush, not chew taken with glass of water. Dose adjustment: In patients with ≥ grade III toxicity: Enzamide 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 Enzamide 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 Enzamide with Strong CYP3A4 inducers, the dosage of Enzamide 40mg increased up to 240mg or stop this combination.WARNING AND PRECAUTIONS
During the treatment with Enzamide 40mg capsule, 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.Enzamide 40mg INTERACT WITH SOME DRUGS LIKE
Enzamide 40mg combined with CYP2C8 strong inhibitors, causes elevation of plasma concentration time curve of Enzalutamide and its active metabolite. So avoid this combination, otherwise dosage of Enzamide should be reduced to 80mg. Enzamide 40mg with CYP2C8 strong inducers causes variation in plasma exposure of Enzamide, to minimize this problem to avoid this concomitant. Co administration of Enzamide 40mg capsule with strong inhibitors or CYP3A4, leads to elevate the AUC of Enzalutamide and its metabolite. CYP3A4 strong inducers example like; phenytoin, Phenobarbital, carbamazepine etc combines with Enzamide tablets causes depletes the plasma exposure of Enzamide. Moderate CYP3A4 inducers like Bosentan, efavirenz, modafinil, st Johns wort causes decreasing the plasma concentration of Enzamide 40mg tablet. Benzamide tablets are strong CYP3A4 inducers and moderate CYP2C8 & CYP2C19. CYP3A4 strong inducers like Midazolam, CYP2C8 inducers like warfarin, & CYP2C19 inducers like Omeprazole with Enzamide causes reducing the plasma risk of Midazolam, warfarin & Omeprazole.
MISSED DOSE
Enzamide 40mg is a chem. Drug, used in prostate cancer. Enzamide 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
Enzamide 40mg capsule 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 Enzamide 40mg.OVER DOSAGE
In the case of over dosage of Enzamide 40mg capsule, causes severe seizures. If occurring of over dosage , immediately discontinue the treatment and maintain the safety measures. In dose acceleration study at ≤ 240mg daily the condition seizure does not occur. If the dose of 360mg, 480mg & 600mg at high risk will causes SeizuresSIDE EFFECTS
Some side effects during the therapy using with Azel; 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, Fractures, joint injury, and hematomas (Fall associated injuries). Hallucinations .STORAGE
Enzamide 40mg capsule container should be stored at the temperature of 20℃ to 25℃ (68℉ to 77℉). Keep the container in cool and dry place Protect from light.PREGNANCY
Pregnancy category of Enzamide 40mg capsule is D Enzamide is contraindicated to pregnancy; it may cause fetal harm even to death.Address:
Apartment No.304 A Wing,Shiva Sakthi chs lts,
JP Road, Near Apna Bazar,
Andheri(West),
Mumbai - 400058
Maharashtra.
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