Enzamide 40mg tablets are containing an active substance known as Enzalutamide, which has anti-tumor activity by exhibiting androgen receptor inhibitory activity. Enzamide 40mg is a non steroidal anti-androgen drug; by inhibiting the androgen synthesis and expels anti-neoplastic activity against prostate tumor. Enzamide 40mg is an oral tablet form, which is endorsed by FDA. Enzalutamide is related with a reducing rate of serum enzyme increased during treatment, be that as it may, have not been connected to instances of clinically clear liver damage with jaundice.
Generally Enzamide is available in the strength of 40mg; the usual dose of Enzalutamide is 160mg taken as once a day. Four Enzamide 40mg tablets should be taken as such at whole. Enzamide 40mg tablets should be administered with or without food Do not chew, open or crush the capsules.
The major clinical indication of Enzamide 40mg is involved in the treatment of long lasting or metastatic castration resistant prostate cancer patients who are not responding with docetaxel therapy.
The maximum plasma concentration time of Enzalutamide is reaches within 1 hour The Cmax value of Enzalutamide and its metabolite are 16.6ng/ml & 12.7ng/ml respectively The steady state value is achieved in day 28 of Enzamide therapy.
After single dose, the apparent volume of distribution of Enzalutamide is 110L The human plasma protein bounds to Enzalutamide at 97 to 98% Nearly 95% of N-desmethyl Enzalutamide is bounds to human plasma protein.
Enzalutamide undergone hepatic metabolism, The two most important cytochrome isoenzymes like CYP2C8 & CYP3A4 are responsible for metabolism of Enzalutamide; whereas CYP2C8 is involved in the formation of active metabolite of Enzalutamide.
The elimination of Enzalutamide is occurs by liver metabolism, whereas 71% excreted through urine; 14% in feces. The clearance value of Enzalutamide after a single dose intake is 0.56L/hr. The mean half life period of Enzalutamide is 5.8 days with approximately 2.8 to 10.2 days.
If patient accomplished with toxicities with the grade of III, postpone the therapy using with Enzamide 40mg capsules until changed to grade II.
Then continue with the same dose or dose will be reduced to 120mg or 80mg depending upon the condition of the patients.
In combination with strong CYP2C8 inhibitors, dosage altered as;
Enzamide 40mg capsules, CYP2C8 inhibitors combination should be avoided if possible. Co administration of Enzamide 40mg capsules with strong CYP2C8 inhibitors, the dose of Enzamide should be decreased to 80mg as a single dose. After discontinuation of strong CYP2C8 inhibitors, the dose of Enzamide 40mg capsules should be used as such before the co administration starts.
A Enzamide 40mg capsule combines with strong CYP2C8 inducers or inhibitors; Co administration of Enzamide with strong CYP2C8 inhibitors causes elevation of Cmax and AUC (plasma concentration) of Enzalutamide, to avoid this problem during this concomitant reduce the dose of Enzamide to 80mg as a single dose. Co administration of Enzamide with CYP2C8 inducers causes variation in plasma exposure of Enzamide. Avoid this combination if required. Concurrent use of Enzamide tablet with CYP3A4 inhibitors, causes elevating the AUC of Enzalutamide. Concurrent use of Enzamide with strong CYP3A4 inducers causes decreasing the plasmaexposure of Enzamide. Avoid concurrent use of Enzamide with anti-convulsants, anti-mycobacterials, anti-virals, herbal product like st. Johns wort. Enzalutamide is considered as strong CYP3A4 inducer & moderate CYP2C9 & CYP2C19 inducers. Enzamide diminish the plasma exposure to Midazolam, Omeprazole, and warfarin. Concurrent use of Enzamide with drugs metabolized by CYP3A4 like cyclosporine, ergotamine, fentanyl, quinidine, sirolimus or Tacrolimus may leads to reduce their exposure. Avoid concomitant use of warfarin with Enzamide capsules.
The major adverse caused during the Enzamide capsules therapy is seizures. Due to avoid the severe problem , the Patient must be counsel with the risk of participating in any action where sudden loss of awareness could make genuine damage themselves or others
Peripheral edema, Back pain, Arthralgia, Musculoskeletal pain, Musculoskeletal stiffness, weakness, Diarrhea, Hot flush, Hypertension, Head ache, Dizziness, Mental impairment, Hypoesthesia, Respiratory tract infection, Insomnia, Anxiety, Hematuria, Pollakiuria, Fall associated injuries, Non pathogenic fractures, Pruritus, Dry skin, Epistaxis, Elevation of AST & ALT, Elevation of bilirubin, Sepsis, Hallucination.
The pregnancy category of Enzalutamide X, which means it, may cause fetal harm even to death. Enzamide 40mg should not be recommended in pregnancy conditions.
The potency and effectiveness of Enzamide 40mg capsules should not be evaluated in pediatric patients. In renal & hepatic damaged patients, the dosage adjustment of Enzamide capsules should not be suggested.
Breast feeding should not be suggested.
The potency and effectiveness of Enzamide 40mg capsules should not be evaluated in pediatric patients. In renal & hepatic damaged patients, the dosage adjustment of Enzamide capsules should not be suggested
In over dosage condition, seizure may expose largely in the patients who are suspected with over dose of Enzamide.
Enzamide capsules should be stored at 20oC to 25oC. Kept the drug in dry and cool place. Protect from light.
Enzamide is contraindicated in pregnancy condition, it may cause fetal damge.
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