Zyterone Tablet 250 mg

Zyterone Tablet 250 mg Uses, Dosage, Side Effects, Food Interaction and all others data.

Zyterone Tablet 250 mg
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Zyterone Tablet 250 mg
Generic	Abiraterone Acetate
Weight	250 mg
Type	Tablet
Therapeutic Class	Cytotoxic Chemotherapy
Manufacturer	Healthcare Pharmaceuticals Ltd.
Available Country	Bangladesh
Last Updated:	October 19, 2023 at 6:27 am

Uses

Zyterone Tablet 250 mg is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC). Metastatic high-risk castration-sensitive prostate cancer (CSPC).

Dosage

Zyterone Tablet 250 mg dosage

Recommended Dose For Metastatic CRPC: The recommended dose of Zyterone Tablet 250 mg is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with Prednisone 5 mg orally twice daily. Recommended Dose For Metastatic High-Risk CSPC: The recommended dose of Zyterone Tablet 250 mg is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with Prednisone 5 mg administered orally once daily. Patients receiving Zyterone Tablet 250 mg should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Zyterone Tablet 250 mg must be taken on an empty stomach, at least one hour before or at least two hours atier a meal. The tablets should be swallowed whole with water. Do not crush or chew tablets.Dose Modification: For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the Zyterone Tablet 250 mg starting dose to 250 mg once daily. For patients who develop hepatotoxicity during treatment, hold Zyterone Tablet 250 mg until recovery. Retreatment may be initated at a reduced dose. Zyterone Tablet 250 mg should be discontinued if patients develop severe hepatotoxicity. Avoid concomitant strong CYP3A4 inducers (e.g., Phenytoin, Carbamazepine, Rifampin, Rifabutin, Rifapentine, Phenobarbital) during Zyterone Tablet 250 mg treatment. If a strong CYP3A4 inducer must be co-administered, increase the Zyterone Tablet 250 mg dosing frequency to twice a day only during the co-administration period (e.g., from 1,000 mg once daily to 1,000 mg twice a day). Reduce the dose back to the previous dose and frequency, if the concomitant strong CYP3A4 inducer is discontinued. Or, as directed by the registered physician. Pediatric Use: The safety and effectiveness in pediatric patients have not been established.

Side Effects

The most common adverse reactions are fatigue, arthalgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache.

Precaution

Zyterone Tablet 250 mg may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Patients should be monitored for hypertension, hypokalemia, and fluid retention at least once a month. Hypertension and hypokalemia should be controlled and corrected before and during treatment with Abiraterone. Patients should be monitored for symptoms and signs of adrenocortical insufficiency. Serum transaminases (ALT and AST) and bilirubin levels should be measured prior to starting treatment with Abiraterone, every two weeks for the first three months of treatment and monthly thereatier.

Interaction

Drugs That Inhibit Or Induce CYP3A4 Enzymes: Based on in vitro data, Zyterone Tablet 250 mg is a substrate of CYP3A4. In a dedicated drug interaction trial, co-administration of Rifampin, a strong CYP3A4 inducer, decreased exposure of Abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during Zyterone Tablet 250 mg treatment. If a strong CYP3A4 inducer must be co-administered, increase the Zyterone Tablet 250 mg dosing frequency. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of Abiraterone.Effects Of Abiraterone On Drug Metabolizing Enzymes: Zyterone Tablet 250 mg is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of Dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when Dextromethorphan was given with Zyterone Tablet 250 mg 1,000 mg daily and Prednisone 5 mg twice daily. Avoid co-administration of Zyterone Tablet 250 mg with substrates of CYP2D6 with a narrow therapeutic index (e.g., Thioridazine). If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug. In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of Pioglitazone (CYP2C8 substrate) was increased by 46% when Pioglitazone was given together with a single dose of 1,000 mg Zyterone Tablet 250 mg. Therefore, patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Zyterone Tablet 250 mg.

Pregnancy & Breastfeeding use

The safety and efficacy of Abiraterone have not been established in females. Based on findings from animal studies and the mechanism of action, Abiraterone can cause fetal harm and potential loss of pregnancy. There are no human data on the use of Abiraterone in pregnant women. The safety and efficacy of Abiraterone have not been established in females. There is no information available on the presence of abiraterone acetate in human milk, or on the effects on the breastfed child or milk production.

Contraindication

Hypersensitivity to the Abiraterone acetate or to any of the excipients of Abiraterone.

Acute Overdose

There is no specific antidote. In the event of an overdose, Zyterone Tablet 250 mg should be stopped, general supportive measures are undertaken, including monitoring for arrhythmias and cardiac failure and assess liver function.