Abirapro 250mg (Abiraterone acetate)

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Abirapro 250 mg tablets contain an active ingredient known as abiraterone acetate that has antitumor activity against prostate cancer. Abirapro is an androstene derivative, which involves the... Citeste mai mult
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ABIRAPRO 250MG

DRUG PROFILE

Abirapro 250 mg tablets contain an active ingredient known as abiraterone acetate that has antitumor activity against prostate cancer.

Abirapro is an androstene derivative, which involves the steroidal 17-alpha-hydroxylase interdiction process and contains antineoplastic activity.

Abiraterone acetate is an oral tablet that is a form of steroidal active ester acetate known as Abiraterone with anti-androgenic activity.

Abiraterone acetate is implicated by interference with testosterone activity by inhibiting synthesis.

Brand: Abirapro

Active substance: Abiraterone acetate

Resistance: 250 mg

Mfg: Glenmark

Pack: 120 tablets in a container

Classified as: Anti-neoplastic agent

DRUG PRESCRIBING INFORMATION

The most important indication for Abirapro 250mg tablets is;

Resistance to castrate cancer

Metastatic prostate cancer sensitive to high-risk sensitive castration

Involved in the treatment of patients with castration-resistant prostate cancer who do not respond to chemotherapy regimen called docetaxel concomitantly with prednisolone.

For the treatment of metastatic CRPC in elderly men who are asymptomatic or somewhat symptomatic after the disappointment of androgen deprivation treatment in which chemotherapy is not clinically presented with prednisone or prednisolone

MECHANISM OF ACTION

Abirapro 250 mg consisting of abiraterone acetate is a form of a prodrug that turns into abiraterone inside the body after oral administration.

Abiraterone, an active form that eliminates its action on androgen biosynthesis by inhibiting an enzyme called 17 alpha-hydroxylase / C17,20-lyase (CYP17).

This enzyme is essential for the biosynthesis of androgen which is expressed in testicular, adrenal and prostatic cells.

An enzyme CYP17 activates two consecutive reactions;

1. Transformation of pregnenolone and progesterone into 17 alpha hydroxyl derivatives by 17 alpha-hydroxylase.

2. Production of dehydroepiandrosterone and androstenedione, relative to CYP17 activity, 20 lysis.

DHEA and androstenedione are androgens, which as testosterone messenger.

Abiraterone has been implicated in the inhibition of this CYP17 which can also lead to an increase in adrenaline formation capacity of mineralocorticoids.

Androgen deprivation, such as the gonadotropin-releasing hormone agonist or orchiectomy, can reduce androgen production in the testicles, not in the adrenal or tumoral glands.

Abirapro is used to lower testosterone levels and affect tumor growth.

ABSORPTION

The maximum plasma concentration of Abirapro is reached within 2 hours of drug administration.

Systemic exposure to Abirapro increases while administered with meals.

No food should be taken for at least 2 hours prior to administration of the Abirapro dose or at least one hour after administration of the Abirapro dose.

DISTRIBUTION

Abirapro is largely bound to human plasma proteins by> 99%.

The volume of distribution of Abiraterone is 19669 ± 13358L

METABOLISM

Abiraterone acetate undergoes hydrolysis and leads to change in Abiraterone, which is an active form.

The two main circulating metabolites of Abiraterone are:

Abiraterone Sulfate

Abiraterone sulfate N-oxide

ELIMINATION

The mean half-life of Abirapro is 12 ± 5 hours.

88% of the metabolite is excreted via the faeces; 5% in urine.

The component present in the feces is an unchanged form of abiraterone.

DOSAGE REGIMENS

In Advanced CRPC:

The prescribed dose of Abirapro is 1000 mg should be given once daily with twice daily dosing of 5 mg prednisolone

In high-risk SCCPs:

The prescribed dose of Abirapro is 1000 mg should be given once daily with twice daily dosing of 5 mg prednisolone

Dose modification:

In patients with hepatic impairment:

In patients with moderate hepatic impairment, the dose of Abirapro should be reduced to 250 mg as a single dose.

In patients with moderate hepatic impairment, AST and ALT should be monitored frequently.

In patients with severe liver disease, Abirapro should not be used.

hepatotoxicity:

The patient has experienced hepatic toxicity during treatment, Abirapro should be postponed and provide supportive measures.

Therapy should be resumed at a reduced dose of 750 mg as a single dose.

If hepatic toxicity reappears with the 750 mg dose, a single 500 mg dose followed by LFT should be resumed.

Discontinue treatment with Abirapro permanently if patients can have a current AST & ALT descent.

Co-administration of Abirapro with CYP3A4 inducers:

If the concomitant use of Abirapro with CYP3A4 inducers, the frequency of Abirapro tablets should be increased twice daily, this may occur only during concomitant administration.

If concomitant administration interrupts, the frequency changes once a day.

DRUG CAUSED SIDE EFFECTS

  • Fatigue
  • Joint pain, swelling or discomfort
  • Hot flush
  • hypertension
  • Diarrhea
  • Vomiting
  • Cough
  • hypertension
  • dyspnea
  • Urinary tract infections
  • Contusion

Laboratory abnormalities:

  • anemia
  • Increase in alkaline phosphatase
  • hypertriglyceridemia
  • lymphopenia
  • Hypercholestremia
  • hyperglycemia
  • AST increased, AST
  • hypophosphatemia
  • hypokalemia

Post-marketing reports:

  • Non-infectious pneumonia
  • Myopathy, involving rhabdomyolysis
  • Fulminating hepatitis, acute liver failure leads to death

FOOD DRUG INTERACTION

Consuming food with Abirapro, leads to the elevation of Abirapro in the body.

Risk factors such as increased blood pressure, water retention, hypokalaemia

Foods should not be taken at least 2 hours before or 1 hour after administration of the Abirapro dose

SAFETY MEASURES

Hypertension, hypokalaemia, and fluid retention:

Abirapro inhibits CYP17, causes increased levels of mineralocorticoids leading to hypopotassemia, hypertension, and fluid retention.

Concomitant use of Abirapro with corticosteroids leads to diminishing the adrenocorticotrophic hormone, which is a reduction in the degree and severity of these side effects.

Control blood pressure and correct potassium and fluid levels if necessary.

Adrenocortical insufficiency:

Adrenocortical deficiency occurs during treatment with Abirapro with prednisolone.

Under this condition, treatment should be discontinued or discontinued.

Monitor the signs and symptoms that occurred as a result of this condition.

Dose gain of corticosteroids occurs both before and during treatment.

Hepatic Toxicity:

In post-marketing studies due to Abirapro treatment, hepatic toxicity may occur due to acute liver injury leading to death.

Increased AST, bilirubin, ALT can lead to this condition.

Patients may frequently experience a liver function test before or during treatment.

DRUG INTERACTION

Concomitant use of Abirapro with CYP3A4 inducers, such as rifampicin, results in decreased exposure to abiraterone.

To avoid this condition, increase the dose of Abirapro to reduce the problem.

Abirapro is an inhibitor of CYP2D6 and CYP2C8 when 30 mg dextromethorphan is administered with Abirapro 100 mg and 5 mg prednisolone causes increased AUC and Cmax of dextromethorphan (CYP2D6 substrate).

Avoid concomitant administration of CYP2D6 substrate with Abirapro.

In combination with Abirapro and pioglitazone, it increases the systemic exposure of pioglitazone.

POSSIBLE CONTRAINDICATION

Abirapro is contraindicated in pregnant and lactating women

Patient hypersensitivity reactions are contraindicated in the tablet component of Abirapro tablets.

PREGNANCY AND LACTATION

Load category: X

Abirapro should not be used under pregnancy

Breastfeeding is not allowed.

The efficacy of Abirapro tablets has not been evaluated in children and adolescents.

The safety of the drug has not been evaluated in geriatric patients over the age of 65 years.

STORAGE AND HANDLING

The Abirapro tablet container should be stored at temperatures between 20 ° C and 25 ° C

Keep the container free of humidity, heat, and light

MISSED DOSE

The unused dose of Abirapro tablets should be avoided.

Consult your oncologist and follow the instructions

Follow the regular dosing schedule

OVERDOSAGE

The dose of Abirapro does not have a specific antidote.

Provide support measures

Monitor patients for arrhythmia, heart failure and liver function to reduce liver damage.

 

 

  • Trade name Abirapro 250mg
  • Substance Abiraterone acetate
  • Manufacturer Glenmark Pharmaceuticals
  • Packaging 120 tablets
  • Country of origin India
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