Full Prescribing Information

USE IN SPECIFIC POPULATIONS

Pregnancy

PREGNANCY CATEGORY X
Anastrozole may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. Anastrozole is contraindicated in women who are or may become pregnant. In animal studies, anastrozole caused pregnancy failure, increased pregnancy loss, and signs of delayed fetal development. There are no studies of anastrozole use in pregnant women. If anastrozole is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus and potential risk for pregnancy loss.

Nursing Mothers

It is not known if anastrozole is excreted in human milk. Because many drugs are excreted in human milk and because of the tumorigenicity shown for anastrozole in animal studies, or the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Clinical studies in pediatric patients included a placebo-controlled trial in pubertal boys of adolescent age with gynecomastia and a single-arm trial in girls with McCune-Albright Syndrome and progressive precocious puberty. The efficacy of anastrozole in the treatment of pubertal gynecomastia in adolescent boys and in the treatment of precocious puberty in girls with McCune-Albright Syndrome has not been demonstrated.

  1. McCune-Albright Syndrome Study
  2. Pharmacokinetics in Pediatric Patientsy

Geriatric Use

The pharmacokinetics of anastrozole is not affected by age.

Renal Impairment

Since only about 10% of anastrozole is excreted unchanged in the urine, the renal impairment does not influence the total body clearance. Dosage adjustment in patients with renal impairment is not necessary.

Hepatic Impairment

TThe plasma anastrozole concentrations in the subjects with hepatic cirrhosis were within the range of concentrations seen in normal subjects across all clinical trials. Therefore, dosage adjustment is also not necessary in patients with stable hepatic cirrhosis. Anastrozole has not been studied in patients with severe hepatic impairment .


VISION

At Taj Pharmaceuticals our goal is to create innovative drugs and diagnostic tools for the medicine of tomorrow. Rapid progress in the sciences is providing crucial insights into the underlying molecular mechanisms of disease, opening up new ways for prevention, diagnosis and therapy. With the expertise in Diagnostics and Pharmaceuticals, Taj Pharmaceuticals is best placed to capture the value from the Healthcare Revolution.

The future will be shaped by fundamental paradigm shifts ushering in a new era of more effective medicine. Diagnosis, prevention and treatment will be linked more closely than ever before in integrated strategies offering patients and healthcare providers highly focused, individualised care. We are confident that, with our outstanding workforce, cutting-edge science and state-of-the-art technology base, we can meet tomorrow's needs for integrated healthcare solutions.

MISSION

As one of the world's leading innovation-driven healthcare groups, whose core businesses are Pharmaceuticals and Diagnostics, Taj Pharmaceuticals aims to supply products and services that significantly improve people's lives by helping to prevent, diagnose and treat disease.

Taj Pharmaceuticals is committed to a system of corporate governance that conforms to the latest standards and takes due account of our corporate development. The safety and health of our employees and the public, as well as the protection of our neighbourhoods and the environment, have high priority at all Group facilities. In all we do, we are guided by the principle of sustainable development.

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Brutrax® (Aastrozole Tablet) may help reduce your risk of breast cancer recurrence sold by Taj Pharmaceuticals Limited (India), a global pharmaceuticals company. It is available in India, Middle East and a few other South Asian countries.

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Information for Health Care Professionals
*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).

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