Entroza( Anastrozole)
Therapeutic Group: Aromatase Inhibitors
Presentation
Entroza : Each tablet contains Anastrozole 1 mg.
Description
Entroza tablet contains Anastrozole, a potent and highly selective nonsteroidal aromatase inhibitor. Anastrozole selectively inhibits the conversion of androgens to estrogens, without affecting synthesis of adrenal corticosteroid, aldosterone or thyroid hormone. Suppression of estrogen biosynthesis in all tissues reduces serum concentrations of circulating estrogens, including estrone, estradiol, and estrone sulphate with a subsequent beneficial effect in breast cancer.
Indications
• Treatment of early breast cancer in hormone receptor positive post-menopausal women.
• Adjuvant treatment of early breast cancer in hormone receptor positive
postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
• Reduction in the incidence of contralateral breast cancers in post menopausal women receiving Anastrozole as adjuvant treatment for early breast cancer.
• Treatment of advanced breast cancer in post-menopausal women.
Dosage & Administration
Adults Including the Elderly: One tablet (1 mg) to be taken orally once a day.
Children: The use of Entroza is not recommended in children, as efficacy has not been established
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.
Side Effects
Very common side effects: Hot flushes, asthenia, joint stiffness, arthritis, headache, nausea, rash etc.
Common side effects: Hair thinning, allergic reactions, diarrhea, vomiting, somnolence etc.
Precautions
Anastrozole is not recommended for use in children or in
pre-menopausal women as safety and efficacy have not been established in these groups of patients.
• Anastrozole has not been investigated in patients with severe hepatic or severe renal impairment. The potential risk/benefit to such patients should be carefully considered before administration of Entroza.
• As Anastrozole lowers circulating estrogen levels, it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.
Use in Pregnancy & Lactation
Entroza must not be administered during pregnancy or lactation
Drug Interaction
Tamoxifen and/or other therapies containing estrogen should not be co-administered with Entroza
Over Dose
There is limited clinical experience of overdose of Anastrozole. There are no reports where a patient has taken a dose in excess of 60 mg. No toxicity was observed and no clinically relevant adverse effects have been seen.
Storage
Store in a cool & dry place, protected from light and moisture. Keep out of reach of children.
Commercial Pack
Entroza : Each box contains 3 blister strips of 10 tablets.