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Anastrozole tablets is not recommended for use in children as safety and efficacy have not been established in this group of patients.
Anastrozole should not be used in premenopausal women. The menopause should be defined biochemically in any patient where there is doubt about hormonal status.
Since anastrozole lowers circulating estrogen levels, it may cause a decrease in bone mineral density resulting in a possible increase risk of fracture.
Bone mineral density assessment should be performed for women with osteoporosis or at risk of osteoporosis at the onset of treatment and at regular intervals subsequently. Prophylaxis or treatment for osteoporosis should be initiated suitably and carefully monitored. Use of specific treatments, such as biphosphates, may prevent further bone mineral loss caused by anastrozole.
Estrogen-containing therapies should not be used with this product as they may diminish its pharmacologic action.
It is unlikely to impair the ability of patients to drive and operate machinery. However, asthenia and somnolence have been reported with the use of it and caution should be observed when driving or operating machinery while such symptoms persist.
There are no data to support the safe use of anastrozole tablets in patients with moderate or severe hepatic impairment, or patients with severe impairment or renal function (creatinine clearance <20 mL/min).
Anastrozole tablets can cause fetal harm when administered to a pregnant woman. There is no adequate and well-controlled study in pregnant women using Anastrozole tablets. If it 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 or potential risk for loss of the pregnancy.
It is not known if anastrozole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Anastrozole tablets is administered to a nursing woman.
