WARNINGS
Megestrol acetate may
cause fetal harm when administered to a pregnant woman. For animal data on fetal
effects, (see PRECAUTIONS:
Impairment of
Fertility section). There are no adequate and well-controlled studies in
pregnant women. If this drug is used during pregnancy, or if the patient becomes
pregnant while taking (receiving) this drug, the patient should be apprised of
the potential hazard to the fetus. Women of childbearing potential should be
advised to avoid becoming pregnant.
Megestrol acetate is not
intended for prophylactic use to avoid weight loss.
(See also PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of
Fertility section).
The glucocorticoid
activity of megestrol acetate oral suspension has not been fully evaluated.
Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing
diabetes mellitus, and overt Cushing’s Syndrome have been reported in
association with the chronic use of megestrol acetate. In addition, clinical
cases of adrenal insufficiency have been observed in patients receiving or being
withdrawn from chronic megestrol acetate therapy in the stressed and
non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing
has revealed the frequent occurrence of asymptomatic pituitary-adrenal
suppression in patients treated with chronic megestrol acetate therapy.
Therefore, the possibility of adrenal insufficiency should be considered in any
patient receiving or being withdrawn from chronic Megace ® ES therapy who presents with symptoms and/or signs suggestive
of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness)
in either the stressed or non-stressed state. Laboratory evaluation for adrenal
insufficiency and consideration of replacement or stress doses of a rapidly
acting glucocorticoid are strongly recommended in such patients. Failure to
recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in
death. Finally, in patients who are receiving or being withdrawn from chronic
Megace® ES therapy, consideration should be given to the
use of empiric therapy with stress doses of a rapidly acting glucocorticoid
during stress or serious intercurrent illness (e.g., surgery, infection).
PRECAUTIONS
GENERAL
Therapy with Megace
® ES (megestrol acetate) oral suspension for weight loss
should only be instituted after treatable causes of weight loss are sought and
addressed. These treatable causes include possible malignancies, systemic
infections, gastrointestinal disorders affecting absorption, endocrine disease
and renal or psychiatric diseases.
Effects on HIV viral
replication have not been determined.
Use with caution in
patients with a history of thromboembolic disease.
Use in Diabetics
Exacerbation of
pre-existing diabetes with increased insulin requirements have been reported in
association with the use of megestrol acetate.
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