|Drug Name:||Megestrol Acetate|
|Manufacturer:||Roxane Laboratories, Inc.|
There is no threshold limit value established by OSHA, NIOSH, or ACGIH.Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS-).Women at risk of pregnancy should avoid such exposure.10000312/05Revised February 2007© RLI, 2007
History of hypersensitivity to megestrol acetate or any component of the formulation.Known or suspected pregnancy.
Megestrol acetate may cause fetal harm when administered to a pregnant woman.
For animal data on fetal effects, see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility.
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, Impairment of Fertility.)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.
In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol therapy in the stressed and non-stressed state.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 therapy.
Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or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 megestrol therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (e.g., surgery, infection).