Megestrol
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Fetal Effects: May cause fetal harm. Females of reproductive potential should be advised to avoid becoming pregnant. Clinical cases of 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 In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate in the stressed and non-stressed state .
Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with megestrol acetate oral suspension [see Dosage and Administration]. Advise females of reproductive potential to use effective contraception while taking megestrol acetate oral suspension [see Use in Specific Populations]. 5.3 Adrenal Insufficiency The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated.
Clinical cases of 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 In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state.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Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol acetate oral suspension therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea,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 Finally, in patients who are receiving or being withdrawn from chronic megestrol acetate oral suspension therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting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). 5.4 Diabetes Clinical cases of new onset diabetes mellitus and exacerbation of pre-existing diabetes mellitus have been reported in association with the chronic use of megestrol acetate.
Preparation and administration
Testing Prior to Megestrol Acetate Oral Suspension Administration Obtain a negative pregnancy test in females of reproductive potential prior to initiating treatment with megestrol acetate oral suspension [see Contraindications, Warnings and Precautions, Use in Specific Populations ( 8.1 , 8.3 )].
Dosing and Administration The recommended adult initial dosage of megestrol acetate oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Shake the container well before using. This strength (125 mg/mL) is not substitutable with other strengths (e.g., 40 mg/mL). Refer to the prescribing information of the 40 mg/mL product for dosage recommendations for the 40 mg/mL strength.
Drug interactions
Check megestrol against a medication listLabel text (3 paragraphs)
Due to a significant decrease in indinavir exposure, administration of a higher dose of indinavir should be considered when coadministering with megestrol acetate ( 7.1 , 12.3 ).
7.1 Indinavir Due to the significant decrease in the exposure of indinavir by megestrol acetate, administration of a higher dose of indinavir should be considered when coadministering with megestrol acetate [See Clinical Pharmacology ( 12.3 )] .
7.2 Zidovudine and Rifabutin No dosage adjustment for zidovudine and rifabutin is needed when megestrol acetate is coadministered with these drugs [See Clinical Pharmacology ( 12.3 )] .
Contraindications
History of hypersensitivity to megestrol acetate or any component of the formulation. Pregnancy [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 , 8.3 )]. History of hypersensitivity to megestrol acetate or any component of the formulation ( 4 ). Pregnancy ( 4 )( 8.1 ).
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on animal data, megestrol acetate may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy [see Contraindications ( 4 )] . There are no available human data to assess for any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. There are no adequate animal developmental toxicity data at clinically relevant doses. Pregnant rats treated with low doses of megestrol acetate resulted in a reduction in fetal weight and number of live births, and feminization of male fetuses at doses below maximum recommended clinical dosing based on body surface area ( see Data ).
Advise a pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Reproduction studies were performed in pregnant rats at oral doses ranging from 0.05 to 12.5 mg/kg/day, which are below the maximum recommended clinical dose based on body surface area.
Reduction in fetal weight and number of live births were observed at 12.5 mg/kg/day (5 times lower than the maximum clinical dose) when dams were dosed on days 12 through 18 of pregnancy. Feminization of male fetuses also occurred when dams were dosed on days 13 through 20 of pregnancy at 3 mg/kg/day, approximately 22 times below the maximum clinical dose.
Lactation
8.3 Females and Males of Reproductive Potential Pregnancy testing Pregnancy testing is recommended prior to treatment with megestrol acetate oral suspension [see Dosage and Administration ( 2.1 ), Use in Specific Populations ( 8.1 )]. Contraception Megestrol acetate oral suspension may cause fetal harm when administered during pregnancy [see Use in Specific Populations ( 8.1 )]. Advise females of reproductive potential to use effective contraception during treatment with megestrol acetate oral suspension.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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