United States - English - NLM (National Library of Medicine)

twi pharmaceuticals, inc. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 125 mg in 1 ml - megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids). limitations of use therapy with 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, renal disease or psychiatric diseases. megestrol acetate oral suspension is not intended for prophylactic use to avoid weight loss. - 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)]. 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. risk summary the centers for disease control and prevention recommend that hiv-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. megestrol acetate is present in human milk. there are no data on the effects of megesterol acetate on the breastfed infant or the effects on milk production. because of the potential for hiv transmission and adverse effects on a breastfed infant, instruct mothers not to breastfeed if they are taking megestrol acetate oral suspension. 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. safety and effectiveness in pediatric patients have not been established. clinical studies of megestrol acetate oral suspension in the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with aids did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. megestrol acetate has had limited use in hiv infected women. all 10 women in the clinical trials reported breakthrough bleeding. megestrol acetate oral suspension is a progesterone derivative, which may induce vaginal bleeding in women.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - megestrol acetate - oral tablet - megestrol acetate steroid-progestin active 5.0 mg/tb - endocrine system - cat | dog | dog - female (bitch) | bitch | castrate | cat - queen | cat - tom | kitten | puppy - eosinophilic granulomas | improving behaviour | mammary tumours | miliary eczema | modify hypersexuality | postpone oestrus | prevent oestrus | pseudo-pregnancy | urine spray | eliminate urine spraying | excess libido - reduce | pseudo-cyesis | pseudo-pregnancy lactation

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - megestrol acetate - oral tablet - megestrol acetate steroid-progestin active 20.0 mg/tb - endocrine system - cat | dog | dog - female (bitch) | bitch | castrate | cat - queen | cat - tom | kitten | puppy - eosinophilic granulomas | improving behaviour | mammary tumours | miliary eczema | modify hypersexuality | postpone oestrus | prevent oestrus | pseudo-pregnancy | urine spray | eliminate urine spraying | excess libido - reduce | pseudo-cyesis | pseudo-pregnancy lactation

United States - English - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 40 mg - megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). it should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy. history of hypersensitivity to megestrol acetate or any component of the formulation.

United States - English - NLM (National Library of Medicine)

atlantic biologicals corp. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 40 mg in 1 ml - megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids). history of hypersensitivity to megestrol acetate or any component of the formulation. known or suspected pregnancy.

Australia - English - Department of Health (Therapeutic Goods Administration)

theramex australia pty ltd - nomegestrol acetate, quantity: 2.5 mg; estradiol hemihydrate, quantity: 1.55 mg (equivalent: estradiol, qty 1.5 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; purified talc; lactose monohydrate; colloidal anhydrous silica; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - oral contraception.

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - megestrol acetate 160mg - tablet - 160 mg - active: megestrol acetate 160mg excipient: colloidal silicon dioxide croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose - apo-megestrol is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e. recurrent, inoperable or metastatic diseases). it should not be used in lieu of currently accepted procedures such as surgery, radiation or chemotherapy. apo-megestrol is indicated for the treatment of anorexia, cachexia, or a significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids).

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - megestrol acetate 40mg - tablet - 40 mg - active: megestrol acetate 40mg excipient: brilliant blue fcf colloidal silicon dioxide croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose - apo-megestrol is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e. recurrent, inoperable or metastatic diseases). it should not be used in lieu of currently accepted procedures such as surgery, radiation or chemotherapy. apo-megestrol is indicated for the treatment of anorexia, cachexia, or a significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids).

United States - English - NLM (National Library of Medicine)

stat rx usa - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 125 mg in 1 ml - megace ® es (megestrol acetate) oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids). history of hypersensitivity to megestrol acetate or any component of the formulation. known or suspected pregnancy.

United States - English - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids). limitations of use therapy with megestrol acetate 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, renal disease or psychiatric diseases. megestrol acetate is not intended for prophylactic use to avoid weight loss. - 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)]. 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