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

teva pharmaceuticals usa, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate tablets usp are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate tablets usp are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - known or suspected pregnancy. there is no indication for norethindrone acetate in pregnancy. (see precautions .) - undiagnosed vaginal bleeding - known, suspected or history of cancer of the breast - active deep vein thrombosis, pulmonary embolism or history of these conditions - active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) - impaired liver function or liver disease - as a diagnostic test for pregnancy - hypersensitivity to any of the drug components

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

cameron pharmaceuticals, llc - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate 30 mg - hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani. hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

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.

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

amring pharmaceuticals, inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 10 ug in 0.1 ml - desmopressin acetate nasal spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. limitations of use : desmopressin acetate nasal spray is not indicated for: - treatment of nephrogenic diabetes insipidus, - treatment of primary nocturnal enuresis [see warnings and precautions (5.1) ], - use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see warnings and precautions (5.2)], - use in patients with an impaired level of consciousness, - use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see dosage forms and strengths (3)]. desmopressin acetate nasal spray is contraindicated in patients with: - known hypersensitivity to desmopressin acetate or to any of the components of desmopress

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 0.1 mg - desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention. desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. desmopressin a

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

pd-rx pharmaceuticals, inc. - fludrocortisone acetate (unii: v47if0pvh4) (fludrocortisone - unii:u0476m545b) - fludrocortisone acetate 0.1 mg - fludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in addison's disease and for the treatment of salt-losing adrenogenital syndrome. fludrocortisone acetate tablets (corticosteroids) are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents.

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

arrotex pharmaceuticals pty ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

arrotex pharmaceuticals pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. apo-cyproterone acetate 50mg inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if apo-cyproterone acetate 50mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of child bearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction of drive in sexual deviations. apo-cyproterone acetate 50mg reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. apo-cyproterone acetate 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

preferred pharmaceuticals, inc. - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate 25 mg - for use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani. hydrocortisone acetate suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components. drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

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

amphastar pharmaceuticals, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 150 mg in 1 ml - medroxyprogesterone acetate is indicated only for the prevention of pregnancy. the loss of bone mineral density (bmd) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in bmd that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate long-term [see warnings and precautions (5.1)] . the use of medroxyprogesterone acetate is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)]. - known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients [see warnings and precautions (5.5)] . - significant liver disease [see warnings and precautions (5.6)]. - undiagnosed vaginal bleeding