Stany Zjednoczone - angielski - 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.

Stany Zjednoczone - angielski - 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

Stany Zjednoczone - angielski - 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

Stany Zjednoczone - angielski - 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.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

glenmark pharmaceuticals inc.,usa - 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 tablets are 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 tablets 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 acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 ml/min). desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.

Stany Zjednoczone - angielski - 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.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

par pharmaceutical, inc. - mafenide acetate (unii: rq6lp6z0wy) (mafenide - unii:58447s8p4l) - mafenide 50 g - mafenide acetate,usp for 5% topical solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. mafenide acetate ,usp for 5% topical solution is contraindicated in patients who are hypersensitive to mafenide acetate. it is not known whether there is cross sensitivity to other sulfonamides.

Stany Zjednoczone - angielski - 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

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 5 mg - medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. they are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. mpa tablets is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen- or progesterone-dependent neoplasia. - active dvt, pe, or a history of these conditions. - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions. - known anaphylactic reaction or angioedema to mpa. - known liver impairment or disease. - known or suspected pregnancy.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see clinical studies (14)] . the efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets to women who are known to have the following conditions: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during pregnancy to treat threatened or habitual abortion. when possible, advise the nursing mother to use other forms of contraception until she has weaned her child. cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets have been established in women of reproductive age. efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets has not been studied in subjects with renal impairment. the pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets has not been studied in subjects with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded [see contraindications (4) and warnings and precautions (5.2)]. the safety and efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) greater than 35 kg/m2 has not been evaluated [see clinical studies (14)].