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

camber pharmaceuticals, inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate tablets contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)]. maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unknown. a c

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

american regent, inc. - sodium acetate anhydrous (unii: nvg71zz7p0) (acetate ion - unii:569dqm74sc, sodium cation - unii:lyr4m0nh37) - sodium acetate anhydrous 328 mg in 1 ml - sodium acetate for injection, usp concentrate is indicated as a source of sodium in patients with restricted or no oral intake. it is also useful as an additive for preparing specific intravenous fluid formulas, when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. sodium acetate for injection, usp concentrate is contraindicated in patients with hypernatremia.

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

west-ward pharmaceuticals corp. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 20 mg - megestrol acetate is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., 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)

pharmaceutical associates, inc. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 40 mg in 1 ml - megestrol acetate oral suspension, usp 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)

hikma pharmaceutical - cortisone acetate (unii: 883wkn7w8x) (cortisone - unii:v27w9254fz) - cortisone acetate 25 mg - 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post-traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus acute rheumatic carditis systemic dermatomyositis

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.

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

orion laboratories pty ltd t/a perrigo australia - ulipristal acetate, quantity: 30 mg - tablet, uncoated - excipient ingredients: povidone; magnesium stearate; croscarmellose sodium; lactose monohydrate - ellaone is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

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

bora pharmaceutical laboratories 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 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 - Department of Health (Therapeutic Goods Administration)

sandoz 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. cyproterone sandoz 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 cyproterone sandoz 50mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of childbearing 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 to drive in sexual deviations. cyproterone sandoz 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. cyproterone sandoz 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to 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)

sun pharmaceutical industries, inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 0.1 mg in 1 ml - central cranial diabetes insipidus: desmopressin nasal spray solution, usp 0.01% is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. it is ineffective for the treatment of nephrogenic diabetes insipidus.   the use of desmopressin nasal spray solution, usp 0.01% in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. this will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.   there are reports of an occasional change in response with time, usually greater than 6 months. some patients may show a decreased responsiveness, others a shortened duration of effect. there is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the p