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prasco laboratories - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. treatment should be limited to 4 consecutive weeks. the total dosage should not exceed 50 g (50 ml or 1.75 fl. oz.) per week. patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see dosage and administration (2) ]. use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (hpa) axis suppression [see warnings and precautions (5.1) and use in specific populations (8.4) ]. clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. avoid any contact of the drug product with the eyes and lips. in case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo. none teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies in pregnant women. therefore, clobetasol propionate shampoo, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.  clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. clobetasol propionate has greater teratogenic potential than steroids that are less potent. the effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 μg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. the maternal no-observed-effect-level (noel) for clobetasol propionate was less than 12.5 μg/kg/day due to reduced body weight gain and feed consumption during the gestation period. the reproductive noel in the dams was 25 μg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m /day basis) based on prolonged delivery at a higher dose level. the no-observed-adverse-effect-level (noael) for viability and growth in the offspring was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m /day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. the weights of the epididymides and testes were significantly reduced at higher dosages. despite these changes, there were no effects on the mating and fertility of the offspring. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate shampoo, 0.05%, is administered to a nursing woman. use of clobetasol propionate shampoo, 0.05%, in patients under 18 years old is not recommended due to potential for hpa axis suppression [see warnings and precautions (5.1) ] the effect of clobetasol propionate shampoo, 0.05%, on hpa axis suppression was evaluated in one trial in adolescents 12 to 17 years of age with moderate to severe scalp psoriasis with involvement of at least 25% of the scalp. in this trial, 5 of 12 evaluable subjects developed suppression of their hpa axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05%, applied once daily for 15 minutes to a dry scalp before lathering and rinsing. only 1 of the 5 subjects who had suppression was tested for recovery of hpa axis, and this subject recovered after 2 weeks. no studies have been performed in patients under the age of 12. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing’s syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. therefore, use is not recommended in patients under the age of 18. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. ​clinical studies of clobetasol propionate shampoo, 0.05%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. in general, dose selection for an elderly patient should be made with caution, 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.​

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prasco laboratories - calcipotriene monohydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary calcipotriene and betamethasone dipropionate ointment contains calcipotriene and betamethasone dipropionate. the limited data with calcipotriene and betamethasone dipropionate ointment and calcipotriene use in pregnant women are not sufficient to evaluate a calcipotriene and betamethasone dipropionate ointment-associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids (see data) . advise pregnant women that calcipotriene and betamethasone dipropionate ointment may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for

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prasco laboratories - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. limitations of use sumatriptan injection is contraindicated in patients with: risk summary data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see data) . in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see data) . 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. the reported rate

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prasco laboratories - sumatriptan (unii: 8r78f6l9vo) (sumatriptan - unii:8r78f6l9vo) - sumatriptan nasal spray is indicated for the acute treatment of migraine with or without aura in adults. limitations of use: sumatriptan nasal spray is contraindicated in patients with: risk summary data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see data) . in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see data ). 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. the reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk: several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. data human data: the sumatriptan/naratriptan/treximet (sumatriptan and naproxen sodium) pregnancy registry, a population-based international prospective study, collected data for sumatriptan from january 1996 to september 2012. the registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). the occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% ci: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% ci: 2.7% to 6.2%]). the sample size in this study had 80% power to detect at least a 1.73- to 1.91-fold increase in the rate of major malformations. the number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis. no other birth defect was reported for more than 2 infants in this group. in a study using data from the swedish medical birth register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% ci: 0.91 to 1.21]). a study using linked data from the medical birth registry of norway to the norwegian prescription database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (or 1.16 [95% ci: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (or 1.83 [95% ci: 1.17 to 2.88]), each compared with the population comparison group. additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. animal data: oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. the highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day. oral administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryolethality and fetal cervicothoracic vascular and skeletal abnormalities. intravenous administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryolethality. the highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 and 0.75 mg/kg/day, respectively. oral administration of sumatriptan to rats prior to and throughout gestation resulted in embryofetal toxicity (decreased body weight, decreased ossification, increased incidence of skeletal abnormalities). the highest no-effect dose was 50 mg/kg/day. in offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. the highest no-effect dose for this effect was 60 mg/kg/day. oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. the highest no-effect dose for this finding was 100 mg/kg/day. risk summary sumatriptan is excreted in human milk following subcutaneous administration (see data) . there is no information regarding sumatriptan concentrations in milk from lactating women following administration of sumatriptan nasal spray. there are no data on the effects of sumatriptan on the breastfed infant or the effects of sumatriptan on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sumatriptan nasal spray and any potential adverse effects on the breastfed infant from sumatriptan or from the underlying maternal condition. clinical considerations infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with sumatriptan nasal spray. data following subcutaneous administration of a 6-mg dose of sumatriptan injection in 5 lactating volunteers, sumatriptan was present in milk. safety and effectiveness in pediatric patients have not been established. sumatriptan nasal spray is not recommended for use in patients younger than 18 years of age. two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack. the trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in adolescents. adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral sumatriptan (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. these trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in adolescents. adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. the frequency of all adverse reactions in these patients appeared to be both dose- and age-dependent, with younger patients reporting reactions more commonly than older adolescents. postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. these reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. a myocardial infarction has been reported in a 14‑year‑old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration. clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal sumatriptan are not presently available. clinical trials of sumatriptan nasal spray did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the 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. a cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of cad) prior to receiving sumatriptan nasal spray [see warnings and precautions (5.1)] .

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prasco, llc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with pseudomonas aeruginosa . safety and efficacy have not been demonstrated in patients under the age of six years, patients with fev1 less than 40% or greater than 80% predicted, or patients colonized with burkholderia cepacia [see clinical studies ( 14 )] . tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. risk summary aminoglycosides can cause fetal harm. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [warnings and precautions ( 5.6 )] . although there are no available data on use of tobramycin inhalation solution in pregnant women to be able to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected

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prasco laboratories - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. important limitations of use: ciclesonide inhalation aerosol is not indicated for the relief of acute bronchospasm. ciclesonide inhalation aerosol is not indicated for children under 12 years of age. ciclesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ciclesonide inhalation aerosol is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of ciclesonide inhalation aerosol. rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. teratogenic effects : pregnancy category c oral administration of ciclesonide in rats up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose

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prasco laboratories - eplerenone (unii: 6995v82d0b) (eplerenone - unii:6995v82d0b) - eplerenone tablets are indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤ 40%) (hfref) after an acute myocardial infarction (mi). eplerenone tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and mi. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cv risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, e

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prasco laboratories - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate (mpa) injectable suspension, usp is indicated for use by females of reproductive potential to prevent pregnancy. limitations of use : the use of mpa injectable suspension, usp is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see dosage and administration (2.1) and warnings and precautions (5.1)]. the use of mpa injectable suspension, usp 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 mpa injectable suspension, usp (medroxyprogesterone acetate or any of its other ingredients) [see warnings and precautions (5.5)] . - significant liver disease [see warnings and precautions (5.7)]

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prasco laboratories - prazosin hydrochloride (unii: x0z7454b90) (prazosin - unii:xm03yj541d) - prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and

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prasco laboratories - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol vaginal cream, usp, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. estradiol vaginal cream, usp, 0.01% should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of cancer of the breast. - known or suspected estrogen-dependent neoplasia. - active dvt, pe or history of these conditions. - active arterial thromboembolic disease (for example, stroke, mi) or a history of these conditions. - known anaphylactic reaction or angioedema to estradiol vaginal cream, usp, 0.01% - known liver dysfunction or disease. - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. - known or suspected pregnancy.