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prasco laboratories - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin 0.5 mg in 1 ml - dactinomycin is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. none. risk summary based on findings from animal studies and its mechanism of action, dactinomycin can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . in animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose ( see data ). advise pregnant women of the potential risk to a fetus [see use in special populations ( 8.3)] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data dactinomycin was teratogenic in animals. administration of dactinomycin to pregnant rats, rabbits, and hamsters during the period of organogenesis, increased the incidence of fetal malformations and caused embryotoxicity at doses (based on body surface area) as low as 0.2 times the clinical dose of 1250 mcg/m 2 . risk summary there are no data on the presence of dactinomycin or its metabolites in human milk or their effects on the breastfed infant or on milk production. because of the potential for serious adverse reactions in breastfed infants from dactinomycin, advise women not to breastfeed during treatment with dactinomycin and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating dactinomycin [see use in specific population ( 8.1)]. contraception dactinomycin can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)]. females advise females of reproductive potential to use effective contraception during treatment with dactinomycin and for at least 6 months after the final dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with dactinomycin and for 3 months after the final dose [see nonclinical toxicology ( 13.1)]. the safety and effectiveness of dactinomycin have been established in pediatric patients with wilms tumor, rhabdomyosarcoma, ewing sarcoma, and metastatic nonseminomatous testicular cancer. the safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. the safety and effectiveness of dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies. clinical studies of dactinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

prasco laboratories - hydroxyprogesterone caproate (unii: 276f2o42f5) (hydroxyprogesterone - unii:21807m87j2) - hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. the effectiveness of hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation. there are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. limitation of use : while there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. it is not intended for use in women with multiple gestations or other risk factors for preterm birth. do not use hydroxyprogesterone caproate in women with any of the following conditions: - current or history of thrombosis or thromboembolic disorders - known or suspected breast cancer, other hormone-sensitive cancer,

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

prasco laboratories - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin phosphate and tretinoin gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled studies in pregnant women treated with clindamycin phosphate and tretinoin gel. clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. a limit teratology study performed in sprague dawley rats treated topically with clindamycin phosphate and tretinoin gel or 0.025% tretinoin gel at a dose

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

prasco laboratories - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil is indicated for the treatment of erectile dysfunction (ed). tadalafil is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph). tadalafil is indicated for the treatment of ed and the signs and symptoms of bph (ed/bph). if tadalafil is used with finasteride to initiate bph treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see clinical studies (14.3)] . administration of tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. in clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [see clinical pharmacology (12.2)] . tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil (also marketed as cialis® or adcirca® ). hypersensitivity reactions have been reported,

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

prasco laboratories - aliskiren hemifumarate (unii: c8a0p8g029) (aliskiren - unii:502fwn4q32) - aliskiren is indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age and older 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. there are no controlled trials demonstrating risk reduction with aliskiren. 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 1 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,

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

prasco laboratories - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only etonogestrel/ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. etonogestrel/ethinyl estradiol vaginal ring is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnin

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

prasco laboratories - calcipotriene hydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3)]. observational studies suggest an increased risk of having low birth weight infants with the maternal use of potent or super potent topical corticosteroids (see data ). advise pregnant women that calcipotriene and betamethasone dipropionate topical suspension may increase the potential risk of having a low birth weight infant and

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

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

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

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

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

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.