الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 0.5 mg -    limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. femhrt 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-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 femhrt - known liver impairment or disease - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - known or suspected pregnancy  femhrt should not be used during pregnancy [see  contraindications (4) ]. there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestin

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine 2.5 mg - saphris is indicated for: - schizophrenia in adults [see clinical studies ( 14.1) ] - bipolar i disorder [see clinical studies ( 14.2) ] • acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age • adjunctive treatment to lithium or valproate in adults • maintenance monotherapy treatment in adults saphris is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations ( 8.7 ), clinical pharmacology ( 12.3 )] . - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions ( 5.6 ), adverse reactions ( 6 )] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to saphris during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensme

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - lo loestrin® fe is indicated for use by women to prevent pregnancy [ see clinical studies (14) ] .   the efficacy of lo loestrin fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. lo loestrin fe 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 w

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - latisse ® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. latisse ® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2) ]. risk summary there are no adequate and well-controlled studies of latisse ® (bimatoprost ophthalmic solution) 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (auc). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. in pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. no adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. because animal reproductive studies are not always predictive of human response latisse ®   0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. data animal data in an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). the no observed adverse effect level (noael) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on auc). no abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. in an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). the noael for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). no abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). in a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. these effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. the noael for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). risk summary it is not known whether topical ocular treatment with latisse ®   0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. in animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the recommended human ophthalmic dose (on a mg/m2 basis), however no animal data is available at clinically relevant doses.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for latisse ®   0.03% and any potential adverse effects on the breastfed child from latisse ®  0.03%. use of latisse ®  was evaluated in a sixteen-week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. no new safety issues were observed. the results of the global eyelash assessment (gea) are provided in table 1. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin 4 mg in 1 g - rectiv® (nitroglycerin) ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. administration of rectiv is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cgmp)-specific phosphodiesterase type 5 (pde5), such as sildenafil, vardenafil, and tadalafil, as these are shown to potentiate the hypotensive effects of organic nitrates [see 7.1 drug interactions]. rectiv is contraindicated in patients with severe anemia. rectiv is contraindicated in patients with increased intracranial pressure. rectiv is contraindicated in patients who have shown hypersensitivity to it or to other nitrates or nitrites. skin reactions consistent with hypersensitivity have been observed with organic nitrates. pregnancy category c animal reproduction and teratogenicity studies have not been conducted with rectiv. nitroglycerin was not teratogenic when administered by topical or dietary route. there are no adequate and well-controlled

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - brimonidine tartrate 2 mg in 1 ml - combigan ®   (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (iop) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled iop; the iop-lowering of combigan ® dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. combigan ® is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [ see warnings and precautions   ( 5.1 , 5.3 ) ] . combigan ®   is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure [see warnings and precautions ( 5.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - nebivolol hydrochloride (unii: jgs34j7l9i) (nebivolol - unii:030y90569u) - nebivolol 2.5 mg - bystolic is indicated for the treatment of hypertension, to lower blood pressure [see clinical studies ( 14.1)]. bystolic may be used alone or in combination with other antihypertensive agents [see drug   interactions ( 7)].   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 the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with bystolic. 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 t

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - triptorelin pamoate (unii: 08an7wa2g0) (triptorelin - unii:9081y98w2v) - triptorelin 3.75 mg in 2 ml - trelstar is indicated for the palliative treatment of advanced prostate cancer [see  clinical studies (14) ]. trelstar is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other gnrh agonists or gnrh [see warnings and precautions (5.1) ]. risk summary based on findings in animal studies and mechanism of action, trelstar can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . expected hormonal changes that occur with trelstar treatment increase the risk for pregnancy loss. in animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. advise pregnant patients and females of reproductive potential of the potential risk to the fetus. dat

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - dexamethasone 0.7 mg - ozurdex ®   (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (brvo) or central retinal vein occlusion (crvo). ozurdex ®   is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye. ozurdex ®   is indicated for the treatment of diabetic macular edema.   ozurdex ®   (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.  ozurdex ® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. ozurdex ® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. laser posterior capsulotomy in pseudophakic pati

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.8 mg - generess fe is indicated for use by women to prevent pregnancy. the efficacy of generess fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. generess fe 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