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baxalta us inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml - artiss is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age. artiss is not indicated for hemostasis. do not inject artiss directly into blood vessels. intravascular application of artiss may result in life-threatening thromboembolic events. do not use artiss in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients (see warnings/precautions, hypersensitivity/allergic/anaphylactic reactions (5.1) and adverse reactions, overall adverse reactions (6.1)). pregnancy category c animal reproduction studies have not been conducted with artiss. it is also not known whether artiss can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. some viruses, such as parvovirus b19, are particularly difficult to remove or inactivate at this time. parvovirus b19 most seriously affects pregnant women (f

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allergan, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - pancrelipase lipase 3000 [usp'u] - zenpep® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. none. teratogenic effects pregnancy category c: animal reproduction studies have not been conducted with pancrelipase. it is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. zenpep should be given to a pregnant woman only if clearly needed. the risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when zenpep is administered to a nursing

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ratiopharm inc - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone .25 mg - adults risperidone tablets are  indicated  for  the  acute  and  maintenance  treatment  of schizophrenia [see clinical studies (14.1)] . adolescents due to janssen pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. pediatric use information  for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for janssen pharmaceuticals corporation’s risperidone drug products. monotherapy - adults risperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with bipolar i disorder in adults [see clinical studies (14.2)] . due to janssen pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. pediatric use information  for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for janssen pharmaceuticals corporation’s risperido

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depo nf sub, llc - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - tapentadol 50 mg - nucynta er (tapentadol) is indicated for the management of: - pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate - neuropathic pain associated with diabetic peripheral neuropathy (dpn) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve nucynta er for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - nucynta er is not indicated as an as-needed (prn) analgesic. nucynta er is contraindicated in patients with: - sign

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lupin pharmaceuticals, inc. - choline fenofibrate (unii: 4bmh7izt98) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 45 mg - fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (tg) in patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied. fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides (tg), and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in patients with primary hypercholesterolemia or mixed dyslipidemia. fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see warnings and precautions (5.1)] . laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy. every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. if the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of vldl. fenofibric acid is contraindicated in: - patients with severe renal impairment, including those receiving dialysis[see clinical pharmacology (12.3)]. - patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see warnings and precautions (5.3)]. - patients with preexisting gallbladder disease [see warnings and precautions (5.5)]. - nursing mothers [see use in specific populations (8.2)]. - patients with hypersensitivity to fenofibric acid or fenofibrate[see warnings and precautions (5.9)]. risk summary limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 135 mg daily, based on body surface area (mg/m2 ). adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see data). fenofibric acid should be used during pregnancy only if the potential benefit justifies 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 miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data: in pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6 to 15 during the period of organogenesis, no adverse developmental findings were observed at 14 mg/kg/day (less than the clinical exposure at the maximum recommended human dose [mrhd] of 300 mg fenofibrate daily, equivalent to 135 mg fenofibric acid daily, based on body surface area comparisons). increased fetal skeletal malformations were observed at maternally toxic doses (361 mg/kg/day, corresponding to 12 times the clinical exposure at the mrhd) that significantly suppressed maternal body weight gain. in pregnant rabbits given oral gavage doses of 15, 150, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, no adverse developmental findings were observed at 15 mg/kg/day (a dose that approximates the clinical exposure at the mrhd, based on body surface area comparisons). aborted litters were observed at maternally toxic doses (≥ 150 mg/kg/day, corresponding to ≥ 10 times the clinical exposure at the mrhd) that suppressed maternal body weight gain. in pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), no adverse developmental effects were observed at 15 mg/kg/day (less than the clinical exposure at the mrhd, based on body surface area comparisons), despite maternal toxicity (decreased weight gain). post-implantation loss was observed at ≥ 75 mg/kg/day (≥ 2 times the clinical exposure at the mrhd) in the presence of maternal toxicity (decreased weight gain). decreased pup survival was noted at 300 mg/kg/day (10 times the clinical exposure at the mrhd), which was associated with decreased maternal body weight gain/maternal neglect. risk summary there is no available information on the presence of fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production. fenofibrate is present in the milk of rats, and is therefore likely to be present in human milk. because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with fenofibric acid and for 5 days after the final dose [see contraindications (4)] . the safety and effectiveness of fenofibric acid in pediatric patients have not been established. fenofibric acid is substantially excreted by the kidney as fenofibric acid and fenofibric acid glucuronide, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. fenofibric acid exposure is not influenced by age. since elderly patients have a higher incidence of renal impairment, dose selection for the elderly should be made on the basis of renal function [see dosage and administration (2.5 ) and clinical pharmacology  (12.3)]. elderly patients with normal renal function should require no dose modifications. consider monitoring renal function in elderly patients taking fenofibric acid. the use of fenofibric acid should be avoided in patients who have severe renal impairment [see contraindications (4)] . dose reduction is required in patients with mild to moderate renal impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)]. monitoring renal function in patients with renal impairment is recommended. the use of fenofibric acid has not been evaluated in subjects with hepatic impairment [see contraindications (4) and clinical pharmacology  (12.3)].

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janssen pharmaceuticals, inc. - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - tapentadol 50 mg - nucynta (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve nucynta tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia nucynta tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.2)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.5)] - known or suspected gastrointestinal obstruction, including suspected paralytic ileus [see warnings and precauti

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zydus lifesciences limited - haloperidol (unii: j6292f8l3d) (haloperidol - unii:j6292f8l3d) - haloperidol 5 mg - haloperidol is indicated for use in the management of manifestations of psychotic disorders. haloperidol is indicated for the control of tics and vocal utterances of tourette’s disorder in children and adults. haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. haloperidol is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this d

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depo nf sub, llc - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - tapentadol 50 mg - nucynta (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve nucynta tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia nucynta tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6)] - known or suspected gastrointestinal obstruction, including suspected paralytic ileus [see warnings and precautions (5.

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

janssen pharmaceuticals, inc. - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - tapentadol 50 mg - nucynta er (tapentadol) is indicated for the management of: - pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate - neuropathic pain associated with diabetic peripheral neuropathy (dpn) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve nucynta er for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. nucynta er is not indicated as an as-needed (prn) analgesic. - nucynta er is not indicated as an as-neede

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lupin pharmaceuticals, inc. - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine 50 mg - desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14)]. - hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine formulation. angioedema has been reported in patients treated with desvenlafaxine [see adverse reactions (6.1)]. - the use of maois intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine is contraindicated because of an increased risk of serotonin syndrome. the use of desvenlafaxine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.7) and warnings and precautions (5.2)]. - starting desvenlafaxine in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin