Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

jubilant cadista pharmaceuticals inc. - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. - niacin extended-release tablets are indicated to reduce elevated tc, ldl-c, apo b and tg levels, and to increase hdl-c in patients with primary hyperlipidemia and mixed dyslipidemia. - in patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. - in patients with a history of coronary artery disease (cad) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. - niacin extended-release tablets in combination with a bile acid b

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bio-pharm, inc. - lactulose (unii: 9u7d5qh5ae) (lactulose - unii:9u7d5qh5ae) - for the treatment of constipation. in patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur. since lactulose solution contains galactose (less than 1.6 g/15 ml), it is contraindicated in patients who require a low galactose diet.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

hospira, inc. - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: limitations of use propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see pediatric use (8.4)] . safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use [see pediatric use (8.4)] . propofol injectable emulsion is not indicated for use in pediatric icu sedation since the safety of this regimen has not been established [see pediatric use (8.4)] . propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products. data from randomized controlled trials, cohort studies and case series over several decades with propofol use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. most of the reported exposures to propofol describe propofol exposure at the time of cesarean delivery. there are reports of neonatal depression in infants exposed to propofol during delivery (see clinical considerations) . in animal reproduction studies, decreased pup survival concurrent with increased maternal mortality was observed with intravenous administration of propofol to pregnant rats either prior to mating and during early gestation or during late gestation and early lactation at exposures less than the human induction dose of 2.5 mg/kg. in pregnant rats administered 15 mg/kg/day intravenous propofol (equivalent to the human induction dose) from two weeks prior to mating to early in gestation (gestation day 7), offspring that were allowed to mate had increased post implantation losses. the pharmacological activity (anesthesia) of the drug on the mother is probably responsible for the adverse effects seen in the offspring. published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block nmda receptors and/or potentiate gaba activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. there are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [see data, warnings and precautions (5.3), and use in specific populations (8.4)] . the clinical significance of these nonclinical findings is not known, and the benefits of appropriate anesthesia in pregnant women who require procedures should be balanced with the potential risks suggested by the nonclinical data. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations fetal/neonatal adverse reactions propofol injectable emulsion crosses the placenta and may be associated with neonatal depression. monitor neonates for hypotonia and sedation following maternal exposure to propofol. pregnant rats were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.3, 0.65, and 1 times the human induction dose of 2.5 mg/kg based on body surface area) during organogenesis (gestational days 6–15). propofol did not cause adverse effects to the fetus at exposures up to 1 times the human induction dose despite evidence of maternal toxicity (decreased weight gain in all groups). pregnant rabbits were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.65, 1.3, 2 times the human induction dose of 2.5 mg/kg based on body surface area comparison) during organogenesis (gestation days 6–18). propofol treatment decreased total numbers of corpora lutea in all treatment groups but did not cause fetal malformations at any dose despite maternal toxicity (one maternal death from anesthesia-related respiratory depression in the high dose group). pregnant rats were administered propofol intravenously at 0, 10, and 15 mg/kg/day (0.65 and 1 times the human induction dose of 2.5 mg/kg based on body surface area) from late gestation through lactation (gestation day 16 to lactation day 22). decreased pup survival was noted at all doses in the presence of maternal toxicity (deaths from anesthesia- induced respiratory depression). this study did not evaluate neurobehavioral function including learning and memory in the pups. pregnant rats were administered propofol intravenously at 0, 10, or 15 mg/kg/day (0.3 and 1 times the human induction dose of 2.5 mg/kg based on body surface area) from 2 weeks prior to mating to gestational day 7. pup (f1) survival was decreased on day 15 and 22 of lactation at maternally toxic doses of 10 and 15 mg/kg/day. when f1 offspring were allowed to mate, postimplantation losses were increased in the 15 mg/kg/day treatment group. in a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on gestation day 122 increased neuronal apoptosis in the developing brain of the fetus. in other published studies, administration of either isoflurane or propofol for 5 hours on gestation day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. with respect to brain development, this time period corresponds to the third trimester of gestation in the human. the clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits [see warnings and precautions (5.3), pediatric use (8.4), and animal toxicology and/or pharmacology (13.2)] . risk summary based on data from published studies, propofol is present in human milk. variable concentrations have been reported in human milk with administration of propofol to nursing mothers in the early post-partum period. available data have not shown adverse reactions in breastfed infants. there are no data on the effects of propofol on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propofol injectable emulsion and any potential adverse effects on the breastfed infant form propofol injectable emulsion or from the underlying maternal condition. the safety and effectiveness of propofol injectable emulsion have been established for induction of anesthesia in pediatric patients aged 3 years and older and for the maintenance of anesthesia aged 2 months and older. in pediatric patients, administration of fentanyl concomitantly with propofol injectable emulsion may result in serious bradycardia [see warnings and precautions (5.4)] . propofol injectable emulsion is not indicated for use in pediatric patients for icu sedation or for mac sedation for surgical, nonsurgical or diagnostic procedures as safety and effectiveness have not been established. there have been anecdotal reports of serious adverse events and death in pediatric patients with upper respiratory tract infections receiving propofol injectable emulsion for icu sedation. in one multicenter clinical trial of icu sedation in critically ill pediatric patients that excluded patients with upper respiratory tract infections, the incidence of mortality observed in patients who received propofol injectable emulsion (n=222) was 9%, while that for patients who received standard sedative agents (n=105) was 4%. while causality was not established in this study, propofol injectable emulsion is not indicated for icu sedation in pediatric patients until further studies have been performed to document its safety in that population [see clinical pharmacology (12.3) and dosage and administration (2.1 and 2.2)] . however, propofol infusions are routinely used to provide safe sedation to critically ill pediatric patients in icus. in pediatric patients, abrupt discontinuation of propofol injectable emulsion following prolonged infusion may result in flushing of the hands and feet, agitation, tremulousness and hyperirritability. increased incidences of bradycardia (5%), agitation (4%), and jitteriness (9%) have also been observed. published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as propofol injectable emulsion, that either block nmda receptors or potentiate the activity of gaba during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately 3 years of age in humans. in primates, exposure to 3 hours of ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. data from isoflurane-treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory. the clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in pregnant women, neonates, and young children who require procedures with the potential risks suggested by the nonclinical data [see warnings and precautions (5.3) , pregnancy (8.1), and animal toxicology and/or pharmacology (13.2)] . benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. the “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth weight neonates. additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. premature and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources. the effect of age on induction dose requirements for propofol was assessed in an open-label study involving 211 unpremedicated patients with approximately 30 patients in each decade between the ages of 16 and 80. the average dose to induce anesthesia was calculated for patients up to 54 years of age and for patients 55 years of age or older. the average dose to induce anesthesia in patients up to 54 years of age was 1.99 mg/kg and in patients above 54 it was 1.66 mg/kg. subsequent clinical studies have demonstrated lower dosing requirements for subjects greater than 60 years of age. a lower induction dose and a slower maintenance rate of administration of propofol injectable emulsion should be used in elderly patients. in this group of patients, rapid (single or repeated) bolus administration should not be used in order to minimize undesirable cardiorespiratory depression. all dosing should be titrated according to patient condition and response [see dosage and administration (2) and clinical pharmacology (12.3)] . the long-term administration of propofol injectable emulsion to patients with hepatic insufficiency has not been evaluated. the pharmacokinetics of propofol do not appear to be different in people with chronic hepatic cirrhosis compared to adults with normal hepatic function. the effects of acute hepatic failure on the pharmacokinetics of propofol have not been studied. the long-term administration of propofol injectable emulsion to patients with renal failure has not been evaluated. the pharmacokinetics of propofol do not appear to be different in people with chronic renal impairment compared to adults with normal renal function. the effects of acute renal failure on the pharmacokinetics of propofol have not been studied. there are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. instances of self-administration of propofol injectable emulsion by health care professionals have also been reported, which have resulted in fatalities and other injuries. inventories of propofol injectable emulsion should be stored and managed to prevent the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bluepoint laboratories - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - bloxiverz is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. bloxiverz is contraindicated in patients with: risk summary there are no adequate or well-controlled studies of bloxiverz in pregnant women. it is not known whether bloxiverz can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss. no adverse effects were noted in rats or rabbits treated with human equivalent doses of neostigmine methylsulfate doses up to 8.1 and 13 mcg/kg/day, respectively, during organogenesis (0.1 to 0.2 times the maximum recommended human dose of 5 mg/60 kg person/day based on body surface area comparisons). anticholinesterase drugs, including neostigmin

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see dosage and administration (2)]. - acute bacterial exacerbations of chronic bronchitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae . - acute bacterial sinusitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae . - community-acquired pneumonia due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae, or streptococcus pneumoniae in patients appropriate for oral therapy. - pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - uncomplicated skin and skin structure infections

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

accord healthcare, inc. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin for injection is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin for injection or its components [see adverse reactions ( 6.3)] . risk summary there are no data available on use of bivalirudin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 2-4% and 15-20%, respectively. data animal data reproductive studies have been performed in rats at subcutaneous doses up to 150 mg/kg/day (1.6 times the maximum recommended human dose based on body surface area) and rabbits at subcutaneous doses up to 150 mg/kg/day (3.2 times the maximum recommended human dose based on body surface area). these studies revealed no harm to the fetus attributable to bivalirudin. at 500 mg/kg/day (equivalent to 5.4 times the maximum recommended human dose based on body surface area) subcutaneously, litter sizes and live fetuses in rats were reduced. fetal skeletal variations were also noted. some of these changes could be attributed to maternal toxicity observed at high doses. there is no study covering the peri-natal period because of the potential complications of drug-induced hemorrhage during delivery. risk summary it is not known whether bivalirudin is present in human milk. no data are available on the effects on the breastfed child or on milk production.   bivalirudin was administered to lactating rats in reproduction studies (see data). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bivalirudin for injection and any potential adverse effects on the breastfed child from bivalirudin for injection or from the underlying maternal condition.   data animal data reproduction studies conducted in lactating female rats dosed subcutaneously daily with bivalirudin at doses up to 150 mg/kg/day (1.6 times the maximum recommended human dose, based on body surface area) from day 2 through day 20 of lactation revealed no adverse developmental outcomes to the pups. the safety and effectiveness of bivalirudin for injection in pediatric patients have not been established. in studies of patients undergoing pci, 44% were ≥65 years of age and 12% of patients were ≥75 years old. elderly patients experienced more bleeding events than younger patients. the disposition of bivalirudin for injection was studied in ptca patients with mild, moderate and severe renal impairment. the clearance of bivalirudin was reduced approximately 21% in patients with moderate and severe renal impairment and was reduced approximately 70% in dialysis-dependent patients [see clinical pharmacology ( 12.3)] . reduce the  infusion dose of bivalirudin for injection and monitor the anticoagulant status more frequently in patients with renal impairment creatinine clearance less than 30ml/min (by cockcroft gault equation)  [see dosage and administration ( 2.2)] .

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

hospira, inc. - sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698, sodium cation - unii:lyr4m0nh37) - this parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - nimodipine (unii: 57wa9qz5wh) (nimodipine - unii:57wa9qz5wh) - nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., hunt and hess grades i-v). the concomitant use of nimodipine with strong inhibitors of cyp3a4 such as some macrolide antibiotics (e.g., clarithromycin, telithromycin), some anti-hiv protease inhibitors (e.g., delaviridine, indinavir, nelfinavir, ritonavir, saquinavir), some azole antimycotics (e.g., ketoconazole, itraconazole, voriconazole) and some antidepressants (e.g., nefazadone) is contraindicated because of a risk of significant hypotension (see precautions, drug interactions ). there have been no reported instances of drug abuse or dependence with nimodipine capsules.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

cipla usa inc. - olopatadine (unii: d27v6190pm) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. none. teratogenic effects: pregnancy category c olopatadine was found not to be teratogenic in rats and rabbits. however, rats treated at 600 mg/kg/day, or 150,000 times the mrohd and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the mrohd, during organogenesis showed a decrease in live fetuses. in addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. there are, however, no adequate and well- controlled studies in pregnant women. because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

strides pharma science limited - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - lidocaine ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. it is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment 5%.