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glaxosmithkline llc - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 900 mg - lovaza (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (greater than or equal to 500 mg/dl) hypertriglyceridemia. usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving lovaza and should continue this diet during treatment with lovaza. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with lovaza. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of tg-lowering drug therapy. limitations of use: the effect of lovaza on the risk for pancreatitis has not

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glaxosmithkline llc - naratriptan hydrochloride (unii: 10x8x4p12z) (naratriptan - unii:qx3kxl1za2) - naratriptan 1 mg - amerge is indicated for the acute treatment of migraine with or without aura in adults. limitations of use amerge is contraindicated in patients with: risk summary there are no adequate data on the developmental risk associated with use of amerge in pregnant women. data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have documented outcomes in women exposed to naratriptan during pregnancy; however, due to small sample sizes, no definitive conclusions can be drawn regarding the risk of birth defects following exposure to naratriptan [see data] . in animal studies, naratriptan produced developmental toxicity (including embryolethality and fetal abnormalities) when administered to pregnant rats and rabbits. the lowest doses producing evidence of developmental toxicity in animals were associated with plasma exposures 2.5 (rabbit) to 11 (rat) times that in humans at the maximum recommended daily dose (mrdd) [see data] . in the u.s. general population, the estimated bac

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

glaxosmithkline llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - fluticasone propionate 45 ug - advair hfa is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. advair hfa should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). limitations of use advair hfa is not indicated for the relief of acute bronchospasm. advair hfa is contraindicated in the following conditions: risk summary there are insufficient data on the use of advair hfa or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. there are clinical considerations with the use of advair hfa in pregnant women. (see clinical considerations.) in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits, was observed with subcutaneously administered maternal toxic doses of fluticasone propionat

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

glaxosmithkline llc - salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt), fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - salmeterol 50 ug - advair diskus is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. advair diskus should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). important limitation of use advair diskus is not indicated for the relief of acute bronchospasm. advair diskus 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. advair diskus 250/50 is also indicated to reduce exacerbations of copd in patients with a history of exacerbations. advair diskus 250/50 twice daily is the only approved dosage for the treatment of copd because an efficacy advantage of the higher strength advair diskus 500/50 over advair diskus 250/50 has not been demonstrated. important limitatio

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

glaxosmithkline llc - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 225 mg - rythmol sr is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (af) in patients with episodic (most likely paroxysmal or persistent) af who do not have structural heart disease. usage considerations: rythmol sr is contraindicated in the following circumstances: risk summary there are no studies of rythmol in pregnant women. available data from published case reports and several decades of postmarketing experience with use of rythmol in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations). propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was not teratogenic. at maternally toxic doses (ranging from 2 to 6 times the maximum recommended human dose [mrhd]), there was evidence of adverse developmental outcomes when administered to pregnant rabbits and rats during organogenesis or when administered to pregnant rats during mid-gestation through weaning of their offspring (see data) . the estimated background risks of major birth defects and miscarriage for the indicated populations are 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% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: the incidence of vt is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions: propafenone and its metabolite have been shown to cross the placenta. adverse reactions such as fetal/neonatal arrhythmias have been associated with the use of other antiarrhythmic agents by pregnant women. fetal/neonatal monitoring for signs and symptoms of arrhythmia is recommended during and after treatment of pregnant women with propafenone. labor or delivery: risk of arrhythmias may increase during labor and delivery. patients treated with rythmol should be monitored continuously for arrhythmias during labor and delivery [see warnings and precautions (5.1)] . data propafenone has been shown to cause embryo-fetal mortality in rabbits and rats when given orally during organogenesis at maternally toxic doses of 150 mg/kg/day (rabbit: maternal mortality, decreased body weight gain and food consumption at approximately 3 times the mrhd on a mg/m2 basis) and 600 mg/kg/day (rat: maternal decreased body weight gain and food consumption at approximately 6 times the mrhd on a mg/m2 basis). in addition, a maternally toxic dose of 600 mg/kg/day (approximately 6 times the mrhd on a mg/m2 basis) also caused decreased fetal weights in rats. increased placental weights and delayed ossification occurred in rabbits at a dose of 30 mg/kg/day (less than the mrhd on a mg/m2 basis) in the absence of maternal toxicity. no adverse developmental outcomes in the absence of maternal toxicity were seen following oral doses of 15 mg/kg/day to rabbits or up to 270 mg/kg/day to rats administered during organogenesis (equivalent to 0.3 times or approximately 3 times the mrhd on a mg/m2 basis, respectively). in an oral study, female rats received propafenone up to 500 mg/kg/day from mid-gestation through weaning. at 90 mg/kg/day (equivalent to the mrhd on a mg/m2 basis), there were no adverse developmental outcomes in the absence of maternal toxicity. however, doses ≥180 mg/kg/day (2 or more times the mrhd on a mg/m2 basis) produced increases in maternal deaths and resulted in reductions in neonatal survival, body weight gain, and delayed development in the presence of maternal toxicity. risk summary propafenone and its active metabolite, 5-oh-propafenone, are present in human milk, but the levels are likely to be low. there are no data on the effects of propafenone on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propafenone and any potential adverse effects on the breastfed infant from propafenone or from the underlying maternal condition. infertility males: based on human and animal studies, rythmol may transiently impair spermatogenesis in males. evaluation of the effects on spermatogenesis was performed in 11 healthy males given oral propafenone 300 mg b.i.d. for 4 days, which was then increased to 300 mg t.i.d. for an additional 4 days. study findings included a 28% reduction in semen sample volume on treatment day 8 and a 27% reduction in sperm count 64 days after treatment (both values remained within the laboratories’ normal reference range). these effects were not seen in follow-up visits up to 120 days after treatment. reversible decreases in spermatogenesis have been demonstrated in monkeys, dogs, and rabbits after lethal or near-lethal intravenous doses of propafenone [see nonclinical toxicology (13.1)]. the safety and effectiveness of propafenone in pediatric patients have not been established. of the total number of subjects in phase 3 clinical trials of rythmol sr (propafenone hydrochloride) 46% were 65 and older, while 16% were 75 and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals at higher doses cannot be ruled out. the effect of age on the pharmacokinetics and pharmacodynamics of propafenone has not been studied.

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glaxosmithkline llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 100 ug - flovent diskus is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. important limitation of use flovent diskus is not indicated for the relief of acute bronchospasm. the use of flovent diskus is contraindicated in the following conditions: risk summary there are insufficient data on the use of flovent diskus in pregnant women. there are clinical considerations with the use of flovent diskus in pregnant women. (see clinical considerations.) in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight, and/or skeletal variations in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (mrhdid) on a mcg/m2 basis. (see data.) however, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the mrhdid on

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

glaxosmithkline llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 44 ug - flovent hfa is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. limitations of use flovent hfa is not indicated for the relief of acute bronchospasm. flovent hfa is contraindicated in the following conditions: risk summary there are insufficient data on the use of flovent hfa in pregnant women. there are clinical considerations with the use of flovent hfa in pregnant women. (see clinical considerations.) in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations in rats, mice, and rabbits, was observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (mrhdid) on a mcg/m2 basis. (see data.) however, fluticasone propionate administered via inhalation to rats decreased fetal body weight but did not induce teratogenicity at a maternal toxic dose less than the mrhdid on a mcg/m2 basis.

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

glaxosmithkline llc - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 2 mg - requip xl is indicated for the treatment of parkinson’s disease. requip xl is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of requip xl in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the mrhd for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [see data] . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies

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

glaxosmithkline llc - epoprostenol sodium (unii: 4k04iq1of4) (epoprostenol - unii:dcr9z582x0) - epoprostenol 0.5 mg - flolan is indicated for the treatment of pulmonary arterial hypertension (pah) (who group i) to improve exercise capacity. trials establishing effectiveness included predominantly (97%) patients with new york heart association (nyha) functional class iii-iv symptoms and etiologies of idiopathic or heritable pah (49%) or pah associated with connective tissue diseases (51%). flolan is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction [see clinical studies (14.3)] . flolan is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients. risk summary limited published data from case series and case reports have not established an association with flolan and major birth defects, miscarriage or adverse maternal or fetal outcomes when flolan is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations) . in animal reproduction studies, pregnant rats and rabbi

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glaxosmithkline llc - valacyclovir hydrochloride (unii: g447s0t1vc) (acyclovir - unii:x4hes1o11f) - valacyclovir 500 mg - cold sores (herpes labialis) valtrex is indicated for treatment of cold sores (herpes labialis). the efficacy of valtrex initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. genital herpes initial episode: valtrex is indicated for treatment of the initial episode of genital herpes in immunocompetent adults. the efficacy of treatment with valtrex when initiated more than 72 hours after the onset of signs and symptoms has not been established. recurrent episodes: valtrex is indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. the efficacy of treatment with valtrex when initiated more than 24 hours after the onset of signs and symptoms has not been established. suppressive therapy: valtrex is indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in hiv-1−infected adults. the efficacy and safety of valtrex for the suppression of genital herpes beyond 1