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upsher-smith laboratories, llc - ethacrynic acid (unii: m5dp350vzv) (ethacrynic acid - unii:m5dp350vzv) - ethacrynic acid tablets are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. - treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. - short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. - short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable. all diuretics, including ethacrynic acid, are contraindicated in anuria. if increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, the diuretic should be discontinued. in a few patients this diuretic has produced severe, watery diarrh

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upsher-smith laboratories, llc - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - zembrace symtouch is indicated for the acute treatment of migraine with or without aura in adults. limitations of use : - use only if a clear diagnosis of migraine has been established. if a patient has no response to the first migraine attack treated with zembrace symtouch, reconsider the diagnosis before zembrace symtouch is administered to treat any subsequent attacks. - zembrace symtouch injection is not indicated for the prevention of migraine attacks. zembrace symtouch injection is contraindicated in patients with: - ischemic coronary artery disease (cad) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including prinzmetal's angina [see warnings and precautions (5.1)] . - wolff-parkinson-white syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see warnings and precautions (5.2)] . - history of stroke or transient ischemic attack (tia) or history of hemiplegic or basilar migraine because these pati

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upsher-smith laboratories, llc - sumatriptan (unii: 8r78f6l9vo) (sumatriptan - unii:8r78f6l9vo) - tosymra is indicated for the acute treatment of migraine with or without aura in adults. limitations of use : - use only if a clear diagnosis of migraine has been established. if a patient has no response to the first migraine attack treated with tosymra, reconsider the diagnosis before tosymra is administered to treat any subsequent attacks. - tosymra is not indicated for the preventive treatment of migraine. - tosymra is not indicated for the treatment of cluster headache. tosymra is contraindicated in patients with: - ischemic coronary artery disease (cad) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including prinzmetal's angina [see warnings and precautions (5.1)] . - wolff-parkinson-white syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see warnings and precautions (5.2)] . - history of stroke or transient ischemic attack (tia) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see warnings and precautions (5.4)] . - peripheral vascular disease [see warnings and precautions (5.5)] . - ischemic bowel disease [see warnings and precautions (5.5)] . - uncontrolled hypertension [see warnings and precautions (5.8)] . - recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-ht1 ) agonist [see drug interactions (7.1, 7.3)] . - concurrent administration of a monoamine oxidase (mao)-a inhibitor or recent (within 2 weeks) use of an mao-a inhibitor [see drug interactions (7.2) and clinical pharmacology (12.3)] . - hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see warnings and precautions (5.9)] . - severe hepatic impairment [see clinical pharmacology (12.3)] . 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 embryo lethality, fetal abnormalities, and pup mortality. when administered by the intravenous route to pregnant rabbits, sumatriptan was embryo lethal (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 with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk: several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. data human data the sumatriptan/naratriptan/treximet (sumatriptan and naproxen sodium) pregnancy registry, a population-based international prospective study, collected data for sumatriptan from january 1996 to september 2012. the registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). the occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% ci: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% ci: 2.7% to 6.2%]). the sample size in this study had 80% power to detect at least a 1.73- to 1.91-fold increase in the rate of major malformations. the number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis. no other birth defect was reported for more than 2 infants in this group. in a study using data from the swedish medical birth register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% ci: 0.91 to 1.21]). a study using linked data from the medical birth registry of norway to the norwegian prescription database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (or 1.16 [95% ci: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (or 1.83 [95% ci: 1.17 to 2.88]), each compared with the population comparison group. additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. animal data oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. the highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day. oral administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryo lethality and fetal cervicothoracic vascular and skeletal abnormalities. intravenous administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryo lethality. the highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 and 0.75 mg/kg/day, respectively. oral administration of sumatriptan to rats prior to and throughout gestation resulted in embryofetal toxicity (decreased body weight, decreased ossification, increased incidence of skeletal abnormalities). the highest no-effect dose was 50 mg/kg/day. in offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. the highest no-effect dose for this effect was 60 mg/kg/day. oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. the highest no-effect dose for this finding was 100 mg/kg/day. risk summary sumatriptan is excreted in human milk following subcutaneous administration (see data) . there are no data on the effects of sumatriptan on the breastfed infant or the effects of sumatriptan on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tosymra and any potential adverse effects on the breastfed infant from sumatriptan or from the underlying maternal condition. clinical considerations infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with tosymra. data following subcutaneous administration of a 6 mg dose of sumatriptan injection in 5 lactating volunteers, sumatriptan was present in milk. safety and effectiveness of tosymra in pediatric patients have not been established. tosymra is not recommended for use in patients younger than 18 years of age. two controlled clinical trials evaluated sumatriptan nasal spray (5 mg to 20 mg) in 1,248 pediatric migraineurs 12 to 17 years of age who treated a single attack. the trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in pediatric patients. adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral sumatriptan (25 mg to 100 mg) in pediatric subjects 12 to 17 years of age enrolled a total of 701 pediatric migraineurs. these trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in pediatric patients. adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. the frequency of all adverse reactions in these patients appeared to be both dose- and age-dependent, with younger patients reporting reactions more commonly than older pediatric patients. post-marketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. these reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. a myocardial infarction has been reported in a 14-year-old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration. clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal sumatriptan are not presently available. clinical trials of sumatriptan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. a cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of cad) prior to receiving tosymra [see warnings and precautions (5.1)] . - only 1 device is needed to deliver a full dose (see figure a). - the device gives a single spray that should be delivered into 1 nostril. - never use more than 1 device or dose into more than 1 nostril. - keep tosymra and all medicines out of reach of children. - do not remove the device from its packaging until ready to use. - do not test the spray or press the plunger before giving a dose into the nostril. - do not use after the expiration date has passed. - the device should be stored at room temperature between 68° to 77°f (20° to 25°c). - do not store in the refrigerator or freezer. - always keep the device in the sealed blister package until time of use.

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upsher-smith laboratories,llc - cholestyramine (unii: 4b33bgi082) (cholestyramine - unii:4b33bgi082) - therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess total cholesterol, hdl-c and triglycerides (tg). for individuals with tg less than 400 mg/dl (<4.5 mmol/l), ldl-c can be estimated using the following equation: ldl-c = total cholesterol -

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upsher-smith laboratories, llc - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - 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 brimonidine tartrate/timolol maleate ophthalmic solution 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. brimonidine tartrate/timolol maleate ophthalmic solution 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)] . brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardi

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upsher-smith laboratories, llc - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see use in specific populations (8.4)] , nursing mothers [see use in specific populations (8.3)] , and in patients with: - unstable cardiovascular status in acute hemorrhage - myasthenia gravis [see warnings and precautions (5.4)] - glaucoma [see adverse reactions (6.3) and drug interactions (7.1)] - obstructive uropathy [see warnings and precautions (5.8)] - obstructive disease of the gastrointestinal tract [see warnings and precautions (5.5)] - severe ulcerative colitis [see warnings and precautions (5.7)] - reflux esophagitis adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. however, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took product

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upsher-smith laboratories, llc - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see use in specific populations (8.4)] , nursing mothers [see use in specific populations (8.3)] , and in patients with: - unstable cardiovascular status in acute hemorrhage myasthenia gravis [see warnings and precautions (5.4)] - glaucoma [see adverse reactions (6.3) and drug interactions (7.1)] - obstructive uropathy [see warnings and precautions (5.8)] - obstructive disease of the gastrointestinal tract [see warnings and precautions (5.5)] - severe ulcerative colitis [see warnings and precautions (5.7)] - reflux esophagitis adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. however, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products

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lake erie medical dba quality care products llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate extended-release capsules, usp is an 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. 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, reserve morphine sulfate extended-release capsules 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. - morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic. morphine sulfate extended-release capsules are contraindicated in patients with - significant respiratory depression - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitativ

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preferred pharmaceuticals, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine is indicated for the treatment of: • acute and maintenance treatment of major depressive disorder [see clinical studies (14.1)]. • acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies (14.2)]. • acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies (14.3)]. • acute treatment of panic disorder, with or without agoraphobia [see clinical studies (14.4)]. fluoxetine  and olanzapine in combination is indicated for the treatment of: • acute treatment of depressive episodes associated with bipolar i disorder. fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder. when using fluoxetine and olanzapine in combination, also refer to the clinical studies section of the package insert for symbyax® . when using fluoxetine capsules and olanzapine in co

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kaiser foundation hospitals - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride extended-release capsules usp in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii-r or dsm-iv category of major depressive disorder (see clinical trials ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of g