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

cardinal health 107, llc - apixaban (unii: 3z9y7uwc1j) (apixaban - unii:3z9y7uwc1j) - apixaban 2.5 mg - eliquis is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. eliquis is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe), in patients who have undergone hip or knee replacement surgery. eliquis is indicated for the treatment of dvt. eliquis is indicated for the treatment of pe. eliquis is indicated to reduce the risk of recurrent dvt and pe following initial therapy. eliquis is contraindicated in patients with the following conditions: the limited available data on eliquis use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. treatment may increase the risk of bleeding during pregnancy and delivery. in animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposure levels up to 4, 1 and 19 times, respectively, the human exposure based on area under plasma-concentration time curve (auc) at the maximum recommended human dose (mrhd) of 5 mg twice daily. the estimated background risk of major birth defects and miscarriage for the indicated populations 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% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnancy confers an increased risk of thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reactions use of anticoagulants, including eliquis, may increase the risk of bleeding in the fetus and neonate. labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. eliquis use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. consider use of a shorter acting anticoagulant as delivery approaches [see warnings and precautions (5.3)] . data animal data no developmental toxicities were observed when apixaban was administered during organogenesis to rats (orally), rabbits (intravenously) and mice (orally) at unbound apixaban exposure levels 4, 1, and 19 times, respectively, the human exposures at the mrhd. there was no evidence of fetal bleeding, although conceptus exposure was confirmed in rats and rabbits. oral administration of apixaban to rat dams from gestation day 6 through lactation day 21 at maternal unbound apixaban exposures ranging from 1.4 to 5 times the human exposures at the mrhd was not associated with reduced maternal mortality or reduced conceptus/neonatal viability, although increased incidences of peri-vaginal bleeding were observed in dams at all doses. there was no evidence of neonatal bleeding. risk summary there are no data on the presence of apixaban or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. apixaban and/or its metabolites were present in the milk of rats (see data). because human exposure through milk is unknown, breastfeeding is not recommended during treatment with eliquis. data animal data maximal plasma concentrations were observed after 30 minutes following a single oral administration of a 5 mg dose to lactating rats. maximal milk concentrations were observed 6 hours after dosing. the milk to plasma auc (0-24) ratio is 30:1 indicating that apixaban can accumulate in milk. the concentrations of apixaban in animal milk does not necessarily predict the concentration of drug in human milk. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including eliquis should be assessed in females of reproductive potential and those with abnormal uterine bleeding. safety and effectiveness in pediatric patients have not been established. of the total subjects in the aristotle and averroes clinical studies, >69% were 65 years of age and older, and >31% were 75 years of age and older. in the advance-1, advance-2, and advance-3 clinical studies, 50% of subjects were 65 years of age and older, while 16% were 75 years of age and older. in the amplify and amplify-ext clinical studies, >32% of subjects were 65 years of age and older and >13% were 75 years of age and older. no clinically significant differences in safety or effectiveness were observed when comparing subjects in different age groups. the recommended dose is 2.5 mg twice daily in patients with at least two of the following characteristics [see dosage and administration (2.1)] : clinical efficacy and safety studies with eliquis did not enroll patients with end-stage renal disease (esrd) on dialysis. in patients with esrd maintained on intermittent hemodialysis, administration of eliquis at the usually recommended dose [see dosage and administration (2.1)] will result in concentrations of apixaban and pharmacodynamic activity similar to those observed in the aristotle study [see clinical pharmacology (12.3)] . it is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with esrd on dialysis as was seen in aristotle. no dose adjustment is recommended for patients with renal impairment, including those with esrd on dialysis [see dosage and administration (2.1)] . clinical efficacy and safety studies with eliquis did not enroll patients with esrd on dialysis or patients with a crcl <15 ml/min; therefore, dosing recommendations are based on pharmacokinetic and pharmacodynamic (anti-fxa activity) data in subjects with esrd maintained on dialysis [see clinical pharmacology (12.3)] . no dose adjustment is required in patients with mild hepatic impairment (child-pugh class a). because patients with moderate hepatic impairment (child-pugh class b) may have intrinsic coagulation abnormalities and there is limited clinical experience with eliquis in these patients, dosing recommendations cannot be provided [see clinical pharmacology (12.2)] . eliquis is not recommended in patients with severe hepatic impairment (child-pugh class c) [see clinical pharmacology (12.2)] .

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

cardinal health 107, llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-fr

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

cardinal health 107, llc - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 30 mg - duloxetine delayed-release capsules are indicated for the treatment of: monoamine oxidase inhibitors (maois) the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration ( 2.8) and warnings and precautions ( 5.4)]. starting duloxetine 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 syndrome [see dosage and administration ( 2.9) and warnings and precautions ( 5.4)]. risk summary: data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. data from published literature an

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

cardinal health 107, llc - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 50 mg - savella is indicated for the management of fibromyalgia.  savella is not approved for use in pediatric patients [see use in specific populations (8.4)] . the use of maois intended to treat psychiatric disorders with savella or within 5 days of stopping treatment with savella is contraindicated because of an increased risk of serotonin syndrome. the use of savella within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.5), warnings and precautions (5.2)] . starting savella 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 syndrome [see dosage and administration (2.6), warnings and precautions (5.2)] . pregnancy category c risk summary there are no adequate or well-controlled studies in pregnant women. neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine (such as savella), or selective serotonin reuptake

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

cardinal health 107, llc - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 500 mg - divalproex sodium extended-release tablet is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).   the efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical studies(14

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

cardinal health 107, llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 250 mg - levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. none. levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.9)]. there are no adequate and controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam tablets should be used during pregnancy only if the potential benefit justifies the poten

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

cardinal health 107, llc - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - adjunctive therapy lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: monotherapy lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see clinical studies (14.2)]. limitations of use treatment of

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

cardinal health 107, llc - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin is contraindicated in patients with: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as extended phenytoin sodium, during pregnancy. physicians are advised to recommend that pregnant patients taking extended phenytoin sodium enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse development outcomes. an increased incidence of major malf

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

cardinal health 107, llc - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see clinical considerations) . in animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo-fetal toxicity at doses less than the maximum recommended human maintenance dose (see data) . advise pregnant women of the potential risk to a fetus. 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% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and or embryo/fetal risk the incidence of ventricular tachycardia 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. most tachycardia episodes are initiated by ectopic beats and the occurrence of arrhythmia episodes may therefore, increase during pregnancy due to the increased propensity to ectopic activity. 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 amiodarone and its metabolite have been shown to cross the placenta. adverse fetal effects associated with maternal amiodarone use during pregnancy may include neonatal bradycardia, qt prolongation, and periodic ventricular extrasystoles, neonatal hypothyroidism (with or without goiter) detected antenatally or in the newborn and reported even after a few days of exposure, neonatal hyperthyroxinemia, neurodevelopmental abnormalities independent of thyroid function, including speech delay and difficulties with written language and arithmetic, delayed motor development, and ataxia, jerk nystagmus with synchronous head titubation, fetal growth restriction, and premature birth. monitor the newborn for signs and symptoms of thyroid disorder and cardiac arrhythmias. labor and delivery risk of arrhythmias may increase during labor and delivery. patients treated with amiodarone hydrochloride should be monitored continuously during labor and delivery [see warnings and precautions (5.4)]. data animal data in pregnant rats and rabbits during the period of organogenesis, amiodarone hydrochloride in doses of 25 mg/kg/day (approximately 0.4 and 0.9 times, respectively, the maximum recommended human maintenance dose*) had no adverse effects on the fetus. in the rabbit, 75 mg/kg/day (approximately 2.7 times the maximum recommended human maintenance dose*) caused abortions in greater than 90% of the animals. in the rat, doses of 50 mg/kg/day or more were associated with slight displacement of the testes and an increased incidence of incomplete ossification of some skull and digital bones; at 100 mg/kg/day or more, fetal body weights were reduced; at 200 mg/kg/day, there was an increased incidence of fetal resorption. (these doses in the rat are approximately 0.8, 1.6 and 3.2 times the maximum recommended human maintenance dose*) adverse effects on fetal growth and survival also were noted in one of two strains of mice at a dose of 5 mg/kg/day (approximately 0.04 times the maximum recommended human maintenance dose*). *600 mg in a 60 kg patient (doses compared on a body surface area basis) risk summary amiodarone and one of its major metabolites, dea, are present in breastmilk at between 3.5% and 45% of the maternal weight- adjusted dosage of amiodarone. there are cases of hypothyroidism and bradycardia in breastfed infants, although it is unclear if these effects are due to amiodarone exposure in breastmilk. breastfeeding is not recommended during treatment with amiodarone hydrochloride [see warnings and precautions (5.6, 5.7)]. infertility based on animal fertility studies, amiodarone hydrochloride may reduce female and male fertility. it is not known if this effect is reversible. [see nonclinical toxicology (13.1)]. the safety and effectiveness of amiodarone hydrochloride in pediatric patients have not been established. normal subjects over 65 years of age show lower clearances and increased drug half-life than younger subjects [see clinical pharmacology (12.3)]. 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.

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

cardinal health 107, llc - pregabalin (unii: 55jg375s6m) (pregabalin - unii:55jg375s6m) - pregabalin capsules are indicated for: pediatric use information is approved for pfizer's lyrica (pregabalin) capsules and oral solution products. however, due to pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information. pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of its components. angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. to provide information regarding the effects of in utero exposure to pregabalin, physicians are advised to recommend that pregnant patients taking pregabalin capsules enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. i