Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar i disorder: - treatment of acute manic and mixed episodes in patients 7 years and older [see clinical studies ( 14 )] - maintenance treatment in patients 7 years and older [see clinical studies ( 14 )] lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate tablet or capsule or lithium citrate products [see adverse reactions ( 6)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-a

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar i disorder: - treatment of acute manic and mixed episodes in patients 7 years and older [see clinical studies ( 14 )] - maintenance treatment in patients 7 years and older [see clinical studies ( 14 )] lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate tablet or capsule or lithium citrate products [see adverse reactions ( 6)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-a

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar i disorder: - treatment of acute manic and mixed episodes in patients 7 years and older [see clinical studies ( 14 )] - maintenance treatment in patients 7 years and older [see clinical studies ( 14 )] lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate tablet or capsule or lithium citrate products [see adverse reactions ( 6)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-a

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate tablets is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate tablets, are metabolized to 5-hydroxymethyl tolterodine.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar i disorder: - •  treatment of acute manic and mixed episodes in patients 7 years and older [see clinical studies ( 14)] - •  maintenance treatment in patients 7 years and older [see clinical studies (14)] lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule [see adverse reactions ( 6)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/o

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies (14.1).] alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis [see clinical studies (14.2)] . alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3)] . alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see clinical studies (14.4)] . alendronate sodium tablets are indicated for the treatment of paget’s disease of bone in men and women. treatment is indicated in patients with paget's disease of bone who have al

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

camber pharmaceuticals inc - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (pgtc) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (aed). safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established. lamotrigine extended-release tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see boxed warning, warnings and precautions ( 5.1, 5.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including lamotrigine extended-release tablets, during pregnancy. encourage women who are taking lamotrigine extended-release tablets during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary data from several prospective pregnancy exposure registries and epidemiological studies of pregnant women have not detected an increased frequency of major congenital malformations or a consistent pattern of malformations among women exposed to lamotrigine compared with the general population (see data) . in animal studies, administration of lamotrigine during pregnancy resulted in developmental toxicity (increased mortality, decreased body weight, increased structural variation, neurobehavioral abnormalities) at doses lower than those administered clinically. lamotrigine decreased fetal folate concentrations in rats, an effect known to be associated with adverse pregnancy outcomes in animals and humans (see data) . 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. clinical considerations as with other aeds, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. there have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre-pregnancy concentrations after delivery. dose adjustments may be necessary to maintain clinical response. data human data: data from several international pregnancy registries have not shown an increased risk for malformations overall. the international lamotrigine pregnancy registry reported major congenital malformations in 2.2% (95% ci: 1.6%, 3.1%) of 1,558 infants exposed to lamotrigine monotherapy in the first trimester of pregnancy. the naaed pregnancy registry reported major congenital malformations among 2.0% of 1,562 infants exposed to lamotrigine monotherapy in the first trimester. eurap, a large international pregnancy registry focused outside of north america, reported major birth defects in 2.9% (95% ci: 2.3%, 3.7%) of 2,514 exposures to lamotrigine monotherapy in the first trimester. the frequency of major congenital malformations was similar to estimates from the general population. the naaed pregnancy registry observed an increased risk of isolated oral clefts: among 2,200 infants exposed to lamotrigine early in pregnancy, the risk of oral clefts was 3.2 per 1,000 (95% ci: 1.4, 6.3), a 3-fold increased risk versus unexposed healthy controls. this finding has not been observed in other large international pregnancy registries. furthermore, a case-control study based on 21 congenital anomaly registries covering over 10 million births in europe reported an adjusted odds ratio for isolated oral clefts with lamotrigine exposure of 1.45 (95% ci: 0.8, 2.63). several meta-analyses have not reported an increased risk of major congenital malformations following lamotrigine exposure in pregnancy compared with healthy and disease-matched controls. no patterns of specific malformation types were observed. the same meta-analyses evaluated the risk of additional maternal and infant outcomes including fetal death, stillbirth, preterm birth, small for gestational age, and neurodevelopmental delay. although there are no data suggesting an increased risk of these outcomes with lamotrigine monotherapy exposure, differences in outcome definition, ascertainment methods, and comparator groups limit the conclusions that can be drawn. animal data: when lamotrigine was administered to pregnant mice, rats, or rabbits during the period of organogenesis (oral doses of up to 125, 25, and 30 mg/kg, respectively), reduced fetal body weight and increased incidences of fetal skeletal variations were seen in mice and rats at doses that were also maternally toxic. the no-effect doses for embryofetal developmental toxicity in mice, rats, and rabbits (75, 6.25, and 30 mg/kg, respectively) are similar to (mice and rabbits) or less than (rats) the human dose of 400 mg/day on a body surface area (mg/m 2 ) basis. in a study in which pregnant rats were administered lamotrigine (oral doses of 0, 5, or 25 mg/kg) during the period of organogenesis and offspring were evaluated postnatally, neurobehavioral abnormalities were observed in exposed offspring at both doses. the lowest effect dose for developmental neurotoxicity in rats is less than the human dose of 400 mg/day on a mg/m 2 basis. maternal toxicity was observed at the higher dose tested. when pregnant rats were administered lamotrigine (oral doses of 0, 5, 10, or 20 mg/kg) during the latter part of gestation and throughout lactation, increased offspring mortality (including stillbirths) was seen at all doses. the lowest effect dose for pre- and post- natal developmental toxicity in rats is less than the human dose of 400 mg/day on a mg/m 2 basis. maternal toxicity was observed at the 2 highest doses tested. when administered to pregnant rats, lamotrigine decreased fetal folate concentrations at doses greater than or equal to 5 mg/kg/day, which is less than the human dose of 400 mg/day on a mg/m 2 basis. risk summary lamotrigine is present in milk from lactating women taking lamotrigine extended-release tablets ( see data ). neonates and young infants are at risk for high serum levels because maternal serum and milk levels can rise to high levels postpartum if lamotrigine dosage has been increased during pregnancy but is not reduced after delivery to the pre-pregnancy dosage. glucuronidation is required for drug clearance. glucuronidation capacity is immature in the infant and this may also contribute to the level of lamotrigine exposure. events including rash, apnea, drowsiness, poor sucking, and poor weight gain (requiring hospitalization in some cases) have been reported in infants who have been human milk-fed by mothers using lamotrigine; whether or not these events were caused by lamotrigine is unknown. no data are available on the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lamotrigine extended-release tablets and any potential adverse effects on the breastfed infant from lamotrigine extended-release tablets or from the underlying maternal condition. clinical considerations human milk-fed infants should be closely monitored for adverse events resulting from lamotrigine. measurement of infant serum levels should be performed to rule out toxicity if concerns arise. human milk-feeding should be discontinued in infants with lamotrigine toxicity. data data from multiple small studies indicate that lamotrigine plasma levels in nursing infants have been reported to be as high as 50% of maternal plasma concentrations. lamotrigine extended-release tablets are indicated as adjunctive therapy for pgtc and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. safety and effectiveness of lamotrigine extended-release tablets for any use in patients younger than 13 years have not been established. immediate-release lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for partial-onset seizures, the generalized seizures of lennox-gastaut syndrome, and pgtc seizures. safety and efficacy of immediate-release lamotrigine used as adjunctive treatment for partial-onset seizures were not demonstrated in a small, randomized, double-blind, placebo-controlled withdrawal trial in very young pediatric patients (aged 1 to 24 months). immediate-release lamotrigine was associated with an increased risk for infectious adverse reactions (lamotrigine 37%, placebo 5%), and respiratory adverse reactions (lamotrigine 26%, placebo 5%). infectious adverse reactions included bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection. respiratory adverse reactions included nasal congestion, cough, and apnea. juvenile animal data in a juvenile animal study in which lamotrigine (oral doses of 0, 5, 15, or 30 mg/kg) was administered to young rats from postnatal day 7 to 62, decreased viability and growth were seen at the highest dose tested and long-term neurobehavioral abnormalities (decreased locomotor activity, increased reactivity, and learning deficits in animals tested as adults) were observed at the 2 highest doses. the no-effect dose for adverse developmental effects in juvenile animals is less than the human dose of 400 mg/day on a mg/m 2 basis. clinical trials of lamotrigine extended-release tablets for epilepsy did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients or exhibit a different safety profile than that of younger patients. 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. experience in patients with hepatic impairment is limited. based on a clinical pharmacology study with immediate-release lamotrigine in 24 subjects with mild, moderate, and severe liver impairment [see clinical pharmacology ( 12.3)] , the following general recommendations can be made. no dosage adjustment is needed in patients with mild liver impairment. initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. escalation and maintenance doses may be adjusted according to clinical response [see dosage and administration ( 2.1)] . lamotrigine is metabolized mainly by glucuronic acid conjugation, with the majority of the metabolites being recovered in the urine. in a small study comparing a single dose of immediate-release lamotrigine in subjects with varying degrees of renal impairment with healthy volunteers, the plasma half-life of lamotrigine was approximately twice as long in the subjects with chronic renal failure [see clinical pharmacology (12.3)] . initial doses of lamotrigine extended-release tablets should be based on patients’ aed regimens; reduced maintenance doses may be effective for patients with significant renal impairment. few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine. because there is inadequate experience in this population, lamotrigine extended-release tablets should be used with caution in these patients [see dosage and administration (2.1)] .

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) [see clinical studies (14.1) ]. alendronate sodium is indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3) ]. the optimal duration of use has not been determined. the safety and effectiveness of alendronate for the treatment of osteoporosis are based on clinical data of four years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. alendronatesodiumiscontraindicatedinpatientswiththefollowing conditions: - abnormalities of the esophagus

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules are indicated for the treatment of: starting duloxetine delayed-release capsules 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)] . pregnancy category c risk summary — there are no adequate and well-controlled studies of duloxetine administration in pregnant women. in animal studies with duloxetine, fetal weights were decreased but there was no evidence of teratogenicity in pregnant rats and rabbits at oral doses administered during the period of organogenesis up to 4 and 7 times the maximum recommended human dose (mrhd) of 120 mg/day, respectively. when duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the mrhd. at this dose, pup behaviors consistent with i

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 30 mg - duloxetine delayed-release capsules are indicated for the treatment of major depressive disorder (mdd). the efficacy of duloxetine was established in four short term and one maintenance trial in adults [see clinical studies (14.1) ]. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. duloxetine delayed-release capsules are indicated for the treatment of generalized anxiety disorder (gad). the efficacy of duloxetine was established in three short-term trials and one maintenance trial in adults [see clinical studies