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zydus lifesciences limited - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine tablets, usp are indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. pregnancy category c there are no adequate and well-controlled studies in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically. galantamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses. the

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pd-rx pharmaceuticals, inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 150 mg - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)]. patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to registe

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amneal pharmaceuticals llc - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the: - adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; - treatment of adults with refractory anaplastic astrocytoma. temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)].   risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to temozolomide during pregnancy. these cases report similar adverse developmental outcomes to those observed in animal studies. administration of temozolomide to rats and rabbits during the period of organogenesis caused numerous external, internal, and skeletal malformations at doses less than the maximum human dose based on body surface area (see data) . advise pregnant women of the potential risk to a fetus. 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. data animal data five consecutive days of oral administration of temozolomide at doses of 75 and 150 mg/m2 (0.38 and 0.75 times the human dose of 200 mg/m2 ) in rats and rabbits, respectively, during the period of organogenesis (gestation days 8 to 12) caused numerous malformations of the external and internal organs and skeleton in both species. in rabbits, temozolomide at the 150 mg/m2 dose (0.75 times the human dose of 200 mg/m2 ) caused embryolethality as indicated by increased resorptions. there are no data on the presence of temozolomide or its metabolites in human milk, the effects on a breastfed child, or the effects on milk production. because of the potential for serious adverse reactions, including myelosuppression from temozolomide in the breastfed children, advise women not to breastfeed during treatment with temozolomide and for 1 week after the last dose.   temozolomide can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating temozolomide [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during treatment with temozolomide and for 6 months after the last dose. males because of the potential for embryofetal toxicity and genotoxic effects on sperm cells, advise male patients with pregnant partners or female partners of reproductive potential to use condoms during treatment with temozolomide and for 3 months after the last dose [see use in specific populations  (8.1) , nonclinical toxicology (13.1)] . advise male patients not to donate semen during treatment with temozolomide and for 3 months after the last dose. infertility temozolomide may impair male fertility [see nonclinical toxicology (13.1)] . limited data from male patients show changes in sperm parameters during treatment with temozolomide; however, no information is available on the duration or reversibility of these changes. safety and effectiveness of temozolomide have not been established in pediatric patients. safety and effectiveness of temozolomide capsules were assessed, but not established, in 2 open-label studies in pediatric patients aged 3 to 18 years. in one study, 29 patients with recurrent brain stem glioma and 34 patients with recurrent high-grade astrocytoma were enrolled. in a second study conducted by the children's oncology group (cog), 122 patients were enrolled, including patients with medulloblastoma/pnet (29), high grade astrocytoma (23), low grade astrocytoma (22), brain stem glioma (16), ependymoma (14), other cns tumors (9), and non-cns tumors (9). the adverse reaction profile in pediatric patients was similar to adults. in mk-7365-051, 15% of patients with newly diagnosed glioblastoma were 65 years and older. this study did not include sufficient numbers of patients aged 65 years and older to determine differences in effectiveness from younger patients. no overall differences in safety were observed between patients ≥ 65 years and younger patients. the catnon trial did not include sufficient numbers of patients aged 65 years and older to determine differences in safety or effectiveness when compared to younger patients. in mk-7365-006, 4% of patients with refractory anaplastic astrocytoma were 70 years and older. this study did not include sufficient numbers of patients aged 70 years and older to determine differences in effectiveness from younger patients. patients 70 years and older had a higher incidence of grade 4 neutropenia (25%) and grade 4 thrombocytopenia (20%) in the first cycle of therapy than patients less than 70 years of age [see warnings and precautions (5.1), adverse reactions (6.1)] . in the entire safety database for which hematologic data exist (n=932), 7% (4/61) and 10% (6/63) of patients > 70 years experienced grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. for patients ≤ 70 years, 7% (62/871) and 6% (48/879) experienced grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. pancytopenia, leukopenia, and anemia also occurred. no dosage adjustment is recommended for patients with creatinine clearance (clcr) of 36 to 130 ml/min/m2 [see clinical pharmacology (12.3)] . the recommended dose of temozolomide has not been established for patients with severe renal impairment (clcr < 36 ml/min/m2 ) or for patients with end-stage renal disease on dialysis. no dosage adjustment is recommended for patients with mild to moderate hepatic impairment (child pugh class a and b) [see clinical pharmacology (12.3)] . the recommended dose of temozolomide has not been established for patients with severe hepatic impairment (child-pugh class c).

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actelion pharmaceuticals us, inc. - bosentan (unii: q326023r30) (bosentan anhydrous - unii:xul93r30k2) - bosentan anhydrous 62.5 mg - tracleer is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): - in adults to improve exercise ability and to decrease clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (60%), pah associated with connective tissue diseases (21%), and pah associated with congenital heart disease with left-to-right shunts (18%) [see clinical studies (14.1)] . - in pediatric patients aged 3 years and older with idiopathic or congenital pah to improve pulmonary vascular resistance (pvr), which is expected to result in an improvement in exercise ability. use of tracleer is contraindicated in females who are or may become pregnant. to prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping tracleer [see boxed warning, warnings and precautions (5.2), drug interactions (7.2), use in specific populations (8.1)] . co-administration of cyclosporine a and bosentan resulted in markedly increased plasma concentrations of bosentan. therefore, concomitant use of tracleer and cyclosporine a is contraindicated [see cytochrome p450 drug interactions (7.1)] . an increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. therefore co-administration of glyburide and tracleer is contraindicated [see cytochrome p450 drug interactions (7.1)] . tracleer is contraindicated in patients who are hypersensitive to bosentan or any component of the product. observed reactions include drug reaction with eosinophilia and systemic symptoms (dress), anaphylaxis, rash, and angioedema [see adverse reactions (6.2), description (11)] . risk summary based on data from animal reproduction studies, tracleer may cause fetal harm, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy [see contraindications (4.1)] . there are limited data on tracleer use in pregnant women. in animal reproduction studies, oral administration of bosentan to pregnant rats at 2-times the maximum recommended human dose (mrhd) on a mg/m 2 basis caused teratogenic effects in rats, including malformations of the head, mouth, face, and large blood vessels [see animal 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 2–4% and 15–20%, respectively. data animal data bosentan was teratogenic in rats given oral doses two times the mrhd (on a mg/m 2 basis). in an embryo-fetal toxicity study in rats, bosentan showed dose-dependent teratogenic effects, including malformations of the head, mouth, face and large blood vessels. bosentan increased stillbirths and pup mortality at oral doses 2 and 10 times the mrhd (on a mg/m 2 basis). although birth defects were not observed in rabbits given oral doses of up to the equivalent of 10.5 g/day in a 70 kg person, plasma concentrations of bosentan in rabbits were lower than those reached in the rat. the similarity of malformations induced by bosentan and those observed in endothelin-1 knockout mice and in animals treated with other endothelin receptor antagonists indicates that embryo-fetal toxicity is a class effect of these drugs. risk summary data from a case report describe the presence of bosentan in human milk. there is insufficient information about the effects of bosentan on the breastfed infant and no information on the effects of bosentan on milk production. because of the potential for serious adverse reactions, such as fluid retention and hepatotoxicity, in breastfed infants from tracleer, advise women not to breastfeed during treatment with tracleer. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating tracleer, monthly during treatment and one month after stopping treatment with tracleer. the patient should contact her physician immediately for pregnancy testing if onset of menses is delayed or pregnancy is suspected. if the pregnancy test is positive, the physician and patient must discuss the risks to her, the pregnancy, and the fetus. contraception drug interaction studies show that bosentan reduces serum levels of the estrogen and progestin in oral contraceptives. based on these findings, hormonal contraceptives (including oral, injectable, transdermal, and implantable contraceptives) may be less effective for preventing pregnancy in patients using tracleer and should not be used as a patient's only contraceptive method [see drug interactions (7.2)] . females of reproductive potential using tracleer must use two acceptable methods of contraception during treatment and for 1 month after treatment with tracleer. patients may choose one highly effective form of contraception (intrauterine devices (iud) or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). if a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see boxed warning] . infertility males decreased sperm counts have been observed in patients receiving tracleer. based on these findings and findings in animals, tracleer may impair fertility in males of reproductive potential. it is not known whether effects on fertility would be reversible [see warnings and precautions (5.6), adverse reactions (6.1), nonclinical toxicology (13.1)] . the efficacy of tracleer in patients <18 years is supported by data from an uncontrolled trial in which 19 pediatric patients were treated with tracleer. in this study, cardiopulmonary hemodynamic improvements were similar to those seen in adults treated with tracleer [see pulmonary arterial hypertension (14.1)] . safety in pediatric patients is supported by data from 100 pediatric patients treated with tracleer for a median of 17 months [see clinical studies experience (6.1), pulmonary arterial hypertension (14.1)] . juvenile animal toxicity data in a juvenile rat toxicity study, rats were treated from day 4 postpartum to adulthood (day 69 postpartum). decreased body weights, absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning. no effect on testis histology or sperm morphology and function was seen. the noael was 4 times (at day 4 postpartum) and 2 times (day 69 postpartum) the human therapeutic exposure, respectively. no effects on general development, sensory, cognitive function and reproductive performance were detected at the highest dose tested in juvenile rats, 7 times the therapeutic exposure in children with pah. clinical studies of tracleer did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. because there is in vitro and in vivo evidence that the main route of excretion of bosentan is biliary, liver impairment could be expected to increase exposure (c max and auc) of bosentan. the pharmacokinetics of tracleer have not been evaluated in patients with severe liver impairment (child-pugh class c). in patients with moderate hepatic impairment (child-pugh class b), the systemic exposures to bosentan and its active metabolite increased significantly. tracleer should generally be avoided in patients with moderate or severe liver impairment. pharmacokinetics of bosentan were not altered in patients with mild impairment of hepatic function (child-pugh class a) [see dosage and administration (2.6), warnings and precautions (5.1), pharmacokinetics (12.3)] . the effect of renal impairment on the pharmacokinetics of bosentan is small and does not require dosing adjustment [see pharmacokinetics (12.3)] .

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aidarex pharmaceuticals llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets usp are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1) ]. topiramate tablets usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.1) ] none. [see warnings and precautions (5.6)] topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero

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celgene corporation - thalidomide (unii: 4z8r6ors6l) (thalidomide - unii:4z8r6ors6l) - thalidomide 50 mg - thalomid in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (mm) [see clinical studies (14.1)] . thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (enl). thalomid is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis. thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence [see clinical studies (14.2)]. thalomid is contraindicated in females who are pregnant. thalomid can cause fetal harm when administered to a pregnant female [see boxed warning, warnings and precautions (5.1) and use in specific populations (8.1)] . thalomid is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects, even after a single dose [see boxed warning] . mortality at or shortly after birth has been reported in about 40% of infants.

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pd-rx pharmaceuticals, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 20 mg - fluoxetine capsules, usp are 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 capsules, usp and olanzapine in combination is indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. - treatment resistant depression (major depressive disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and

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pd-rx pharmaceuticals, inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 30 mg - prevacid and prevacid solutab are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)] . triple therapy: prevacid or prevacid solutab/amoxicillin/clarithromycin prevacid or prevacid solutab in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)] . please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: prevacid or prevacid solutab/amoxicillin prevacid or prevacid solutab in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (ac

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contract pharmacy services-pa - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 20 mg - fluoxetine capsules are 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 capsules and olanzapine in combination are indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associate

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takeda pharmaceuticals america, inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy actos is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use actos exerts its antihyperglycemic effect only in the presence of endogenous insulin. actos should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . risk summary limited data with actos in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. in animal reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 5- and 35-times the 45 mg