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

direct rx - nabumetone (unii: lw0tiw155z) (nabumetone - unii:lw0tiw155z) - carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. nabumetone tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions, and precautions, general, preexisting asthma). in the setting of coronary artery bypass graft (cabg) surgery [see warnings].

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

direct rx - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - 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)]. 8.1 pregnancy teratogenic effects pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 6 to 9 times the maximum recommended human dose (mrhd) of 400 mg/day on mg/m2in adolescents. there is also an increase in congenital anomalies in the rabbit at approximately 6 to 17 times the mrhd on mg/m2 basis in adolescents. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potenti

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

direct_rx - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets usp are indicated for the treatment of major depressive disorder (mdd) in adults. the efficacy of trazodone hydrochloride tablets usp has been established in trials with the immediate release formulation of trazodone [see clinical studies (14)]. none. 8.1 pregnancy teratogenic effects pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. there was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 nursing mothers trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that th

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

direct rx - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), methyl salicylate (unii: lav5u5022y) (salicylic acid - unii:o414pz4lpz), capsaicin (unii: s07o44r1zm) (capsaicin - unii:s07o44r1zm), menthol (unii: l7t10eip3a) (menthol - unii:l7t10eip3a) - for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness.

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

direct_rx - desipramine hydrochloride (unii: 1y58do4my1) (desipramine - unii:tg537d343b) - desipramine hydrochloride tablets, usp is indicated for the treatment of depression. the use of maois intended to treat psychiatric disorders with desipramine hydrochloride or within 14 days of stopping treatment with desipramine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. the use of desipramine hydrochloride within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration). starting desipramine hydrochloride 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 warnings and dosage and administration). desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. it should not be used in those who have shown prior hypersensitivity to the drug. cross-sensitivity between this and other dibenzazepines is a possibility.

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

direct_rx - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14)]. hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine formulation. angioedema has been reported in patients treated with desvenlafaxine [see adverse reactions (6.1)]. the use of maois intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine is contraindicated because of an increased risk of serotonin syndrome. the use of desvenlafaxine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.7) and warnings and precautions (5.2)]. starting desvenlafaxine 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 (2.8) and warnings and precautions (5.2)]. 8.1 pregnancy 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 register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185. risk summary there are no published studies on desvenlafaxine in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see data). there are risks associated with untreated depression in pregnancy and with exposure to snris and ssris, including desvenlafaxine, during pregnancy (see clinical considerations). in reproductive developmental studies in rats and rabbits treated with desvenlafaxine succinate, there was no evidence of teratogenicity at a plasma exposure (auc) that is up to 19-times (rats) and 0.5-times (rabbits) the exposure at an adult human dose of 100 mg per day. however, fetotoxicity and pup deaths were observed in rats at 4.5-times the auc exposure observed with an adult human dose of 100 mg per day. 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: a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy, showed that women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication. maternal adverse reactions: exposure to snris in mid to late pregnancy may increase the risk for preeclampsia, and exposure to snris near delivery may increase the risk for postpartum hemorrhage. fetal/neonatal adverse reactions: exposure to snris or ssris in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding. monitor neonates who were exposed to desvenlafaxine in the third trimester of pregnancy for drug discontinuation syndrome (see data). data human data: published epidemiological studies of pregnant women exposed to the parent compound venlafaxine have not reported a clear association with major birth defects or miscarriage. methodological limitations of these observational studies include possible exposure and outcome misclassification, lack of adequate controls, adjustment for confounders, and confirmatory studies; therefore, these studies cannot establish or exclude any drug-associated risk during pregnancy. retrospective cohort studies based on claims data have shown an association between venlafaxine use and preeclampsia, compared to depressed women who did not take an antidepressant during pregnancy. one study that assessed venlafaxine exposure in the second trimester or first half of the third trimester and preeclampsia showed an increased risk compared to unexposed depressed women (adjusted (adj) rr 1.57, 95% ci 1.29 to 1.91). preeclampsia was observed at venlafaxine doses equal to or greater than 75 mg/day and a duration of treatment >30 days. another study that assessed venlafaxine exposure in gestational weeks 10 to 20 and preeclampsia showed an increased risk at doses equal to or greater than 150 mg/day. available data are limited by possible outcome misclassification and possible confounding due to depression severity and other confounders. retrospective cohort studies based on claims data have suggested an association between venlafaxine use near the time of delivery or through delivery and postpartum hemorrhage. one study showed an increased risk for postpartum hemorrhage when venlafaxine exposure occurred through delivery, compared to unexposed depressed women (adj rr 2.24 (95% ci 1.69 to 2.97). there was no increased risk in women who were exposed to venlafaxine earlier in pregnancy. limitations of this study include possible confounding due to depression severity and other confounders. another study showed an increased risk for postpartum hemorrhage when snri exposure occurred for at least 15 days in in the last month of pregnancy or through delivery, compared to unexposed women (adj rr 1.64 to 1.76). the results of this study may be confounded by the effects of depression. neonates exposed to snris, or ssris, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these features are consistent with either a direct toxic effect of ssris and snris or, possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.2)]. animal data: when desvenlafaxine succinate was administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 300 mg/kg/day and 75 mg/kg/day, respectively, no teratogenic effects were observed. these doses were associated with a plasma exposure (auc) 19 times (rats) and 0.5 times (rabbits) the auc exposure at an adult human dose of 100 mg per day. however, fetal weights were decreased and skeletal ossification was delayed in rats in association with maternal toxicity at the highest dose, with an auc exposure at the no-effect dose that is 4.5-times the auc exposure at an adult human dose of 100 mg per day. when desvenlafaxine succinate was administered orally to pregnant rats throughout gestation and lactation, there was a decrease in pup weights and an increase in pup deaths during the first four days of lactation at the highest dose of 300 mg/kg/day. the cause of these deaths is not known. the auc exposure at the no-effect dose for rat pup mortality was 4.5-times the auc exposure at an adult human dose of 100 mg per day. post-weaning growth and reproductive performance of the progeny were not affected by maternal treatment with desvenlafaxine succinate at exposures 19 times the auc exposure at an adult human dose of 100 mg per day. 8.6 lactation risk summary available limited data from published literature show low levels of desvenlafaxine in human milk, and have not shown adverse reactions in breastfed infants (see data). there are no data on the effects of desvenlafaxine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for desvenlafaxine and any potential adverse effects on the breastfed child from desvenlafaxine or from the underlying maternal condition. data a lactation study was conducted in 10 breastfeeding women (at a mean of 4.3 months postpartum) who were being treated with a 50 to 150 mg daily dose of desvenlafaxine for postpartum depression. sampling was performed at steady state (up to 8 samples) over a 24 hour dosing period, and included foremilk and hindmilk. the mean relative infant dose was calculated to be 6.8% (range of 5.5 to 8.1%). no adverse reactions were seen in the infants. 8.4 pediatric use the safety and effectiveness of desvenlafaxine have not been established in pediatric patients for the treatment of mdd. antidepressants, such as desvenlafaxine, increase the risk of suicidal thoughts and behaviors in pediatric patients [see the boxed warning and warnings and precautions (5.1)]. additional information describing clinical studies in which efficacy was not demonstrated in pediatric patients is approved for wyeth pharmaceuticals inc., a subsidiary of pfizer inc.'s pristiq® (desvenlafaxine) extended-release tablets. however, due to wyeth pharmaceuticals inc., a subsidiary of pfizer inc.'s marketing exclusivity rights, this product is not labeled with that pediatric information. juvenile animal studies in a juvenile animal study, male and female rats were treated with desvenlafaxine (75, 225 and 675 mg/kg/day) starting on postnatal day (pnd) 22 through 112. behavioral deficits (longer time immobile in a motor activity test, longer time swimming in a straight channel test, and lack of habituation in an acoustic startle test) were observed in males and females but were reversed after a recovery period. a no adverse effect level (noael) was not identified for these deficits. the low adverse effect level (loael) was 75 mg/kg/day which was associated with plasma exposure (auc) twice the levels measured with a pediatric dose of 100 mg/day. in a second juvenile animal study, male and female rats were administered desvenlafaxine (75, 225 or 675 mg/kg/day) for 8 to 9 weeks starting on pnd 22 and were mated with naïve counterparts. delays in sexual maturation and decreased fertility, number of implantation sites and total live embryos were observed in treated females at all doses. the loael for these findings is 75 mg/kg/day which was associated with an auc twice the levels measured with a pediatric dose of 100 mg/day. these findings were reversed at the end of a 4-week recovery period. the relevance of these findings to humans is not known. 8.5 geriatric use of the 4,158 patients in pre-marketing clinical studies with desvenlafaxine, 6% were 65 years of age or older. no overall differences in safety or efficacy were observed between these patients and younger patients; however, in the short-term placebo-controlled studies, there was a higher incidence of systolic orthostatic hypotension in patients ≥65 years of age compared to patients <65 years of age treated with desvenlafaxine [see adverse reactions (6.1)]. for elderly patients, possible reduced renal clearance of desvenlafaxine should be considered when determining dose [see dosage and administration (2.2) and clinical pharmacology (12.3)]. ssris and snris, including desvenlafaxine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions (5.9)]. 8.7 renal impairment adjust the maximum recommended dosage in patients with moderate or severe renal impairment (clcr 15 to 50 ml/min, c-g), or end-stage renal disease (clcr < 15 ml/min, c-g) [see dosage and administration (2.2) and clinical pharmacology (12.3)]. 8.8 hepatic impairment adjust the maximum recommended dosage in patients with moderate to severe hepatic impairment (child-pugh score 7 to 15) [see dosage and administration (2.3) and clinical pharmacology (12.3)]. 9.1 controlled substance desvenlafaxine is not a controlled substance.

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

direct_rx - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - anxiety disorders alprazolam tablets, usp (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the apa diagnostic and statistical manual [dsm-iii-r] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. at least 6 of the following 18 symptoms are often present in these patients: motor tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); autonomic hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold cla

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

direct_rx - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - anxiety disorders alprazolam tablets, usp (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the apa diagnostic and statistical manual [dsm-iii-r] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. at least 6 of the following 18 symptoms are often present in these patients: motor tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); autonomic hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold cla

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

direct_rx - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - anxiety disorders alprazolam tablets, usp (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the apa diagnostic and statistical manual [dsm-iii-r] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. at least 6 of the following 18 symptoms are often present in these patients: motor tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); autonomic hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold cla

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

direct rx - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - anxiety disorders alprazolam tablets, usp (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the apa diagnostic and statistical manual [dsm-iii-r] diagnosis of generalized anxiety disorder) or the short- term relief of symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. at least 6 of the following 18 symptoms are often present in these patients: motor tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); autonomic hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clam