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greenstone llc - diclofenac epolamine (unii: x5f8ekl9zg) (diclofenac - unii:144o8ql0l1) - diclofenac epolamine topical patch 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. diclofenac epolamine topical patch 1.3% is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] - diclofenac epolamine topical patch 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. risk summary published literature reports that use of nsaids, including di

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

greenstone llc - diclofenac epolamine (unii: x5f8ekl9zg) (diclofenac - unii:144o8ql0l1) - diclofenac epolamine topical system 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. diclofenac epolamine topical system 1.3% is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions (5.1) ] - diclofenac epolamine topical system 1.3% is contraindicated for use on non-intac

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

greenstone llc - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine 50 mg - desvenlafaxine is indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14)] . 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 based on data from published observational studies, exposure to snris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.4) and clinical considerations]. 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 a

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

greenstone llc - risedronate sodium hemi-pentahydrate (unii: hu2yaq274o) (risedronic acid - unii:km2z91756z), risedronate sodium monohydrate (unii: f67l43ut5c) (risedronic acid - unii:km2z91756z) - risedronate sodium anhydrous 30.1 mg - risedronate sodium delayed-release is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies (14.1) ].  the optimal duration of use has not been determined. the safety and effectiveness of risedronate sodium delayed-release for the treatment of osteoporosis are based on clinical data of one year 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. risedronate sodium delayed-release is contraindicated in patients with the following conditions: - abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see warnings and precautions (5.2) ] - inability to stand or sit upright for at least 30 minutes [see dosage and administration (2) , warnings and precautions (5.2) ] - hypocalcemia [see  warnings and precautions (5.3) ] - known hypersensitivity to any component of this product. angioedema, generalized rash, bullous skin reactions, stevens-johnson syndrome and toxic epidermal necrolysis have been reported [see  adverse reactions (6.2) ] risk summary available data on use of risedronate sodium delayed-release in pregnant women are insufficient to inform drug-associated risk of adverse maternal or fetal outcomes. discontinue risedronate sodium delayed-release when pregnancy is recognized. in animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m2 ), the dose indicated for treatment of paget’s disease. a low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to the 30 mg human daily dose. delayed skeletal ossification was observed in fetuses of dams treated at approximately 2.5 to 5 times the 30 mg human daily dose. periparturient mortality due to maternal hypocalcemia occurred in dams and neonates upon daily oral administration of risedronate to pregnant rats during mating and/or gestation starting at doses equivalent to the 30 mg daily human dose. bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of weeks to years. the amount of bisphosphonate incorporated into adult bone available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. consequently, based on mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. the impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal d ata in animal studies, pregnant rats received risedronate sodium during organogenesis at doses 1 to 26 times the human paget’s disease dose of 30 mg/day (based on body surface area, mg/m2 ). survival of neonates was decreased in rats treated during gestation with oral doses approximately 5 times the human dose and body weight was decreased in neonates from dams treated with approximately 26 times the human dose. a low incidence of cleft palate was observed in fetuses from female rats treated with oral doses approximately equal to the human dose. the number of fetuses exhibiting incomplete ossification of sternebrae or skull of dams treated with approximately 2.5 times the human dose was significantly increased compared to controls. both incomplete ossification and unossified sternebrae were increased in fetuses of dams treated with oral doses approximately 5 times the human dose. no significant ossification effects were seen in fetuses of rabbits treated with oral doses approximately 7 times the human dose (the highest dose tested). however, 1 of 14 litters were aborted and 1 of 14 litters were delivered prematurely. periparturient mortality due to maternal hypocalcemia occurred in dams and neonates when pregnant rats were treated daily during mating and/or gestation with oral doses equivalent to the human dose or higher. risk summary there are no data to assess the presence of risedronate in human milk, the effects on the breastfed infant, or the effects on milk production. a small degree of lacteal transfer occurred in nursing rats. the concentration of the drug in animal milk does not necessarily predict the concentration of drug in human milk. however, when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for risedronate sodium delayed-release and any potential adverse effects on the breast-fed child from risedronate sodium delayed-release or from the underlying maternal condition. data animal data risedronate was detected in neonates of lactating rats given a single oral dose of risedronate at 24-hours post-dosing, indicating a small degree of lacteal transfer. infertility there are no data available in humans. female and male fertility may be impaired based on animal studies demonstrating adverse effects of risedronate sodium delayed-release on fertility parameters [see nonclinical toxicology (13.1) ] . risedronate sodium delayed-release is not indicated for use in pediatric patients. the safety and effectiveness of risedronate sodium immediate-release was assessed in a one-year, randomized, double-blind, placebo-controlled study of 143 pediatric patients (94 received risedronate) with osteogenesis imperfecta (oi). the enrolled population was predominantly patients with mild oi (85% type-i), aged 4 to less than 16 years, 50% male and 82% caucasian, with a mean lumbar spine bmd z-score of -2.08 (2.08 standard deviations below the mean for age-matched controls). patients received either a 2.5 mg (less than or equal to 30 kg body weight) or 5 mg (greater than 30 kg body weight) daily oral dose. after one year, an increase in lumbar spine bmd in the risedronate sodium immediate-release group compared to the placebo group was observed. however, treatment with risedronate sodium immediate-release did not result in a reduction in the risk of fracture in pediatric patients with oi. in risedronate sodium immediate-release treated subjects, no mineralization defects were noted in paired bone biopsy specimens obtained at baseline and month 12. the overall safety profile of risedronate in oi patients treated for up to 12 months was generally similar to that of adults with osteoporosis. however, there was an increased incidence of vomiting compared to placebo. in this study, vomiting was observed in 15% of children treated with risedronate sodium immediate-release and 6% of patients treated with placebo. other adverse reactions reported in greater than or equal to 10% of patients treated with risedronate sodium immediate-release and with a higher frequency than placebo were: pain in the extremity (21% with risedronate sodium immediate-release versus 16% with placebo), headache (20% versus 8%), back pain (17% versus 10%), pain (15% versus 10%), upper abdominal pain (11% versus 8%), and bone pain (10% versus 4%). of the patients receiving risedronate sodium delayed-release in postmenopausal osteoporosis studies, 59% were 65 and over, while 13% were 75 and over. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. risedronate sodium delayed-release is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 ml/min) because of lack of clinical experience. no dosage adjustment is necessary in patients with a creatinine clearance greater than or equal to 30 ml/min. no studies have been performed to assess risedronate sodium’s safety or efficacy in patients with hepatic impairment. risedronate is not metabolized in human liver preparations. dosage adjustment is unlikely to be needed in patients with hepatic impairment.

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

greenstone llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus 0.5 mg - sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low- to moderate-immunologic risk, it is recommended that sirolimus be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2) ]. in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level >80%]), it is recommended that sirolimus be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration (2.3) , clinical studies (14.3) ]. cyclosporine withdrawal has not been studied in patients with banff grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those

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

greenstone llc - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam 0.25 mg - alprazolam is indicated for the: alprazolam is contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to alprazolam during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for other psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/. risk summary neonates born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation and neonatal withdrawal [see warnings and precautions (5.4), clinical considerations)]. overall available data from published observational studies of pregnant women exposed to alprazolam have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). the estimated background risk of major birth defects an

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

greenstone llc - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 125 mg in 5 ml - phenytoin is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. phenytoin is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)]. reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)]. - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the tollfree number 1-888-233

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

greenstone llc - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 50 mg - phenytoin infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)]. - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in

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

greenstone llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low- to moderate-immunologic risk, it is recommended that sirolimus be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2) ]. in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level >80%]), it is recommended that sirolimus be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration (2.3) , clinical studies (14.3) ]. cyclosporine withdrawal has not been studied in patients with banff grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those

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

greenstone llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications [see warnings and precautions (5.3)] . diclofenac sodium/misoprostol is contraindicated in the following patients: risk summary diclofenac sodium/misoprostol is contraindicated in pregnant women [see contraindications (4)] . if a woman becomes pregnant while taking diclofenac sodium/misoprostol, discontinue the drug and advise the woman of the potential risks to her and to a fetus. there are no adequate and well-controlled studies of diclofenac sodium/misoprostol in pregnant women; however, there is information available about the active drug components of diclofenac sodium/misoprostol, diclofenac sodium and misoprostol. administration of misoprostol to pregnan