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vistapharm, llc - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions ( 5.6 )]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/ . risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8) and clinical considerations] . available data from published observatio

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vistapharm, llc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole oral solution is indicated for the treatment of: - schizophrenia [see clinical studies (14.1)] - acute treatment of manic and mixed episodes associated with bipolar  i disorder [see clinical studies (14.2)] - adjunctive treatment of major depressive disorder [see clinical studies (14.3)] - irritability associated with autistic disorder [see clinical studies (14.4) ] - treatment of tourette’s disorder [see clinical studies (14.5)] aripiprazole oral solution is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2) ] .   pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations) . overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother associated with untreated schizophrenia, bipolar i disorder, or major depressive disorder, and with exposure to antipsychotics, including aripiprazole, during pregnancy (see clinical considerations). in animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 19 times, respectively, the maximum recommended human dose (mrhd) of 30 mg/day based on mg/m2 body surface area, produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses 10 times the mrhd based on mg/m2 body surface area, produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival (see data) . 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. disease-associated maternal and/or embryo/fetal risk there is a risk to the mother from untreated schizophrenia or bipolar i disorder, including increased risk of relapse, hospitalization, and suicide. schizophrenia and bipolar i disorder are associated with increased adverse perinatal outcomes, including preterm birth. it is not known if this is a direct result of the illness or other comorbid factors. a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including aripiprazole) during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms, and manage symptoms appropriately. some neonates recovered within hours or days without specific treatment; other required prolonged hospitalization. human data published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. a retrospective study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. animal data in animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. in pregnant rats treated orally with aripiprazole during organogenesis at doses of 3, 10, and 30 mg/kg/day, which are approximately 1, 3 and 10 times the mrhd of 30 mg/day based on mg/m2  body surface area, a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight and undescended testes, were observed at 10 times the mrhd. delayed skeletal ossification was observed at 3 and 10 times the mrhd. delivered offspring had increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed at 10 times the mrhd (the other dose groups were not examined for these findings). postnatally, delayed vaginal opening was seen at 3 and 10 times the mrhd. impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) were observed at 10 times the mrhd; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. in pregnant rats injected intravenously with aripiprazole during organogenesis at doses of 3, 9, and 27 mg/kg/day, which are 1, 3, and 9 times the mrhd of 30 mg/day based on mg/m2  body surface area, decreased fetal weight and delayed skeletal ossification were observed at 9 times the mrhd; this dose also caused maternal toxicity. in pregnant rabbits treated orally with aripiprazole during organogenesis at doses of 10, 30, and 100 mg/kg/day which are 6, 19, and 65 times the mrhd of 30 mg/day based on mg/m2  body surface area, decreased maternal food consumption, and increased abortions as well as increased fetal mortality were observed at 65 times the mrhd. decreased fetal weight and increased incidence of fused sternebrae were observed at 19 and 65 times the mrhd. in pregnant rabbits injected intravenously with aripiprazole during organogenesis at doses of 3, 10, and 30 mg/kg/day, which are 2, 6, and 19 times the mrhd of 30 mg/day based on mg/m2  body surface area, decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification were observed at 19 times the mrhd; this dose also caused maternal toxicity. the fetal no-effect dose was 10 mg/kg/day, which is 6 times the mrhd. in rats treated orally with aripiprazole peri- and post-natally from gestation day 17 through postpartum day 21 at doses of 3, 10, and 30 mg/kg/day which are 1, 3, and 10 times the mrhd of 30 mg/day based on mg/m2  body surface area slight maternal toxicity and slightly prolonged gestation were observed at 10 times the mrhd. an increase in stillbirths and, decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. in rats injected intravenously with aripiprazole from gestation day 6 through lactation day 20 at doses of 3, 8, and 20 mg/kg/day, which are 1, 3, and 6 times the mrhd of 30 mg/day based on mg/m2  body surface area, increased stillbirths were observed at 3 and 6 times the mrhd; and decreases in early postnatal pup weight and survival were observed at 6 times the mrhd; these doses also caused some maternal toxicity. there were no effects on postnatal behavioral and reproductive development. risk summary limited data from published literature report the presence of aripiprazole in human breast milk, at relative infant doses ranging between 0.7% to 8.3% of the maternal weight-adjusted dosage. there are reports of poor weight gain in breastfed infants exposed to aripiprazole and reports of inadequate milk supply in lactating women taking aripiprazole. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for aripiprazole and any potential adverse effects on the breastfed infant from aripiprazole or from the underlying maternal condition. safety and effectiveness in pediatric patients with major depressive disorder or agitation associated with schizophrenia or bipolar mania have not been established. the pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting  for the differences in body weight [see clinical pharmacology (12.3) ] . schizophrenia safety and effectiveness in pediatric patients with schizophrenia were established in a 6-week, placebo-controlled clinical trial in 202 pediatric patients aged 13 to 17 years [see dosage and administration (2.1), adverse  reactions (6.1) , and  clinical studies (14.1) ]. although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. bipolar i disorder safety and effectiveness in pediatric patients with bipolar mania were established in a 4-week, placebo-controlled clinical trial in 197 pediatric patients aged 10 to 17 years [see dosage and administration (2.2),  adverse  reactions (6.1) , and clinical studies (14.2) ] . although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. the efficacy of adjunctive aripiprazole with concomitant lithium or valproate in the treatment of manic or mixed episodes in pediatric patients has not been systematically evaluated. however, such efficacy and lack of pharmacokinetic interaction between aripiprazole and lithium or valproate can be extrapolated from adult data, along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. irritability associated with autistic disorder safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two 8-week, placebo-controlled clinical trials in 212 pediatric patients aged 6 to 17 years [see indications and usage  (1) , dosage and administration  (2.4) , adverse reactions (6.1) , and clinical studies (14.4) ] . a maintenance trial was conducted in pediatric patients (6 to 17 years of age) with irritability associated with autistic disorder. the first phase of this trial was an open-label, flexibly dosed (aripiprazole 2 to 15 mg/day) phase in which patients were stabilized (defined as > 25% improvement on the abc-i subscale, and a cgi-i rating of “much improved” or “very much improved”) on aripiprazole for 12 consecutive weeks. overall, 85 patients were stabilized and entered the second, 16-week, double-blind phase where they were randomized to either continue aripiprazole treatment or switch to placebo. in this trial, the efficacy of aripiprazole for the maintenance treatment of irritability associated with autistic disorder was not established. tourette’s disorder safety and effectiveness of aripiprazole in pediatric patients with tourette’s disorder were established in one 8-week (aged 7 to 17) and one 10-week trial (aged 6 to 18) in 194 pediatric patients [see dosage and administration (2.5) , adverse reactions (6.1) , and clinical studies (14.5) ] . maintenance efficacy in pediatric patients has not been systematically evaluated. juvenile animal studies aripiprazole in juvenile rats caused mortality, cns clinical signs, impaired memory and learning, and delayed sexual maturation when administered at oral doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). at 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other cns signs were observed in both genders. in addition, delayed sexual maturation was observed in males. at all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. the changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. a no observed adverse effect level (noael) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (auc0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. aripiprazole in juvenile dogs (2 months old) caused cns clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. a noael could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (auc0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period. no dosage adjustment is recommended for elderly patients [see boxed  warning ,  warnings and precautions (5.1), and clinical  pharmacology (12.3) ] . of the 13,543 patients treated with oral aripiprazole in clinical trials, 1073 (8%) were ≥65 years old and 799 (6%) were ≥75 years old. placebo-controlled studies of oral aripiprazole in schizophrenia, bipolar mania, or major depressive disorder did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. aripiprazole is not approved for the treatment of patients with psychosis associated with alzheimer’s disease [see boxed warning and warnings and  precautions (5.1) ] . dosage adjustment is recommended in known cyp2d6 poor metabolizers due to high aripiprazole concentrations. approximately 8% of caucasians and 3–8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm) [see dosage and administration  (2.7)  and clinical pharmacology (12.3) ]. no dosage adjustment for aripiprazole is required on the basis of a patient’s hepatic function (mild to severe hepatic impairment, child-pugh score  between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see clinical pharmacology (12.3) ] . no dosage adjustment for aripiprazole is required on the basis of a patient’s sex, race, or smoking status [see clinical pharmacology (12.3) ] . aripiprazole is not a controlled substance. aripiprazole has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of aripiprazole misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). in physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed.

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vistapharm, llc - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)] , heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary use of mycophenolate mofetil (mmf) during pregnancy is associated with

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vistapharm, llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam oral solution is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam oral solution is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam oral solution is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry

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vistapharm, llc - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg in 5 ml - the use of metoclopramide oral solution is recommended for adults only. therapy should not exceed 12 weeks in duration. metoclopramide oral solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. the principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. if symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of 12-week trial using doses of 15 mg q.i.d. as there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. metoclopramide is indicated for the relief of sympt

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vistapharm, llc - sucralfate (unii: xx73205dh5) (sucralfate - unii:xx73205dh5) - sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. sucralfate oral suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

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vistapharm, llc - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride 10 mg - methadone hydrochloride tablets are indicated for the: 1. management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, [see warnings and precautions (5.1)], reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic. 2. detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 3. maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate so

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vistapharm, llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus oral solution 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 oral solution 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 oral solution 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 with serum creatinine > 4.5 mg/dl, black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies [see clinical studies (14.2) ]. in patients at high-immunologic risk , the safety and efficacy of sirolimus oral solution used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient [see clinical studies (14.3) ]. in pediatric patients , the safety and efficacy of sirolimus oral solution have not been established in patients < 13 years old, or in pediatric (< 18 years) renal transplant patients considered at high-immunologic risk [see adverse reactions (6.5), clinical studies (14.6) ]. the safety and efficacy of de novo use of sirolimus oral solution without cyclosporine have not been established in renal transplant patients [see warnings and precautions (5.12) ]. the safety and efficacy of conversion from calcineurin inhibitors to sirolimus oral solution  in maintenance renal transplantpatients have not been established [see clinical studies (14.4) ]. sirolimus oral solution is contraindicated in patients with a hypersensitivity to sirolimus [see warnings and precautions (5.4) ]. risk summary based on animal studies and the mechanism of action, sirolimus can cause fetal harm when administered to a pregnant woman [see data, clinical pharmacology (12.1) ]. there are limited data on the use of sirolimus during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal studies, sirolimus was embryo/fetotoxic in rats at sub-therapeutic doses [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. 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 sirolimus crossed the placenta and was toxic to the conceptus. in rat embryo-fetal development studies, pregnant rats were administered sirolimus orally during the period of organogenesis (gestational day 6-15). sirolimus produced embryo-fetal lethality at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg, on a body surface area basis) and reduced fetal weight at 1 mg/kg (5-fold the clinical dose of 2 mg). the no observed adverse effect level (noael) for fetal toxicity in rats was 0.1 mg/kg (0.5-fold the clinical dose of 2 mg). maternal toxicity (weight loss) was observed at 2 mg/kg (10-fold the clinical dose of 2 mg). the noael for maternal toxicity was 1 mg/kg. in combination with cyclosporine, rats had increased embryo-fetal mortality compared with sirolimus alone. in rabbit embryo-fetal development studies, pregnant rabbits were administered sirolimus orally during the period of organogenesis (gestational day 6-18). there were no effects on embryo-fetal development at doses up to 0.05 mg/kg (0.5-fold the clinical dose of 2 mg, on a body surface area basis); however, at doses of 0.05 mg/kg and above, the ability to sustain a successful pregnancy was impaired (i.e., embryo-fetal abortion or early resorption). maternal toxicity (decreased body weight) was observed at 0.05 mg/kg. the noael for maternal toxicity was 0.025 mg/kg (0.25-fold the clinical dose of 2 mg). in a pre-and post-natal development study in rats, pregnant females were dosed during gestation and lactation (gestational day 6 through lactation day 20). an increased incidence of dead pups, resulting in reduced live litter size, occurred at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg/kg on a body surface area basis). at 0.1 mg/kg (0.5-fold the clinical dose of 2 mg), there were no adverse effects on offspring. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg, the highest dose tested. risk summary it is not known whether sirolimus is present in human milk. there are no data on its effects on the breastfed infant or milk production. the pharmacokinetic and safety profiles of sirolimus in infants are not known. sirolimus is present in the milk of lactating rats. there is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action [see clinical pharmacology (12.1) ]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sirolimus and any potential adverse effects on the breastfed child from sirolimus. contraception females should not be pregnant or become pregnant while receiving sirolimus. advise females of reproductive potential that animal studies have been shown sirolimus to be harmful to the developing fetus. females of reproductive potential are recommended to use highly effective contraceptive method. effective contraception must be initiated before sirolimus therapy, during sirolimus therapy, and for 12 weeks after sirolimus therapy has been stopped [see warnings and precautions (5.15), use in specific populations (8.1) ]. infertility based on clinical findings and findings in animals, male and female fertility may be compromised by the treatment with sirolimus [see adverse reactions (6.7), nonclinical toxicology (13.1) ]. ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of sirolimus. azoospermia has been reported in males with the use of sirolimus and has been reversible upon discontinuation of sirolimus in most cases. renal transplant the safety and efficacy of sirolimus in pediatric patients < 13 years have not been established. the safety and efficacy of sirolimus oral solution have been established for prophylaxis of organ rejection in renal transplantation in children ≥ 13 years judged to be at low- to moderate-immunologic risk. use of sirolimus oral solution in this subpopulation of children ≥ 13 years is supported by evidence from adequate and well-controlled trials of sirolimus oral solution in adults with additional pharmacokinetic data in pediatric renal transplantation patients [see clinical pharmacology (12.3) ]. safety and efficacy information from a controlled clinical trial in pediatric and adolescent (< 18 years of age) renal transplant patients judged to be at high-immunologic risk, defined as a history of one or more acute rejection episodes and/or the presence of chronic allograft nephropathy, do not support the chronic use of sirolimus oral solution in combination with calcineurin inhibitors and corticosteroids, due to the higher incidence of lipid abnormalities and deterioration of renal function associated with these immunosuppressive regimens compared to calcineurin inhibitors, without increased benefit with respect to acute rejection, graft survival, or patient survival [see clinical studies (14.6) ]. clinical studies of sirolimus oral solution did not include sufficient numbers of patients ≥ 65 years to determine whether they respond differently from younger patients. data pertaining to sirolimus trough concentrations suggest that dose adjustments based upon age in geriatric renal patients are not necessary. differences in responses between the elderly and younger patients have not been identified. 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, or cardiac function, and of concomitant disease or other drug therapy. the maintenance dose of sirolimus should be reduced in patients with hepatic impairment [see dosage and administration (2.7), clinical pharmacology (12.3) ]. dosage adjustment is not required in patients with renal impairment [see dosage and administration (2.8), clinical pharmacology (12.3) ]. sirolimus (sir-oh-li-mus) oral solution be sure that you read and understand the following instructions for the correct way to dilute and take sirolimus oral solution. ask your pharmacist or doctor if you are not sure. important: - always keep the bottle in an upright position. - you may store sirolimus oral solution that is in a syringe at room temperature up to 77°f (25°c) or in the refrigerator at 36°f to 46°f (2°c to 8°c) for up to 24 hours. see “how should i store sirolimus oral solution?” at the end of these instructions for use. - sirolimus oral solution can develop a slight haze when it is refrigerated. if this happens, bring the sirolimus oral solution to room temperature and then gently shake the bottle until the haze goes away. - only use a glass or plastic cup to dilute sirolimus oral solution. - if you are a caregiver, do not let sirolimus oral solution come in contact with your skin or eyes. if you get the oral solution on your skin, wash the area well with soap and water. if you get the oral solution in your eyes, rinse with plain water. - if you spill sirolimus oral solution, dry the area with a dry paper towel and then wipe the area with a wet paper towel. throw away the paper towels in the trash and wash your hands well with soap and water. each sirolimus oral solution carton contains: a) a 2 oz. (60 ml fill) amber glass bottle of sirolimus (concentration of 1 mg/ml) b) 1 oral syringe adapter for fitting into the neck of the bottle c) enough disposable amber oral syringes and caps for daily dosing d) 1 carrying case you will also need: - glass or plastic cup - 6 oz. of water or orange juice only. 1. opening the solution bottle. - remove the safety cap by pushing down and turning counterclockwise (figure 1). 2. the first time you use a bottle of sirolimus oral solution: - insert the oral syringe adapter (plastic tube with stopper) tightly into the bottle until it is even with the top of the bottle (figure 2). - do not remove the oral syringe adapter from the bottle once inserted.  3. use a new disposable amber oral syringe for each dose of sirolimus oral solution. - fully push down (depress) on the plunger of the disposable amber oral syringe. - then, tightly insert the oral syringe into the opening in the adapter (figure 3). 4. withdraw the prescribed amount of sirolimus oral solution: - gently pull back the plunger of the syringe until the level of the oral solution is even with the marking on the syringe for your prescribed dose. - always keep the bottle in an upright position. - if bubbles form within the oral solution in the syringe, empty the syringe into the bottle and repeat step 4 (figure 4). - you may need to repeat step 4 more than once to draw up your prescribed dose. 5. if your doctor tells you to carry your medicine with you: - each dose of sirolimus oral solution should be placed in an oral syringe. place a cap securely on each syringe. the cap should snap into place (figure 5). figure 6: placing syringe in carrying case - place the capped syringe in the enclosed carrying case (figure 6). if you need more than 1 carrying case, talk with your doctor or pharmacist. - see `how should i store sirolimus oral solution? ' for storage instructions. figure 7: emptying syringe into glass 6. taking a dose of sirolimus oral solution: - choose a clean flat work surface. place a clean paper towel on the work surface. wash and dry your hands. - empty the syringe into a glass or plastic cup containing at least 2 ounces (1/4 cup, 60 ml) of water or orange juice, stir vigorously for 1 minute and drink right away (figure 7). - if more than 1 syringe is needed for your prescribed dose, empty the oral solution from each syringe into the same glass or plastic cup of water or orange juice. - refill the container with at least 4 ounces (1/2 cup, 120 ml) of water or orange juice, stir vigorously again and drink the rinse solution.do not mix sirolimus oral solution with apple juice, grapefruit juice, or other liquids. only glass or plastic cups should be used to mix sirolimus oral solution. - the syringe and cap should be used only one time and then thrown away. - throw away the paper towel and clean the work surface. wash your hands. 7. always store the bottles of medication in the refrigerator. how should i store sirolimus oral solution? - store bottles of sirolimus oral solution in the refrigerator at 36°f to 46°f (2°c to 8°c) - protect from light - store sirolimus oral solution that is in a syringe at room temperature up to 77°f (25°c) or in the refrigerator at 36°f to 46°f (2°c to 8°c) for up to 24 hours - if necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°f (25°c) for up to 15 days - when a bottle of sirolimus oral solution is opened, it should be used within 1 month - use any diluted sirolimus oral solution right away keep sirolimus oral solution and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: novitium pharma llc 70 lake drive, east windsor new jersey 08520 distributed by: vistapharm, inc. largo, fl 33771 usa trademarks are the property of their respective owners. revised: april, 2022 lb4062-05

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

vistapharm, llc - sucralfate (unii: xx73205dh5) (sucralfate - unii:xx73205dh5) - sucralfate 1 g in 10 ml - sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. sucralfate oral suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

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

vistapharm, llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - pain reliever/fever reducer ■ temporarily relieves minor aches and pains due to: ■ headache ■ muscle aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps ■ temporarily reduces fever