Stati Uniti - Ingliż - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine is indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [ see clinical studies (14.1) ]. quetiapineis indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see clinical studies (14.2) ]. quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adul

Stati Uniti - Ingliż - NLM (National Library of Medicine)

ascend laboratories, llc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic

Stati Uniti - Ingliż - NLM (National Library of Medicine)

major pharmaceuticals - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine is indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1) ]. quetiapine is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2) ]. quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult patients with bipolar i and bipolar ii disorder [see clinical stud

Stati Uniti - Ingliż - NLM (National Library of Medicine)

ascend laboratories, llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine is indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1) ]. quetiapine is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2) ]. quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult patients with bipolar i and bipolar ii disorder [see clinical studies (14.2) ]. quetiapine is indicated for the maintenance treatment of bipolar i disorder, as an adjunct to lithium or divalproex. efficacy was established in two maintenance trials in adults. the effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see clinical studies (14.2) ]. pediatric schizophrenia and bipolar i disorder are serious mental disorders, however, diagnosis can be challenging. for pediatric schizophrenia, symptom profiles can be variable, and for bipolar i disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. it is recommended that medication therapy for pediatric schizophrenia and bipolar i disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. medication treatment for both pediatric schizophrenia and bipolar i disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions. hypersensitivity to quetiapine or to any excipients in the quetiapine formulation. anaphylactic reactions have been reported in patients treated with quetiapine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine tablets, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.   risk summary neonates exposed to antipsychotic drugs ( including quetiapine tablet) during the third trimester 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 quetiapine 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, or major depressive disorder, and with exposure to antipsychotics, including, quetiapine tablet during pregnancy (see clinical considerations) . in animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times the maximum recommended human dose (mrhd) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the mrhd. in addition, fetal weights were decreased in both species. maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the mrhd in rats and approximately 1-2 times the mrhd in rabbits. the estimated background risk of major birth defects and miscarriage for the indicated populations 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 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 quetiapine tablets, during the third trimester of pregnancy. these symptoms 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; others required prolonged hospitalization. data   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 cohort study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk of major birth defects. animal data   when pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect in fetuses. doses were 25, 50 and 200 mg/kg in rats and 25, 50 and 100 mg/kg in rabbits which are approximately 0.3, 0.6 and 2-times (rats) and 0.6, 1 and 2-times (rabbits) the mrhd, for schizophrenia of 800 mg/day based on mg/m2 body surface area. however, there was evidence of embryo-fetal toxicity, including delays in skeletal ossification at approximately 1 and 2 times the mrhd of 800 mg/day in both rats and rabbits and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the mrhd. in addition, fetal weights were decreased in both species. maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the mrhd in rats and at approximately 1-2 times the mrhd (all doses tested) in rabbits. in a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.1, and 0.2 times the mrhd of 800 mg/day based on mg/m2 body surface area. however, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the mrhd. risk summary limited data from published literature report the presence of quetiapine in human breast milk at relative infant dose of <1% of the maternal weight-adjusted dosage. there are no consistent adverse events that have been reported in infants exposed to quetiapine through breast milk. there is no information on the effects of quetiapine on milk production. the developmental and health  benefits of breastfeeding should be considered along with the mother’s clinical need for quetiapine tablets and any potential adverse effects on the breastfed child from quetiapine tablets or from the mother’s underlying condition. infertility   females   based on the pharmacologic action of quetiapine (d2 antagonism), treatment with quetiapine tablets may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see warnings and precautions (5.15)]. in general, the adverse reactions observed in children and adolescents during the clinical trials were similar to those in the adult population with few exceptions.  increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults.  orthostatic hypotension occurred more frequently in adults (4-7%) compared to children and adolescents (< 1%) [see warnings and precautions (5.7) and adverse reactions (6.1)]. schizophrenia the efficacy and safety of quetiapine in the treatment of schizophrenia in adolescents aged 13 to 17 years were demonstrated in one 6-week, double-blind, placebo-controlled trial [see indications and usage (1.1), dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.1)]. safety and effectiveness of quetiapine in pediatric patients less than 13 years of age with schizophrenia have not been established. maintenance the safety and effectiveness of quetiapine in the maintenance treatment of bipolar disorder has not been established in pediatric patients less than 18 years of age. the safety and effectiveness of quetiapine in the maintenance treatment of schizophrenia has not been established in any patient population, including pediatric patients. bipolar mania the efficacy and safety of quetiapine in the treatment of mania in children and adolescents ages 10 to 17 years with bipolar i disorder was demonstrated in a 3-week, double-blind, placebo-controlled, multicenter trial [see indications and usage (1.2), dosage and administration (2.3), adverse reactions (6.1), and clinical studies (14.2)] . safety and effectiveness of quetiapine in pediatric patients less than 10 years of age with bipolar mania have not been established. bipolar depression safety and effectiveness of quetiapine in pediatric patients less than 18 years of age with bipolar depression have not been established. a clinical trial with seroquel xr was conducted in children and adolescents (10 to 17 years of age) with bipolar depression, efficacy was not established. some differences in the pharmacokinetics of quetiapine were noted between children/adolescents (10 to 17 years of age) and adults.  when adjusted for weight, the auc and cmax of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults. the pharmacokinetics of the active metabolite, norquetiapine, were similar between children/adolescents and adults after adjusting for weight [see clinical pharmacology (12.3)] . of the approximately 3700 patients in clinical studies with quetiapine, 7% (232) were 65 years of age or over.  in general, there was no indication of any different tolerability of quetiapine in the elderly compared to younger adults. nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to quetiapine, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period in the elderly.  the mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see clinical pharmacology (12.3) and dosage and administration (2.3 )] . clinical experience with quetiapine in patients with renal impairment is limited [see clinical pharmacology (12.3)]. since quetiapine is extensively metabolized by the liver, higher plasma levels are expected in patients with hepatic impairment.  in this population, a low starting dose of 25 mg/day is recommended and the dose may be increased in increments of 25 mg/day - 50 mg/day [see dosage and administration (2.4) and clinical pharmacology (12.3)] .  quetiapine is not a controlled substance. quetiapine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. 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.  consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of quetiapine, e.g., development of tolerance, increases in dose, drug-seeking behavior.

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contract pharmacy services-pa - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - gabapentin is indicated for: - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c : there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryo-fetal developmental toxicity in mice was 500 mg/kg/day or app

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ascend laboratories, llc - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 200 mg in 1 ml - 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. mycophenolate mofetil intravenous is contraindicated in patients who are allergic to polysorbate 80 (tween). 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 an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see human data] . oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see animal data]. consider alternative immunosuppressants with less potential for embryofetal toxicity. risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman. the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. 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 human data a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following mmf exposure. animal data in animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. oral administration of mmf to pregnant rats from gestational day 7 to day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to  0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. oral administration of mmf to pregnant rabbits from gestational day 7 to day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. risk summary there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child [see data]. studies in rats treated with mmf have shown mycophenolic acid (mpa) to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition. data limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34-40 weeks gestation, and breastfed for up to 14 months. no adverse events were reported. females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. pregnancy planning for patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. risks and benefits of mycophenolate mofetil should be discussed with the patient. pregnancy testing to prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting mycophenolate mofetil. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. contraception female patients females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see table 9 for acceptable contraception methods). patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence. patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see drug interactions (7.2)]. table 9.    acceptable contraception methods for females of reproductive potential pick from the following birth control options: - intrauterine devices (iuds) - tubal sterilization - patient’s partner vasectomy or - oral  contraceptive pill - transdermal patch -   vaginal ring - injection - implant   - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom or - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom male patients genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolate mofetil and for at least 90 days after cessation of treatment [see use in special populations (8.1), nonclinical toxicology (13.1), patient counseling information (17.9)]. safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants. kidney transplant use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] heart transplant and liver transplant use of mycophenolate mofetil in pediatric heart transplant and liver transplant patients is supported by adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [see dosage and administration (2.3, 2.4), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)]. clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between geriatric and younger patients. in general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies. [see adverse reactions (6.1), drug interactions (7)].   patients with kidney transplant no dosage adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see clinical pharmacology (12.3)]. in kidney transplant patients with severe chronic impairment of the graft (gfr less than 25 ml/min/1.73 m2 ), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided. patients with heart and liver transplant no data are available for heart or liver transplant patients with severe chronic renal impairment. mycophenolate mofetil may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks. patients with kidney transplant no dosage adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. however, it is not known whether dosage adjustments are needed for hepatic disease with other etiologies [see clinical pharmacology (12.3)]. patients with heart transplant no data are available for heart transplant patients with severe hepatic parenchymal disease. mycophenolate mofetil for oral suspension read this instructions for use before you take or give mycophenolate mofetil for the first time and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important: - always use the oral dispenser provided with mycophenolate mofetil for oral suspension to make sure you measure the right amount of medicine. if your mycophenolate mofetil for oral suspension does not come with the oral dispenser, contact your pharmacist. - call your pharmacist if your oral dispenser is lost or damaged.  - your pharmacist will write the expiration date on your mycophenolate mofetil for oral suspension bottle label. do not use mycophenolate mofetil after the expiration date. -  ask your doctor or pharmacist if you have any questions or are unsure about how to take or give the right amount of medicine. - the mycophenolate mofetil for oral suspension should not be mixed with any type of liquids before taking or giving the dose. - do not let the mycophenolate mofetil for oral suspension come in contact with the skin. if this happens, wash the skin well with soap and water. if the mycophenolate mofetil for oral suspension gets in the eyes, rinse the eyes with plain water. - if you spill any mycophenolate mofetil for oral suspension, wipe it up using paper towels wet with water. put the child-resistant bottle cap back on the bottle and wipe the outside of the bottle with wet paper towels. supplies needed to take or give a dose of mycophenolate mofetil for oral suspension: to take or give a dose of mycophenolate mofetil for oral suspension, you will need the bottle of medicine and the oral dispenser provided with the medicine (see figure 1 ). your pharmacist will insert the bottle adapter in the mycophenolate mofetil for oral suspension bottle. do not remove the bottle adapter from the bottle. figure 1 taking or giving a dose of mycophenolate mofetil for oral suspension: step 1 : with the child-resistant cap on the bottle, shake the bottle well for about 5 seconds before each use. step 2 : open the bottle by firmly pressing down on the child-resistant bottle cap and turning it to the left (counterclockwise). do not throw away the child-resistant bottle cap. step 3: place the bottle on a flat surface. before inserting the tip of the oral dispenser into the bottle adapter, push the plunger completely down toward the tip of the oral dispenser. use 1 hand to hold the bottle upright. insert the oral dispenser tip firmly into the opening of the bottle adapter.  step 4 : carefully turn the bottle upside down with the oral dispenser tip in place. slowly pull the plunger down to withdraw your prescribed dose. do not pull the plunger out of the oral dispenser (see figure 2 ).   figure 2 step 5 : leave the oral dispenser tip in the bottle and turn the bottle to an upright position. slowly remove the oral dispenser tip from the bottle. if there are air bubbles in the oral dispenser or if you have withdrawn the wrong dose, insert the oral dispenser tip back into the bottle adapter while the bottle is in an upright position. push the plunger gently all the way up so the mycophenolate mofetil for oral suspension flows back into the bottle. repeat step 4 .  step 6 : place the tip of the oral dispenser in the mouth directed towards the cheek and slowly push the plunger down until the oral dispenser is empty.  step 7 : put the child-resistant bottle cap back on the bottle and turn the cap to the right (clockwise) to close the bottle. keep the bottle tightly closed after each use.  step 8 : rinse the oral dispenser under running tap water after each use: - remove the plunger from the oral dispenser. - rinse the oral dispenser and plunger with water only and let them air dry on a paper towel. -  when the oral dispenser and plunger are dry, put the plunger back in the oral dispenser for the next use. do not throw away the oral dispenser. store the oral dispenser in a clean, dry place. - do not boil the oral dispenser. do not use solvent-containing wipes to clean the oral dispenser. do not use cloths or wipes to dry the oral dispenser.   how should i store mycophenolate mofetil for  oral suspension?   - store the mycophenolate mofetil for oral suspension at room temperature between 59°f to 86°f (15°c to 30°c), for up to 60 days. you can also store the mycophenolate mofetil for oral suspension in the refrigerator between 36°f to 46°f (2°c to 8°c).  -  do no t freeze. keep mycophenolate mofetil for oral suspension and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. revised: october, 2023 pt 2156-12

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liberty pharmaceuticals, inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets usp is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride is contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ).   - known hypersensitivity to metformin hydrochloride.   - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (see also precautions. )

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ascend laboratories, llc - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - lidocaine 50 mg in 1 g - lidocaine ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. it is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment 5%.

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ascend laboratories, llc - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg - adults esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8-week course of esomeprazole magnesium may be considered. pediatric patients 12 years to 17 years of age   esomeprazole magnesium delayed-release capsules indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age.  esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of ee in adults. controlled studies do not extend beyond 6 months.  adults esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with gerd in pediatric patients 12 years to 17 years of age.  esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous nsaid therapy in adult patients at risk for developing gastric ulcers. patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. controlled studies do not extend beyond 6 months. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy esomeprazole magnesium delayed-release capsules in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with h. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate h. pylori . in patients who fail therapy, susceptibility testing should be done. if resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see clinical pharmacology (12.4) and the prescribing information for clarithromycin] .  esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome, in adults.  - esomeprazole magnesium is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see warnings and precautions (5.2), adverse reactions (6.2)]. - for information about contraindications of amoxicillin and clarithromycin, indicated in combination with esomeprazole magnesium for h. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the contraindications section of the respective prescribing information. - proton pump inhibitors (ppis), including esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products [see drug interactions (7) ] . risk summary there are no adequate and well-controlled studies with esomeprazole in pregnant women. esomeprazole is the s-isomer of omeprazole. available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use (see data) . reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis for a 60 kg person). changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age (see data) . the estimated background risks of major birth defects and miscarriage for the indicated population are 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. data human data esomeprazole is the s-isomer of omeprazole. four epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to h2-receptor antagonists or other controls. a population-based retrospective cohort epidemiological study from the swedish medical birth registry, covering approximately 99% of pregnancies, from 1995 to 1999, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. the number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low apgar score, or hospitalization was similar to the number observed in this population. the number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. a population-based retrospective cohort study covering all live births in denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitor. the overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester. a retrospective cohort study reported on 689 pregnant women exposed to either h2-blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. the overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an h2-blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively. a small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% with first trimester exposures). the reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease paired controls. rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups. several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.   animal data omeprazole reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at doses up to 69.1 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) during organogenesis did not disclose any evidence for a teratogenic potential of omeprazole. in rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions. in rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis), administered prior to mating through the lactation period. esomeprazole no effects on embryo-fetal development were observed in reproduction studies with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) or in rabbits at oral doses up to 86 mg/kg/day (about 41 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis. a pre-and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with esomeprazole magnesium at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg on a body surface area basis). neonatal/early postnatal (birth to weaning) survival was decreased at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis). body weight and body weight gain were reduced and neurobehavioral or general developmental delays in the immediate post-weaning timeframe were evident at doses equal to or greater than 69 mg/kg/day (about 17 times an oral human dose of 40 mg on a body surface area basis). in addition, decreased femur length, width and thickness of cortical bone, decreased thickness of the tibial growth plate and minimal to mild bone marrow hypocellularity were noted at doses equal to or greater than 14 mg/kg/day (about 3.4 times an oral human dose of 40 mg on a body surface area basis). physeal dysplasia in the femur was observed in offspring of rats treated with oral doses of esomeprazole magnesium at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis). effects on maternal bone were observed in pregnant and lactating rats in a pre-and postnatal toxicity study when esomeprazole magnesium was administered at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg on a body surface area basis). when rats were dosed from gestational day 7 through weaning on postnatal day 21, a statistically significant decrease in maternal femur weight of up to 14% (as compared to placebo treatment) was observed at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis). a pre-and postnatal development study in rats with esomeprazole strontium (using equimolar doses compared to esomeprazole magnesium study) produced similar results in dams and pups as described above. a follow up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with esomeprazole magnesium at oral doses of 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) where esomeprazole administration was from either gestational day 7 or gestational day 16 until parturition. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age. risk summary  esomeprazole is the s-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk. there are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for esomeprazole magnesium and any potential adverse effects on the breastfed infant from esomeprazole magnesium or from the underlying maternal condition.  healing of ee pediatric patients 1 year to 17 years of age the safety and effectiveness of esomeprazole magnesium delayed-release capsules have been established in pediatric patients 12 years to 17 years for short-term treatment (4 to 8 weeks) for healing of ee. use of esomeprazole magnesium for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data in pediatric patients 1 year to 17 years of age. the safety profile in pediatric patients 1 year to 17 years of age was similar to adults [see adverse reactions (6.1) , clinical pharmacology (12.3) , clinical studies (14.4) ] . symptomatic gerd pediatric patients 1 year to 17 years of age the safety and effectiveness of esomeprazole magnesium delayed-release capsules have been established in pediatric patients 12 years to 17 years of age for the short-term treatment (4 weeks) of heartburn and other symptoms associated with gerd. use of esomeprazole magnesium for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data in pediatric patients 1 year to 17 years of age. the safety profile in pediatric patients 1 year to 17 years of age was similar to adults [see adverse reactions (6.1) , clinical pharmacology (12.3) , clinical studies (14.4) ] . the safety and effectiveness of esomeprazole magnesium delayed-release capsules for the treatment of symptomatic gerd in pediatric patients less than 1 year of age have not been established. other conditions the safety and effectiveness of esomeprazole magnesium for the risk reduction of nsaid-associated gastric ulcer, h. pylori eradication to reduce the risk of duodenal ulcer recurrence and treatment of pathological hypersecretory conditions have not been established in pediatric patients. juvenile animal toxicity studies in a juvenile rat toxicity study, esomeprazole was administered with both magnesium and strontium salts at oral doses about 34 to 68 times a daily human dose of 40 mg based on body surface area. increases in death were seen at the high dose, and at all doses of esomeprazole, there were decreases in body weight, body weight gain, femur weight and femur length, and decreases in overall growth [see nonclinical toxicology (13.2) ] .  of the total number of patients who received esomeprazole magnesium in clinical trials, 1459 were 65 to 74 years of age and 354 patients were 75 years of age and older. no overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.  in patients with severe hepatic impairment (child-pugh class c) exposure to esomeprazole substantially increased compared to healthy subjects. dosage modification of esomeprazole magnesium is recommended for patients with severe hepatic impairment for the healing of ee, risk reduction of nsaid-associated gastric ulcer, h. pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions including zollinger-ellison syndrome [see dosage and administration (2.1) , clinical pharmacology (12.3) ] . in patients with mild to moderate liver impairment (child-pugh classes a and b), no dosage adjustment is necessary. 

Stati Uniti - Ingliż - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 300 mg - gabapentin is indicated for: • management of postherpetic neuralgia in adults • adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal