USA - engelsk - NLM (National Library of Medicine)

a-s medication solutions - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 100 mg - sertraline hydrochloride tablets are indicated for the treatment of the following [see clinical studies (14)] : - major depressive disorder (mdd) - obsessive-compulsive disorder (ocd) - panic disorder (pd) - posttraumatic stress disorder (ptsd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) sertraline hydrochloride tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . - taking pimozide [see drug interactions (7.1)] . - with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions (6.1, 6.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers should encourage patients to enroll by calling the national pregnancy registry for antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. risk summary based on data from published observational studies, exposure to ssris, 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 (5.3) and clinical considerations] . overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. some studies have reported increases for specific major birth defects; however, these study results are inconclusive [see data] . there are clinical considerations regarding neonates exposed to ssris and snris, including sertraline hydrochloride, during the third trimester of pregnancy [see clinical considerations]. although no teratogenicity was observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (mrhd) in rats and doses 3.1 times the mrhd in rabbits on a mg/m2 basis in adolescents. when sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the mrhd [see data] . the background risk of major birth defects and miscarriage for the indicated population are unknown. 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. advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride. clinical considerations disease-associated maternal and/or embryo/fetal risk a prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic 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 risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. maternal adverse reactions use of sertraline hydrochloride in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.3)]. fetal/neonatal adverse reactions exposure to ssris and snris, including sertraline hydrochloride in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (pphn). when treating a pregnant woman with sertraline hydrochloride during the third trimester, carefully consider both the potential risks and benefits of treatment. monitor neonates who were exposed to sertraline hydrochloride in the third trimester of pregnancy for pphn and drug discontinuation syndrome [see data]. data human data third trimester exposure neonates exposed to sertraline hydrochloride and other ssris or snris late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. these findings are based on post-marketing reports. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these features are consistent with either a direct toxic effect of ssris and snris or, possibly, a drug discontinuation syndrome. in some cases, the clinical picture was consistent with serotonin syndrome [see warnings and precautions (5.2) ] . exposure during late pregnancy to ssris may have an increased risk for persistent pulmonary hypertension of the newborn (pphn). pphn occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. in a retrospective case-control study of 377 women whose infants were born with pphn and 836 women whose infants were born healthy, the risk for developing pphn was approximately six-fold higher for infants exposed to ssris after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. a study of 831,324 infants born in sweden in 1997 to 2005 found a pphn risk ratio of 2.4 (95% ci 1.2 to 4.3) associated with patient-reported maternal use of ssris “in early pregnancy” and a pphn risk ratio of 3.6 (95% ci 1.2 to 8.3) associated with a combination of patient-reported maternal use of ssris “in early pregnancy” and an antenatal ssri prescription “in later pregnancy”. first trimester exposure the weight of evidence from epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in pregnant women who were not exposed to sertraline. a meta-analysis of studies suggest no increase in the risk of total malformations (summary odds ratio=1.01, 95% ci=0.88 to 1.17) or cardiac malformations (summary odds ratio=0.93, 95% ci=0.70 to 1.23) among offspring of women with first trimester exposure to sertraline. an increased risk of congenital cardiac defects, specifically septal defects, the most common type of congenital heart defect, was observed in some published epidemiologic studies with first trimester sertraline exposure; however, most of these studies were limited by the use of comparison populations that did not allow for the control of confounders such as the underlying depression and associated conditions and behaviors, which may be factors associated with increased risk of these malformations. animal data reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. these doses correspond to approximately 3.1 times the maximum recommended human dose (mrhd) of 200 mg/day on a mg/m2 basis in adolescents. there was no evidence of teratogenicity at any dose level. when pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 10 mg/kg (0.4 times the mrhd on a mg/m2 basis) in rats and 40 mg/kg (3.1 times the mrhd on a mg/m2 basis) in rabbits. when female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in stillborn pups and pup deaths during the first 4 days after birth. pup body weights were also decreased during the first four days after birth. these effects occurred at a dose of 20 mg/kg (0.8 times the mrhd on a mg/m2 basis). the no effect dose for rat pup mortality was 10 mg/kg (0.4 times the mrhd on a mg/m2 basis). the decrease in pup survival was shown to be due to in utero exposure to sertraline. the clinical significance of these effects is unknown. risk summary available data from published literature demonstrate low levels of sertraline and its metabolites in human milk [see data] . there are no data on the effects of sertraline on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sertraline hydrochloride and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. data in a published pooled analysis of 53 mother-infant pairs, exclusively human milk-fed infants had an average of 2% (range 0% to 15%) of the sertraline serum levels measured in their mothers. no adverse reactions were observed in these infants. the safety and efficacy of sertraline hydrochloride have been established in the treatment of ocd in pediatric patients aged 6 to 17 [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.2)] . safety and effectiveness in pediatric patients in patients with ocd below the age of 6 have not been established. safety and effectiveness have not been established in pediatric patients for indications other than ocd. two placebo-controlled trials were conducted in pediatric patients with mdd, but the data were not sufficient to support an indication for use in pediatric patients. monitoring pediatric patients treated with sertraline hydrochloride monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases [see boxed warning, warnings and precautions (5.1)] . decreased appetite and weight loss have been observed with the use of ssris. monitor weight and growth in pediatric patients treated with an ssri such as sertraline hydrochloride. weight loss in studies in pediatric patients with mdd in a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50 to 200 mg) outpatient trials for mdd (n=373), there was a difference in weight change between sertraline hydrochloride and placebo of roughly 1 kg, for both children (ages 6 to 11) and adolescents (ages 12 to 17), in both age groups representing a slight weight loss for the sertraline hydrochloride group compared to a slight gain for the placebo group. for children, about 7% of the sertraline hydrochloride-treated patients had a weight loss greater than 7% of body weight compared to 0% of the placebo-treated patients; for adolescents, about 2% of sertraline hydrochloride-treated patients had a weight loss > 7% of body weight compared to about 1% of placebo-treated patients. a subset of patients who completed the randomized controlled trials in patients with mdd (sertraline hydrochloride n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study. those subjects who completed 34 weeks of sertraline hydrochloride treatment (10 weeks in a placebo-controlled trial + 24 weeks open-label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers. however, there are no studies that directly evaluate the long-term effects of sertraline hydrochloride on the growth, development, and maturation in pediatric patients. juvenile animal data a study conducted in juvenile rats at clinically relevant doses showed delay in sexual maturation, but there was no effect on fertility in either males or females. in this study in which juvenile rats were treated with oral doses of sertraline at 0, 10, 40 or 80 mg/kg/day from postnatal day 21 to 56, a delay in sexual maturation was observed in males treated with 80 mg/kg/day and females treated with doses ≥10 mg/kg/day. there was no effect on male and female reproductive endpoints or neurobehavioral development up to the highest dose tested (80 mg/kg/day), except a decrease in auditory startle response in females at 40 and 80 mg/kg/day at the end of treatment but not at the end of the drug-free period. the highest dose of 80 mg/kg/day produced plasma levels (auc) of sertraline 5 times those seen in pediatric patients (6 to 17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day). of the total number of patients in clinical studies of sertraline hydrochloride in patients with mdd, ocd, pd, ptsd, sad and pmdd, 797 (17%) were ≥ 65 years old, while 197 (4%) were ≥ 75 years old. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in 354 geriatric subjects treated with sertraline hydrochloride in mdd placebo-controlled trials, the overall profile of adverse reactions was generally similar to that shown in table 3 [see adverse reactions (6.1)], except for tinnitus, arthralgia with an incidence of at least 2% and at a rate greater than placebo in geriatric patients. snris and ssris, including sertraline hydrochloride, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions (5.8) ]. the recommended dosage in patients with mild hepatic impairment (child-pugh score 5 or 6) is half the recommended dosage due to increased exposure in this patient population. the use of sertraline hydrochloride in patients with moderate (child-pugh score 7 to 10) or severe hepatic impairment (child-pugh score 10 to 15) is not recommended, because sertraline hydrochloride is extensively metabolized, and the effects of sertraline hydrochloride in patients with moderate and severe hepatic impairment have not been studied [see dosage and administration (2.4), clinical pharmacology (12.3)] . no dose adjustment is needed in patients with mild to severe renal impairment. sertraline exposure does not appear to be affected by renal impairment [see clinical pharmacology (12.3)] . sertraline hydrochloride tablets contain sertraline, which is not a controlled substance. in a placebo-controlled, double-blind, randomized study of the comparative abuse liability of sertraline hydrochloride, alprazolam, and d-amphetamine in humans, sertraline hydrochloride did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs.

USA - engelsk - NLM (National Library of Medicine)

zydus lifesciences limited - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 10 mg - metastatic breast cancer tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. adjuvant treatment of breast cancer tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whe

USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - lovastatin 40 mg - therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-c and ldl-c to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. in individuals without symptomatic cardiovascular disease, average to moderately elevated total-c and ldl-c, and below average hdl-c, lovastatin is indicated to reduce the risk of: - myocardial infarction - unstable angina - coronary revascularization procedures (see clinical pharmacology, clinical studies .) lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-c and ldl-c to target levels. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for artherosclerotic vascular disease due to hypercholesterolemia. lovastatin is indicated as an adjunct to diet for the reduction of elevated total-c and ldl-c levels in patients with primary hypercholesterolemia (types iia and iib 2 ), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. lovastatin is indicated as an adjunct to diet to reduce total-c, ldl-c and apolipoprotein b levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with hefh if after an adequate trial of diet therapy the following findings are present: - ldl-c remains >189 mg/dl or - ldl-c remains >160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the adolescent patient - there is a positive family history of premature cardiovascular disease or - two or more other cvd risk factors are present in the adolescent patient prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-c, hdl-c, and tg. for patients with tg less than 400 mg/dl (<4.5 mmol/l), ldl-c can be estimated using the following equation: ldl-c = total-c - [0.2 × (tg) + hdl-c] for tg levels >400 mg/dl (>4.5 mmol/l), this equation is less accurate and ldl-c concentrations should be determined by ultracentrifugation. in hypertriglyceridemic patients, ldl-c may be low or normal despite elevated total-c. in such cases, lovastatin is not indicated. the national cholesterol education program (ncep) treatment guidelines are summarized below: † chd, coronary heart disease †† some authorities recommend use of ldl-lowering drugs in this category if an ldl-c level of <100 mg/dl cannot be achieved by therapeutic lifestyle changes. others prefer use of drugs that primarily modify triglycerides and hdl-c, e.g., nicotinic acid or fibrate. clinical judgment also may call for deferring drug therapy in this subcategory. ††† almost all people with 0-1 risk factor have a 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. after the ldl-c goal has been achieved, if the tg is still ≥200 mg/dl, non-hdl-c (total-c minus hdl-c) becomes a secondary target of therapy. non-hdl-c goals are set 30 mg/dl higher than ldl-c goals for each risk category. at the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the ldl-c is ≥130 mg/dl (see ncep guidelines above). since the goal of treatment is to lower ldl-c, the ncep recommends that ldl-c levels be used to initiate and assess treatment response. only if ldl-c levels are not available, should the total-c be used to monitor therapy. although lovastatin may be useful to reduce elevated ldl-c levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (type iib hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, vldl or idl (i.e., hyperlipoproteinemia types i, iii, iv, or v). *** the ncep classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below: children treated with lovastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for ldl-c. hypersensitivity to any component of this medication. active liver disease or unexplained persistent elevations of serum transaminases (see warnings ). concomitant administration with strong cyp3a4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, hiv protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin ,nefazodone, and cobicistat-containing products) (see warnings, myopathy/rhabdomyolysis) . pregnancy and lactation. ( see precautions, pregnancy and nursing mothers).    atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. because of the ability of inhibitors of hmg-coa reductase such as lovastatin to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, lovastatin is contraindicated during pregnancy and in nursing mothers. lovastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive. if the patient becomes pregnant while taking this drug, lovastatin should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus (see precautions, pregnancy ).

USA - engelsk - NLM (National Library of Medicine)

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 150 mg - venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of generalized anxiety disorder (gad). efficacy was established in two 8-week and two 26-week placebo-controlled trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psych

USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-c and ldl-c to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. in individuals without symptomatic cardiovascular disease, average to moderately elevated total-c and ldl-c, and below average hdl-c, lovastatin is indicated to reduce the risk of: - myocardial infarction - unstable angina - coronary revascularization procedures (see clinical pharmacology, clinical studies .) lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-c and ldl-c to target levels. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for artherosclerotic vascular disease due to hypercholesterolemia. lovastatin is indicated as an adjunct to diet for the reduction of elevated total-c and ldl-c levels in patients with primary hypercholesterolemia (types iia and iib 2 ), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. lovastatin is indicated as an adjunct to diet to reduce total-c, ldl-c and apolipoprotein b levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with hefh if after an adequate trial of diet therapy the following findings are present: - ldl-c remains >189 mg/dl or - ldl-c remains >160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the adolescent patient - there is a positive family history of premature cardiovascular disease or - two or more other cvd risk factors are present in the adolescent patient prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-c, hdl-c, and tg. for patients with tg less than 400 mg/dl (<4.5 mmol/l), ldl-c can be estimated using the following equation: ldl-c = total-c - [0.2 × (tg) + hdl-c] for tg levels >400 mg/dl (>4.5 mmol/l), this equation is less accurate and ldl-c concentrations should be determined by ultracentrifugation. in hypertriglyceridemic patients, ldl-c may be low or normal despite elevated total-c. in such cases, lovastatin is not indicated. the national cholesterol education program (ncep) treatment guidelines are summarized below: † chd, coronary heart disease †† some authorities recommend use of ldl-lowering drugs in this category if an ldl-c level of <100 mg/dl cannot be achieved by therapeutic lifestyle changes. others prefer use of drugs that primarily modify triglycerides and hdl-c, e.g., nicotinic acid or fibrate. clinical judgment also may call for deferring drug therapy in this subcategory. ††† almost all people with 0-1 risk factor have a 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. after the ldl-c goal has been achieved, if the tg is still ≥200 mg/dl, non-hdl-c (total-c minus hdl-c) becomes a secondary target of therapy. non-hdl-c goals are set 30 mg/dl higher than ldl-c goals for each risk category. at the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the ldl-c is ≥130 mg/dl (see ncep guidelines above). since the goal of treatment is to lower ldl-c, the ncep recommends that ldl-c levels be used to initiate and assess treatment response. only if ldl-c levels are not available, should the total-c be used to monitor therapy. although lovastatin may be useful to reduce elevated ldl-c levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (type iib hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, vldl or idl (i.e., hyperlipoproteinemia types i, iii, iv, or v). *** the ncep classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below: children treated with lovastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for ldl-c. hypersensitivity to any component of this medication. active liver disease or unexplained persistent elevations of serum transaminases (see warnings ). concomitant administration with strong cyp3a4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, hiv protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin ,nefazodone, and cobicistat-containing products) (see warnings, myopathy/rhabdomyolysis) . pregnancy and lactation. ( see precautions, pregnancy and nursing mothers).    atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. because of the ability of inhibitors of hmg-coa reductase such as lovastatin to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, lovastatin is contraindicated during pregnancy and in nursing mothers. lovastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive. if the patient becomes pregnant while taking this drug, lovastatin should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus (see precautions, pregnancy ).

USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see warnings ]. ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets, usp in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients [see

USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - 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 mg/kg/day, 1,000 mg/kg/day, or 3,000 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

USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see warnings ]. ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets, usp in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients [see warnings,   ana

USA - engelsk - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz), naloxone hydrochloride dihydrate (unii: 5q187997ee) (naloxone - unii:36b82amq7n) - buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. buprenorphine and naloxone sublingual film is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9) ] . the data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone sublingual film, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data] . observational studies have reported on congenital malformations among buprenorphine-e