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

mylan institutional llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st- elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and fetus (see clinical considerations) . in animal reproduc

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

solco healthcare us,llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride tablets are indicated for the treatment of: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/. risk summary published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations) . no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 an

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

mckesson corporation dba sky packaging - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - 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 and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see data]. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data   when pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryofetal developmental toxicity in mice (500 mg/kg/day) is less than the maximum recommended human dose (mrhd) of 3600 mg on a body surface area (mg/m2 ) basis. in studies in which rats received oral doses of gabapentin (500 to 2000 mg/kg/day) during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses. the lowest dose tested is similar to the mrhd on a mg/m2 basis. when pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryofetal mortality was observed at all doses tested (60, 300, or 1500 mg/kg). the lowest dose tested is less than the mrhd on a mg/m2 basis. in a published study, gabapentin (400 mg/kg/day) was administered by intraperitoneal injection to neonatal mice during the first postnatal week, a period of synaptogenesis in rodents (corresponding to the last trimester of pregnancy in humans). gabapentin caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis. the clinical significance of these findings is unknown. risk summary gabapentin is secreted in human milk following oral administration. the effects on the breastfed infant and on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin and any potential adverse effects on the breastfed infant from gabapentin or from the underlying maternal condition. safety and effectiveness of gabapentin in the management of postherpetic neuralgia in pediatric patients have not been established. safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established [see clinical studies (14.2)]. the total number of patients treated with gabapentin in controlled clinical trials in patients with postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were 75 years of age and older. there was a larger treatment effect in patients 75 years of age and older compared to younger patients who received the same dosage.   since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment effect observed in patients ≥ 75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function. however, other factors cannot be excluded. the types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age. clinical studies of gabapentin in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. 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 cautious, 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. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients [see dosage and administration (2.4), adverse reactions (6), and clinical pharmacology (12.3)] . dosage adjustment in adult patients with compromised renal function is necessary [see dosage and administration (2.3) and clinical pharmacology (12.3)] . pediatric patients with renal insufficiency have not been studied. dosage adjustment in patients undergoing hemodialysis is necessary [see dosage and administration (2.3) and clinical pharmacology (12.3)] . gabapentin is not a scheduled drug. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. gabapentin does not exhibit affinity for benzodiazepine, opioid (mu, delta or kappa), or cannabinoid 1 receptor sites. gabapentin misuse and abuse have been reported in the postmarketing setting and published literature. most of the individuals described in these reports had a history of polysubstance abuse. some of these individuals were taking higher than recommended doses of gabapentin for unapproved uses. when prescribing gabapentin, carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., self-dose escalation and drug-seeking behavior). the abuse potential of gabapentin has not been evaluated in human studies. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. there are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not approved. such symptoms included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. the dependence potential of gabapentin has not been evaluated in human studies.

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

quallent pharmaceuticals health llc - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin tablets are indicated:  • to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  • as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c):  o in adults with primary hyperlipidemia.  o in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (hefh).  • as an adjunct to other ldl-c-lowering therapies to reduce ldl-c in adults with homozygous familial hypercholesterolemia (hofh).  • as an adjunct to diet for the treatment of adults with:  o primary dysbetalipoproteinemia.  o hypertriglyceridemia.  simvastatin  tablets are contraindicated in the following co

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

vertical pharmaceuticals, llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - relexxii is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [ see clinical studies (14)] . relexxii is contraindicated in patients: - with a known hypersensitivity to methylphenidate or other components of relexxii. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6.2)] . - receiving concomitant treatment with monoamine oxidase inhibitors (maois), and also within 14 days following discontinuation of treatment with a maoi, because of the risk of hypertensive crisis [see drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including relexxii, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388. risk summary published studies and post-marketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the fetus associated with the use of central nervous system (cns) stimulants during pregnancy ( see clinical considerations).    no effects on morphological development were observed in development studies with oral administration of methylphenidate to pregnant rats at doses up to 4 times the maximum recommended human dose (mrhd) of 72 mg/day given to adults on a mg/m2  basis. however, malformations were observed in rabbits at a dose 54 times the mrhd given to adults. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cns stimulants, such as relexxii, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine‑dependent mothers. data animal data in development studies conducted in rats and rabbits, methylphenidate was administered at doses up to 30 and 200 mg/kg/day, respectively. methylphenidate has been shown to cause malformations in rabbits when given in doses of 200 mg/kg/day, which is approximately 54 times the mrhd on a mg/m2 basis, respectively. a reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 4-fold the mrhd on a mg/m2 basis. risk summary limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. however, long‑term neurodevelopmental effects on infants from cns stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for relexxii and any potential adverse effects on the breastfed infant from relexxii or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, anorexia, and reduced weight gain. the safety and effectiveness of relexxii for the treatment of adhd have been established in pediatric patients 6 to 17 years. the safety and effectiveness of relexxii in pediatric patients less than 6 years have not been established. the long-term efficacy of methylphenidate in pediatric patients have not been established. long term suppression of growth growth should be monitored during treatment with stimulants, including relexxii. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions ( 5.7) and adverse reactions (6.1)] . juvenile animal toxicity data in the study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10).  when these animals were tested as adults (postnatal weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the mrhd of 54 mg/day given to children on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was observed in females exposed to the highest dose (9 times the mrhd given to children on a mg/m2 basis). the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (equal to the mrhd given to children on a mg/m2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. relexxii has not been studied in patients greater than 65 years of age. relexxii contains methylphenidate, a schedule ii controlled substance. relexxii has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)] . relexxii can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including relexxii, can result in overdose and death [see overdosage ( 10)] , and this risk is increased with higher doses or unapproved methods of administration such as snorting or injection. in two placebo-controlled human abuse potential studies, single oral doses of another formulation of methylphenidate hydrochloride extended-release tablets were compared to single oral doses of immediate-release methylphenidate (ir mph) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. for the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration. in one study (n=40), both the other formulation of methylphenidate hydrochloride extended-release tablets (108 mg, which is 1.5 times the maximum recommended dosage of methylphenidate hydrochloride extended-release tablets) and 60 mg ir mph compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. in comparisons between the two active treatments, however, the other formulation of methylphenidate hydrochloride extended-release tablets (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (abuse potential, drug liking, amphetamine, and morphine benzedrine group [euphoria]) or statistically less than (stimulation – euphoria) responses produced by 60 mg ir mph. in another study (n=49), both doses of another formulation of methylphenidate hydrochloride extended-release tablets (54 mg and 108 mg) and both doses of ir mph (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (drug liking, euphoria). when doses of the other methylphenidate hydrochloride extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hydrochloride extended-release tablets (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by ir mph (50 mg). differences in subjective responses to the respective doses should be considered in the context that only 18% of the total amount of methylphenidate in relexxii is available for immediate release from the drug overcoat. although these findings reveal a relatively lower response to another formulation of methylphenidate hydrochloride extended-release tablets on subjective measures suggestive of abuse potential compared to ir mph at roughly equivalent total mph doses, the relevance of these findings to the abuse potential of relexxii in the community is unknown. physical dependence relexxii may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including relexxii include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance relexxii may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained by a lower dose).

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

ani pharmaceuticals, inc. - dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. dermatologic diseases bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (stevens-johnson syndrome). endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. hematologic disorders acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (diamond-blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. miscellaneous diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. neoplastic diseases for the palliative management of leukemias and lymphomas. nervous system acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. ophthalmic diseases sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. renal diseases to induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. respiratory diseases berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). for the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. systemic fungal infections (see warnings, fungal infections). dexamethasone tablets are contraindicated in patients who are hypersensitive to any components of this product.

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

asclemed usa, inc. - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate capsules are indicated for the prophylaxis of influenza a and b in patients 1 year and older. • oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. • influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules [ see microbiology ( 12.4)]. • oseltam

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

golden state medical supply, inc. - terazosin hydrochloride (unii: d32s14f082) (terazosin - unii:8l5014xet7) - terazosin capsules, usp are indicated for the treatment of symptomatic benign prostatic hyperplasia (bph). there is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of bph when treated with terazosin capsules, usp. the long-term effects of terazosin capsules, usp on the incidence of surgery, acute urinary obstruction or other complications of bph are yet to be determined. terazosin capsules, usp are also indicated for the treatment of hypertension. terazosin capsules, usp can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents. terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.

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

steriscience specialties private limited - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin for injection, usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: respiratory tract infections caused by s. pneumoniae . staphylococcus aureus (penicillinase and nonpenicillinase-producing), h. influenzae , and group a beta-hemolytic streptococci. bacterial meningitis caused by e. coli , group b streptococci, and other gram-negative bacteria ( listeria monocytogenes, n. meningitidis ). the addition of an aminoglycoside with ampicillin may increase its effectiveness against gram-negative bacteria. septicemia and endocarditis caused by susceptible gram-positive organisms including streptococcus spp ., penicillin g-susceptible staphylococci, and enterococci. gram-negative sepsis caused by e. coli, proteus mirabilis and salmonella spp. responds to ampicillin. endocarditis due to enterococcal strains usually respond to intraven

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

bayer healthcare pharmaceuticals inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg