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

solstice neurosciences, llc - rimabotulinumtoxinb (unii: 0y70779m1f) (rimabotulinumtoxinb - unii:0y70779m1f) - rimabotulinumtoxinb 2500 [usp'u] in 0.5 ml - myobloc is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults. myobloc is indicated for the treatment of chronic sialorrhea in adults. myobloc is contraindicated in patients with: - a known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions (5.3), description (11)] - infection at the proposed injection site(s) risk summary there are no adequate data on the developmental risks associated with the use of myobloc in pregnant women. no developmental toxicity was observed in pregnant rats administered myobloc by intramuscular injection during gestation and lactation, at doses producing maternal toxicity. in the u.s. general population, the 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 myobloc was administered by intramuscular injection to pregnant rats (0, 300, 1000, or 3000 units/kg/day) or rabbits (0, 0.03, 0.1, 0.3, or 1.0 units/kg/day) throughout gestation, no adverse effects on embryofetal development were observed. the highest dose tested in rat, which was associated with maternal toxicity, was 36 times the maximum recommended human dose (mrhd) for cervical dystonia (5000 units) on a body weight (units/kg) basis. the highest dose tested in rabbit was substantially less than the mrhd for cervical dystonia on a units/kg basis; maternal toxicity was observed at all but the lowest dose tested. risk summary there are no data on the presence of myobloc in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for myobloc and any potential adverse effects on the breastfed infant from myobloc or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. cervical dystonia in the controlled studies for myobloc in patients with cervical dystonia, 152 (75%) were under the age of 65, and 52 (26%) were 65 years of age or older [see clinical studies (14.1)] . for these age groups, the most frequently reported adverse reactions occurred at similar rates in both age groups. efficacy results did not suggest any large differences between these age groups. very few patients age 75 or older were enrolled; therefore, no conclusions regarding the safety and efficacy of myobloc within this age group can be determined. chronic sialorrhea of the 166 myobloc-treated patients in the placebo-controlled studies for treatment of chronic sialorrhea [see clinical studies (14.2)] , 105 (63%) were 65 years of age or older, and 43 (26%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients over 65 years of age and younger patients, but greater sensitivity of some older patients cannot be ruled out.

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

international laboratories, llc - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - lovastatin 10 mg - therapy with lovastatin tablets usp should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. lovastatin tablets usp 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. primary prevention of coronary heart disease in individuals without symptomatic cardiovascular disease, average to moderately elevated total-c and ldl-c, and below average hdl-c, lovastatin tablets usp are indicated to reduce the risk of: - myocardial infarction - unstable angina - coronary revascularization procedures (see clinical pharmacology , clinical studies in adults .) coronary heart disease lovastatin tablets usp are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment str

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

international laboratories, llc - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14) ]. important limitations of use pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3) ]. •   initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. •   use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. teratogenic effects pregnancy category c. there are no adequate and well-controlled studies of pioglitazone hydrochloride in pregnant women. animal studies show increased rates of post-implantation loss, delayed development,

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

trupharma, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of ve

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

zogenix, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - hydrocodone bitartrate 10 mg - zohydro® er (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve zohydro er for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - zohydro er is not indicated as an as-needed (prn) analgesic. zohydro er is contraindicated in patients with: - significant respiratory depression - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - known or suspected paralytic ileus - hypersensitivity (e.g., anaphylaxis) to hydrocodone bitartr

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

takeda pharmaceuticals america, inc. - lisdexamfetamine dimesylate (unii: sjt761gegs) (lisdexamfetamine - unii:h645gul8kj) - lisdexamfetamine dimesylate 10 mg - vyvanse® is indicated for the treatment of: - attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years and older [see clinical studies (14.1)] - moderate to severe binge eating disorder (bed) in adults [see clinical studies (14.2)] . limitations of use: - pediatric patients with adhd younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see use in specific populations (8.4)] . - vyvanse is not indicated or recommended for weight loss. use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. the safety and effectiveness of vyvanse for the treatment of obesity have not been established [see warnings and precautions (5.2)] . vyvanse is contraindicated in patients with: - known hypersensitivity to amphetamine products or other ingredients of vyvanse. anaphylactic reactions, stevens-johnson syndrome, angioedema, and urticaria have been observed in postmarketing reports [see adve

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

amneal pharmaceuticals of new york llc - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg - dextroamphetamine sulfate is indicated in: as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for

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

actavis pharma, inc. - oxazepam (unii: 6gow6dwn2a) (oxazepam - unii:6gow6dwn2a) - oxazepam 10 mg - oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. anxiety associated with depression is also responsive to oxazepam therapy. this product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients. alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy. the effectiveness of oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. history of previous hypersensitivity reaction to oxazepam. oxazepam is not indicated in psychoses. controlled substance oxazepam is a schedule iv controlled substance. abuse oxazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, nontherapeutic 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. 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. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders [see warnings: abuse, misuse, and addiction ] . the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). dependence physical dependence oxazepam may produce physical dependence from continued therapy. 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. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use [see warnings: dependence and withdrawal reactions ] . to reduce the risk of withdrawal reactions, use a gradual taper to discontinue oxazepam or reduce the dosage [see dosage and administration: discontinuation or dosage reduction of oxazepam  and warnings: dependence and withdrawal reactions ] . acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations,  mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to oxazepam may develop from continued therapy. 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 at a lower dose). tolerance to the therapeutic effect of oxazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

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

wg critical care, llc - cefuroxime sodium (unii: r8a7m9my61) (cefuroxime - unii:o1r9fj93ed) - cefuroxime 750 mg - cefuroxime for injection, usp is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: - lower respiratory tract infections, including pneumonia, caused by streptococcus pneumoniae, haemophilus influenzae (including ampicillin-resistant strains), klebsiella spp., staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), streptococcus pyogenes , and escherichia coli . - urinary tract infections caused by escherichia coli and klebsiella spp. - skin and skin structure infections caused by staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), streptococcus pyogenes , escherichia coli, klebsiella spp., and enterobacter spp. - septicemia caused by staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), streptococcus pneumoniae, escherichia coli, haemophilus influenzae (including ampicillin-resistant strains), and klebsiella spp. - meningitis

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

daiichi sankyo inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 15 mg - morphabond er is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions ( 5.1 )] , reserve morphabond er for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - morphabond er is not indicated as an as-needed (prn) analgesic. morphabond er is contraindicated in patients with: - significant respiratory depression [see warnings and precautions ( 5.3 )] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (