États-Unis - anglais - NLM (National Library of Medicine)

concordia pharmaceuticals inc. - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.125 mg - lanoxin is indicated for the treatment of mild to moderate heart failure in adults. lanoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, lanoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. lanoxin increases myocardial contractility in pediatric patients with heart failure. lanoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. lanoxin is contraindicated in patients with: - ventricular fibrillation [see warnings and precautions (5.1)] - known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). a hypersensitivity reaction to other digitalis preparations usually constitutes a co

États-Unis - anglais - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - fexofenadine hydrochloride (unii: 2s068b75zu) (fexofenadine - unii:e6582loh6v) - fexofenadine hydrochloride 30 mg

États-Unis - anglais - NLM (National Library of Medicine)

hikma pharmaceutical - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone .25 mg - adults risperidone tablets, usp are indicated for the acute and maintenance treatment of schizophrenia [see clinical studies  (14.1)]. adolescents due to janssen pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for janssen pharmaceuticals corporation's risperidone drug products. monotherapy adults and pediatrics risperidone tablets usp, are indicated for the short-term treatment of acute manic or mixed episodes associated with bipolar i disorder in adults [see clinical studies  (14.2)]. due to janssen pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for janssen pharmaceut

États-Unis - anglais - NLM (National Library of Medicine)

fresenius kabi usa, llc - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 2 mg in 1 ml - naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. surgical anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration acute pain management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

États-Unis - anglais - NLM (National Library of Medicine)

par pharmaceutical, inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone 3 mg - risperidone is indicated for the treatment of schizophrenia. efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults. [see clinical studies (14.1)]. monotherapy risperidone is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see clinical studies (14.2)]. adjunctive therapy risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in one short-term trial in adults [see clinical studies (14.3)]. risperidone is indicated for the treatment of irritability associated with autistic disorder including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moo

États-Unis - anglais - NLM (National Library of Medicine)

glaxosmithkline llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - wellbutrin sr (bupropion hydrochloride) is indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . the efficacy of wellbutrin sr in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo‑controlled trial [see clinical studies (14)] . pregnancy exposure registry there is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/. risk summary da

États-Unis - anglais - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 1000 [usp'u] in 1 ml - heparin sodium injection is indicated for: - prophylaxis and treatment of venous thrombosis and pulmonary embolism; - prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; - atrial fibrillation with embolization; - treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); - prevention of clotting in arterial and cardiac surgery; - prophylaxis and treatment of peripheral arterial embolism. - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium injection is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see warnings and precautions (5.3)] ; - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions (6.1)] ; - in whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin); - an uncontrolled active bleeding state [see warnings and precautions (5.2) ], except when this is due to disseminated intravascular coagulation. risk summary there are no available data on heparin sodium injection use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.  in published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. no teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (mrhd) of 45,000 units/day [see data ]. consider the benefits and risks of heparin sodium injection for the mother and possible risks to the fetus when prescribing heparin sodium injection to a pregnant woman. if available, preservative-free heparin sodium injection is recommended when heparin therapy is needed during pregnancy. there are no known adverse outcomes associated with fetal exposure to the preservative benzyl alcohol through maternal drug administration; however, the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants [see warnings and precautions (5.4) ] the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data human data the maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. these studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. animal data in a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 units/kg/day, approximately 10 times the maximum human daily dose based on body weight. the number of early resorptions increased in both species. there was no evidence of teratogenic effects. risk summary if available, preservative-free heparin sodium injection is recommended when heparin therapy is needed during lactation. benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant. there is no information regarding the presence of heparin sodium injection in human milk, the effects on the breastfed infant, or the effects on milk production. due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for heparin sodium injection and any potential adverse effects on the breastfed infant from heparin sodium injection or from the underlying maternal condition [see use in specific populations (8.4) ]. there are no adequate and well controlled studies on heparin use in pediatric patients. pediatric dosing recommendations are based on clinical experience [see dosage and administration (2.5) ]. carefully examine all heparin sodium injection vials and syringes to confirm choice of the correct strength prior to administration of the drug. pediatric patients, including neonates, have died as a result of medication errors in which heparin sodium injection vials have been confused with “catheter lock flush” vials [see warnings and precautions (5.1) ]. benzyl alcohol toxicity use preservative-free heparin sodium injection in neonates and infants. serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. there are limited adequate and well-controlled studies in patients 65 years and older, however, a higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see warnings and precautions (5.2) ]. patients over 60 years of age may require lower doses of heparin. lower doses of heparin may be indicated in these patients [see clinical pharmacology (12.3) ].

États-Unis - anglais - NLM (National Library of Medicine)

avadel specialty pharmaceuticals, llc - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 0.83 ug - noctiva is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. nocturnal polyuria was defined in the noctiva clinical trials as nighttime urine production exceeding one-third of the 24-hour urine production. before starting noctiva: - evaluate the patient for possible causes for the nocturia, including excessive fluid intake prior to bedtime, and optimize the treatment of underlying conditions that may be contributing to the nocturia. - confirm the diagnosis of nocturnal polyuria with a 24-hour urine collection, if one has not been obtained previously. limitation of use : noctiva has not been studied in patients less than 50 years of age. noctiva is contraindicated in patients with the following conditions due to an increased risk of severe hyponatremia: - hyponatremia or a history of hyponatremia [see warnings and precautions (5.1)] - polydipsia - primary nocturnal enuresis [see use in specific populations (8.4)] - concomitant use with

États-Unis - anglais - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone tablets are indicated in the following conditions:   primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic cardit

États-Unis - anglais - NLM (National Library of Medicine)

iris llc - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. in children less than two months of age on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.