Соединенные Штаты - английский - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic seizures (pgtc) seizures. - generalized seizures of lennox-gastaut syndrome. monotherapy lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in

Соединенные Штаты - английский - NLM (National Library of Medicine)

mckesson corporation - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - lovastatin 20 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. 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 are indicated to reduce the risk of: -  myocardial infarction -  unstable angina -  coronary revascularization procedures (see clinical pharmacology, clinical studies.) coronary heart disease: lovastatin tablets are 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

Соединенные Штаты - английский - NLM (National Library of Medicine)

wg critical care, llc - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime 1 g in 20 ml - cefepime for injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of streptococcus pneumoniae , including cases associated with concurrent bacteremia, pseudomonas aeruginosa , klebsiella pneumoniae , or enterobacter species. cefepime for injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see clinical studies (14.1)] . cefepime for injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of escherichia coli or klebsiella pneumoniae , when the infection is severe, or caused by escherichia coli , klebsiella pneumoniae , or proteus mirabilis , when the infection is mild to moderate, including cases associated with concurrent bacteremia with these bacteria. cefepime for injection is indicated in the treatment of uncomplicated skin and skin structure infections caused by staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyogenes . cefepime for injection is indicated in the treatment of complicated intra-abdominal infections (used in combination with metronidazole) in adults caused by susceptible isolates of escherichia coli , viridans group streptococci, pseudomonas aeruginosa , klebsiella pneumoniae , enterobacter species, or bacteroides fragilis [see clinical studies (14.2)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefepime for injection and other antibacterial drugs, cefepime for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefepime for injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterial drugs, penicillins or other beta-lactam antibacterial drugs. risk summary there are no cases of cefepime exposure during pregnancy reported from postmarketing experience or from clinical trials. available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data ). cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during organogenesis. the doses used in these studies were 1.6 (rats), approximately equal to (mice), and 0.3 times (rabbits) the recommended maximum human dose (see data ). 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. data human data while available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. animal data cefepime was not embryocidal and did not cause fetal malformations when administered parenterally during the period of organogenesis to rats at doses up to 1000 mg/kg/day, to mice at doses up to 1200 mg/kg/day, or to rabbits at doses up to 100 mg/kg/day. these doses are 1.6 times (rats), approximately equal to (mice), and 0.3 times (rabbits) the maximum recommended clinical dose based on body surface area. risk summary cefepime is present in human breast milk at low concentrations (approximately 0.5 mcg/ml) following a single intravenous dose of 1000 mg. a nursing infant consuming approximately 1000 ml of human milk per day would receive approximately 0.5 mg of cefepime per day (see data ). there is no information regarding the effects of cefepime on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefepime and any potential adverse effects on the breastfed child from cefepime or from the underlying maternal condition. data a pharmacokinetic study was conducted in 9 healthy lactating women to evaluate the concentrations of cefepime in plasma and breast milk following a single intravenous dose of 1000 mg. the mean breast milk concentrations of cefepime during the first 8 hours post-dose were approximately 0.5 mcg/ml and then declined and became undetectable between 12- and 24-hours post-dose. the mean cumulative breast milk excretion of cefepime over 24 hours was 0.01% of the administered dose. the pharmacokinetics of cefepime are similar between lactating and non-lactating women. the safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years. use of cefepime for injection in these age groups is supported by evidence from adequate and well-controlled studies of cefepime in adults with additional pharmacokinetic and safety data from pediatric trials [see clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients below the age of 2 months have not been established. there are insufficient clinical data to support the use of cefepime for injection in pediatric patients for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is h. influenzae type b. in those patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented, an alternate agent with demonstrated clinical efficacy in this setting should be used. of the more than 6,400 adults treated with cefepime for injection in clinical studies, 35% were 65 years or older while 16% were 75 years or older. when geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in non-geriatric adult patients. serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures [see warnings and precautions (5.2), adverse reactions (6.2)] . 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 renal function should be monitored [see clinical pharmacology (12.3), warnings and precautions (5.2), dosage and administration (2.3)] . adjust the dose of cefepime for injection in patients with creatinine clearance less than or equal to 60 ml/min to compensate for the slower rate of renal elimination [see dosage adjustments in patients with renal impairment (2.3)] .

Соединенные Штаты - английский - NLM (National Library of Medicine)

wg critical care, llc - nafcillin sodium (unii: 49g3001bck) (nafcillin - unii:4cnz27m7rv) - nafcillin 1 g - nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology – susceptibility test methods ). nafcillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to methicillin-resistant staphylococcus sp., therapy with nafcillin for injection should be discontinued and alternative therapy provided. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nafcillin for injection and other antibacterial drugs, nafcillin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in s

Соединенные Штаты - английский - NLM (National Library of Medicine)

rebel distributors corp - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.125 mg - triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). use for more than 2 to 3 weeks requires complete reevaluation of the patient (see warnings). prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines. benzodiazepines may cause fetal damage when administered during pregnancy. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. triazolam tablets are contraindicated in pregnant women. if there is a likelihood of the patient becoming pregnant while recei

Соединенные Штаты - английский - NLM (National Library of Medicine)

wg critical care, llc - esmolol hydrochloride (unii: v05260lc8d) (esmolol - unii:mdy902uxsr) - esmolol hydrochloride 10 mg in 1 ml - esmolol hydrochloride is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol hydrochloride is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. esmolol hydrochloride is intended for short-term use. esmolol hydrochloride is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated. use of esmolol hydrochloride to prevent such events is not recommended. esmolol hydrochloride is contraindicated in patients with: pregnancy category c esmolol hydrochloride has been shown to produce increased fetal resorptions with minimal maternal toxicity in rabbits when given in doses approximately 8 times the maximum human maintenance dose (300 mcg/kg/min). there are no adequate and well-controlled studies in pregnant women. esmolol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. teratogenicity studies in rats at intravenous dosages of esmolol hydrochloride up to 3000 mcg/kg/min (10 times the maximum human maintenance dosage) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while a dosage of 10,000 mcg/kg/min produced maternal toxicity and lethality. in rabbits, intravenous dosages up to 1000 mcg/kg/min for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while 2500 mcg/kg/min produced minimal maternal toxicity and increased fetal resorptions. although there are no adequate and well-controlled studies in pregnant women, use of esmolol in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of drug infusion. esmolol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from esmolol hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of esmolol hydrochloride in pediatric patients have not been established. clinical studies of esmolol hydrochloride 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 usually start at the low end of the dosing range, reflecting greater frequency of decreased renal or cardiac function and of concomitant disease or other drug therapy. no special precautions are necessary in patients with hepatic impairment because esmolol hydrochloride is metabolized by red-blood cell esterases [see clinical pharmacology (12.3) ]. no dosage adjustment is required for esmolol in patients with renal impairment receiving a maintenance infusion of esmolol 150 mcg/kg for 4 hours. there is no information on the tolerability of maintenance infusions of esmolol using rates in excess of 150 mcg/kg or maintained longer than 4 hours [see clinical pharmacology (12.3) ].

Австралия - английский - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: hypromellose; lactose monohydrate; microcrystalline cellulose; propyl gallate; magnesium stearate; citric acid monohydrate; butylated hydroxyanisole; sodium lauryl sulfate; croscarmellose sodium - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Австралия - английский - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; lactose monohydrate; citric acid monohydrate; propyl gallate; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; butylated hydroxyanisole; hypromellose - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Австралия - английский - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; croscarmellose sodium; citric acid monohydrate; butylated hydroxyanisole; magnesium stearate; hypromellose; microcrystalline cellulose; propyl gallate; sodium lauryl sulfate - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Австралия - английский - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: sodium lauryl sulfate; citric acid monohydrate; lactose monohydrate; croscarmellose sodium; propyl gallate; magnesium stearate; microcrystalline cellulose; hypromellose; butylated hydroxyanisole - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,children and adolescents 10-17 years,(pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone.,? patients already treated with a statin and ezetimibe.,homozygous familial hypercholesterolaemia (hofh),ezetimibe and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).