Amerika Serikat - Inggris - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - amikacin sulfate (unii: n6m33094fd) (amikacin - unii:84319sgc3c) - amikacin 250 mg in 1 ml - amikacin sulfate injection is indicated in the short-term treatment of serious infections due to susceptible strains of gram-negative bacteria, including pseudomonas species, escherichia coli , species of indole-positive and indole-negative proteus , providencia species, klebsiella-enterobacter-serratia species, and acinetobacter (mima-herellea ) species. clinical studies have shown amikacin sulfate injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and post-operative infections (including post-vascular surgery). clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to these organisms. aminoglycosides, including amikacin sulfate injection are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. bacteriologic studies should be performed to identify causative organisms and their susceptibilities to amikacin. amikacin may be considered as initial therapy in suspected gram-negative infections and therapy may be instituted before obtaining the results of susceptibility testing. clinical trials demonstrated that amikacin was effective in infections caused by gentamicin- and/or tobramycin-resistant strains of gram-negative organisms, particularly proteus rettgeri , providencia stuartii , serratia marcescens , and pseudomonas aeruginosa . the decision to continue therapy with the drug should be based on results of the susceptibility tests, the severity of the infection, the response of the patient and the important additional considerations contained in the warnings box above. amikacin has also been shown to be effective in staphylococcal infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a gram-negative bacterium or a staphylococcus, infections due to susceptible strains of staphylococci in patients allergic to other antibiotics, and in mixed staphylococci/gram-negative infections. in certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin-type drug may be indicated because of the possibility of infections due to gram-positive organisms such as streptococci or pneumococci. to reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin and other antibacterial drugs, amikacin 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. a history of hypersensitivity to amikacin is a contraindication for its use. a history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any other aminoglycoside because of the known cross-sensitivities of patients to drugs in this class.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

jacobus pharmaceutical company, inc. - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - dapsone 25 mg - dermatitis herpetiformis: (d.h.) leprosy: all forms of leprosy except for cases of proven dapsone resistance.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

jacobus pharmaceutical company, inc. - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - dermatitis herpetiformis: (d.h.) leprosy: all forms of leprosy except for cases of proven dapsone resistance.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - prednisone (unii: vb0r961hzt) (prednisone - unii:vb0r961hzt) - prednisone 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 hypercalcemia associated with cancer nonsuppurative thyroiditis as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post-traumatic osteoarthritis synovitis of osteoarthritis epicondylitis during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic carditis pemphigu

Amerika Serikat - Inggris - NLM (National Library of Medicine)

contract pharmacy services-pa - allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - allopurinol 100 mg - this is not an innocuous drug. it is not recommended for the treatment of asymptomatic hyperuricemia. allopurinol reduces serum and urinary uric acid concentrations. its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see clinical pharmacology, contraindications, warnings, and precautions). allopurinol is indicated in: - the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis and/or nephropathy). - the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present. - the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in mal

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. treatment: doxycycline is indicated for the treatment of the following infections: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae . - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. - inclusion conjunctivitis caused by chlamydia trachomatis . - uncomplicated urethral, endocervical, or rectal infections in adults caused by chlamydia trachomatis . - nongonococcal urethritis caused by ureaplasma urealyticum . - relapsing fever due to borrelia recurrentis . doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: - chancroid caused by haemophilus ducreyi . - plague due to yersinia pestis . - tularemia due to francisella tularensis . - cholera caused by vibrio cholerae . - campylobacter fetus infections caused by campylobacter fetus . - brucellosis due to brucella species (in conjunction with streptomycin). - bartonellosis due to bartonella bacilliformis . - granuloma inguinale caused by klebsiella granulomatis . because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: - escherichia coli. - enterobacter aerogenes . - shigella species. - acinetobacter species. - respiratory tract infections caused by haemophilus influenzae . - respiratory tract and urinary tract infections caused by klebsiella species. doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: - upper respiratory infections caused by streptococcus pneumoniae . - anthrax due to bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis . when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: - uncomplicated gonorrhea caused by neisseria gonorrhoeae . - syphilis caused by treponema pallidum . - yaws caused by treponema pallidum subspecies pertenue . - listeriosis due to listeria monocytogenes . - vincent's infection caused by fusobacterium fusiforme . - actinomycosis caused by actinomyces israelii . - infections caused by clostridium species. in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. in severe acne, doxycycline may be useful adjunctive therapy. prophylaxis: doxycycline is indicated for the prophylaxis of malaria due to plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (see dosage and administrationsection and information for patientssubsection of the precautionssection.) this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

h.j. harkins company, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2 , or ≥27 kg/m2 in the presence of other risk factors (e. g., hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows; pounds ÷ 2.2 = kg; inches × 0.0254 = meters. the limited usefulness of agents of this class (see clinical pharmacology ) should be measured against possible risk factors inherent in their use such as those described below. advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. agita

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - carvedilol phosphate (unii: eqt531s367) (carvedilol - unii:0k47ul67f2) - carvedilol phosphate 10 mg - carvedilol phosphate extended-release capsules are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ace inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see drug interactions (7.4), clinical studies (14.1)]. carvedilol phosphate extended-release capsules are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see clinical studies (14.2)]. carvedilol phosphate extended-release capsules are indicated for the management of essential hypertension [see clinical studies (14.3, 14.4)] . they can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see drug interactions (7.2)] . carvedilol phosphate extended-release capsules are contraindicated in the following conditions: - bronchial asthma or related bronchospastic conditions. deaths from status asthmaticus have been reported following single doses of immediate-release carvedilol. - second- or third-degree av block. - sick sinus syndrome. - severe bradycardia (unless a permanent pacemaker is in place). - patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. such patients should first be weaned from intravenous therapy before initiating carvedilol phosphate extended-release capsules. - patients with severe hepatic impairment. - patients with a history of a serious hypersensitivity reaction (e.g., stevens-johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of carvedilol phosphate extended-release capsules. risk summary available data regarding use of carvedilol phosphate extended-release capsules in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. there are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. the use of beta-blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate (see clinical considerations). in animal reproduction studies, there was no evidence of adverse developmental outcomes at clinically relevant doses (see data). oral administration of carvedilol to pregnant rats during organogenesis resulted in post-implantation loss, decreased fetal body weight, and an increased frequency of delayed fetal skeletal development at maternally toxic doses that were 50 times the maximum recommended human dose (mrhd). in addition, oral administration of carvedilol to pregnant rabbits during organogenesis resulted in increased post-implantation loss at doses 25 times the mrhd (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations are 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 disease-associated maternal and/or embryo/fetal risk : hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions : neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly. data animal data: studies performed in rats and rabbits given carvedilol during fetal organogenesis revealed increased post-implantation loss in rats at a maternally toxic dose of 300 mg/kg/day (50 times the mrhd as mg/m 2 ) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg/kg/day (25 times the mrhd as mg/m 2 ). in the rats, there was also a decrease in fetal body weight at 300 mg/kg/day (50 times the mrhd as mg/m 2 ) accompanied by an increased incidence of fetuses with delayed skeletal development. in rats, the no-effect level for embryo-fetal toxicity was 60 mg/kg/day (10 times the mrhd as mg/m 2 ); in rabbits, it was 15 mg/kg/day (5 times the mrhd as mg/m 2 ). in a pre- and post-natal development study in rats administered carvedilol from late gestation through lactation, increased embryo-lethality was observed at a maternally toxic dose of 200 mg/kg/day (approximately 32 times the mrhd as mg/m 2 ), and pup mortality and delays in physical growth/development were observed at 60 mg/kg/day (10 times the mrhd as mg/m 2 ) in the absence of maternal toxicity. the no-effect level was 12 mg/kg/day (2 times the mrhd as mg/m 2 ). carvedilol was present in fetal rat tissue. risk summary there are no data on the presence of carvedilol in human milk, the effects on the breastfed infant, or the effects on milk production. carvedilol is present in the milk of lactating rats. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for carvedilol phosphate extended-release capsules and any potential adverse effects on the breastfed infant from carvedilol phosphate extended-release capsules or from the underlying maternal condition. effectiveness of carvedilol in patients younger than 18 years has not been established. in a double-blind trial, 161 children (mean age: 6 years; range: 2 months to 17 years; 45% younger than 2 years) with chronic heart failure [nyha class ii-iv, left ventricular ejection fraction less than 40% for children with a systemic left ventricle (lv), and moderate-severe ventricular dysfunction qualitatively by echo for those with a systemic ventricle that was not an lv] who were receiving standard background treatment were randomized to placebo or to 2 dose levels of carvedilol. these dose levels produced placebo-corrected heart rate reduction of 4 to 6 heart beats per minute, indicative of beta-blockade activity. exposure appeared to be lower in pediatric subjects than adults. after 8 months of follow-up, there was no significant effect of treatment on clinical outcomes. adverse reactions in this trial that occurred in greater than 10% of subjects treated with immediate-release carvedilol and at twice the rate of placebo-treated subjects included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%). the initial clinical trials of carvedilol phosphate extended-release capsules in subjects with hypertension, heart failure, and left ventricular dysfunction following myocardial infarction did not include sufficient numbers of subjects aged 65 years or older to determine whether they respond differently from younger patients. a randomized trial (n = 405) comparing subjects with mild to severe heart failure switched to carvedilol phosphate extended-release capsules or maintained on immediate-release carvedilol tablets included 220 subjects who were aged 65 years or older. in this elderly subgroup, the combined incidence of dizziness, hypotension, or syncope was 24% (18/75) in subjects switched from the highest dose of immediate-release carvedilol tablets (25 mg twice daily) to the highest dose of carvedilol phosphate extended-release capsules (80 mg once daily) compared with 11% (4/36) in subjects maintained on immediate-release carvedilol tablets (25 mg twice daily). when switching from the higher doses of immediate-release carvedilol tablets to carvedilol phosphate extended-release capsules, a lower starting dose is recommended for elderly patients [see dosage and administration (2.5)] . the following information is available for trials with immediate-release carvedilol. of the 765 subjects with heart failure randomized to carvedilol in u.s. clinical trials, 31% (235) were aged 65 years or older, and 7.3% (56) were aged 75 years or older. of the 1,156 subjects randomized to carvedilol in a long-term, placebo-controlled trial in severe heart failure, 47% (547) were aged 65 years or older, and 15% (174) were aged 75 years or older. of 3,025 subjects receiving carvedilol in heart failure trials worldwide, 42% were aged 65 years or older. of the 975 subjects with myocardial infarction randomized to carvedilol in the capricorn trial, 48% (468) were aged 65 years or older, and 11% (111) were aged 75 years or older. of the 2,065 hypertensive subjects in u.s. clinical trials of efficacy or safety who were treated with carvedilol, 21% (436) were aged 65 years or older. of 3,722 subjects receiving immediate-release carvedilol in hypertension clinical trials conducted worldwide, 24% were aged 65 years or older. with the exception of dizziness in hypertensive subjects (incidence 8.8% in the elderly versus 6% in younger subjects), no overall differences in the safety or effectiveness (see figures 2 and 4) were observed between the older subjects and younger subjects in each of these populations. similarly, other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - amphotericin b (unii: 7xu7a7droe) (amphotericin b - unii:7xu7a7droe) - amphotericin b liposome for injection is indicated for the following: - empirical therapy for presumed fungal infection in febrile, neutropenic patients. - treatment of cryptococcal meningitis in hiv infected patients (see description of clinical studies) . - treatment of patients with aspergillus species, candida species and/or cryptococcus species infections (see above for the treatment of cryptococcal meningitis) refractory to amphotericin b deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin b deoxycholate. - treatment of visceral leishmaniasis. in immunocompromised patients with visceral leishmaniasis treated with amphotericin b liposome for injection, relapse rates were high following initial clearance of parasites (see description of clinical studies) . see dosage and administration for recommended doses by indication. amphotericin b liposome for injection is contraindicated in those patients who have demonstrated or have known hypersensiti

Amerika Serikat - Inggris - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m 2 , or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. the limited usefulness of agents of this class, including phentermine hydrochloride tablets, [ see clinical pharmacology (12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. - history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart fail