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par pharmaceutical - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 10 mg - oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): - have not been tolerated or are not expected to be tolerated, - have not provided adequate analgesia or are not expected to provide adequate analgesia. oxycodone hydrochloride tablets are 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 or hypercarbia [see warnings and precautions (5.7)] -   known or suspected gastrointestinal obstruction, including paralytic ileus

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merck sharp & dohme llc - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 5 ug in 0.5 ml - recombivax hb® [hepatitis b vaccine, recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. recombivax hb is approved for use in individuals of all ages. recombivax hb dialysis formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. do not administer recombivax hb to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis b-containing vaccine or to any component of recombivax hb, including yeast [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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. there are no adequate and well-controlled studies designed to evaluate recombivax hb in pregnant women. available post-approval data do not suggest an in

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pharmacia & upjohn company llc - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 600 mg in 300 ml - zyvox is indicated for the treatment of nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [see clinical studies (14) ]. zyvox is indicated for the treatment of community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [see clinical studies (14) ]. zyvox is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus pyogenes , or streptococcus agalactiae . zyvox has not been studied in the treatment of decubitus ulcers [see clinical studies (14) ]. zyvox is indicated for the treatment of uncomplicated skin and skin structure infections caused by staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyo

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cardinal health 107, llc - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd) - lisinopril 5 mg - lisinopril tablet usp is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variet

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nucare pharmaceuticals,inc. - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate tablets, usp are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. fenofibrate tablets, usp are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients wit

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride 120 mg - diltiazem hydrochloride extended-release capsules is indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive medications. diltiazem hydrochloride extended-release capsules is indicated for the treatment of chronic stable angina. diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree av block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

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fresenius kabi norge as - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - zyvox is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. zyvox is not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [ see warnings and precautions (5.4) ]. nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [ see clinical studies (14) ]. community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [ s

United States - English - NLM (National Library of Medicine)

specgx llc - oxymorphone hydrochloride (unii: 5y2ei94nbc) (oxymorphone - unii:9vxa968e0c) - oxymorphone hydrochloride 5 mg - oxymorphone hydrochloride tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve oxymorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia oxymorphone hydrochloride tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.2)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.5)] - known or suspected gastrointestinal obstruction, including paralytic ileus [see w

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial  [ see clinical studies ( 14.1)].    when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks  when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see   warnings and precautions ( 5.5) ].  oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or mixed e

United States - English - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae. adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1) ]. levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus , streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila , or mycoplasma pneumoniae [see dosage and administration ( 2.1 ) and clinical studies (14.2 )]. mdrsp i