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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

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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 (

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sigmapharm laboratories, llc - dofetilide (unii: r4z9x1n2nd) (dofetilide - unii:r4z9x1n2nd) - dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [af/afl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. in general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation. dofetilide is contraindicated in patients with congenital or acquired long qt syndromes. dof

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vivus llc - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50) - pancreaze is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. none. risk summary published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. animal reproduction studies have not been conducted with pancrelipase. the 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. risk summary there are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant or the effects on milk production. pancrelipase is minimally absorbed systemically following oral administration, therefore maternal use is not expected to result in clinically relevant exposure of breastfed infants to the drug. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pancreaze and any potential adverse effects on the breastfed infant from pancreaze or from the underlying maternal condition. the safety and effectiveness of pancreaze for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. use of pancreaze for this indication is supported by an adequate and well-controlled trial in adult and pediatric patients 8 to 17 years of age (study 1) along with supportive data from a randomized, investigator-blinded, dose-ranging study in 17 pediatric patients aged 6 to 30 months (study 2). both study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis. the safety in pediatric patients in these studies was similar to that observed in adult patients [see adverse reactions (6.1) and clinical studies (14)] . dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. if there is a history of fibrosing colonopathy, monitor patients during treatment with pancreaze because some patients may be at risk of progressing to stricture formation. do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in pediatric patients greater than 12 months of age without further investigation . [see dosage and administration (2.2)and warnings and precautions (5.1)] . crushing or chewing pancreaze capsules or mixing the capsule contents in foods having a ph greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see dosage and administration (2.3)and warnings and precautions (5.2)]. clinical studies of pancreaze did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.

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mylan institutional llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st- elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and fetus (see clinical considerations) . in animal reproduc

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alembic pharmaceuticals inc. - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate capsules are indicated for the prophylaxis of influenza a and b in patients 1 year and older. - oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. - influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules[see microbiology (12.4)] . - oseltamivir phosphate capsules are not recomm

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alembic pharmaceuticals limited - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate capsules are indicated for the prophylaxis of influenza a and b in patients 1 year and older. - oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. - influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules[see microbiology (12.4)] . - oseltamivir phosphate capsules are not recomm

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inventia healthcare limited - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)]. the efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)]. the efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults. paliperidoneis contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone is a metabolite of risperidone. pregnancy exposure reg

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trupharma, llc - midodrine hydrochloride (unii: 59jv96ytxv) (midodrine - unii:6ye7pbm15h) - midodrine hydrochloride tablets, usp are indicated for the treatment of symptomatic orthostatic hypotension (oh). because midodrine hydrochloride tablets, usp can cause marked elevation of supine blood pressure (bp>200 mmhg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. the indication is based on midodrine hydrochloride tablets, usp effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. at present, however, clinical benefits of midodrine hydrochloride tablets, usp principally improved ability to perform life activities, have not been established. further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets, usp. after initiation of treatment, midodrine hydrochloride tablets, usp should be continued

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mckesson corporation dba sky packaginng - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to:  - reduce the risk of myocardial infarction     - reduce the risk of stroke     - reduce the risk for revascularization procedures and angina in adult patients with type 2 diabetes, and without clinically evident coronary hear