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cumberland pharmaceuticals inc. - telavancin hydrochloride (unii: 0701472zg0) (telavancin - unii:xk134822z0) - vibativ is indicated for the treatment of adult patients with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive microorganisms: staphylococcus aureus (including methicillin-susceptible and -resistant isolates), streptococcus pyogenes , streptococcus agalactiae , streptococcus anginosus group (includes s. anginosus, s. intermedius, and s. constellatus) , or enterococcus faecalis (vancomycinsusceptible isolates only). vibativ is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (habp/vabp), caused by susceptible isolates of staphylococcus aureus (both methicillin-susceptible and -resistant isolates). vibativ should be reserved for use when alternative treatments are not suitable. combination therapy may be clinically indicated if the documented or presumed pathogens include gram-negative organisms. appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. vibativ may be initiated as empiric therapy before results of these tests are known. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vibativ and other antibacterial drugs, vibativ should be used only to treat 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. use of intravenous unfractionated heparin sodium is contraindicated with vibativ administration because the activated partial thromboplastin time (aptt) test results are expected to be artificially prolonged for 0 to 18 hours after vibativ administration [see warnings and precautions (5.5) and drug interactions (7.1) ]. vibativ is contraindicated in patients with known hypersensitivity to telavancin. risk summary based on findings in animal reproduction studies, vibativ may cause fetal harm. there are no available data on vibativ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses providing approximately 1- to 2-fold the human exposure at the maximum recommended clinical dose (see data). advise pregnant women of the potential risk to a fetus. 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 animal data in embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses up to 150, 45, or 75 mg/kg/day, respectively. these doses resulted in exposure levels approximately 1- to 2-fold the human exposure (auc) at the maximum recommended clinical dose. malformations observed at <1% (but absent or at lower rates in historical or concurrent controls), included brachymelia (rats and rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs). additional findings in rabbits included flexed front paw and absent ulna, and in the minipigs included misshapen digits and deformed front leg. fetal body weights were decreased in rats. in a prenatal/perinatal development study, pregnant rats received intravenous telavancin at up to 150 mg/kg/day (approximately the same auc as observed at the maximum clinical dose) from the start of organogenesis through lactation. offspring showed decreases in fetal body weight and an increase in the number of stillborn pups. brachymelia was also observed. developmental milestones and fertility of the pups were unaffected. risk summary there are no data on the presence of telavancin in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vibativ and any potential adverse effects on the breastfed child from vibativ or from the underlying maternal conditions. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating vibativ. contraception females vibativ may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment and for 2 days after the final dose. infertility males based on findings in rats, vibativ may impair male fertility [see nonclinical toxicology (13.1)]. the effect on fertility was reversible in rats. the safety and effectiveness of vibativ have not been established in pediatric patients. in particular, there is a concern for poor clinical outcomes in pediatric patients less than one year of age due to immature renal function. increased mortality in adult patients with habp/vabp and renal impairment and decreased clinical response in adults with csssi and renal impairment were observed [see boxed warning and warnings and precautions (5.1, 5.2)] . of the 929 patients treated with vibativ at a dose of 10 mg/kg once daily in clinical trials of csssi, 174 (19%) were ≥65 years of age and 87 (9%) were ≥75 years of age. in the csssi trials, lower clinical cure rates were observed in patients ≥65 years of age compared with those <65 years of age. overall, treatment-emergent adverse events occurred with similar frequencies in patients ≥65 (75% of patients) and <65 years of age (83% of patients). fifteen of 174 (9%) patients ≥65 years of age treated with vibativ had adverse events indicative of renal impairment compared with 16 of 755 (2%) patients <65 years of age [see warnings and precautions (5.3), clinical trials (14.1) ]. of the 749 habp/vabp patients treated with vibativ at a dose of 10 mg/kg once daily in clinical trials of habp/vabp, 397 (53%) were ≥65 years of age and 230 (31%) were ≥75 years of age. treatment-emergent adverse events as well as deaths and other serious adverse events occurred more often in patients ≥ 65 years of age than in those <65 years of age in both treatment groups. telavancin is substantially excreted by the kidney, and the risk of adverse reactions 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 in this age group. the mean plasma auc values of telavancin were similar in healthy young and elderly subjects. dosage adjustment for elderly patients should be based on renal function [see dosage and administration (2), clinical pharmacology (12.3) ]. the habp/vabp and csssi trials included patients with normal renal function and patients with varying degrees of renal impairment. patients with underlying renal dysfunction or risk factors for renal dysfunction had a higher incidence of renal adverse events [see warnings and precautions (5.3) ]. in the habp/vabp studies higher mortality rates were observed in the vibativ-treated patients with baseline crcl ≤50 ml/min. use of vibativ in patients with pre-existing moderate/severe renal impairment should be considered only when the anticipated benefit to the patient outweighs the potential risk [see warnings and precautions (5.1, )]. vibativ-treated patients in the csssi studies with baseline creatinine clearance ≤50 ml/min had lower clinical cure rates. consider these data when selecting antibacterial therapy in patients with baseline moderate/severe renal impairment (crcl ≤50 ml/min) [see warnings and precautions (5.2 )]. dosage adjustment is required in patients with ≤50 ml/min renal impairment [see dosage and administration (2 )]. there is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (crcl <10 ml/min), including patients receiving hemodialysis [see overdosage (10), clinical pharmacology (12.3) ]. hydroxypropyl-beta-cyclodextrin is excreted in urine and may accumulate in patients with renal impairment. serum creatinine should be closely monitored and, if renal toxicity is suspected, an alternative agent should be considered [see warnings and precautions (5.3), clinical pharmacology (12.3) ]. the habp/vabp and csssi trials included patients with normal hepatic function and with hepatic impairment. no dosage adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3) ].

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

cumberland pharmaceuticals inc. - lactulose (unii: 9u7d5qh5ae) (lactulose - unii:9u7d5qh5ae) - lactulose 10 g in 10 g - kristalose® (lactulose) for oral solution is indicated for the treatment of constipation. in patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur. since kristalose® (lactulose) for oral solution contains galactose (less than 0.3 g/10 g as a total sum with lactose), it is contraindicated in patients who require a low galactose diet.

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

cumberland pharmaceuticals inc. - amifostine (unii: m487qf2f4v) (amifostine anhydrous - unii:ila426l95o) - amifostine anhydrous 500 mg in 10 ml - ethyol (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see clinical studies (14.1)] . ethyol is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see clinical studies (14.2)] . limitation of use do not use ethyol in other settings where chemotherapy can produce a significant survival benefit or cure [see warnings and precautions (5.1)] , or in patients receiving definitive radiotherapy [see warnings and precautions (5.2)] , except in the context of a clinical study. ethyol is contraindicated in patients with known hypersensitivity to aminothiol compounds. when ethyol is used in combination with cisplatin, refer to the cisplatin full prescribing information for pregnancy information. based on findings in animals, ethyol ca

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

cumberland pharmaceuticals inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 400 mg in 4 ml - caldolor is indicated in adults and pediatric patients aged 3 months and older for the: - management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics - reduction of fever caldolor is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or any components of the drug product [see warnings and precautions ( 5.7, 5.9 ) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] risk summary use of nsaids, including caldolor, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of

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

cumberland pharmaceuticals inc. - methotrexate (unii: yl5fz2y5u1) (methotrexate - unii:yl5fz2y5u1) - reditrex is indicated in the management of selected adults with severe, active rheumatoid arthritis (ra) (acr criteria), or children with active polyarticular juvenile idiopathic arthritis (pjia), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (nsaids). reditrex is indicated in adults for the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. it is important to ensure that a psoriasis "flare" is not due to an undiagnosed concomitant disease affecting immune responses. reditrex is not indicated for the treatment of neoplastic diseases. reditrex is contraindicated in the following: - pregnancy reditrex can cause embryo-fetal toxicity and fetal death when administered during pregnancy. [see warnings and precaut

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

cumberland pharmaceuticals inc. - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine 200 mg in 1 ml - acetadote is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (rsi). acetadote is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see warnings and precautions (5.1)] . risk summary limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see clinical considerations]. reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated po

Canada - English - Health Canada

cumberland pharmaceuticals inc - ibuprofen - solution - 100mg - ibuprofen 100mg - other nonsteroidal antiimflammatory agents

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cumberland pharmaceuticals inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 500 mg - totect® is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. none. risk summary based on findings from animal studies and its mechanism of action, totect can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with totect use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at maternal doses that were approximately 0.1 and 0.2 times, respectively, the human dose of 1000 mg/m². advise pregnant women of the potential risk to a fetus. 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 ma

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

cumberland pharmaceuticals inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeclamox-pak (omeprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules taken together) are indicated for the treatment of patients with helicobacter pylori infection and duodenal ulcer disease (active or one-year history) to eradicate h. pylori in adults. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.1) ]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of omeclamox-pak and other antibacterial drugs omeclamox-pak 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. omeclamox-pak is contraindicated in the following patients: - known history of h

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

cumberland pharmaceuticals inc. - conivaptan hydrochloride (unii: 75l57r6x36) (conivaptan - unii:0nj98y462x) - conivaptan hydrochloride 20 mg in 100 ml - vaprisol® is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia. limitations of use: vaprisol has not been shown to be effective for the treatment of the signs and symptoms of heart failure and is not approved for this indication. it has not been established that raising serum sodium with vaprisol provides a symptomatic benefit to patients. vaprisol is contraindicated in patients with hypovolemic hyponatremia. the coadministration of vaprisol with potent cyp3a inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated [see drug interactions (7.1)] . in patients unable to make urine, no benefit can be expected [see clinical pharmacology (12.3)] . risk summary there are no available data with vaprisol in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregn