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ingenus pharmaceuticals, llc - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - furosemide 20 mg

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

ingenus pharmaceuticals, llc - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 400 mg

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ingenus pharmaceuticals, llc - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin 20 mg - transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack. nitroglycerin is contraindicated in patients who are allergic to it. allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the use of this product. do not use nitro-dur in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension. concomitant use can cause severe drops in blood pressure. do not use nitro-dur in patients who are taking the soluble guanylate cyclase stimulator riociguat. concomitant use can cause hypotension.

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

ingenus pharmaceuticals, llc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. this indication is based upon response rate. there are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine injection. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m2 based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potent

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

ingenus pharmaceuticals, llc - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin injection, used in combination with infusional fluorouracil/leucovorin, is indicated for: - adjuvant treatment of stage iii colon cancer in patients who have undergone complete resection of the primary tumor. - treatment of advanced colorectal cancer. oxaliplatin injection should not be administered to patients with a history of known allergy to oxaliplatin or other platinum compounds [see warnings and precautions (5.1)]. risk summary based on direct interaction with dna, oxaliplatin injection can cause fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see data) . advise a pregnant woman of the potential hazard to a fetus. in the u.s. general population, the estimated background r

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

ingenus pharmaceuticals, llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide injection is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide injection can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m  basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m  basis and in hamsters at an intravenous dose approximat

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

ingenus pharmaceuticals, llc - metoprolol succinate (unii: th25pd4ccb) (metoprolol - unii:geb06nhm23) - metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, 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 including metoprolol. 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 variety of pharmacologic

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

ingenus pharmaceuticals, llc - leucovorin calcium (unii: rpr1r4c0p4) (leucovorin - unii:q573i9dvlp) - leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin b12 . a hematologic remission may occur while neurologic manifestations continue to progress.

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

ingenus pharmaceuticals, llc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan for injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy. topotecan for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan for injection in combination with cisplatin is indicated for the treatment of patients with stage iv-b, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment. topotecan for injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. reactions have included anaphylactoid reactions [see adverse reactions (6.2)] . risk summary based on animal data and its mechanism of action, topotecan for injection can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use o

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

ingenus pharmaceuticals, llc - mafenide acetate (unii: rq6lp6z0wy) (mafenide - unii:58447s8p4l) - mafenide acetate for 5% topical solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. mafenide acetate for 5% topical solution is contraindicated in patients who are hypersensitive to mafenide acetate. it is not known whether there is cross sensitivity to other sulfonamides.