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hf acquisition co llc, dba healthfirst - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - xylocaine (lidocaine hcl) injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

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hf acquisition co llc, dba healthfirst - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients. acetaminophen is contraindicated: in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation. in patients with severe hepatic impairment or severe active liver disease [see warnings and precautions (5.1)]. 8.1 pregnancy risk summary published epidemiological studies with oral acetaminophen use during pregnancy have not reported a clear association with acetaminophen use and birth defects, miscarriage, or adverse maternal or fetal outcomes [see data]. animal reproduction studies have not been conducted with iv acetaminophen. reproductive and developmental studies in rats and mice from the published literature identified adverse events at clinically relevant doses with acetaminophen. treatment of pregnant rats with doses of acetaminophen approximately equal to the maximum human daily dose (mhdd) showed evidence of fetotoxicity and increases in bone variations in the fetuses. in another study, necrosis was observed in the liver and kidney of both pregnant rats and fetuses at doses approximately equal to the mhdd. in mice and rats treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproductive capacity were reported. in mice, a reduction in number of litters of the parental mating pair was observed as well as retarded growth, abnormal sperm in their offspring and reduced birth weight in the next generation. in rats, female fertility was decreased following in utero exposure to acetaminophen [see data]. the estimated background risk of major birth defects and miscarriages 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 human data the results from a large population-based prospective cohort, including data from 26,424 women with live born singletons who were exposed to oral acetaminophen during the first trimester, indicate no increased risk for congenital malformations, compared to a control group of unexposed children. the rate of congenital malformations (4.3%) was similar to the rate in the general population. a population-based, case-control study from the national birth defects prevention study showed that 11,610 children with prenatal exposure to acetaminophen during the first trimester had no increased risk of major birth defects compared to 4,500 children in the control group. other epidemiological data showed similar results. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including recall bias. animal data studies in pregnant rats that received oral acetaminophen during organogenesis at doses up to 0.85 times the maximum human daily dose (mhdd = 4 grams/day, based on a body surface area comparison) showed evidence of fetotoxicity (reduced fetal weight and length) and a dose-related increase in bone variations (reduced ossification and rudimentary rib changes). offspring had no evidence of external, visceral, or skeletal malformations. when pregnant rats received oral acetaminophen throughout gestation at doses of 1.2 times the mhdd (based on a body surface area comparison), areas of necrosis occurred in both the liver and kidney of pregnant rats and fetuses. these effects did not occur in animals that received oral acetaminophen at doses 0.3 times the mhdd, based on a body surface area comparison. in a continuous breeding study, pregnant mice received 0.25, 0.5, or 1.0% acetaminophen via the diet (357, 715, or 1,430 mg/kg/day). these doses are approximately 0.43, 0.87, and 1.7 times the mhdd, respectively, based on a body surface area comparison. a dose related reduction in body weights of fourth and fifth litter offspring of the treated mating pair occurred during lactation and post-weaning at all doses. animals in the high dose group had a reduced number of litters per mating pair, male offspring with an increased percentage of abnormal sperm, and reduced birth weights in the next generation pups. 8.2 lactation risk summary there is no information regarding the presence of acetaminophen in human milk, the effects on the breastfed infant, or the effects on milk production. however, limited published studies report that acetaminophen passes rapidly into human milk with similar levels in the milk and plasma. average and maximum neonatal doses of 1% and 2%, respectively, of the weight-adjusted maternal dose are reported after a single oral administration of 1 gram apap. there is one well-documented report of a rash in a breast-fed infant that resolved when the mother stopped acetaminophen use and recurred when she resumed acetaminophen use. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for acetaminophen and any potential adverse effects on the breastfed infant from acetaminophen or from the underlying maternal condition. 8.3 females and males of reproductive potential based on animal data use of acetaminophen may cause reduced fertility in males and females of reproductive potential. it is not known whether these effects on fertility are reversible. published animal studies reported that oral acetaminophen treatment of male animals at doses that are 1.2 times the mhdd and greater (based on a body surface area comparison) result in decreased testicular weights, reduced spermatogenesis, and reduced fertility. in female animals given the same doses, reduced implantation sites were reported. additional published animal studies indicate that acetaminophen exposure in utero adversely impacts reproductive capacity of both male and female offspring at clinically relevant exposures [see nonclinical toxicology (13.1)]. 8.4 pediatric use treatment of acute pain the safety and effectiveness of acetaminophen for the treatment of acute pain in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of acetaminophen in adults and safety and pharmacokinetic data from adult and 483 pediatric patients across all age groups [see dosage and administration (2.3) and pharmacokinetics (12.3)]. the effectiveness of acetaminophen for the treatment of acute pain in pediatric patients younger than 2 years of age has not been established. in patients younger than 2 years, efficacy was not demonstrated in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. no difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control was observed. treatment of fever the safety and effectiveness of acetaminophen for the treatment of fever in pediatric patients, including premature neonates born at ≥ 32 weeks gestational age is supported by adequate and well-controlled studies of acetaminophen in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates ≥ 32 weeks gestational age. 8.5 geriatric use of the total number of subjects in clinical studies of acetaminophen, 15% were age 65 and over, while 5% were age 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 patients with hepatic impairment acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease [ see warnings and precautions (5.1) and clinical pharmacology (12)]. a reduced total daily dose of acetaminophen may be warranted. 8.7 patients with renal impairment in cases of severe renal impairment (creatinine clearance ≤ 30 ml/min), longer dosing intervals and a reduced total daily dose of acetaminophen may be warranted.

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hf acquisition co. llc, dba healthfirst - methylprednisolone sodium succinate (unii: lec9gky20k) (methylprednisolone - unii:x4w7zr7023) - when oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of solu-medrol sterile powder is indicated as follows: allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. dermatologic diseases bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (stevens-johnson syndrome). endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of 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. gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. hematologic disorders acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (diamond-blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. miscellaneous trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. neoplastic diseases for the palliative management of leukemias and lymphomas. nervous system acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. ophthalmic diseases sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. respiratory diseases berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). for the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus. solu-medrol sterile powder is contraindicated: in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. the solu-medrol 40 mg presentation includes lactose monohydrate produced from cow's milk. this presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow's milk or its components or other dairy products because it may contain trace amounts of milk ingredients. for intrathecal administration. reports of severe medical events have been associated with this route of administration. intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. additional contraindication for the use of solu-medrol sterile powder preserved with benzyl alcohol: formulations preserved with benzyl alcohol are contraindicated for use in premature infants. (see warnings and precautions, pediatric use.)

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hf acquisition co llc, dba healthfirst - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - 1.1 prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. 1.2 prevention of postoperative nausea and/or vomiting ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. anaphylactic reactions have been reported in patients taking ondansetron. [see adverse reactions 6-(6.2).] the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. 8.1 pregnancy risk summary available data do not reliably inform the association of ondansetron and adverse fetal outcomes. published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see data]. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area, respectively [see data]. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy. two large retrospective cohort studies of ondansetron use in pregnancy have been published. in one study with 1,349 infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimester, no increased risk for major congenital malformations was seen in aggregate analysis. in this same study, however, a sub-analysis for specific malformations reported an association between ondansetron exposure and cardiovascular defect (odds ratio (or) 1.62 [95% ci (1.04, 2.14)]) and cardiac septal defect (or 2.05 [95% ci (1.19, 3.28)]). the second study examined 1970 women who received ondansetron prescription during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage or stillbirth, and infants of low birth weight or small for gestational age. important methodological limitations with these studies include the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, and other unadjusted confounders that may account for the study findings. a case-control study evaluating associations between several common non-cardiac malformations and multiple antiemetic drugs reported an association between maternal use of ondansetron and isolated cleft palate (reported adjusted or = 2.37 [95% ci (1.18, 4.76)]). however, this association could be a chance finding, given the large number of drugs-birth defect comparisons in this study. it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy) or whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspring. in addition, no cases of isolated cleft palate were identified in the aforementioned two large retrospective cohort studies. at this time, there is no clear evidence that ondansetron exposure in early pregnancy can cause cleft palate. animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis. with the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. at doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on body surface area. no intravenous pre- and post-natal developmental toxicity study was performed with ondansetron. in an oral pre- and post-natal development study pregnant rats received doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21. with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. 8.2 lactation risk summary it is not known whether ondansetron is present in human milk. there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. however, it has been demonstrated that ondansetron is present in the milk of rats. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breast-fed infant from ondansetron or from the underlying maternal condition. 8.4 pediatric use little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month. [see clinical studies 14-(14.2).] little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months. [see clinical studies 14-(14.1), dosage and administration ( 2).] the clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5-fold longer than patients who are aged >4 to 24 months. as a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored. [see clinical pharmacology 12-(12.3).] 8.5 geriatric use of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting us- and foreign-controlled clinical trials, 862 were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology 12-(12.3)]. there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. dosage adjustment is not needed in patients over the age of 65. 8.6 hepatic impairment in patients with severe hepatic impairment (child-pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see clinical pharmacology 12-(12.3)]. in such patients, a total daily dose of 8 mg should not be exceeded [see dosage and administration 2-(2.3)]. 8.7 renal impairment although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min), no dosage adjustment is recommended [see clinical pharmacology 12-(12.3)]. animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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hf acquisition co llc, dba healthfirst - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin sodium is indicated for: • prophylaxis and treatment of venous thrombosis and pulmonary embolism; • prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation; • treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation); • prevention of clotting in arterial and cardiac surgery; • prophylaxis and treatment of peripheral arterial embolism; • anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium in 0.45% sodium chloride injection is contraindicated in patients: • with history of heparin-induced thrombocytopenia (hit) (with or without thrombosis) [see warnings and precautions 5-(5.3)] • with a known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions 6-(6.1)] • in whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thromboplastin time, etc., — cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin) 8.1 pregnancy risk summary in published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. no teratogenicity was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses up to 10,000 units/kg/day, approximately 10 times the maximum recommended human dose (mrhd) of 40,000 units/24 hours infusion [see data]. in pregnant animals, doses up to10 times higher than the maximum human daily dose based on body weight resulted in increased resorptions. consider the benefits and risks of heparin sodium in 0.45% sodium chloride injection to a pregnant woman and possible risks to the fetus when prescribing heparin sodium in 0.45% sodium chloride injection. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data human data the maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. these studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. animal data in a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 units/kg/day, approximately 10 times the maximum human daily dose based on body weight. the number of early resorptions increased in both species. there was no evidence of teratogenic effects. 8.2 lactation risk summary there is no information regarding the presence of heparin sodium in 0.45% sodium chloride injection in human milk, the effects on the breastfed infant, or the effects on milk production. due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for heparin sodium in 0.45% sodium chloride injection and any potential adverse effects on the breastfed infant from heparin sodium in 0.45% sodium chloride injection or from the underlying maternal condition [see use in specific populations 8-(8.4)]. 8.4 pediatric use there are no adequate and well controlled studies on heparin use in pediatric patients. pediatric dosing recommendations are based on clinical experience [see dosage and administration 2-(2.4)]. 8.5 geriatric use there are limited adequate and well-controlled studies in patients 65 years and older. however, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see warnings and precautions 5-(5.2)]. lower doses of heparin may be indicated in these patients [see clinical pharmacology 12-(12.3)].

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hf acquisition co llc, dba healthfirst - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. nitroglycerin sublingual tablets are contraindicated in patients who are allergic to it. sublingual nitroglycerin therapy is contraindicated in patients with early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin. administration of nitroglycerin sublingual tablets are contraindicated in patients who are using a phosphodiesterase-5 (pde-5) inhibitor (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride) since these compounds have been shown to potentiate the hypotensive effects of organic nitrates. do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulator riociguat. concomitant use can cause hypotension.

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hf acquisition co llc, dba healthfirst - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - in anesthesia glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. in peptic ulcer for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate injection or any of its inactive ingredients. in addition, in the management of pe

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hf acquisition co llc, dba healthfirst - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see clinical pharmacology; clinical pharmacology-adjunctive use in septic shock). naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients contained in the formulation. naloxone hydrochloride injection is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride injection has not been reported. tolerance to the opioid antagonist effect of naloxone is not

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hf acquisition co llc, dba healthfirst - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - xylocaine (lidocaine hcl) injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

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

hf acquisition co llc, dba healthfirst - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin lingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. 4.1 pde-5-inhibitors and sgc-stimulators do not use nitroglycerin lingual spray in patients who are taking pde-5-inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions]. do not use nitroglycerin lingual spray in patients who are taking soluble guanylate cyclase (sgc) stimulators, such as riociguat. concomitant use can cause hypotension. 4.2 severe anemia nitroglycerin lingual spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 increased intracranial pressure nitroglycerin lingual spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cerebral hemorrhage or traumatic brain injury). 4.4 hypersensitivity nitroglycerin lingual spray is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. 4.5 circulatory failure and shock nitroglycerin lingual spray is contraindicated in patients with acute circulatory failure or shock. 8.1 pregnancy risk summary limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage. in animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. data animal data no embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 240 mg/kg/day for 13 days, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day for 11 days, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day for 13 days. 8.2 lactation risk summary sublingual nitroglycerin has not been studied in lactating women. it is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitroglycerin and any potential adverse effects on the breastfed child from nitroglycerin or from the underlying maternal condition. 8.4 pediatric use safety and effectiveness of nitroglycerin in pediatric patients have not been established. 8.5 geriatric use clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between elderly (greater than or equal to 65 years) and younger (less than 65 years) patients. in general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.