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eugia us llc - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd), sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330) - ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus , escherichia coli ,* klebsiella spp.* (including k. pneumoniae * ), proteus mirabilis ,* bacteroides fragilis ,* enterobacter spp.,* and acinetobacter calcoaceticus .* note: for information on use in pediatric patients (see precautions–pediatric use and clinical studies sections). intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli , klebsiella spp. (including k. pneumoniae * ), bacteroides spp. (including b. fragilis ), and enterobacter spp.*  gynecological infections caused by beta-lactamase producing strains of escherichia coli ,* and bacteroides spp.* (including b. fragilis * ). *  efficacy for this organism in this organ system was studied in

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eugia us llc - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin 250 mg - ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: respiratory tract infections caused by streptococcus pneumoniae, s taphylococcus aureus (penicillinase and nonpenicillinase-producing), h. influenzae , and group a beta-hemolytic streptococci . bacterial meningitis caused by e. coli , group b streptococci , and other gram-negative bacteria (listeria m onocytogenes , n. meningitidis ). the addition of an aminoglycoside with ampicillin may increase its effectiveness against gram-negative bacteria. septicemia and endocarditis caused by susceptible gram-positive organisms including streptococcus spp., penicillin g-susceptible staphylococci , and enterococci . gram-negative sepsis caused by e. coli , proteus mirabilis and salmonella spp. responds to ampicillin. endocarditis due to enterococcal strains usually respond to intravenous therapy. the addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. urinary tract infections caused by sensitive strains of e. coli and proteus mirabilis . gastrointestinal infections caused by salmonella typhi (typhoid fever), other salmonella spp., and shigella spp. (dysentery) usually respond to oral or intravenous therapy. bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. therapy may be instituted prior to obtaining results of susceptibility testing. it is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. a change to oral ampicillin may be made as soon as appropriate. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin for injection 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. indicated surgical procedures should be performed. a history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

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asclemed usa, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 30 mg in 1 ml - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ).  acute pain in adult patients ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and adverse reactions ). patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. ( see also boxed warning) ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. ketorolac tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings –  anaphylactoid reactions , and precautions – pre-existing asthma ). ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ). ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see warnings for correction of volume depletion). ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage. ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see warnings and precautions ). ketorolac tromethamine is contraindicated in patients currently receiving aspirin or nsaids because of the cumulative risks of inducing serious nsaid-related adverse events. the concomitant use of ketorolac tromethamine and probenecid is contraindicated. the concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.  ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content. lidocaine hydrochloride injection is 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 hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. purpose: - first aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns. - for preparation of the skin prior to surgery. - helps reduce bacteria that can potentially cause skin infections. - as a first aid antiseptic for more than 1 week. - in the eyes. - over large areas of the body. - deep puncture wounds - animal bites - serious burns - if irritation and redness develop - if condition persists for more than 72 hours, consult a physician. for use as an - first aid antiseptic - pre-operative skin preperation antiseptic for first aid to decrease germs in - minor cuts - scrapes - burns for preparation of the skin prior to injection

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eugia us llc - fondaparinux sodium (unii: x0q6n9usoz) (fondaparinux - unii:j177fow5jl) - fondaparinux sodium 2.5 mg in 0.5 ml - fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing hip fracture surgery, including extended prophylaxis; - in patients undergoing hip replacement surgery; - in patients undergoing knee replacement surgery; - in patients undergoing abdominal surgery who are at risk for thromboembolic complications. fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium. fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital. fondaparinux sodium injection is contraindicated in the following conditions: - severe renal impairment (creatinine clearance [crcl] <30 ml/min) [ see  warnings and precautions (5.3) and use in specific populations (8.6) ]. - active major bleeding. - bacterial endocarditis. - thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium. - body weight <50 kg (venous thromboembolism [vte] prophylaxis only) [see warnings and precautions (5.4) ]. - history of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reactions) to fondaparinux sodium. risk summary available data from published literature and postmarketing reports have not reported a clear association with fondaparinux sodium and adverse developmental outcomes. fondaparinux sodium plasma concentrations obtained from four women treated with fondaparinux sodium during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium (see data). there are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with use of anticoagulants (see clinical considerations). in animal reproduction studies, there was no evidence of adverse developmental outcomes when fondaparinux sodium was administered to pregnant rats and rabbits during organogenesis at doses 32 and 65 times, respectively, the recommended human dose based on body surface area. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reactions fondaparinux sodium has been demonstrated to cross the placenta in humans (see data). use of anticoagulants, including fondaparinux sodium, may increase the risk of bleeding in the fetus and neonate. monitor neonates for bleeding [see warnings and precautions (5.2, 5.4, 5.6)]. labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. fondaparinux sodium use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. pregnant women receiving fondaparinux sodium should be carefully monitored for evidence of bleeding or unexpected changes in coagulation parameters. consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [see warnings and precautions (5.1, 5.6)]. data human data in a study of five pregnant women treated with fondaparinux sodium during the third trimester of pregnancy at a dose of 2.5 mg/day, four of the women had elevated anti-factor xa activity noted in the cord blood. anti-factor xa clotting times in these four cases were between 37.5 and 50.9 seconds. the patient who did not have elevated anti-factor xa activity had received only one dose of fondaparinux sodium 22 hours prior to delivery. the concentration of fondaparinux sodium in umbilical cord plasma was approximately 1/10th the level of fondaparinux sodium in maternal plasma. none of the infants experienced adverse effects. animal data embryo-fetal development studies have been conducted with fondaparinux sodium in pregnant rats at subcutaneous doses up to 10 mg/kg/day (about 32 times the recommended human dose based on body surface area) administered from days 6 to 17 of gestation and pregnant rabbits at subcutaneous doses up to 10 mg/kg/day (about 65 times the recommended human dose based on body surface area) administered from days 6 to 18 of gestation. these studies have revealed no evidence of adverse developmental outcomes when fondaparinux sodium was administered to pregnant rats and rabbits during organogenesis. additionally, there were no effects on pre and postnatal development in a study conducted in rats at subcutaneous doses up to 10 mg/kg/day (about 32 times the recommended human dose based on body surface area). risk summary there are no data on the presence of fondaparinux sodium in human milk, or the effects on milk production. limited clinical data during lactation preclude a clear determination of the risk of fondaparinux sodium to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fondaparinux sodium and any potential adverse effects on the breastfed infant from fondaparinux sodium or from the underlying maternal condition. safety and effectiveness of fondaparinux sodium in pediatric patients have not been established. because risk for bleeding during treatment with fondaparinux sodium is increased in adults who weigh <50 kg, bleeding may be a particular safety concern for use of fondaparinux sodium in the pediatric population [see warnings and precautions (5.4)]. in clinical trials the efficacy of fondaparinux sodium in the elderly (65 years or older) was similar to that seen in patients younger than 65 years; however, serious adverse events increased with age. when using fondaparinux sodium in elderly patients, paying particular attention to dosing directions and concomitant medications (especially anti-platelet medication) [see warnings and precautions (5.2)]. fondaparinux sodium is substantially excreted by the kidney, and the risk of adverse reactions to fondaparinux sodium may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, assess renal function prior to fondaparinux sodium administration [see contraindications (4), warnings and precautions (5.3), and clinical pharmacology (12.4)]. in the peri-operative hip fracture, hip replacement, or knee replacement surgery clinical trials with patients receiving fondaparinux sodium 2.5 mg, serious adverse events increased with age for patients receiving fondaparinux sodium. the incidence of major bleeding in clinical trials of fondaparinux sodium by age is provided in table 6. patients with impaired renal function are at increased risk of bleeding due to reduced clearance of fondaparinux sodium [see contraindications (4) and warnings and precautions (5.3)] . assess renal function periodically in patients receiving fondaparinux sodium. discontinue fondaparinux sodium immediately in patients who develop severe renal impairment while on therapy. after discontinuation of fondaparinux sodium, its anticoagulant effects may persist for 2 to 4 days in patients with normal renal function (i.e., at least 3 to 5 half-lives). the anticoagulant effects of fondaparinux sodium may persist even longer in patients with renal impairment [see clinical pharmacology (12.4)]. following a single, subcutaneous dose of 7.5 mg of fondaparinux sodium in patients with moderate hepatic impairment (child-pugh category b) compared to subjects with normal liver function, changes from baseline in aptt, pt/inr, and antithrombin iii were similar in the two groups. however, a higher incidence of hemorrhage was observed in subjects with moderate hepatic impairment than in normal subjects, especially mild hematomas at the blood sampling or injection site. the pharmacokinetics of fondaparinux have not been studied in patients with severe hepatic impairment [see dosage and administration (2.5) and clinical pharmacology (12.4)]. fondaparinux sodium (fon'' da par' in ux soe' dee um) injection, usp for subcutaneous use be sure that you read, understand, and follow the step-by-step instructions for use, before you try to give yourself an injection of fondaparinux sodium for the first time and each time you get a new prescription. there may be new information. talk to your doctor or pharmacist if you have any questions. do not use fondaparinux sodium if: - the solution appears discolored (the solution should normally appear clear) the solution appears discolored (the solution should normally appear clear) -  you see any particles in the solution  you see any particles in the solution -  the syringe is damaged  the syringe is damaged how should i give an injection of fondaparinux sodium? fondaparinux sodium is injected into a skin fold of the lower stomach area (abdomen). do not inject fondaparinux sodium into muscle. usually a doctor or nurse will give this injection to you. in some cases you may be taught how to do this yourself.  - do not touch the needle or let it come in contact with any surface before the injection. a small air bubble in the syringe is normal. - to be sure that you do not lose any medicine from the syringe, do not try to remove air bubbles from the syringe before giving the injection. - put your used fondaparinux sodium needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - the safety system can only be activated once the syringe has been emptied. - activation of the safety system must be done only after removing the needle from the patient’s skin. - do not replace the needle shield after injection. - the safety system should not be sterilized. - activation of the safety system may cause minimal splatter of fluid. for optimal safety activate the system while orienting it downwards away from yourself and others.  this instructions for use has been approved by the u.s. food and drug administration. distributed by: eugia us llc 279 princeton-hightstown rd. e. windsor, nj 08520 manufactured by: eugia pharma specialities limited hyderabad - 500032 india revised: july 2023

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eugia us llc - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin 1 g - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology - susceptibility test methods ). oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus , therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection, usp and other antibacterial drugs, oxacillin for injection, usp should be used only to treat or prevent infections that are proven or st

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eugia us llc - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin 10 g in 100 ml - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology - susceptibility test methods ). oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus , therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection, usp and other antibacterial drugs, oxacillin for injection, usp should be used only to treat or prevent infections that are proven or str

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eugia us llc - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - the injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol injection should not be administered to patients with known or suspected renal pathology. this caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. a much larger amount of polyethylene glycol 300 than is present in recommended doses of methocarbamol injection is known to have increased pre-existing acidosis and urea retention in patients with renal impairment. although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. methocarbamol injection is contraindicated in patients hypersensitive to methocarbamol or to any o

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eugia us llc - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin for injection, usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: respiratory tract infections caused by streptococcus pneumoniae , staphylococcus aureus (penicillinase and nonpenicillinase-producing), h. influenzae , and group a beta-hemolytic streptococci. bacterial meningitis caused by e. coli , group b streptococci, and other gram-negative bacteria (listeria monocytogenes , n. meningitidis ). the addition of an aminoglycoside with ampicillin may increase its effectiveness against gram-negative bacteria. septicemia and endocarditis caused by susceptible gram-positive organisms including streptococcus spp., penicillin g-susceptible staphylococci, and enterococci. gram-negative sepsis caused by e. coli , proteus mirabilis and salmonella spp. responds to ampicillin. endocarditis due to enterococcal strains usually respond to intravenous therapy. the addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. urinary tract infections caused by sensitive strains of e. coli and proteus mirabilis . gastrointestinal infections caused by salmonella typhi (typhoid fever), other salmonella spp., and shigella spp. (dysentery) usually respond to oral or intravenous therapy. bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. therapy may be instituted prior to obtaining results of susceptibility testing. it is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. a change to oral ampicillin may be made as soon as appropriate. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection, usp and other antibacterial drugs, ampicillin for injection, usp 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. indicated surgical procedures should be performed. a history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

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eugia us llc - milrinone lactate (unii: 9k8xr81mo8) (milrinone - unii:ju9yax04c7) - milrinone lactate in 5% dextrose injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. the facility for immediate treatment of potential cardiac events, which may include life-threatening ventricular arrhythmias, must be available. the majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. there is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. milrinone is contraindicated in patients who are hypersensitive to it. solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

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eugia us llc - vasopressin (unii: y87y826h08) (vasopressin - unii:y87y826h08) - vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. vasopressin injection is contraindicated in patients with known allergy or hypersensitivity to 8-l-arginine vasopressin or chlorobutanol. risk summary there are no available data on vasopressin use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with vasopressin. clinical considerations dose adjustments during pregnancy and the postpartum period: because of increased clearance of vasopressin in the second and third trimester, the dose of vasopressin may need to be increased [see dosage and administration (2.2) and clinical pharmacology (12.3)] . maternal adverse reactions: vasopressin  may produce tonic uterine contractions that could threaten the continuation of pregnancy. there are no data on the presence of vasopressin injec