HIGHLIGHTS OF PRESCRIBING INFORMATION United States - English - NLM (National Library of Medicine)

highlights of prescribing information

auromedics pharma llc - vasopressin, unspecified (unii: y87y826h08) (vasopressin, unspecified - unii:y87y826h08) - vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. vasopressin injection 1 ml single dose vial does not contain chlorobutanol and is therefore contraindicated only in patients with a known allergy or hypersensitivity to 8-l-arginine vasopressin. risk summary  there are no available data on vasopressin injection 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.  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 injection may need to be increased [see dosage and administration (2.2) and clinical pharmacology (12.3)].    maternal adverse reactions: vasopressin injection may produce tonic uterine contractions that could threaten the continuation of pregnancy.  there are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.  safety and effectiveness of vasopressin injection in pediatric patients with vasodilatory shock have not been established. clinical studies of vasopressin 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 the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting 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 [see warnings and precautions (5), adverse reactions (6), and clinical pharmacology (12.3)]. 

IBANDRONATE SODIUM injection, solution United States - English - NLM (National Library of Medicine)

ibandronate sodium injection, solution

auromedics pharma llc - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 3 mg in 3 ml - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies (14)] . the safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium injection is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.1)] - known hypersensitivity to ibandronate sodium injection or to any of its ex

EPHEDRINE SULFATE injection United States - English - NLM (National Library of Medicine)

ephedrine sulfate injection

auromedics pharma llc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data] . the estimated

CAFFEINE CITRATE injection, solution United States - English - NLM (National Library of Medicine)

caffeine citrate injection, solution

auromedics pharma llc - caffeine citrate (unii: u26eo4675q) (caffeine - unii:3g6a5w338e) - caffeine citrate 20 mg in 1 ml - caffeine citrate injection, usp is indicated for the treatment of apnea of prematurity. caffeine citrate injection is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

LEVOFLOXACIN- levofloxacin in 5% dextrose injection, solution United States - English - NLM (National Library of Medicine)

levofloxacin- levofloxacin in 5% dextrose injection, solution

auromedics pharma llc - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg in 50 ml - levofloxacin injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). levofloxacin injection is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levofloxacin injection is indicated for the treatment of community-acquired pneumonia due to methicillin-s

LEVOFLOXACIN injection, solution, concentrate United States - English - NLM (National Library of Medicine)

levofloxacin injection, solution, concentrate

auromedics pharma llc - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 500 mg in 20 ml - levofloxacin injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). levofloxacin injection is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levofloxacin injection is indicated for the treatment of community-acquired pneumonia due to methicillin-s

HYDROXYPROGESTERONE CAPROATE injection United States - English - NLM (National Library of Medicine)

hydroxyprogesterone caproate injection

auromedics pharma llc - hydroxyprogesterone caproate (unii: 276f2o42f5) (hydroxyprogesterone - unii:21807m87j2) - hydroxyprogesterone caproate injection, usp is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (stage iii or iv); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation. hydroxyprogesterone caproate is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug. hydroxyprogesterone caproate is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders.

GLYCOPYRROLATE injection, solution United States - English - NLM (National Library of Medicine)

glycopyrrolate injection, solution

auromedics pharma llc - 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 or any of its inactive ingredients. in addition, in the man

ATRACURIUM BESYLATE injection, solution United States - English - NLM (National Library of Medicine)

atracurium besylate injection, solution

auromedics pharma llc - atracurium besylate (unii: 40ax66p76p) (atracurium - unii:2gq1iry63p) - atracurium besylate 50 mg in 5 ml - atracurium besylate injection, usp is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. atracurium besylate is contraindicated in patients known to have a hypersensitivity to it. use of atracurium besylate from multiple dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.

ATRACURIUM BESYLATE injection, solution United States - English - NLM (National Library of Medicine)

atracurium besylate injection, solution

auromedics pharma llc - atracurium besylate (unii: 40ax66p76p) (atracurium - unii:2gq1iry63p) - atracurium besylate injection, usp is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. atracurium besylate is contraindicated in patients known to have a hypersensitivity to it. use of atracurium besylate from multiple-dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.