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DoseEdge Pharmacy Workflow Manager

Manual compounding has been associated with the underreporting of errors by a magnitude of 14x1. Approximately 4% of all doses experience a compounding error, meaning that the average hospital facility can encounter ~2,800 potential errors2. Despite the prevalence of compounding errors, only 33% of hospital facilities in the U.S. have adopted pharmacy workflow technology3. The DoseEdge System helps protect patients, pharmacy technicians, and pharmacists through its robust error-catching algorithms that intercepts a compounding error every 22 seconds.

The DoseEdge Pharmacy Workflow Manager is an enterprise solution that interfaces with your Pharmacy Information System (PIS) to automate the process of routing, preparing, inspecting, tracking and reporting on IV and oral liquid doses. The DoseEdge System enables remote verification, allowing pharmacists to verify compounded doses remotely (outside of the cleanroom or hospital facility, where permitted), and to verify doses of sister facilities.

The DoseEdge System helps pharmacies:

  • Increase safety from preparation to delivery  by intercepting compounding errors before they reach the patient
  • Drive efficiency and optimization  through automated label sorting and routing to the correct preparation area, and through remote verification of prepared doses
  • Reduce waste and drive savings  by allowing pharmacists to recycle doses to use for other patients and tracking volume remaining for multi-dose vials
  • Achieve regulatory compliance  by automating documentation necessary to meet USP 797 standards

References:

  1. Stephen F Eckel, Jordyn P Higgins, Elizabeth Hess, Thomas Cerbone, Jennifer B Civiello, Christian Conley, Nilofar Jafari, Shailly Shah, Stephen L Speth, Lynn Thornton, Multicenter study to evaluate the benefits of technology-assisted workflow on i.v. room efficiency, costs, and safety, American Journal of Health-System Pharmacy, Volume 76, Issue 12, 15 June 2019, Pages 895–901, https://doi.org/10.1093/ajhp/zxz067
  2. Baxter Internal Data on File. DoseEdge System 2019 Safety Statistics.
  3. Pharmacy Purchasing & Products. IV Safety. Volume 12. March 2020.
Myxredlin (Insulin Human) in 0.9% Sodium Chloride Injection

The First and Only Ready-to-Use Insulin Infusion

  • Manufacturer-prepared insulin infusion with a consistent concentration: 100 units per 100 mL (1 unit/mL)
  • Barcoding on the bag helps ensure the right drug gets to the right patient
  • On-Demand availability
    • 30 day room temperature storage to store the product closer to the patient
    • 24 month refrigerated shelf life to simplify inventory management
    • Store Myxredlin in the refrigerator (36°F to 46°F [2°C to 8°C]) in the original carton to protect from light. If needed, Myxredlin may be removed from the original carton and stored at room temperature up to 77°F (25°C) for up to 30 days.
  • Increased operational efficiency: Help preserve time and resources with the first and only ready-to-use insulin infusion

Indication

Myxredlin is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Important Risk Information

Contraindications
• During episodes of hypoglycemia
• Hypersensitivity to insulin human or any of the excipients in MYXREDLIN

Warnings and Precautions
• Hyper- or Hypoglycemia with Changes in Insulin Regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring.
• Administer MYXREDLIN intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels. Hypokalemia may be life-threatening if not treated.
• Individualize dose based on metabolic needs, blood glucose monitoring results, and glycemic control goal. Dosage adjustments may be needed with changes in nutrition, renal, or hepatic function or during acute illness.
• Adverse reactions observed with insulin human injection include hypoglycemia, allergic reactions, weight gain and edema.
• Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.

Dosage and Administration
• Inspect MYXREDLIN visually before use. It should appear clear and colorless. Do not use MYXREDLIN if particulate matter or coloration is seen.
• Do not add supplementary medication or additives.
• Do not use in series connections.
• Do not shake or freeze. Discard unused portion.

Please see the accompanying link for the full Prescribing Information (PI).

Clinolipid 20% Lipid Injectable Emulsion, USP
  • Only 20% Soybean Oil
  • Rich in Immune Neutral Omega-9
  • Stable and well tolerated

Explore Clinolipid Here

IMPORTANT RISK INFORMATION FOR CLINOLIPID

Clinolipid (Lipid Injectable Emulsion) for Intravenous Use 20% Indication

Clinolipid injection is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Limitations of Use

Clinolipid injection is not indicated for use in pediatric patients because there is insufficient data to demonstrate that Clinolipid injection provides sufficient amounts of essential fatty acids in this population.

The omega-3: omega-6 fatty acid ratio in Clinolipid injection has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.

Important Risk Information

WARNING: DEATH IN PRETERM INFANTS
● Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.
● Autopsy findings included intravascular fat accumulation in the lungs.
● Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increase free fatty acid plasma levels following lipid emulsion infusion.

The use of Clinolipid injection is contraindicated in patients with the following:

  • Known hypersensitivity to egg or soybean proteins, the lipid emulsion and/or excipients.
  • Severe hyperlipidemia or severe disorders of lipid metabolism

Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity or allergic reaction develop.

Monitor for signs and symptoms of fat overload, essential fatty acid deficiency (EFAD) and infections including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device.

Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding, to prevent refeeding complications.

Frequent clinical and laboratory determinations are necessary throughout treatment. Monitor fluid status closely in patients with pulmonary edema or heart failure.

Content of vitamin K may counteract anticoagulant activity.

Clinolipid injection contains no more than 25 mcg/L of aluminum. There is an increased aluminum toxicity risk in patients with impaired kidney function, including preterm infants.

Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. Monitor liver function tests. If patients develop liver test abnormalities consider discontinuation or dose reduction.

Reduce dose of Clinolipid injection and monitor serum triglyceride levels in patients with serum triglyceride concentrations above 400 mg/dL.

The most common (5%) adverse drug reactions reported during Clinolipid injection clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests.

Clinimix (amino acids in dextrose) Injections

Clinimix sulfite-free (amino acid in dextrose) Injections

Clinimix E sulfite-free (amino acid with electrolytes in dextrose and calcium) Injections

  • Clinimix is a ready-to-use amino acids in dextrose parenteral nutrition (PN) solution NOW AVAILABLE with higher protein (amino acid) and with and without electrolytes.
  • Choose from formulations as distinct as your patients

Explore Clinimix Here

INDICATIONS AND IMPORTANT RISK INFORMATION FOR CLINIMIX

Indications

CLINIMIX (amino acids in dextrose) Injections and CLINIMIX E (amino acids with electrolytes in dextrose with calcium) Injections are indicated as a source of calories and protein (and electrolytes for CLINIMIX E) for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX and CLINIMIX E may be used to treat negative nitrogen balance in patients.

Important Risk Information

  • CLINIMIX and CLINIMIX E Injections are contraindicated in patients with known hypersensitivity to one or more amino acids or dextrose; in patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications; and in patients with pulmonary edema or acidosis due to low cardiac output. In addition, CLINIMIX E is contraindicated in neonates (less than 28 days of age) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream.
  • Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. Excess addition of calcium and phopshate increases the risk of the formation of calcium phosphate precipitates. The solution should be inspected for precipitates before admixing, after admixing, and again before administration. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
  • Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with CLINIMIX E, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site.
  • Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop.
  • Monitor for signs and symptoms of early infections.
  • Refeeding severely undernourished patients may result in refeeding syndrome. Thiamine deficiency and fluid retention may also develop. Monitor severely undernourished patients and slowly increase nutrient intakes.
  • CLINIMIX and CLINIMIX E solutions containing more than 5% dextrose have an osmolarity of ≥ 900 mOsm/L and must be infused through a central catheter.
  • CLINIMIX and CLINIMIX E contain no more than 25 mcg/L of aluminum which may reach toxic levels with prolonged administration in patients with renal impairment. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions which contain aluminum. Patients with renal impairment, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
  • Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. If CLINIMIX and CLINIMIX E treated patients develop liver test abnormalities consider discontinuation or dosage reduction.
  • Use CLINIMIX and CLINIMIX E with caution in patients with cardiac insufficiency or renal impairment due to increased risk of electrolyte and fluid volume imbalance.
  • Monitor renal and liver function parameters, ammonia levels, fluid and electrolyte status, serum osmolarity, blood glucose, blood count and coagulation parameters throughout treatment. In situations of severely elevated electrolyte levels, stop CLINIMIX and CLINIMIX E until levels have been corrected.
  • Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma.

Please click here for full Prescribing Information for Clinimix.
Please click here for full Prescribing Information for Clinimix E.

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

Rx for an Efficient Pharmacy: Flexibility

  • The first and only Dexmedetomidine premix formulation in 0.9% sodium chloride in a flexible container
  • Does not require vented sets
  • Requires less space than glass bottles
  • Stackable storage solution

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

200 mcg/50 mL (4 mcg/mL) in a 50 mL GALAXY container

400 mcg/ 100 mL (4 mcg/ mL) in a 100 mL GALAXY container

Important Risk Information

Indications

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha2-adrenergic agonist indicated for:

  • Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours.
  • Sedation of non-intubated patients prior to and/or during surgical and other procedures.

Warnings and Precautions

  • Monitoring: Continuously monitor patients while receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection.
  • Bradycardia and Sinus Arrest: Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration.
  • Hypotension and Bradycardia: Patients must be monitored closely and may require medical intervention, as some cases have resulted in fatalities. Hypotension and/or bradycardia may be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly. Use with caution in patients with advanced heart block or severe ventricular dysfunction.
  • Co-administration with Other Vasodilators or Negative Chronotropic Agents: Use with caution due to additive pharmacodynamic effects.
  • Transient Hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate.
  • Hepatic Impairment: Dexmedetomidine hydrochloride in 0.9% sodium chloride injection clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function.
  • The most common adverse reactions (incidence >2%) are hypotension, bradycardia, and dry mouth.
  • Adverse reactions associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation.

Please see the accompanyin link for the full Prescription Information (PI).

Spectrum IQ Infusion System

The full range of intelligence in an IV pump

Focusing on the IV medication use process is a high safety priority. Studies show 85% of all medication errors reach the patient if an infusion pump is used1 and 61% of the most serious and life-threatening ADEs are associated with IV medications2. The recent introduction of bidirectional pump/EMR interoperability has significantly improved infusion administration safety, with ECRI reporting 75% of infusion-related medication errors potentially being avoided by using interoperability3. Despite this pivotal technological advancement, IV medication errors still continue to occur.

To truly close the loop on medication safety, hospitals should choose a pump that creates an integrated safety ecosystem to protect clinicians and patients. Spectrum IQ Infusion System revolutionizes the traditional idea of a smart pump by offering both innovative safety checks and advanced integration capabilities to help reduce errors. Only Spectrum IQ offers:

Advanced Integration Capabilities:

  • Broadest range of auto-programming workflows to support bidirectional EMR interoperability
  • On-screen barcode with scan prompts to maximize auto-programming compliance – no stickers required
  • Scan key on device keypad to simplify auto-programming workflow updates and back-association process for accurate documentation
  • On-demand Line Check Notification to visually confirm correct medication/pump association, reducing complexities inherent to multiple IV infusions
  • Both tagged and tag-less RTLS options, providing near-real time infusion pump status and location of devices across your health system

Innovative Safety Checks:

  • Intercepts excessive dose rate change errors within each drug’s soft limits
  • Auto defaults to DERS at startup, with Basic mode only being accessible after a drug is not found in the library
  • Care Area configuration to disallow entry in the Rate field for non-Rate based dosing

References:

1Guiliano KK. The Urgent Need for Innovation in IV Infusion Devices. Nursing. 2016; 46(4): 66-68.

2Smart Pump EMR Interoperability Report. Orem, UT: KLAS Research; 2017. Available at: http://klasresearch.com.

3Taylor, Matthew, PhD and Jones, Rebecca, MBA, RN. Risk of Medication Errors with Infusion Pumps, Patient Safety Journal. December 2019; pp. 61-19. DOI: 10.33940/biomed/2019.12.7

Rx Only. For safe and proper use of the product mentioned herein, please refer to the appropriate Operator’s Manual or Instructions for Use.

Mini-Bag Plus Container System

0.9% Sodium Chloride Injection, USP in Mini-Bag Plus Container & 5% Dextrose Injection, USP in Mini-Plus Container

  • Available in single and multi pack configurations
  • Closed system
  • Compatible with single dose powder of liquid (up to 10 mL) vials
Amino Acid Injections
  • A comprehensive range of amino acids, with 10%, 15% and the only 20% concentration
  • Premasol, pediatric amino acid in a plastic-container, backed by calcium-phosphate solubility data

Explore Amino Acids Here

Indications

6% and 10% Premasol sulfite-free (Amino Acid) Injections are indicated for the nutrition support of Infants (including those of very low birth weight) and young children requiring TPN via central or peripheral infusion routes. Please read the accompanying Full Indication(s) and Important Risk Information and the Package Insert for Full Prescribing Information for Premasol.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Indications and Important Risk Information for CLINISOL

Indications for 15% CLINISOL sulfite-free (Amino Acid) Injection

15% CLINISOL sulfite-free (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

Important Risk Information

  • Contraindicated in patients with hypersensitivity to one or more amino acids, severe liver disease or hepatic coma, Anuria and Metabolic disorders involving impaired nitrogen utilization.
  • Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrition admixture.
  • This injection is for compounding only, not for direct infusion.
  • Administration of amino acid solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. If hyperammonemia develops, discontinue the amino acid administration and reevaluate the patient’s clinical status.
  • This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amount of calcium and phosphate solutions, which contain aluminum.
  • The administration of 15% Clinisol Injection as part of the total parenteral nutrition with large volumes of hyperosmotic fluids requires periodic monitoring for signs of hyperosmolarity, hyperglycemia, glycosuria, hypertriglyceridemia and volume overload. Initiation and termination of TPN infusion must be gradual to permit adjustment of endogenous insulin release.
  • During parenteral nutrition with concentrated dextrose and amino acid solutions, essential fatty acid deficiency syndrome may develop and therefore plasma lipids should be monitored. This syndrome may be prevented or corrected by treatment with intravenous fat emulsions.
  • Frequent clinical evaluations and laboratory determinations are necessary for proper monitoring during administration.
  • Total parenteral nutrition therapy may include multiple vitamins, trace elements and additional electrolytes. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate containers to avoid precipitation.
  • Local adverse reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids. Generalized flushing, fever and nausea have been reported during peripheral infusions of amino acid solutions.
  • The following metabolic complications have been reported with administration of TPN: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia, coma and death.

Please click here for full prescribing information for CLINISOL.

 

Indications and Important Risk Information for PREMASOL

Indications for 6% and 10% PREMASOL sulfite-free (Amino Acid) Injections

6% and 10% PREMASOL sulfite-free (Amino Acid) Injections are indicated for the nutrition support of Infants (including those of very low birth weight) and young children requiring TPN via central or peripheral infusion routes. Parenteral nutrition with PREMASOL injections is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired, or (3) protein requirements are substantially increased, as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance.

Important Risk Information

  • PREMASOL Injections are contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism, including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia, or hypersensitivity to one or more amino acids in the solution.
  • This injection is for compounding only, not for direct infusion.
  • Safe, effective use of parenteral nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur.
  • Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Depending on the patient’s conditions or disease state, additional electrolyte supplementation may be required.
  • Fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema can occur with IV administration.
  • Administration of amino acids in patients with impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Do not inf use amino acids in patients with azotemia.
  • Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
  • It is essential that blood ammonia be measured frequently in infants. Hyperammonemia in the syndrome is caused by genetic metabolic defects and is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose related and is more likely to develop during prolonged therapy.
  • This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
  • Strongly hypertonic nutrient solutions should be administered via an intravenous catheter placed in a central vein, preferably the superior vena cava.
  • Special care must be taken when giving hypertonic dextrose to patients with diabetes or impaired glucose tolerance. To prevent hyperglycemia in such patients, insulin may be required.
  • The final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
  • Adverse reactions reported in clinical studies were: water weight gain, edema, increase in BUN, and mild acidosis. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypovolemia. Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorous intake can precipitate hypocalcemia with cramps, tetany, and muscular hyperexcitability. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic counter measures and save the remainder of the fluid for examination, if deemed necessary.

Please click here for full prescribing information for PREMASOL.

Cardene I.V. (nicardipine hydrochloride) Premixed Injection

Rapid Acting and Titrated

  • Manufacturer-prepared premix
  • Ready to administer bags
  • Two-year shelf life at controlled room temperature range of 20-25° C (68-77° F)
  • Can be stored at point of care

Indication

CARDENE I.V. (nicardipine hydrochloride) Premixed Injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits.

Important Safety Information

Contraindications

Do not use in patients with advanced aortic stenosis.

Warnings and Precautions

  • If unacceptable hypotension or tachycardia occurs, discontinue the CARDENE I.V. When blood pressure and heart rate stabilize, restart the infusion at low doses.
  • Titrate slowly when using CARDENE I.V., particularly in combination with a beta-blocker, in patients with heart failure or significant left ventricular dysfunction because of possible negative inotropic effects.
  • Closely monitor response to CARDENE I.V. in patients with angina, heart failure, impaired hepatic function, or renal impairment.
  • To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the occurrence of vascular impairment, administer drug through large peripheral veins or central veins rather than arteries or small peripheral veins. To minimize the risk of peripheral venous irritation, change the site of infusion of CARDENE I.V. every 12 hours.
  • The most common adverse reactions are headache (15%), hypotension (6%), tachycardia (4%), and nausea/vomiting (5%).
  • Cimetidine increases oral nicardipine plasma levels.
  • CARDENE I.V. may increase cyclosporine and tacrolimus plasma levels. Frequent monitoring of trough blood levels is recommended when co-administering CARDENE I.V.
  • Pregnancy: Based on animal data may cause fetal harm. CARDENE I.V. should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Dosage and Administration

  • Inspect CARDENE I.V. visually for particulate matter and discoloration prior to administration. CARDENE I.V. is normally a clear, colorless to yellow solution.
  • Do not combine CARDENE I.V. with any product in the same intravenous line or premixed container. Do not add supplementary medication to the bag. Protect from light until ready to use.

Please see Full Prescribing Information for Cardene I.V. (nicardipine hydrochloride) 20 mg

Please see Full Prescribing Information for Cardene I.V. (nicardipine hydrochloride) 40 mg

Nexterone (amiodarone HCI) Premixed Injection

Ready at a Moment’s Notice

  • Manufacturer-prepared premix
  • Ready to administer bags
  • Two-year shelf life at controlled room temperature range of 20-25° C (68-77° F)
  • Can be stored at point of care

NEXTERONE (amiodarone HCl) Premixed Injection Indications and Important Risk Information (IRI)

Indications and Usage

NEXTERONE (amiodarone HCl) Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy.

Important Risk Information (IRI)

NEXTERONE (amiodarone HCl) Premixed Injection should be administered only by physicians who are experienced in the treatment of life‐threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.

NEXTERONE is contraindicated in patients with:

    • Known hypersensitivity to any of the components of NEXTERONE, including iodine
    • Cardiogenic shock
    • Marked sinus bradycardia
    • Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available

 

  • Hypotension is the most common adverse reaction seen with intravenous amiodarone. Clinically significant hypotension was seen most often in the first several hours of treatment and appeared to be related to the rate of infusion. To treat hypotension, slow the infusion; as needed, add vasopressor drugs, positive inotropic agents, and volume expansion.
  • Drug-related bradycardia that was not dose‐related occurred while patients were receiving intravenous amiodarone for life‐threatening VT/VF. To treat bradycardia, slow the infusion or discontinue NEXTERONE. In some patients, inserting a pacemaker is required.
  • Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing NEXTERONE.
  • NEXTERONE may cause worsening of existing arrhythmias or precipitate a new arrhythmia sometimes leading to fatal outcomes. Monitor patients for QTc prolongation during infusion with NEXTERONE.
  • Amiodarone is a substrate for CYP3A and CYP2C8, so inhibitors and inducers affect amiodarone exposure.
  • Amiodarone inhibits p‐glycoprotein and CYP1A2, CYP2C9, CYP2D6, and CYP3A, increasing exposure to other drugs.
  • The most important adverse reactions were hypotension, asystole/cardiac arrest/pulseless electrical activity (PEA), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, AV block, and torsade de pointes.
  • The most common adverse reactions (1-2%) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock.

Please see the accompanying link for full Prescribing Information (PI).

Premix Products

Comprehensive Premix Portfolio

  • Premix products help minimize medication errors related to compounding
  • Provide an accurately prepared dose
  • Can help increase efficiencies in your pharmacy by requiring fewer preparation steps
  • Can help reduce waste
Repeater Pharmacy Pump

Proven Leadership for automated workflow in the pharmacy.

  • The Repeater Pump is a versatile peristaltic pump designed to reduce the workload of pharmacy technicians through automated fluid transfers.
  • Quick set up helps streamline pharmacy operations.
  • Used for multiple applications – reconstitution of drugs, IV admixing and transfer and filling of IV bags, syringes, elastomeric devices and oral syringes.

Rx Only: For safe and proper use of this device, refer to the Instructions for Use of Appropriate Manual.

Suprane (desflurane, USP) Liquid for Inhalation

25 years of market leadership in anesthesia gases. Suprane in an aluminum bottle is designed for safe packaging and space efficiency. Suprane offers a space efficient and lighter bottle that may help facilitate the ease of handling for the filling of vaporizers. The aluminum bottle helps to reduce the safety hazards of cracked or broken glass bottles.

SUPRANE (desflurane, USP) Volatile Liquid for Inhalation

INDICATIONS 

SUPRANE is indicated as an inhalation agent for induction and/or maintenance of anesthesia for inpatient and outpatient surgery in adults.

SUPRANE is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in pediatric patients following induction with agents other than SUPRANE and intubation.

IMPORTANT RISK INFORMATION

DOSAGE AND ADMINISTRATION

  • SUPRANE should be administered only by persons trained in the administration of general anesthesia. It should only be administered using a vaporizer specifically designed and designated for use with SUPRANE.
  • SUPRANE should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or where increases in heart rate or blood pressure are undesirable.
  • SUPRANE should be administered at 0.8 MAC or less in patients with known or suspected increases in cerebrospinal fluid pressure (CSFP).

CONTRAINDICATIONS

  • Patients with known or suspected genetic susceptibility to malignant hyperthermia
  • Patients in whom general anesthesia is contraindicated
  • Induction of anesthesia in pediatric patients due to high incidence of upper airway adverse events
  • Patients with known sensitivity to SUPRANE or other halogenated agents
  • Patients with a history of moderate to severe hepatic dysfunction following anesthesia with SUPRANE or other halogenated agents and not otherwise explained.

WARNINGS AND PRECAUTIONS

  • Malignant Hyperthermia: Malignant hyperthermia may occur. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapy. Renal failure may appear later, and urine flow should be monitored and sustained if possible.

Fatal outcome of malignant hyperthermia has been reported with desflurane.

  • Perioperative Hyperkalemia: Perioperative hyperkalemia may occur. Patients with latent or overt neuromuscular disease, particularly with Duchenne muscular dystrophy, appear to be most vulnerable. Early, aggressive intervention is recommended.
  • Respiratory Adverse Reactions in Pediatric Patients: SUPRANE is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions including coughing, laryngospasm and secretions. Monitor and treat accordingly.

May cause airway narrowing and increased airway resistance in children with asthma or a history of recent upper airway infection. Monitor and treat accordingly.

  • QTc Prolongation: Carefully monitor cardiac rhythm when administering SUPRANE to susceptible patients.
  • Interactions with Desiccated Carbon Dioxide (CO2) Absorbents: Desflurane may react with desiccated CO2 absorbents to produce carbon monoxide. Replace desiccated CO2 absorbent before administration of SUPRANE.
  • Hepatobiliary Disorders: May cause sensitivity hepatitis in patients sensitized by previous exposure to halogenated anesthetics. Cirrhosis, viral hepatitis or other pre-existing hepatic disease may be a reason to select an anesthetic other than a halogenated anesthetic. Approach repeated anesthesia with caution.
  • Pediatric Neurotoxicity: In developing animals, exposures greater than 3 hours cause neurotoxicity. Weigh benefits against potential risks when considering elective procedures in children under 3 years old.
  • Postoperative Agitation in Children: May cause postoperative agitation during emergence from anesthesia in children.

ADVERSE REACTIONS

The most common adverse reactions (incidence> 10%) are coughing, breath holding, apnea, nausea, and vomiting.

DRUG INTERACTIONS

  • Concomitant use of N2O, benzodiazepines and/or opioids reduces the MAC of SUPRANE. Adjust dose accordingly.
  • SUPRANE decreases the doses of neuromuscular blocking agents required. Adjust dose accordingly.

 USE IN SPECIFIC POPULATIONS

Geriatric Use: The minimum alveolar concentration (MAC) of SUPRANE decreases with increasing patient age. Adjust dose accordingly.

Please see the accompanying link for the full Prescribing Information (PI).

Sevoflurane, USP Volatile Liquid for Inhalation

Sevoflurane, USP Volatile Liquid for Inhalation Indications

  • Sevoflurane, USP is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.
  • Sevoflurane, USP should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available.  Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of Sevoflurane, USP should be used.

Important Risk Information

  • Sevoflurane can cause malignant hyperthermia. Postmarketing reports of malignant hyperthermia, some of which have been fatal, have occurred. Sevoflurane should not be used in patients with known sensitivity to sevoflurane or to other halogenated agents, or in patients with known or suspected susceptibility to malignant hyperthermia.
  • Findings taken from patient and animal studies suggest that there is a potential for renal injury when Sevoflurane is used at low flow rates, which is presumed due to Compound A. The level of Compound A exposure at which clinical nephrotoxicity might be expected to occur has not been established. To minimize exposure to Compound A, Sevoflurane exposure should not exceed 2 MAC-hours at flow rates of 1 to <2 L/min. Fresh gas flow rates <1 L/min are not recommended.
  • Because clinical experience in administering Sevoflurane to patients with renal insufficiency (creatinine >1.5 mg/dL) is limited, its safety in these patients has not been established.
  • Sevoflurane may be associated with glycosuria and proteinuria when used for long procedures at low flow rates.
  • KOH containing CO2 absorbents are not recommended for use with Sevoflurane. An exothermic reaction occurs when Sevoflurane is exposed to CO2 absorbents. This reaction is increased when the absorbent becomes desiccated. Rare cases of extreme heat, smoke, and/or spontaneous fire have been reported during Sevoflurane use in conjunction with the use of desiccated CO2 absorbent, specifically those containing potassium hydroxide (e.g., Baralyme).
  • Reports of QT prolongation, associated with torsade de pointes (in exceptional cases, fatal), have been received. Caution should be exercised when administering Sevoflurane to susceptible patients (e.g. patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval).
  • Rare increases in serum potassium resulting in cardiac arrhythmias and death have been noted in pediatric patients during the postoperative period following the use of inhaled anesthetic agents. Contributing risk factors appear to be latent or overt neuromuscular disease, particularly Duchenne muscular dystrophy. Concomitant use of succinylcholine has been associated with most, but not all, of these cases. Early, aggressive intervention to treat both hyperkalemia and resistant arrhythmias, and subsequent evaluation for latent neuromuscular disease, is recommended.
  • Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend to approximately three years of age in humans.  Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects.
  • Due to Sevoflurane’s insolubility in blood, hemodynamic changes may occur more rapidly than with other volatile anesthetics. Excessive decreases in blood pressure or respiratory depression may be related to depth of anesthesia and may be corrected by decreasing the inspired concentration of Sevoflurane.
  • Seizures have been reported in association with Sevoflurane use, the majority of which have occurred in children and young adults, most of whom had no predisposing risk factors. Clinical judgment should be exercised when using Sevoflurane in patients who may be at risk for seizures.
  • Drug interactions: Benzodiazepines and opioids would be expected to decrease the MAC of Sevoflurane. The anesthetic requirement for Sevoflurane is decreased when administered in combination with nitrous oxide. Sevoflurane increases both the intensity and duration of neuromuscular blockade induced by nondepolarizing muscle relaxants.
  • Very rare cases of mild, moderate, and severe postoperative hepatic dysfunction or hepatitis with or without jaundice have been reported from postmarketing experiences. In addition, rare postmarketing reports of hepatic failure and hepatic necrosis have been associated with the use of Sevoflurane. Clinical judgment should be used in patients with underlying hepatic conditions or who are under treatment with drugs known to cause hepatic dysfunction. It has been reported that previous exposure to halogenated hydrocarbon anesthetics may increase the potential for hepatic injury.
  • Adverse events reported by ≥5% of the surgical patients receiving Sevoflurane during clinical trials during induction included: bradycardia, tachycardia, agitation, laryngospasm, airway obstruction, breathholding, and increased cough; during maintenance and emergence: shivering, hypotension, bradycardia, somnolence, agitation, nausea, vomiting, and increased cough were reported.

Please see the accompanying link for the full Prescribing Information (PI).

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