Ready-to-Use Premix Medications.

A broad portfolio of premixes that are there when your patients need them.

Baxter Ready-to-Use (RTU)

Baxter offers practical and innovative products in premix ready-to-use IV formulations, which may help increase hospital efficiency, while helping with your overall safety protocols.1,2

Ready for Safety:

• Consistent drug concentrations may help minimize medication errors associated with compounding1,2

 

• Barcoded for bedside scanning to help ensure the right patient gets the right medication1

Ready for Efficiency:

• Improved workflow by allowing on-demand availability of medication, which may help reduce the steps required to prepare medication for administration

 

• Supports inventory management and helps reduce waste3

Ready for Value:

• Manufacturer-prepared premix medications have a shelf life of 9 to 24 months

 

• Proprietary GALAXY container technology—a non-PVC and non-DEHP system—enables certain premix medicines to have an extended shelf life when stored at room temperature

Ready for Patient Care:

• Designed for ready use, helping to reduce the risk of preventable medication errors in patients associated with compounding1,2

 

• Formulations that are shelf-stable at room temperature allow for storage in automated dispensing cabinets and closer to the patient

Baxter’s manufacturer-prepared premixes are convenient and ready when you need them, potentially shortening the time between ordering and administration. This may allow you to spend more time with your patients.

See Our Value to Customers

30% of hospitals have experienced a patient event involving a compounding error in the past 5 years

There is a 33% overall error rate, including preparation and diluent/solvent issues, infusion rate errors, and chemical incompatibility of IV drugs

There is a $600,000 increase per hospital due to preventable ADEs associated with injectable medications

Baxter's Partnership Promise

For 90 years, Baxter has been focused on helping support patient care.

We are committed to partnering with healthcare facilities to help solve their most pressing challenges, including supporting patient safety, operational efficiencies and worker shortages.

The launch of our Mini-Bag Plus containers in 1974 marked our first of many innovations to bring ready-to-use presentation options to market.

Featured Ready-to-Use Products

Baxter offers a breadth of ready-to-use medications, both liquid and frozen, to help your healthcare facility meet the needs of your patients and helping to ensure they receive optimal care from the ER to the OR and beyond.

Please see accompanying Indications, Important Risk Information, and link to the Prescribing
Information for each of these products below
.

Ready to purchase? Call your Baxter sales representative, or dial: 1.800.229.0001

Passive Thawing—Frozen Premix Medications Video

Thawing frozen premix medications is an important step in preparing a hospital for a full day of patient care. And trying to minimize the number of touchpoints in the process is key to creating efficiencies. Watch the Passive Medication-Thawing Video to learn more about how this may be a solution to your thawing needs.

Premix Manufacturing Process Video

Baxter has developed a premix manufacturing process in the US specifically designed for long-term storage of unstable and temperature-sensitive medications. This may help reduce waste,3 streamline workflow, support efficient delivery of medications, and reduce human errors related to admixing.1,2

Watch the Manufacturing Video to learn about our cGMP-compliant manufacturing process.

Norepinephrine Bitartrate in 5% Dextrose Injection

4 mg equivalent of norepinephrine (16 mcg/mL) in 5% dextrose 250 mL

8 mg equivalent of norepinephrine (32 mcg/mL) in 5% dextrose 250 mL

Important Risk Information

Indication

Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.

Contraindications

• None

Warnings and Precautions

Tissue Ischemia: Administration of Norepinephrine Bitartrate in Dextrose Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Norepinephrine Bitartrate in Dextrose Injection. Avoid use in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction.

Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients.

Extravasation of Norepinephrine Bitartrate in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation. Avoid administration into the veins in the leg in elderly patients.

Emergency Treatment of Extravasation: Infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults.

Hypotension after Abrupt Discontinuation: Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the Norepinephrine Bitartrate in Dextrose Injection infusion rate while expanding blood volume with intravenous fluids.

Cardiac Arrhythmias: Norepinephrine Bitartrate in Dextrose Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.

• Most common adverse reactions are hypertension and bradycardia.

Drug Interactions:
Co-administration of Norepinephrine Bitartrate in Dextrose Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) or with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension.

Anti-diabetics: Norepinephrine Bitartrate in Dextrose Injection can decrease insulin sensitivity and raise blood glucose.

Concomitant use of Norepinephrine Bitartrate in Dextrose Injection with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics.

• Elderly patients may be at greater risk of developing adverse reactions.

Please see accompanying full Prescribing Information for Norepinephrine Bitartrate in 5% Dextrose Injection.

 

Myxredlin (Insulin Human) in 0.9% Sodium Chloride Injection

100 units/100 mL (1 unit/mL)

INDICATIONS AND IMPORTANT RISK INFORMATION

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 accompanying full Prescribing Information for MYXREDLIN.

 

Cardene I.V. (nicardipine hydrochloride)

20 mg in 200mL (0.1 mg/mL) in 0.86% Sodium Chloride

40 mg in 200mL (0.2 mg/mL) in 0.83% Sodium Chloride

Indication and Important Risk Information

Indication

CARDENE I.V. 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 Risk Information

Contraindications

Do not use in patients with advanced aortic stenosis.

Warnings and Precautions

Exacerbation of Angina:  Increases in frequency, duration, or severity of angina have been seen in chronic therapy with oral nicardipine.  Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with CARDENE I.V.  The mechanism of this effect has not been established.

Exacerbation of Heart Failure:  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.

Increased effect with Impaired Hepatic Function:  Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor responses in patients with impaired liver function or reduced hepatic blood flow.

Prolonged effect with Impaired Renal Function:  When CARDENE I.V. was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) was observed.  Titrate gradually in patients with renal impairment.

Local Irritation:  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, such as those on the dorsum of the hand or wrist.  To minimize the risk of peripheral venous irritation, change the site of the drug infusion every 12 hours.

Adverse Reactions:  Most common adverse reactions are headache (15%), hypotension (6%), tachycardia (4%) and nausea/vomiting (5%).

Drug Interactions:

Cimetidine has been shown to increase nicardipine plasma concentrations with oral nicardipine administration.  Frequently monitor response in patients receiving both drugs.

Oral or intravenous nicardipine may increase cyclosporine and tacrolimus plasma levels.  Frequent monitoring of trough blood levels of cyclosporine and tacrolimus 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

If unacceptable hypotension or tachycardia occurs, discontinue the CARDENE I.V. infusion.  When blood pressure and heart rate stabilize, restart the infusion at low doses.

Please see accompanying full Prescribing Information for CARDENE I.V.

 

NEXTERONE (amiodarone HCl) Premixed Injection

150 mg/100 mL and 360 mg/200 mL

Indication and Important Risk Information

Indication

NEXTERONE 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.

Important Risk Information

Contraindications

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 atrioventricular (AV) block unless a functioning pacemaker is available

Warnings and Precautions

Persistence of Adverse Effects: Because of the long half-life of amiodarone (9 to 36 days) and its metabolite desethylamiodarone (9 to 30 days), adverse reactions or interactions, as well as observed adverse effects, can persist following amiodarone withdrawal.

Hypotension: Most often seen in the first several hours of treatment and likely related to the rate of infusion. In some cases, hypotension may be refractory and result in a fatal outcome.

To treat: Slow the infusion; as needed, add vasopressor drugs, positive inotropic agents, and volume expansion.

Bradycardia and Atrioventricular Block: May require slowing the infusion rate or discontinuing NEXTERONE. In some patients, inserting a pacemaker is required. Have a temporary pacemaker available when treating a patient predisposed to bradycardia or AV block.

Hepatic Injury: Acute hepatocellular necrosis leading to hepatic coma, acute renal failure, and death has been associated. Intravenous infusions at much higher concentrations and rates of infusion than those recommended appear to increase this risk. Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. Consider reducing the rate of administration or withdrawing NEXTERONE if hepatic injury occurs.

Proarrhythmia: NEXTERONE may cause a worsening of existing arrhythmias or precipitate a new arrhythmia, sometimes leading to fatal outcomes. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation by intravenous amiodarone. Monitor patients for QTc prolongation during infusion with NEXTERONE. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent. Correct hypokalemia, hypomagnesemia or hypocalcemia whenever possible before initiating treatment with NEXTERONE.

Pulmonary Injury: There have been post-marketing reports of acute-onset (days to weeks) pulmonary injury. Some cases have progressed to respiratory failure or death. Monitor for new respiratory symptoms and evaluate appropriately. Obtain a baseline chest X-ray and pulmonary function tests in patients who are expected to be receiving amiodarone chronically.

Loss of Vision: Cases of optic neuropathy and optic neuritis, usually resulting in visual impairment, have been reported. In some cases, visual impairment has progressed to permanent blindness. Optic neuropathy and neuritis may occur at any time following initiation of therapy. Perform an ophthalmic examination if symptoms of visual impairment appear. Reevaluate the necessity of amiodarone therapy if optic neuropathy or neuritis is suspected.

Thyroid Abnormalities: NEXTERONE inhibits peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause increased T3 levels, and increased levels of inactive reverse T3 (rT3) in clinically euthyroid patients. Monitor thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction. Hyperthyroidism may induce arrhythmia breakthrough. If any new signs of arrhythmia appear, the possibility of hyperthyroidism should be considered.

Neonatal Injury: Amiodarone can cause fetal harm when administered to a pregnant woman. Fetal exposure may increase the potential for adverse experiences including cardiac, thyroid, neurodevelopmental, neurological and growth effects in neonate. Inform the patient of the potential hazard to the fetus if NEXTERONE is administered during pregnancy or if the patient becomes pregnant while taking NEXTERONE.

Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions have been reported including shock (sometimes fatal), cardiac arrest, and the following manifestations: hypotension, tachycardia, hypoxia, cyanosis, rash, Stevens-Johnson syndrome, flushing, hyperhidrosis and cold sweat.

Adverse Reactions: 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. Other important adverse reactions are torsade de pointes, congestive heart failure, and liver function test abnormalities.

Drug Interactions: 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.

Please see accompanying full Prescribing Information for NEXTERONE (amiodarone HCl) Premixed Injection.

 

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

Indications and 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.

Important Risk Information

Contraindications

• None

Warnings and Precautions

Monitoring:  Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered only by persons skilled in the management of patients in the intensive care or operating room setting.  Patients should be continuously monitored while receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection.

Hypotension, Bradycardia, and Sinus Arrest:  Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine hydrochloride in 0.9% sodium chloride injection administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration.

Reports of hypotension and bradycardia have been associated with dexmedetomidine hydrochloride in 0.9% sodium chloride injection infusion.  Some of these cases have resulted in fatalities.  If medical intervention is required, treatment may include decreasing or stopping the infusion, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents.

Caution should be exercised when administering to patients with advanced heart block and/or severe ventricular dysfunction.  Because dexmedetomidine hydrochloride in 0.9% sodium chloride injection decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients.

Transient Hypertension:  Has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of dexmedetomidine hydrochloride in 0.9% sodium chloride injection.  Treatment has generally not been necessary, although reduction of the loading infusion rate may be desirable.

Arousability:  Some patients receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection have been observed to be arousable and alert when stimulated.  This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.

Tolerance and Tachyphylaxis:  Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions.

Hyperthermia or Pyrexia:  Dexmedetomidine hydrochloride in 0.9% sodium chloride injection may induce hyperthermia or pyrexia, which may be resistant to traditional cooling methods, such as administration of cooled intravenous fluids and antipyretic medications.  Discontinue if drug-related hyperthermia or pyrexia is suspected and monitor patients until body temperature normalizes.

Hepatic Impairment:  Since 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.

Adverse Reactions:

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.

• Drug Interactions:

Anesthetics, Sedatives, Hypnotics, Opioids:  Enhancement of pharmacodynamic effects.  Reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant medication may be required.

Please see accompanying full Prescribing Information for Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection.

 

BREVIBLOC (esmolol HCl) Injection

2,500 mg/250 mL (10 mg/mL) in INTRAVIA Plastic Container

2,000 mg/100mL (20 mg/mL) Double Strength in INTRAVIA Plastic Container

Indications for BREVIBLOC (esmolol HCl) Injection

Supraventricular Tachycardia

• BREVIBLOC Injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable.

• BREVIBLOC Injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. BREVIBLOC Injection is intended for short-term use.

Intraoperative and Postoperative Tachycardia and Hypertension

• BREVIBLOC Injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated.

• Use of BREVIBLOC Injection to prevent such events is not recommended.

Important Risk Information for BREVIBLOC (esmolol HCl) Injection

• BREVIBLOC Injection is contraindicated in patients with:

o Severe sinus bradycardia, heart block greater than first degree and sick sinus syndrome all of which may precipitate or worsen bradycardia

o Decompensated heart failure

o Cardiogenic shock

o IV administration of cardiodepressant calcium-channel antagonists (e.g. verapamil) and BREVIBLOC Injection in close proximity (i.e., while cardiac effects from the other drug are still present); fatal cardiac arrests have occurred in patients receiving BREVIBLOC Injection and IV verapamil

o Pulmonary hypertension

o Known hypersensitivity to esmolol or any inactive product ingredients

• Hypotension can occur at any dose but is dose-related. For control of ventricular heart rate, maintenance doses greater than 200 mcg per kg per min are not recommended. Monitor patients closely, especially if pretreatment blood pressure is low. In case of an unacceptable drop in blood pressure, reduce or stop BREVIBLOC Injection.

• Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred. Monitor patient’s heart rate and rhythm. If severe bradycardia develops, reduce or stop BREVIBLOC Injection.

• Beta-blockers, like BREVIBLOC Injection, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. Stop BREVIBLOC Injection and start support therapy at first sign of impending cardiac failure.

• Monitor vital signs closely and titrate BREVIBLOC Injection slowly in the treatment of patients whose blood pressure is primarily driven by vasoconstriction associated with hypothermia.

• Patients with reactive airways disease should, in general, not receive beta blockers. Titrate BREVIBLOC Injection to the lowest possible effective dose. Stop infusion immediately in the event of a bronchospasm.

• In patients with hypoglycemia or diabetes, beta blockers may mask tachycardia occurring with hypoglycemia.

• Avoid infusions into small veins or through a butterfly catheter.

• Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma. If used in the setting of pheochromocytoma, give it in combination with an alpha-blocker, and only after the alpha-blocker has been initiated.

• Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease.

Drug Interactions:

• Concomitant use of BREVIBLOC Injection with other drugs that can lower blood pressure, reduce myocardial contractility, or interfere with sinus node function or electrical impulse propagation in the myocardium can exaggerate BREVIBLOC Injection’s effects on blood pressure, contractility, and impulse propagation. Severe interactions with such drugs can result in, for example, severe hypotension, cardiac failure, severe bradycardia, sinus pause, sinoatrial block, atrioventricular block, and/or cardiac arrest.

• Concomitant administration of digoxin and BREVIBLOC Injection leads to an approximate 10% to 20% increase of digoxin blood levels at some time points and increases the risk of bradycardia.

• BREVIBLOC Injection can prolong the duration of neuromuscular blockade.

• Beta blockers increase the risk of withdrawal rebound hypertension when used with antihypertensive agents, such as clonidine, guanfacine, or moxonidine.

• Calcium channel antagonists and BREVIBLOC Injection can cause fatal cardiac arrest in patients with depressed myocardial function.

• Sympathomimetic drugs having beta-adrenergic agonist activity will counteract the effects of BREVIBLOC Injection.

• Do not use BREVIBLOC Injection in patients receiving drugs that are vasoconstrictive and have positive inotropic effects, such as epinephrine, norepinephrine, and dopamine.

• Adverse reactions most commonly (≥3%) reported in clinical trials included asymptomatic (25%) and symptomatic (12%) hypotension, infusion site reaction (8%), nausea (7%), dizziness (3%), and somnolence (3%).

Please see accompanying full Prescribing Information for BREVIBLOC Injection.

Cefazolin Injection, USP

1 g /50 mL and 2 g /100 mL

Indications and Important Risk Information

Indications

Cefazolin injection is a cephalosporin antibacterial indicated for:

• Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: Respiratory tract infections; Urinary tract infections; Skin and skin structure infections; Biliary tract infections; Bone and joint infections; Genital infections; Septicemia; Endocarditis

• Perioperative prophylaxis in adults for whom appropriate dosing with this formulation can be achieved

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin injection and other antibacterial drugs, cefazolin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Important Risk Information

Contraindications

Hypersensitivity to Cefazolin or the Cephalosporin Class of Antibacterial Drugs, Penicillins, or Other Beta-lactams

Warnings and Precautions

• Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins, or Other Beta-lactams: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with cefazolin injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cefazolin injection occurs, discontinue the drug.

• Seizures in Patients with Renal Impairment: Seizures may occur with the administration of cefazolin injection, particularly in patients with renal impairment when the dosage is not reduced appropriately. Discontinue cefazolin injection if seizures occur or make appropriate dosage adjustments in patients with renal impairment. Anticonvulsant therapy should be continued in patients with known seizure disorders.

Clostridioides difficile-associated Diarrhea: Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefazolin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

• Hypersensitivity to Dextrose-containing Products: Hypersensitivity reactions, including anaphylaxis, have been reported with administration of dextrose-containing products. These reactions have been reported in patients receiving high concentrations of dextrose (i.e. 50% dextrose). The reactions have also been reported when corn-derived dextrose solutions were administered to patients with or without a history of hypersensitivity to corn products

• Risk of Development of Drug-resistant Bacteria: Prescribing cefazolin injection in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. As with other antimicrobials, prolonged use of cefazolin injection may result in overgrowth of non-susceptible microorganisms. Repeated evaluation of the patient's condition is essential. Should superinfection occur during therapy, appropriate measures should be taken.

• Adverse Reactions: Adult and Pediatric Patients: Most common adverse reactions: gastrointestinal (nausea, vomiting, diarrhea), and allergic reactions (anaphylaxis, urticaria, skin rash).

• Drug Interactions: The renal excretion of cefazolin is inhibited by probenecid. Co-administration of probenecid with cefazolin injection is not recommended.

Please see accompanying full Prescribing Information for Cefazolin Injection, USP.