LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today the launch and immediate availability in the U.S. of Diazepam Injection, USP in 10 mg per 2 mL Simplist® ready-to-administer prefilled syringes.
Fresenius Kabi Simplist Diazepam Injection, USP is the most recent manufacturer-prepared product available in the company’s proprietary, ready-to-administer portfolio of Simplist prefilled syringes, designed for efficient medication delivery and ease of use, to help eliminate steps where errors can occur.1
"Fresenius Kabi understands the immense pressure nurses and pharmacists are under when caring for patients, which is why helping reduce clinician burden is a priority for us," said John Ducker, president and CEO of Fresenius Kabi USA. "We're pleased to add Diazepam Injection to our Simplist prefilled syringe portfolio, which will simplify preparation processes and streamline workflows for clinicians in the U.S., all while helping enhance patient safety."
Preventable medication errors caused by injectable medications impact more than 1 million hospitalizations annually, adding an estimated $2.7 billion to $5.1 billion of medical costs to the U.S. health care system.2 Ready-to-administer medication systems, such as the Fresenius Kabi Simplist portfolio, can play a vital role in simplifying drug preparation and administration processes, and are recommended by the Joint Commission, American Society of Health-System Pharmacists (ASHP), Institute for Safe Medication Practices (ISMP), and Anesthesia Patient Safety Foundation (APSF).3,4,5,6
Expanding its range of ready-to-administer (RTA) offerings, Fresenius Kabi continues to invest in providing pharmacists and nurses with a wide range of prefilled, standard strengths, single-patient delivery system options — from premix IV bags to prefilled syringes — that streamline medication management from the pharmacy to the bedside.
Simplist Diazepam Injection, USP is formulated, filled, and packaged in the U.S. using fully automated state-of-the-art technology. The company has invested nearly $1 billion on an advanced manufacturing and distribution network dedicated to serving U.S. hospitals and health systems. To learn more about how Fresenius Kabi is strengthening America’s supply chain of care, please visit MoreInAmerica.com.
To learn more about the Simplist portfolio with pharmacy clinical education support, please visit www.simplist-us.com.
INDICATIONS AND USAGE
- Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
- In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
- As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient’s recall of the procedures.
- Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus.
- Diazepam Injection is a useful adjunct in status epilepticus.
- Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient’s recall of the procedure.
IMPORTANT SAFETY INFORMATION
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS |
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Diazepam injection is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; and open angle glaucoma unless patients are receiving appropriate therapy.
Risks from Concomitant Use with Opioids: Concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of benzodiazepines and opioids in patients for whom alternative treatment options are inadequate.
Abuse, Misuse, and Addiction: The use of benzodiazepines, including diazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing diazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
Dependence and Withdrawal Reactions After Use of Diazepam More Frequently Than Recommended: To reduce risk of withdrawal reactions, use a gradual taper to discontinue diazepam. Acute Withdrawal Reactions: The continued use of benzodiazepines may lead to clinically significant physical dependence. If used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of diazepam or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures). Protracted Withdrawal Syndrome: In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.
Diazepam injection should not be administered to patients in shock, coma, or in acute alcoholic intoxication with depression of vital signs. Patients receiving diazepam should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.
Tonic status epilepticus has been precipitated in patients treated with intravenous diazepam for petit mal status or petit mal variant status.
Usage in Pregnancy: Avoid use during the first trimester of pregnancy. Until additional information is available, Diazepam Injection is not recommended for obstetrical use.
Pediatric Use: Efficacy and safety of parenteral diazepam has not been established in the neonate (30 days or less of age). Prolonged central nervous system depression has been observed in neonates. In pediatric use for the treatment of status epilepticus, in order to obtain maximal clinical effect with the minimum amount of drug and thus to reduce the risk of hazardous side effects, such as apnea or prolonged periods of somnolence, it is recommended that the drug be given as a slow IV push over 1 minute.
Benzyl alcohol has been reported to be associated with a fatal gasping syndrome in premature infants.
Compromised kidney function: Metabolites of diazepam are excreted by the kidney; to avoid their excess accumulation, caution should be exercised in the administration to patients with compromised kidney function.
Propylene glycol toxicity has been reported in patients treated with diazepam injection at doses significantly greater than recommended. Propylene glycol toxicity is associated with an anion gap metabolic acidosis, serum hyperosmolality, and increased lactate.
Drug Interactions: If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed, particularly with known compounds which may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors, and other antidepressants. In highly anxious patients with evidence of accompanying depression, particularly those who may have suicidal tendencies, protective measures may be necessary.
Most commonly reported side effects were drowsiness, fatigue, and ataxia, venous thrombosis and phlebitis at the site of injection.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Overdosage: Manifestations of diazepam overdosage include somnolence, confusion, coma, and diminished reflexes. Respiration, pulse, and blood pressure should be monitored. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Dialysis is of a limited value.
This Important Safety Information does not include all the information needed to use Diazepam Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Diazepam Injection, USP at www.fresenius-kabi.com/us.
References
1. Fanikos J, Burger M, Canada T. An assessment of currently available i.v. push medication delivery systems. Am J Health Syst Pharm. 2017;74(9): e230-e235.
2. Lahue BJ, Pyenson B, Iwasaki K, Blumen HE, Forray S, Rothschild JM. National burden of preventable adverse drug events associated with inpatient injectable medications: healthcare and medical professional liability costs. Am Health Drug Benefits. 2012 Nov;5(7):1-10. PMID: 24991335; PMCID: PMC4031698.
3. Institute for Safe Medication Practices. ISMP safe practice guidelines for adult IV push medications: a compilation of safe practices from the ISMP Adult IV Push Medication Safety Summit. http://www.ismp.org/Tools/guidelines/ivsummitpush/ivpushmedguidelines.pdf. Accessed July 11, 2017.
4. 2022 Comprehensive Accreditation Manual (CAMH) for Hospitals. Standard MM 03.01.03. Oakbrook Terrace, IL: Joint Commission Resources. CAMH (PDF manual), January 2022.
5. ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals. (2013). American Journal of Health-System Pharmacy, 70(18), 1619-1630. doi:10.2146/sp130001.
6. Anesthesia Patient Safety Foundation. (2019). Recommendations of the Four Work Groups at the 2018 APSF Stoelting Conference on Medication Safety – Anesthesia Patient Safety Foundation. [Accessed Jan. 2022].
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn.
