FDA-APPROVED MEDICATIONS DIFFER FROM EXTEMPORANEOUSLY COMPOUNDED DRUGS
The FDA is reinforcing the importance of prescribing FDA-approved products such as Epaned. According to the FDA:
“When a drug is FDA-approved, patients are assured that FDA has reviewed the safety and efficacy of the drug and the adequacy of the manufacturing process to produce a quality product….compounded drugs do not provide such assurance and, therefore, should only be used when an FDA-approved product is not available to meet the medical needs of an individual patient.”1The FDA approval process helps ensure safety and effectiveness for your pediatric patients over 1 month of age.
|EPANED Oral Solution||Extemporaneously compounded enalapril suspension|
|Meets FDA standards for potency and purity||Unknown1,2|
|Required compliance with FDA’s CGMPs*||Unconfirmed2|
|Sourcing of active ingredient approved by FDA||Unknown2|
|Shaking required||Solution does not require shaking||Suspension requires vigorous shaking prior to each administration2|
|Shelf life/stability||Well established4,5||Unknown/varies|
|Refrigeration required||NO (after dispensing)||Unknown3|
|Available at retail pharmacies||YES||Unknown|
|Covered by Medicaid||YES||Unknown|
Trusted efficacy delivered with consistent potency
Well-established efficacy: The efficacy of enalapril is well established for pediatric patients with hypertension who are older than one month.4 Epaned is also indicated for symptomatic heart failure and asymptomatic left ventricular dysfunction† in adults.4
Weight-based dosing: Epaned Oral Solution provides weight-based dosing (mg/kg) for the treatment of hypertension in children over 1 month of age.
Consistent potency: When you choose to prescribe or dispense Epaned, it provides consistent potency from first to last dose in every prescription, and helps ensure consistency from hospital to home.
*Current Good Manufacturing Practices
†To decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.4
References: 1. Hamberg MA. Department of Health and Human Services. Letter to: Colleague. January 8, 2014. 2. Sellers S, Utian WH. Pharmacy compounding primer for physicians. Drugs. 2012;72:2043-2050. 3. FDA/CDER. Guidance for Industry: Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the Federal FDCA. (Draft). July 2016. 4. Epaned Oral Solution [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc.; 2016. 5. Data on file, Silvergate Pharmaceuticals, Inc.; 2016.