DENVER, Nov. 4, 2013 /PRNewswire/ — Silvergate Pharmaceuticals, Inc., focused on the development and commercialization of innovative and safe medicines for children, today announced the availability by prescription of Epaned™ (enalapril maleate Powder for Oral Solution) to treat hypertension (high blood pressure) in people older than one month. Enalapril is one of the most commonly prescribed medicines in the United States to treat high blood pressure.
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Approved by the FDA in August 2013, Epaned is specially formulated as a flavored liquid solution to appeal to children and people who have difficulty swallowing enalapril tablets. Many medicines are tested and developed for adults, leaving doctors and pharmacies to adjust adult doses for pediatric use. Approximately half of the prescription drugs commonly given to children do not have information on appropriate pediatric doses on their labels.1 Epaned is a powder form of enalapril that a pharmacist will use to make an oral solution so that children will no longer have to rely on adult tablets being made into a suspension.
"We're pleased to launch Epaned so quickly after receiving FDA approval," said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "Silvergate is happy to take the lead in developing FDA-approved medicines for children – an area of drug development that is often overlooked."
Epaned is available through an extensive network of pharmacies and may be eligible for reimbursement by most private insurance plans and state Medicaid programs. For additional information on how to obtain Epaned, please call 1-855-379-0382 or visitwww.SilvergatePharma.com.
About Epaned
Epaned (enalapril maleate Powder for Oral Solution) is an FDA-approved powder form of enalapril maleate indicated for the treatment of hypertension (high blood pressure) in adults and children older than one month, to lower blood pressure. Enalapril is one of the most commonly prescribed drugs in the United States to treat high blood pressure.
Epaned is an oral solution formulation that has a taste that appeals to children, which may help to ensure compliance. People who have trouble swallowing enalapril tablets may also benefit from Epaned.
Enalapril is indicated for the treatment of high blood pressure in children over one month and adults. It works by blocking a natural chemical in the body that causes blood vessels to narrow. As a result, the blood vessels relax. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of a comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
About Pediatric Hypertension
According to the International Pediatric Hypertension Association:2
- The effects of high blood pressure can begin during childhood. Mild to moderate high blood pressure is most commonly asymptomatic but may be associated with subtle changes in behavior or school performance.
- Children with high blood pressure are more likely to have a definable cause for high blood pressure (such as kidney disease) than adults.
- Children with high blood pressure also tend to have other medical problems, such as obesity, high blood lipids and/or diabetes mellitus.
- In addition, children with high blood pressure tend to have high blood pressure as adults.
Childhood obesity rates in the US have tripled in the last 30 years. Recent statistics show that nearly 1 in 3 children are overweight or obese. In addition, approximately 10 percent of infants and toddlers (birth to two years of age) have higher than normal weight based on their length.3,4 Children and adolescents should have their blood pressure measured at least once per year.
About Silvergate Pharmaceuticals, Inc.
Headquartered near Denver, Colorado, Silvergate Pharmaceuticals, Inc. is a privately held pharmaceutical company dedicated to leading the way in the development and commercialization of innovative pediatric medications.
Silvergate Pharmaceuticals, Inc. is dedicated to filling the unmet needs of children, developing innovative medications that will help improve the quality of care and outcomes for pediatric patients. For additional information, please visit www.SilvergatePharma.com.
Indication
Epaned™ (enalapril maleate Powder for Oral Solution) is an angiotensin-converting enzyme (ACE) inhibitor indicated for treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
- When pregnancy is detected, discontinue Epaned as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
ADDITIONAL IMPORTANT SAFETY INFORMATION
- Epaned is contraindicated in patients who are hypersensitive to enalapril or any component of Epaned.
- Epaned is contraindicated in patients with a history of hypersensitivity related to previous treatment with an ACE inhibitor.
- Epaned is contraindicated in patients with hereditary or idiopathic angioedema.
- Do not coadminister aliskiren with Epaned in patients with diabetes.
- Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx, including some fatal reactions, have been reported in patients treated with ACE inhibitors, including Epaned, at any time during treatment. Epaned should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema may be at increased risk of angioedema while receiving an ACE inhibitor.
- Anaphylactoid Reactions during Dialysis: Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. Symptoms have not been relieved by antihistamines in these situations. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
- Intestinal Angioedema has been reported in patients treated with ACE inhibitors.
- Hypotension: Epaned can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure, or death. Patients at risk of excessive hypotension include those with the following conditions or characteristics: heart failure with systolic blood pressure below 100 mmHg, ischemic heart disease, cerebrovascular disease, hyponatremia, high-dose diuretic therapy, renal dialysis, or severe volume and/or salt depletion of any etiology. These patients should be started under close medical supervision and closely followed for the first 2 weeks of treatment with Epaned and whenever the dose of Epaned and/or a diuretic is increased. Symptomatic hypotension is also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathy.
- Surgery/Anesthesia: In patients undergoing major surgery or during anesthesia with agents that produce hypotension, Epaned may block angiotensin II formation secondary to compensatory renin release.
- Hepatic Failure: Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Patients who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
- Impaired Renal Function: Monitor renal function in patients treated with Epaned. Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, sever congestive heart failure, post-myocardial infarction or volume depletion) may be at particular risk of developing acute renal failure on Epaned. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Epaned.
- Hyperkalemia: Serum potassium should be monitored in patients receiving Epaned. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.
- Adverse Reactions (where rate on enalapril exceeds the rate on placebo by at least 0.2%) occurring in greater than 1% of patients with hypertension treated with enalapril in controlled trials include: fatigue, orthostatic effects, asthenia, cough, and rash. See full prescribing information for other Adverse Reactions.
- In patients who are elderly, volume-depleted (as on diuretic therapy), or with compromised renal function, use of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including renal failure. Monitor renal function periodically in patients receiving enalapril and NSAID therapy.
- Dual inhibition of the renin-angiotensin system (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia and changes in renal function, (including acute renal failure) compared to monotherapy. Closely monitor BP, renal function and electrolytes.
- Avoid use of aliskiren with Epaned in patients with renal impairment.
- Epaned attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
- Lithium toxicity has been reported in patients receiving enalapril and lithium concomitantly. Monitor serum lithium levels frequently if lithium is concomitantly administered with Epaned.
- Nitritoid reactions have been reported rarely in patients with injectable gold (sodium aurothiomalate) and concomitant enalapril therapy.
- Epaned is not recommended in neonates and in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2.
To report SUSPECTED ADVERSE EVENTS, contact Silvergate Pharmaceuticals, Inc. at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Please see accompanying full PRESCRIBING INFORMATION for additional important safety information, including BOXED WARNING.
1 Sachs AN, Avant D, Lee CS, Rodriguez W, Murphy MD. Pediatric Information in Drug Product Labeling. JAMA. 2012;307(18):1914-1915.
2 http://www.pediatrichypertension.org/
3 Barnes M, Chair, Task Force on Childhood Obesity, and Director, Domestic Policy Council. Solving the problem of childhood obesity within a generation. White House Task Force on Childhood Obesity Report to the President. 2010. Available at: http://www.letsmove.gov/sites/letsmove.gov/files/TaskForce_on_Childhood_Obesity_May2010_FullReport.pdf
4 Ogden CL, et al. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA.2012;307:483-490.
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Contact:
Amy Berry
415-793-2258