EPANED

The pharmacokinetics of ready-to-use EPANED Oral Solution was shown to be bioequivalent to that of reconstituted EPANED Powder for Oral Solution under fasted conditions. Reconstituted EPANED Powder for Oral Solution was shown to be bioequivalent to Vasotec ® tablets. Reconstituted EPANED Powder for Oral Solution was also evaluated under fed and fasted conditions. A high-fat meal reduced the C max of enalapril and enalaprilat by 46% and 36%, respectively. The exposure, as measured by AUC, to enal...

14.1 Heart Failure, Mortality Trials In a multicenter, placebo-controlled clinical trial, 2,569 patients with all degrees of symptomatic heart failure and ejection fraction ≤35 percent were randomized to placebo or enalapril and followed for up to 55 months (SOLVD-Treatment). Use of enalapril was associated with an 11 percent reduction in all-cause mortality and a 30 percent reduction in hospitalization for heart failure. Diseases that excluded patients from enrollment in the study included severe stable angina (>2 attacks/day), hemodynamically significant valvular or outflow tract obstruction...

The following adverse reactions are described elsewhere: Angioedema [see Warnings and Precautions ( 5.2 )] Hypotension [see Warnings and Precautions ( 5.3 )] Hepatic failure [see Warnings and Precautions ( 5.4 )] Renal impairment [see Warnings and Precautions ( 5.5 )] Hyperkalemia [see Warnings and Precautions ( 5.6 )] The most common adverse reaction for patients treated for hypertension (≥3%) was fatigue ( 6.1 ). The most common adverse reactions for patients treated for heart failure (>6%) we...

EPANED is contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor [see Warnings and Precautions ( 5.2 )] . hereditary or idiopathic angioedema [see Warnings and Precautions ( 5.2 )] . Do not co-administer aliskiren with EPANED in patients with diabetes [see Drug Interactions ( 7.2 )] . EPANED ...

Angioedema and Anaphylactoid Reactions ( 5.2 ). Impaired Renal Function: Assess renal function ( 5.5 ). Hyperkalemia ( 5.6 ). 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria,...

7 DRUG INTERACTIONS In patients who are elderly, volume-depleted (as on diuretic therapy), or with compromised renal function, use with NSAIDs, including selective COX-2 inhibitors, may result in deterioration of renal function, including renal failure. Monitor renal function periodically ( 7.1 ). Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and ...