Enalbal can cause a severe allergic reaction. Symptoms include:
- trouble breathing
- swelling of your face, lips, tongue, or throat
Call 911 or go to the nearest emergency room if you develop these symptoms.
Don’t take this drug again if you’ve ever had an allergic reaction to it before. Taking it again could be fatal (cause death).
Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin converting enzyme inhibitors, including Enalbal. Patients should be so advised and told to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.
¿Qué debo evitar mientras tomo Enalbal?
Beber alcohol puede bajar mucho más su presión arterial y puede aumentar ciertos efectos secundarios de Enalbal.
No use sustitutos de la sal o suplementos de potasio mientras esté tomando Enalbal, salvo que su médico le indique hacerlo.
Evite levantarse muy rápido de la posición de sentado o acostado, ya que puede sentirse mareado. Levántese despacio y estabilícese para evitar que se caiga.
Conversion from intravenous (IV) to oral dosage form
If not concurrently receiving diuretics, initiate Enalbal 5 mg orally once/day; if concurrently receiving diuretics and responding to 0.625 mg IV every 6 hours, initiate at 2.5 mg orally once/day; titrate upwards as necessary
Pharmacokinetics And Metabolism
Following oral administration of VASOTEC, peak serum concentrations of Enalbal occur within about one hour. Based on urinary recovery, the extent of absorption of Enalbal is approximately 60 percent. Enalbal absorption is not influenced by the presence of food in the gastrointestinal tract. Following absorption, Enalbal is hydrolyzed to Enalbalat, which is a more potent angiotensin converting enzyme inhibitor than Enalbal; Enalbalat is poorly absorbed when administered orally. Peak serum concentrations of Enalbalat occur three to four hours after an oral dose of Enalbal maleate. Excretion of VASOTEC is primarily renal. Approximately 94 percent of the dose is recovered in the urine and feces as Enalbalat or Enalbal. The principal components in urine are Enalbalat, accounting for about 40 percent of the dose, and intact Enalbal. There is no evidence of metabolites of Enalbal, other than Enalbalat.
The serum concentration profile of Enalbalat exhibits a prolonged terminal phase, apparently representing a small fraction of the administered dose that has been bound to ACE. The amount bound does not increase with dose, indicating a saturable site of binding. The effective half-life for accumulation of Enalbalat following multiple doses of Enalbal maleate is 11 hours. The disposition of Enalbal and Enalbalat in patients with renal insufficiency is similar to that in patients with normal renal function until the glomerular filtration rate is 30 mL/min or less. With glomerular filtration rate ≤ 30 mL/min, peak and trough Enalbalat levels increase, time to peak concentration increases and time to steady state may be delayed. The effective half-life of Enalbalat following multiple doses of Enalbal maleate is prolonged at this level of renal insufficiency (see DOSAGE AND ADMINISTRATION). Enalbalat is dialyzable at the rate of 62 mL/min.
Studies in dogs indicate that Enalbal crosses the blood-brain barrier poorly, if at all; Enalbalat does not enter the brain. Multiple doses of Enalbal maleate in rats do not result in accumulation in any tissues. Milk of lactating rats contains radioactivity following administration of 14 C-Enalbal maleate. Radioactivity was found to cross the placenta following administration of labeled drug to pregnant hamsters.
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or death.
This medication contains Enalbal. Do not take Enalbalat, Epaned, Vasotec, or Vasotec IV if you are allergic to Enalbal or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.