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Vasotec (enalapril) is an ACE inhibitor. ACE stands for angiotensin converting enzyme.
Vasotec is used to treat high blood pressure (hypertension) in adults and children who are at least 1 month old.
Vasotec is also used to treat congestive heart failure in adults.
Vasotec is also used to treat a disorder of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). This disorder can decrease the heart's ability to pump blood to the body.
Do not use Vasotec if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.
You should not use Vasotec if you have ever had angioedema. Do not take Vasotec within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).
If you have diabetes, do not use enalapril together with any medication that contains aliskiren (a blood pressure medicine).
Vasotec can affect your heart or your electrolyte levels. Call your doctor if you have chest pain, pounding heartbeats or fluttering in your chest, a slow heart rate or weak pulse, a tingly feeling, muscle weakness, or muscle tightness or contraction.
You should not use Vasotec if you are allergic to enalapril:
you have hereditary angioedema;
you recently took a heart medicine called sacubitril; or
you have ever had a severe allergic reaction to any ACE inhibitor (benazepril, captopril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril).
Do not take Vasotec within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).
If you have diabetes, do not use enalapril together with any medication that contains aliskiren (a blood pressure medicine).
You may also need to avoid taking enalapril with aliskiren if you have kidney disease.
To make sure this medicine is safe for you, tell your doctor if you have:
kidney disease (or if you are on dialysis);
liver disease; or
an electrolyte imbalance (such as high levels of potassium in your blood).
Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Enalapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.
You should not breast-feed while you are using Vasotec.
Enalapril is not approved for use by anyone younger than 1 month old.
Take Vasotec exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Your blood pressure will need to be checked often. Your kidney or liver function may also need to be tested.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Vasotec. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.
If you need surgery, tell the surgeon ahead of time that you are using enalapril.
If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Usual Adult Dose for Hypertension:
Initial dose: 5 mg orally once a day
Maintenance dose: 10 to 40 mg orally per day as a single dose or in 2 divided doses
Maximum dose: 40 mg orally daily as a single dose or in 2 divided doses
In combination with diuretics:
Initial dose: 2.5 mg orally once a day
If feasible, the diuretic should be discontinued 2 to 3 days prior to initiation of therapy with enalapril. If required, diuretic therapy may be gradually resumed.
Usual Adult Dose for Congestive Heart Failure:
Initial dose: 2.5 mg orally once a day
Maintenance dose: 2.5 to 20 mg daily in 2 divided doses
Maximum dose: 40 mg orally per day in 2 divided doses
Comments:
-Treatment is usually combined with diuretics and digitalis.
-Doses should be titrated upward, as tolerated, over a period of a few days or weeks.
Usual Adult Dose for Left Ventricular Dysfunction:
Initial dose: 2.5 mg orally twice a day
Maintenance dose: 20 mg orally per day in 2 divided doses
Comments:
-After the initial dose, the patient should be observed for at least 2 hours and until blood pressure has stabilized for at least an additional hour.
-If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension.
Usual Pediatric Dose for Hypertension:
Children 1 month to 17 years:
Initial dose: 0.08 mg/kg/day (up to 5 mg) in 1 to 2 divided doses. Adjust dosage based on patient response.
Maximum dose: Doses greater than 0.58 mg/kg (40 mg) have not been evaluated in pediatric patients.
Comment:
-Not recommended in neonates and in pediatric patients with glomerular filtration rate less than 30 mL/min, as no data are available.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Enalapril can decrease sweating and you may be more prone to heat stroke.
Drinking alcohol can further lower your blood pressure and may increase certain side effects of enalapril.
Do not use potassium supplements or salt substitutes, unless your doctor has told you to.
Get emergency medical help if you have signs of an allergic reaction to Vasotec: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.
Call your doctor at once if you have:
a light-headed feeling, like you might pass out;
chest pain;
jaundice (yellowing of the skin or eyes);
little or no urination;
fever, chills, sore throat; or
high potassium - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.
Common Vasotec side effects may include:
dizziness;
tiredness; or
feeling light-headed.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your current medicines. Many drugs can interact with enalapril, especially:
a diuretic ("water pill"), or any other blood pressure medications;
lithium;
gold injections to treat arthritis;
insulin or oral diabetes medicine; or
NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete and many other drugs may interact with Vasotec. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Vasotec only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Vasotec (www.drugs.com/vasotec.html).
Note: This document contains side effect information about enalapril. Some of the dosage forms listed on this page may not apply to the brand name Vasotec.
Common side effects of Vasotec include: increased blood urea nitrogen and increased serum creatinine. Other side effects include: hypotension. See below for a comprehensive list of adverse effects.
Applies to enalapril: oral solution, oral tablet
Oral route (Tablet; Solution; Powder for Solution)
Discontinue enalapril maleate as soon as possible when pregnancy is detected, since fetal toxicity, including injury and death to the developing fetus, can be caused by drugs that act directly on the renin-angiotensin system.
Along with its needed effects, enalapril (the active ingredient contained in Vasotec) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking enalapril:
More common
Less common
Some side effects of enalapril may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to enalapril: compounding powder, intravenous solution, oral liquid, oral tablet
Predisposing risk factors for hypotension after enalapril (the active ingredient contained in Vasotec) administration are decreased intravascular volume (angiotensin-dependency), hyponatremia, and concurrent use of a diuretic agent.
Very common (10% or more): Hypotension
Common (1% to 10%): Edema
Uncommon (0.1% to 1%): Angioedema
Very common (10% or more): Headache
Common (1% to 10%): Vertigo, fatigue, peripheral paresthesias, insomnia, dizziness, syncope
Enalapril, like other angiotensin converting enzyme inhibitors, may decrease serum aldosterone levels, resulting in mild to moderate hyperkalemia. Diuretic use and advanced age increase the risk of renal impairment. Enalapril reduced the risk of renal impairment compared to placebo in diabetic patients. The concomitant use of beta blockers with enalapril (the active ingredient contained in Vasotec) has been shown to be renoprotective.
Enalapril may worsen renal insufficiency, especially if the patient is hypovolemic or hypotensive.
Patients with underlying congestive heart failure are predisposed to renal side effects associated with enalapril.
Common (1% to 10%): Increased serum creatinine, uric acid, and potassium
Rare case reports of enalapril-associated hepatitis, where liver function tests rose despite resolution of congestive heart failure, are reported.
A 54-year-old woman with hypertension developed asymptomatic abnormal liver function tests associated with eosinophilia and relatively normal abdominal ultrasonography seven weeks after beginning enalapril (the active ingredient contained in Vasotec) An extensive work-up revealed no evidence of infection; liver biopsy revealed cellular degeneration, portal eosinophilic and mononuclear infiltration, and centrilobular necrosis. The signs and symptoms of hepatitis resolved upon discontinuation of enalapril.
An 80-year-old woman with hypertension and mild heart failure developed hepatomegaly and icterus accompanied by increased conjugated bilirubin, alkaline phosphatase, and aspartate aminotransferase thirty days after beginning enalapril treatment. The patient had not been taking any other medications or herbal products. Tests for hemochromatosis, Wilson's disease, and alpha-1 antitrypsin deficiency returned with normal results. Serology for hepatitis A, B, C and autoimmune screen were negative. Other infectious causes were ruled out. Twenty days after admission, the patient developed grade III encephalopathy and severe coagulation disorders and died 30 days after admission.
In patients with liver dysfunction, frequent monitoring of liver function tests during enalapril administration is recommended.
Frequency not reported: Cholestatic jaundice, centrilobular necrosis, fulminant hepatic necrosis, death
Uncommon (0.1% to 1%): Photosensitivity, urticaria
Frequency not reported: Angioedema, obstructive laryngeal and glossal angioedema, intestinal angioedema, Henoch-Schonlein purpura
Late-onset enalapril-induced angioedema (more than three months) is reported in at least one patient who had taken enalapril without incident for three years. Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.
Common (1% to 10%): Dry, nonproductive cough
Frequency not reported: New bronchial hyperactivity, rhinorrhea, exacerbation of obstructive sleep apnea
Rare case reports of asthma associated with some angiotensin converting enzyme inhibitors suggest that these drugs seem to play a role in the genesis and metabolism of bronchodilatory mediators. For this reason, some experts recommend cautious use of enalapril in patients with preexisting asthma.
A retrospective study has revealed a significantly higher incidence of discontinuation of angiotensin converting enzyme (ACE) inhibitor therapy due to cough among black patients compared with non-black patients (9.6% vs. 2.4%).
Several agents have been studied for treating cough with ACE inhibitors. No long term trials exist to allow a definitive treatment option. Cromolyn has the most data showing some benefit. Other agents studied include baclofen, theophylline, sulindac, and benzonatate.
Rare, reversible cases of agranulocytosis associated with enalapril (the active ingredient contained in Vasotec) and other angiotensin converting enzyme (ACE) inhibitors have been reported. ACE inhibitors have been used to treat post renal transplant erythrocytosis. Data have shown that they may decrease circulating erythropoietin levels in these patients.
Rare (less than 0.1%): Neutropenia, agranulocytosis
Common (1% to 10%): Nausea, vomiting, diarrhea
Uncommon (0.1% to 1%): Dysgeusia
Frequency not reported: Pancreatitis, acute small bowel mucosal edema
A 56-year-old woman with hypertension and diabetes developed acute abdominal pain, nausea, and vomiting associated upper abdominal tenderness, hyperamylasemia, hyperlipasemia, and normal upper abdominal ultrasonography within 24 hours of starting enalapril. The signs and symptoms of pancreatitis resolved over the next several days once the drug was discontinued. No rechallenge was performed.
A 65-year-old woman was diagnosed with acute pancreatitis by ultrasonography, CT scan, and serum amylase level of 980 units/L. The patient had been receiving enalapril, HCTZ, and amiloride for one year. The pancreatitis resolved over 7 days. The patient upon rechallenge with enalapril developed severe upper abdominal pain, vomiting, and hypotension. CT scan showed intrapancreatic necrosis and peripancreatic fluid. Four weeks later a CT scan showed three pseudocysts that took 4 months to resolve. The author of the report concluded that rechallenging patients who develop acute pancreatitis while on enalapril is not recommended.
A 52-year-old Korean woman with hypertension experienced a generalized, erythematous, scaly rash associated with a positive Nikolsky sign and biopsy results consistent with pemphigus foliaceous within three weeks after beginning enalapril (the active ingredient contained in Vasotec) Direct immunofluorescence revealed intercellular IgG deposition. The pemphigus remained active at least 12 months after enalapril was discontinued.
A 35-year-old woman with hypertension developed alopecia during enalapril therapy, which resolved upon discontinuation of the drug, and recurred upon rechallenge.
A 77-year-old man with heart failure developed a generalized morbilliform rash after starting enalapril. Biopsy was consistent with toxic pustuloderma.
Common (1% to 10%): Pruritic, maculopapular eruption
Uncommon (0.1% to 1%): Rash
Frequency not reported: Alopecia, photosensitive lichenoid eruptions, erythema with vasculitis, bullous pemphigoid, pemphigus foliaceous, toxic pustuloderma
Frequency not reported: Depression, acute psychosis
A 52-year-old woman with hypertension and a history of depression associated with the use of beta-blockers, developed fatigue, malaise, and clinical signs and symptoms of depression, including suicidal ideation, within five weeks after starting enalapril. The depression gradually resolved with substitution of a thiazide diuretic and a low sodium diet. Rechallenge resulted in recurrent depression.
A 41-year-old man with hypertension became agitated, anxious, depressed, and unable to sleep four weeks after starting enalapril. The psychosis resolved when enalapril was stopped, and recurred upon rechallenge.
Frequency not reported: Syndrome of inappropriate ADH secretion, gynecomastia
A 69-year-old woman with diabetes mellitus and hypertension developed symptomatic hyponatremia associated with decreased plasma and increased urine osmolalities, normal thyroid and basal cortisol studies, and a positive water load test four months after beginning enalapril. The syndrome resolved upon discontinuation of enalapril, and recurred upon rechallenge.
Frequency not reported: Severe arthralgias and myalgias
A 76-year-old woman with hypertension, on enalapril monotherapy for three weeks, developed progressive myalgias, asthenia, morning stiffness, and weakness associated with no abnormal laboratory values. Due to the absence of other apparent causes, enalapril was discontinued, and the patient's myalgias disappeared. In at least one other case, rechallenge resulted in recurrent symptoms.
Frequency not reported: Positive fluorescent antinuclear antibody test
Frequency not reported: Vulvovaginal pruritus, dysuria, incontinence
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Vasotec (www.drugs.com/vasotec.html).
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