What happens if I overdose M-Enalapril?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of M-Enalapril solution:
Store M-Enalapril solution at 77 degrees F (25 degrees C) in a tightly-closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep M-Enalapril solution out of the reach of children and away from pets.
Overdose of M-Enalapril in details
Symptoms: Limited data are available for overdosage in humans. The most prominent features of overdosage reported to date are marked hypotension, beginning some 6 hrs after ingestion of tablets, concomitant with blockade of the renin-angiotensin system and stupor. Serum enalaprilat levels 100- and 200-fold higher than usually seen after therapeutic doses have been reported after ingestion of M-Enalapril 300 and 440 mg, respectively.
Treatment: The recommended treatment of overdosage is IV infusion of normal saline solution. If available, angiotensin II infusion may be beneficial. If ingestion is recent, induce emesis. Enalaprilat may be removed from the general circulation by hemodialysis.
What should I avoid while taking M-Enalapril?
Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of M-Enalapril.
Do not use salt substitutes or potassium supplements while taking M-Enalapril, unless your doctor has told you to.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
M-Enalapril warnings
Anaphylactoid And Possibly Related Reactions
Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including M-Enalapril) may be subject to a variety of adverse reactions, some of them serious.
Head and Neck Angioedema
Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including M-Enalapril. This may occur at any time during treatment. In such cases M-Enalapril should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. In instances where swelling has been confined to the face and lips the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway, should be promptly provided.
Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema
Intestinal Angioedema
Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor.
Anaphylactoid Reactions During Desensitization
Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.
Anaphylactoid Reactions During Membrane Exposure
Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
Hypotension
Excessive hypotension is rare in uncomplicated hypertensive patients treated with M-Enalapril alone. Patients with heart failure given M-Enalapril commonly have some reduction in blood pressure, especially with the first dose, but discontinuation of therapy for continuing symptomatic hypotension usually is not necessary when dosing instructions are followed; caution should be observed when initiating therapy. Patients at risk for excessive hypotension, sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death, include those with the following conditions or characteristics: heart failure, hyponatremia, high dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis, or severe volume and/or salt depletion of any etiology. It may be advisable to eliminate the diuretic (except in patients with heart failure), reduce the diuretic dose or increase salt intake cautiously before initiating therapy with M-Enalapril in patients at risk for excessive hypotension who are able to tolerate such adjustments. In patients at risk for excessive hypotension, therapy should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of M-Enalapril and/or diuretic is increased. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses of M-Enalapril, which usually can be given without difficulty once the blood pressure has stabilized. If symptomatic hypotension develops, a dose reduction or discontinuation of M-Enalapril or concomitant diuretic may be necessary.
Neutropenia/Agranulocytosis
Another angiotensin converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients but more frequently in patients with renal impairment especially if they also have a collagen vascular disease. Available data from clinical trials of M-Enalapril are insufficient to show that M-Enalapril does not cause agranulocytosis at similar rates. Marketing experience has revealed cases of neutropenia or agranulocytosis in which a causal relationship to M-Enalapril cannot be excluded. Periodic monitoring of white blood cell counts in patients with collagen vascular disease and renal disease should be considered.
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. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
Fetal Toxicity
Pregnancy Category D
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, hypotension, renal failure, and death. When pregnancy is detected, discontinue M-Enalapril as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the reninangiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue M-Enalapril, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to M-Enalapril for hypotension, oliguria, and hyperkalemia.
No teratogenic effects of M-Enalapril were seen in studies of pregnant rats and rabbits. On a body surface area basis, the doses used were 57 times and 12 times, respectively, the maximum recommended human daily dose (MRHDD).
What should I discuss with my healthcare provider before taking M-Enalapril?
You should not use M-Enalapril if you are allergic to M-Enalapril, or if you have:
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a history of angioedema; or
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if you are allergic to any other ACE inhibitor, such as benazepril, captopril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.
If you have diabetes, do not use M-Enalapril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).
You may also need to avoid taking M-Enalapril with aliskiren if you have kidney disease.
To make sure M-Enalapril is safe for you, tell your doctor if you have:
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kidney disease (or if you are on dialysis);
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liver disease;
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a history of blood clot or stroke (including "mini-stroke";
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an electrolyte imbalance (such as high levels of potassium in your blood); or
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heart disease or congestive heart failure (unless you are taking M-Enalapril for this condition).
Do not use M-Enalapril if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant. M-Enalapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking this medication.
M-Enalapril can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using M-Enalapril.
M-Enalapril precautions
Symptomatic Hypotension: Symptomatic hypotension was seen rarely in uncomplicated hypertensive patients. In hypertensive patients receiving M-Enalapril MALEATE (M-Enalapril), hypotension is more likely to occur if the patient has been volume - depleted, e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting. In patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed. This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatremia or functional renal impairment. In these patients, therapy should be started under medical supervision and the patients should be followed closely whenever the dose of M-Enalapril MALEATE (M-Enalapril) and/or diuretic is adjusted. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.
In some patients with heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with M-Enalapril MALEATE (M-Enalapril). This effect is anticipated, and usually is not a reason to discontinue treatment. If hypotension becomes symptomatic, a reduction of dose and/or discontinuation of the diuretic and/or M-Enalapril MALEATE (M-Enalapril) may be necessary.
Aortic Stenosis/Hypertrophic Cardiomyopathy: As with all vasodilators, ACE inhibitors should be given with caution to patients with obstruction in the outflow tract of the left ventricle.
Renal Function Impairment: In some patients hypotension following the initiation of therapy with ACE inhibitors may lead to some further impairment in renal function. Acute renal failure, usually reversible, has been reported in this situation.
Patients with renal insufficiency may require reduced and/or less frequent doses of M-Enalapril MALEATE (M-Enalapril). In some patients, with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, increases of blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen. This is especially likely in patients with renal insufficiency.
Some patients with no apparent pre-existing renal disease, have developed usually minor and transient increases in blood urea and serum creatinine when M-Enalapril MALEATE (M-Enalapril) has been given concomitantly with a diuretic. Dosage reduction and/or discontinuation of the diuretic and/or M-Enalapril MALEATE (M-Enalapril) may be required.
Hypersensitivity/Angioneurotic Edema: Angioneurotic edema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, including M-Enalapril MALEATE (M-Enalapril). This may occur at any time during treatment. In such cases, M-Enalapril MALEATE (M-Enalapril) should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient. Even in those instances where swelling of only the tongue is involved, without respiratory distress, patients may require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient.
Very rarely, fatalities have been reported due to angioedema associated with laryngeal edema or tongue edema. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures to ensure a patent airway, should be administered promptly.
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks.
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor.
Anaphylactoid Reactions During Hymenoptera Desensitization: Rarely, patients receiving ACE inhibitors during desensitization with hymenoptera venom have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each desensitization.
Hemodialysis Patients: Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes (e.g., AN 69) and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Cough: Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Surgery/Anesthesia: In patients undergoing major surgery or during anesthesia with agents that produce hypotension, M-Enalapril blocks angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Hyperkalemia : Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and concomitant use of potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes.
The use of potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes particularly in patients with impaired renal function may lead to a significant increase in serum potassium. Hyperkalemia can cause serious, sometimes fatal, arrhythmias.
If concomitant use of M-Enalapril MALEATE (M-Enalapril) and any of the above-mentioned agents is deemed appropriate, they should be used with caution and with frequent monitoring of serum potassium.
Hypoglycemia: Diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor should be told to closely monitor for hypoglycemia, especially during the first month of combined use.
Use in Children: The safety and effectiveness of M-Enalapril MALEATE (M-Enalapril) have been established in hypertensive pediatric patients age 1 month to 16 years. Use of M-Enalapril MALEATE (M-Enalapril) in these age groups is supported by evidence from adequate and well-controlled studies of M-Enalapril MALEATE (M-Enalapril) in pediatric and adult patients as well as by published literature in pediatric patients.
In a multiple dose pharmacokinetic study in 40 hypertensive pediatric patients, excluding neonates, M-Enalapril MALEATE (M-Enalapril) was generally well tolerated. Pharmacokinetics following oral administration of M-Enalapril are similar in these patients and comparable to historical values in adults.
In a clinical study involving 110 hypertensive pediatric patients 6 to 16 years of age, patients who weighed <50 kg received either 0.625, 2.5 or 20 mg of M-Enalapril daily and patients who weighed ≥50 kg received either 1.25, 5 or 40 mg of M-Enalapril daily. M-Enalapril administration once daily lowered trough blood pressure in a dose-dependent manner. The dose-dependent antihypertensive efficacy of M-Enalapril was consistent across all subgroups (age, Tanner stage, gender, race). However, the lowest doses studied, 0.625 mg and 1.25 mg, corresponding to an average of 0.02 mg/kg once daily, did not appear to offer consistent antihypertensive efficacy. The maximum dose studied was 0.58 mg/kg (up to 40 mg) once daily. In this study, M-Enalapril MALEATE (M-Enalapril) was generally well tolerated.
The adverse experience profile for pediatric patients is not different from that seen in adult patients.
M-Enalapril MALEATE (M-Enalapril) is not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2, as no data are available.
What happens if I miss a dose of M-Enalapril?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "enalapril". http://www.drugbank.ca/drugs/DB00584 (accessed September 17, 2018).
- MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
