HYPACE Enalapril Maleate 10mg Tablet 1's

Treatment of hypertension and heart failure. May also be given prophylactically to patients with asymptomatic left ventricular dysfunction to delay the onset of symptomatic heart failure and to those with left ventricular dysfunction to reduce the incidence of coronary ischemic events, including myocardial infarction.

 

Hypertension: Initial Dose: 5 mg daily. Usual dosage range: 10 to 40 mg per day as a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, consider increasing dose or administering twice daily.
Dosage Adjustment in Hypertensive Patients with Renal Impairment: The usual dose of enalapril maleate (Hypace) is recommended for patients with a creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≤30mL/min (serum creatinine ≥3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
Heart Failure: Initial Dose: 2.5 mg daily. Maintenance Dose: 20 mg daily as a single dose or in 2 divided doses. Recommended dosing range: 2.5 to 20 mg given twice a day. Maximum daily dose: 40 mg in divided doses.
Asymptomatic Left Ventricular Dysfunction: Initially, 2.5 mg twice daily. Titrate as tolerated to the targeted daily dose of 20 mg (in divided doses).
Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia: In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision. The dose may be increased to 2.5 twice a day, then 5 mg twice a day and higher as needed, usually at intervals of four days or more if at time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. Maximum daily dose: 40 mg.
Pediatric Hypertensive Patients: Antihypertensive effects of enalapril maleate (Hypace) have been established in hypertensive pediatric patient’s age 1 month to 16 years. Recommended starting dose: 0.08 mg/kg (up to 5 mg) once daily. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients.
Administration: It should be taken with food or immediately after meals.

 

Overdosage

Should be taken with food: Take w/ food or immediately after meals.

 

Hypersensitivity to any component of Hypace and history of angioneurotic edema relating to previous treatment with an angiotensin-converting enzyme inhibitor.

 

Hypotension [systolic blood pressure (SBP) <90 mmHg]: More likely to occur if a patient has been volume-depleted eg, by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting. Patients with severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatremia or functional renal impairment should be closely supervised so that the doses of diuretic and/or enalapril maleate be adjusted. If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive IV infusion of normal saline.
Impaired Renal Function: Acute renal failure, usually reversible after discontinuation of use. Patients with renal insufficiency may require reduced and/or less frequent doses.
Hypersensitivity/Angioneurotic Edema: Rarely reported, but in such cases, Hypace-therapy should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to discharging the patient. In instances where swelling has been confined in the lips and the face, the conditions generally resolved without treatment, although antihistamines are useful in relieving the symptoms.
Angioneurotic edema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, appropriate therapy eg, SC epinephrine solution 1:1000 (0.3-0.5 mL) should be administered promptly.
Anaphylactoid Reactions During Hymenoptera Desensitization: Rarely reported, but in such case can be 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 and treated concomitantly with ACE inhibitor. Consideration should be given to these patients to use a different type of dialysis membrane or a different class of antihypertensive agent.
Cough: Characteristically, it is nonproductive, persistent and resolves after discontinuation of therapy.
Surgery/Anesthesia: If hypotension occurs and is considered to be due to enalapril's blockade of angiotensin II formation secondary to compensatory renin release, it can be corrected by volume expansion.

 

Use In Pregnancy & Lactation

Cardiovascular: Myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients, syncope, orthostatic hypotension, palpitations, chest pain, rhythm disturbances, angina pectoris, Raynaud's phenomenon.
Endocrine: Syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Gastrointestinal system: Ileus, pancreatitis, hepatic failure, hepatitis either hepatocellular or cholestatic, jaundice, abdominal pain, vomiting, dyspepsia, constipation, anorexia, stomatitis.
Metabolic: Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin have been reported.
Nervous system/Psychiatric: Depression, confusion, somnolence, insomnia, nervousness, paresthesia, vertigo, dream abnormality.
Renal: Renal failure, oliguria, renal dysfunction.
Respiratory: Pulmonary infiltrates, bronchospasm/asthma, dyspnea, rhinorrhea, sore throat and hoarseness.
Skin: Diaphoresis, erythema multiform, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, urticaria, alopecia.
Others: Angioedema, vasculitis, muscle cramps, hyperhidrosis, impotence, asthenia, photosensitivity, flushing, taste alteration, tinnitus, glossitis, blurred vision.

 

Agents Causing Renin Release: The antihypertensive effect of enalapril maleate (Hypace) is augmented by antihypertensive agents that cause renin release (e.g., diuretics).
Other Cardiovascular Agents: Concomitant use with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine and prazosin shows no evidence of clinically significant adverse interactions.
Agents Increasing Serum Potassium: Enalapril maleate (Hypace) may attenuate potassium loss caused by thiazide-type diuretics. 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, potassium-containing salt substitutes, or other drugs that may increase serum potassium (e.g., trimethoprim-containing products).
Antidiabetics: Concomitant administration of ACEI and antidiabetic agents may cause an increased risk of hypoglycemia more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Serum Lithium: As with other drugs which eliminate sodium, lithium clearance may be reduced. Therefore, the serum lithium levels should be monitored carefully if lithium salts are to be administered.
Non-Steroidal Anti-Inflammatory Drugs including Selective Cyclooxygenase-2 Inhibitors: NSAIDs including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) may reduce the effect of diuretics and other antihypertensive drugs. Administer with caution in patients with compromised renal function (e.g., elderly patients or patients who are volume-depleted, including those on diuretic therapy).
Combination Use of ACE Inhibitors or Angiotensin Receptor Antagonists, Anti-inflammatory drugs and Thiazide Diuretics: The use of ACEI or ARB, NSAID or COX-2 inhibitor, and a thiazide diuretic at the same time increases the risk of renal impairment. This includes use in fixed-dose combination products containing more than one class of drug.
Dual Blockade of the Renin-Angiotensin-Aldosterone System: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) with ARB, ACEI, or direct renin inhibitors (such as aliskiren) is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not co-administer aliskiren with enalapril maleate (Hypace) in patients with diabetes. Avoid use of aliskiren with enalapril maleate (Hypace) in patients with renal impairment (GFR <60 mL/min).
Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACEI therapy.
Mammalian Target of Rapamycin (mTOR) Inhibitors: Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.
Neprilysin Inhibitors: Patients taking a concomitant neprilysin inhibitor (e.g., sacubitril) may be at increased risk for angioedema.

 

Storage

Action

ACE Inhibitors/Direct Renin Inhibitors