Hypace

Hypace

enalapril

Manufacturer:

Pascual Pharma Corp

Distributor:

Zuellig
Concise Prescribing Info
Contents
Enalapril maleate
Indications/Uses
Treatment of HTN & heart failure. Prophylaxis to patients w/ asymptomatic left ventricular dysfunction to delay the onset of symptomatic heart failure & those w/ left ventricular dysfunction to reduce the incidence of coronary ischemic events, including MI.
Dosage/Direction for Use
HTN Initially 5 mg/day. Usually 10-40 mg/day as a single or 2 divided doses. Renal impairment CrCl ≤30 mL/min (serum creatinine ≥3 mg/dL) 2.5 mg once daily on the 1st dose. Then may titrate dose upward until BP is controlled. Max of 40 mg daily. Ped hypertensive patients 1 mth to 16 yr 0.08 mg/kg (up to 5 mg) once daily. Max: >0.58 mg/kg (or >40 mg). Heart failure Initially 2.5 mg/day. Maintenance: 20 mg/day as a single dose or in 2 divided doses. Recommended dosing range: 2.5-20 mg bid. Max daily dose: 40 mg in divided doses. Asymptomatic left ventricular dysfunction Initially, 2.5 mg bid. Titrate as tolerated to the targeted daily dose of 20 mg in divided doses. Renal impairment (serum creatinine >1.6 mg/dL) or hyponatremia (serum Na <130 mEq/L) Initially at 2.5 mg daily. May increase dose to 2.5 bid, then 5 mg bid & higher as needed, usually at intervals of 4 days or more. Max daily dose: 40 mg.
Administration
Should be taken with food: Take w/ food or immediately after meals.
Contraindications
Hypersensitivity. History of angioneurotic edema.
Special Precautions
Hypotension may occur in vol-depleted patient eg, by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting. Severe degrees heart failure, use of high doses of loop diuretics, hyponatremia or functional renal impairment; renal insufficiency. Discontinue in case hypersensitivity/angioneurotic edema occurs. Anaphylactoid reactions during Hymenoptera desensitization also in patients dialyzed w/ high-flux membranes & treated concomitantly w/ ACE inhibitor. Nonproductive & persistent cough during therapy. Lactation.
Adverse Reactions
MI or CVA, syncope, orthostatic hypotension, palpitations, chest pain, rhythm disturbances, angina pectoris, Raynaud's phenomenon; inappropriate antidiuretic hormone secretion (SIADH); ileus, pancreatitis, hepatic failure, hepatitis either hepatocellular or cholestatic, jaundice, abdominal pain, vomiting, dyspepsia, constipation, anorexia, stomatitis; hypoglycemia in diabetic patients; depression, confusion, somnolence, insomnia, nervousness, paresthesia, vertigo, dream abnormality; renal failure, oliguria, renal dysfunction; pulmonary infiltrates, bronchospasm/asthma, dyspnea, rhinorrhea, sore throat & hoarseness; diaphoresis, erythema multiform, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, urticaria, alopecia; angioedema, vasculitis, muscle cramps, hyperhidrosis, impotence, asthenia, photosensitivity, flushing, taste alteration, tinnitus, glossitis, blurred vision.
Drug Interactions
Augmented antihypertensive effect w/ antihypertensive agents that cause renin release (eg, diuretics). May attenuate K loss caused by thiazide-type diuretics. Risk for hyperkalemia include renal w/ K-sparing diuretics (eg, spironolactone, eplerenone, triamterene or amiloride), K supplements, K-containing salt substitutes, or other drugs that may increase serum K (eg, trimethoprim-containing products). Increased risk of hypoglycemia w/ antidiabetic agents. May reduce clearance of lithium. Reduced effect w/ NSAIDs including COX-2 inhibitors. Risk of renal impairment when in combination use of ACE inhibitors or angiotensin receptor antagonists, anti-inflammatory drugs & thiazide diuretics. Increased risks of hypotension, syncope, hyperkalemia & changes in renal function w/ dual blockade of the renin-angiotensin-aldosterone system (RAAS) w/ ARB, ACE inhibitors or direct renin inhibitors. Nitritoid reactions w/ w/ inj gold (Na aurothiomalate). Increased risk for angioedema w/ mTOR inhibitor (eg, temsirolimus, sirolimus, everolimus). Increased risk for angioedema w/ neprilysin inhibitor (eg, sacubitril).
MIMS Class
ACE Inhibitors/Direct Renin Inhibitors
ATC Classification
C09AA02 - enalapril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Hypace tab 10 mg
Packing/Price
28's
Form
Hypace tab 20 mg
Packing/Price
28's
Form
Hypace tab 5 mg
Packing/Price
28's
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