Renitec tab    B   

  

Manufacturer 

Merck Sharp & Dohme

 

Contents

Enalapril maleate 

 

MIMS Class

ACE Inhibitors 

 

Indications  

All grades of essential hypertension. Renovascular hypertension. All degrees of heart failure. Prevention of symptomatic heart failure. Prevention of coronary ischemic events in patient w/ left ventricular dysfunction. 

 

Dosage  

Essential hypertension Mild hypertension: initially 10 mg daily. Other degrees of hypertension: initially 20 mg daily. Maintenance: 20 mg once daily to a max. 40 mg daily. Renovascular hypertension Initiate therapy w/ a lower starting dose (eg 5 mg or less). Adjust dose according to patient's needs. Concomitant diuretic therapy in hypertension Diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy w/ Renitec. If this is not possible, the initial dose of Renitec should be low (5 mg or less) to determine the initial effect on the BP. Adjust dose according to patient's needs. Renal insufficiency Generally, the intervals between the administration of enalapril should be prolonged &/or the dosage reduced. Mild impairment (CrCl > 30 to < 80 mL/min): 5-10 mg; moderate impairment (CrCl > 10 to ≤ (smaller than or equal to) 30 mL/min): 2.5-5 mg; severe impairment (CrCL ≤ (smaller than or equal to) 10 mL/min): 2.5 mg on dialysis days. Dosage on nondialysis days should be adjusted depending on the BP response. Heart failure/asymptomatic LV dysfunction Initially 2.5 mg administered under close medical supervision to determine the initial effect on the BP. In the absence of, or after effective management of, symptomatic hypotension following initiation of therapy in heart failure, increase dose gradually to the maintenance dose of 20 mg in single or 2 divided doses. Dose titration may be performed over 2-4 wk period, or more rapidly if indicated by the presence of residual signs & symptoms of heart failure. In patients treated w/ diuretics, reduce dose if possible before beginning treatment.

 

ADMINISTRATION:

May be taken with or without food. 

 

Contraindication   

Hypersensitivity. History of angioneurotic edema related to previous treatment w/ an ACE inhibitor. Hereditary or idiopathic angioedema. 

 

Precautions    

Symptomatic hypotension likely to occur in vol-depleted patients eg. by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting; patients w/ heart failure, w/ or w/o associated renal insufficiency. Caution in severe heart failure, esp ischemic heart or cerebrovascular disease. Patients w/ obstruction in the outflow tract of the left ventricle. Renal impairment; patients w/ bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Dosage reduction &/or discontinuation of the diuretic &/or Renitec may be required. Serum K should be monitored. Not recommended during pregnancy. Lactation. Childn. 

 

Adverse Reactions  

Dizziness, headache, fatigue, asthenia, hypotension, orthostatic hypotension, syncope, nausea, diarrhoea, muscle cramps, rash, cough. Less frequently renal dysfunction, renal failure & oliguria. Symptomatic hypotension occurred more frequently w/ inj than w/ tab. Angioneurotic edema of the face, extremities, lips, tongue, glottis &/or larynx has been reported rarely. 

 

Drug Interaction   

Antihypertensive therapy; use of K supplements, K-sparing diuretics, or K-containing salt substitutes; lithium; NSAIDs. 

 

Packing/Presentation  

Tab

5mg x 30's  

10mg x 30's  

20mg x 30's  

 

Pregnancy Category

C; D in 2nd & 3rd trimesters