INDICATION AND USE
1. Mild to severe hypertension, where it may be used alone or in
combination with thiazide diuretics
2. Congestive heart failure
3. To reduce the risk of stroke, myocardial infarction and death from
cardiovascular events in patients with a history of cardiovascular
4. Proteinuric non-diabetic nephropathy
DOSAGE AND ADMINISTRATION
Dosage of Ripril® must be adjusted according to the patient’s tolerance and
Hypertension : For the management of hypertension in adults not receiving
a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage
generally is adjusted no more rapidly than at 2-week intervals. The usual
maintenance dosage in adults is 2.5-20 mg daily given as a single dose or
in 2 divided doses daily. If BP is not controlled with ramipril alone, a diuretic
may be added.
Congestive Heart failure after myocardial infarction : In this case, ramipril
therapy may be initiated as early as 2 days after myocardial infarction. An
initial dose 2.5 mg twice daily is recommended, but if hypotension occurs,
dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a
target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events : In this case, the recommended
dose is 2.5 mg twice daily for the first week of therapy and 5 mg once daily
for the following 3 weeks; dosage then may be increased, as tolerated, to a
maintenance dosage of 10 mg once daily.
Dosage in renal impairment : For the patients with hypertension and renal
impairment, the recommended initial dose is 1.25 mg ramipril once daily.
Subsequent dosage should be titrated according to individual tolerance and
BP response, up to a maximum of 5 mg daily. For the patients with heart
failure and renal impairment, the recommended dose is 1.25 mg once daily.
The dose may be increased to 1.25 mg twice daily and up to a maximum
dose of 2.5 mg twice daily depending upon clinical response and tolerability.
Ramipril is contraindicated in patients who are hypersensitive to any
component of this product and in patients with a history of angioedema
related to previous treatment with a ACE inhibitor.
Ramipril is generally well tolerated. Dizziness, headache, fatigue and
asthenia are commonly reported side effects. Other side effects occurring
less frequently include symptomatic hypotension, cough, nausea, vomiting,
diarrhoea, rash, urticaria, oliguria, anxiety, amnesia, etc. Angioneurotic
edema, anaphylactic reactions and hyperkalemia have also been reported
Warnings : Ramipril should be used with caution in patients with impaired
renal function, hyperkalemia, hypotension, surgery/anesthesia and impaired
With Diuretics : Patients on diuretics, especially those in whom diuretic
therapy was recently instituted, may occasionally experience an excessive
reduction of blood pressure after initiation of therapy with ramipril. The
possibility of hypotensive effects with ramipril can be minimized by either
discontinuing the diuretic or increasing the salt intake prior to initiation of
treatment with ramipril. If this is not possible, the starting dose should be
With Potassium Supplements and Potassium-sparing Diuretics : Ramipril can
attenuate potassium loss caused by thiazide diuretics. Potassium-sparing
diuretics (spironolactone, amiloride, triamterene, and others) or potassium
supplements can increase the risk of hyperkalemia. Therefore, if
concomitant use of such agents is indicated, they should be given with
caution, and the patient’s serum potassium should be monitored frequently.
With Lithium : Increased serum lithium levels and symptoms of lithium
toxicity have been reported in patients receiving ACE inhibitors during
therapy with lithium. These drugs should be co-administered with caution,
and frequent monitoring of serum lithium levels is recommended. If a
diuretic is also used, the risk of lithium toxicity may be increased.
With nonsteroidal anti-inflammatory agents : Rarely, concomitant treatment
with ACE inhibitors and nonsteroidal anti-inflammatory agents have been
associated with worsening of renal failure and an increase in serum
Other : Neither ramipril nor its metabolites have been found to interact with
food, digoxin, antacid, frusemide, cimetidine, indomethacin, and simvastatin.
The combination of ramipril and propranolol showed no adverse effects on
dynamic parameters (blood pressure and heart rate). The co-administration
of ramipril and warfarin did not adversely affect the anticoagulant effects of
the latter drug.
USE IN PREGNANCY
Pregnancy should be excluded before start of treatment with ramipril and
avoided during treatment. However, if pregnancy is detected, ramipril should
be discontinued as early as possible unless continued use is considered life
USE IN LACTATION
Ramipril should not be used during lactation.
USE IN PEDIATRIC PATIENTS
Safely and effectiveness in pediatric patients have not been established.
Store at cool & dry place, Protect from light and moisture.
INDICATION AND USE