Indications/Uses

Treatment of hypertension.

Dosage/Direction for Use

Initial Dose: 5-10 mg once daily in hypertensive patients with normal renal function. Doses can be increased up to 20 mg according to patient response. The dosage should be reduced in patients with renal insufficiency, renal hypertension or severe hypertension. Or as prescribed by the physician.

Administration

Should be taken on an empty stomach: Take 15 min before meals. However, when initiating therapy, 1st dose should be given at bedtime.

Contraindications

Patients with known hypersensitivity to ACE inhibitors or with a history of angioneurotic edema.

Warnings

Use in pregnancy: Imidapril, like any other ACE inhibitors, should not be given during pregnancy as it may cause fetal/neonatal morbidity or mortality. Discontinue use of imidapril once pregnancy is detected. Fetal exposure to ACE inhibitors can cause hypotension, renal failure, anuria, skull hypoplasia or even death in the newborn. Maternal oligohydramnios has been reported, presumably resulting from decreased fetal renal function. Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In these patients, it is advised to use a different type of dialysis membrane or a different class of antihypertensive agent.

Special Precautions

Administer with caution in the elderly and in patients with renal disease. Increased age and impaired renal function may decrease the urinary excretion of imidapril and its metabolites.
Imidapril should be used with caution in patients with unilateral or bilateral renal artery stenosis since increase in blood urea nitrogen and serum creatinine may occur.
In general, ACE inhibitors should be used with caution in patients with sodium depletion or hypovolemia and those undergoing dialysis, major surgery or during anesthesia since severe hypotension may occur.
Use in lactation: Imidapril is excreted in breast milk therefore, avoid use of the drug in nursing mothers.

Use In Pregnancy & Lactation

Use in pregnancy: Imidapril, like any other ACE inhibitors, should not be given during pregnancy as it may cause fetal/neonatal morbidity or mortality. Discontinue use of imidapril once pregnancy is detected. Fetal exposure to ACE inhibitors can cause hypotension, renal failure, anuria, skull hypoplasia or even death in the newborn. Maternal oligohydramnios has been reported, presumably resulting from decreased fetal renal function. Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In these patients, it is advised to use a different type of dialysis membrane or a different class of antihypertensive agent.
Use in lactation: Imidapril is excreted in breast milk therefore, avoid use of the drug in nursing mothers.

Adverse Reactions

Imidapril is well-tolerated. Adverse reactions are usually mild and transient. The most frequent adverse reactions include dry cough (2.8%), discomfort in the throat (0.5%), palpitation (0.2%), headache (0.2%) and rash (0.2%). The following adverse effects occurred rarely (0.1% each) and include fatigue, dizziness, hot flush, diarrhea, nausea and vomiting.
Abnormal laboratory test values were observed in 5.6% (47/832) of patients but none is considered related to imidapril treatment.

Drug Interactions

Combination of imidapril with other antihypertensive drugs eg, diuretics, β-blockers and other vasodilators, potentiates the drug's hypotensive effects. Co-administration of imidapril and rifampicin decreases hypotensive effect of imidapril due to decrease in plasma level of imidaprilat. Concomitant administration of imidapril with potassium-sparing diuretics (ie, amiloride, spironolactone or triamterene), potassium supplements or potassium-sparing salt substitutes may lead to hyperkalemia.
Lithium toxicity has been reported in patients receiving lithium concomitantly with ACE inhibitors.

Storage

Store at temperatures not more than 30°C.

Action

Angiotensin-converting enzyme inhibitor/antihypertensive.
Pharmacology: Imidapril is an ester prodrug which is hydrolyzed after absorption to imidaprilat, the active metabolite. Imidaprilat has potent angiotensin-converting enzyme (ACE) inhibitory effects, 1.2 and 2.6 times that of enalaprilat and captopril, respectively.
The hypotensive effect of imidapril is mainly due to ACE inhibition and the consequent reduction in angiotensin II, resulting in dilatation of peripheral vessels and reduction in vascular resistance. The hypotensive effect of imidapril is comparable to enalapril and 5-10 times more potent than that of captopril.
Imidapril decreases total peripheral vascular resistance without increase in heart rate or cardiac contractility. Imidapril increases renal blood flow and reduces renal vascular resistance mainly due to dilatation of the efferent arteriole. It showed no specific effect on the CNS, digestive, respiratory, smooth muscle, reproductive, urologic, hematologic and metabolic systems.
Pharmacokinetics: About 25-40% of imidapril is absorbed after oral administration. Imidapril undergoes deesterification in the liver to form imidaprilat. Peak plasma concentrations of imidaprilat are reached within 6-8 hrs after single oral doses of 2.5-20 mg of imidapril, and decline slowly with a t_½ of 7-9 hrs. Imidapril and imidaprilat were shown to be about 85% and 51% protein bound, respectively.
Drug elimination is primarily via the renal (40%) and hepatobiliary (50%) routes. Increased age and impaired renal function may decrease the urinary excretion of imidapril and its metabolites.

MedsGo Class

ACE Inhibitors/Direct Renin Inhibitors

VASCOR Imidapril Hydrochloride 5mg Tablet 100's