Each tablet contains : Enalapril maleate 5 mg and 20 mg
DOSAGE FORM AVAILABLE
ORAL : TABLETS 5 mg
TABLETS 20 mg
PRODUCT DESCRIPTION :
ACETEC TABLET 5 mg
Heart shape, biconvex, white tablets, impressed "BIOLAB" on one face and bisected
on the obverse.
ACETEC TABLET 20 mg :
Heart shape, biconvex, light orange tablets, impressed "BIOLAB" on one face and
bisected on the obverse.
ACETEC is an angiotensin converting enzyme (ACE) inhibitor. The effect of a dose
will gradually take place within one hour and will usually stay for 24 hours, daily
dosage may be given in one or two single administrations. Enalapril is a prodrug and
will be transformed to enalaprilat which is active by liver.
ACETEC can reduce blood pressure in normal and hypertensive person by reducing
peripheral vascular resistant but has no effect to heart rate. For the patient without
congestive heart failure, ACETEC has no effect or little effect to cardiac output and
does not interfere renal blood flow or glomerular filtration rate.
Enalapril maleate is rapidly absorbed from gastro-intestinal tract, approximately 60%
of a dose is absorbed and peak serum concentrations occur within about one hour.
Enalapril absorption is not influenced by the presence of food. Enalapril is metabolited
in the liver by hydrolysis to enalaprilat, the active metabolite. Excretion of
enalaprilat and enalapril is primarily renal. Approximately 94% of the dose is recovered
in the urine and feces as enalaprilat or enalapril. The principle components in urine
are enalaprilat, accounting for about 40% of the dose, and intact Enalapril. The elimination
half-life is approximately 11 hours, and is increased in patients with renal failure.
-- High blood pressure, whether alone or in combination with other anti-hypertensive
drugs especially diuretics.
-- Congestive heart failure : Should be used as an adjunctive therapy with digitalis
DOSAGE AND ADMINISTRATIONS
Essential Hypertension : The initial dose is 10-20 mg, depending on the degree of
hypertension, and is given once daily. In mild hypertension, the recommended initial
dose is 10 mg daily. For other degrees of hypertension the initial dose is 20 mg daily.
The usual maintenance dose is one 20 mg tab taken once daily. The dosage should
be adjusted according to the needs of the patient to a maximum of 40 mg daily.
Renovascular Hypertension : Since blood pressure and renal function in such patients
may be particularly sensitive to ACE inhibition, therapy should be initiated with a lower
starting dose (e.g. 5 mg or less). The dosage should then be adjusted according to the
needs of the patient. Most patients may be expected to respond to one 20 mg tab
taken once daily. For patients with hypertension who have been treated recently with
diuretics, caution is recommended.
Concomitant Diuretic Therapy in Hypertension : Symptomatic hypotension may
occur following the initial dose of ACETEC ; this is more likely in patients who are
being treated currently with diuretics. Caution is recommended, therefore, since these
patients may be volume or salt-depleted. The diuretic therapy should be discontinued
for 2-3 days prior to initiation of therapy with ACETEC. If this is not possible, the initial
dose of ACETEC should be low (5 mg or less) to determine the initial effect on the
blood pressure. Dosage should then be adjusted according to the needs of the patient.
Dosage in Renal Insufficiency : Generally, the intervals between the administration
of enalapril should be prolonged and/or the dosage reduced. (See table).
Creatinine Clearance ( ml/min )
Initial Dose ( mg/day )
< 80 > 30
5 - 10
30 > 10
2.5 - 5
Normally, these patients will be on dialysis.
2.5 mg on dialysis days
Heart Failure and/or Symptomatic Left Ventricular Dysfunction : The initial dose of ACETEC in patients with symptomatic heart failure or symptomatic left ventricular
dysfunction is 2.5 mg and it should be administered under close medical supervision
to determine the initial effect on the blood pressure. In the absence of, or after effective
management of, symptomatic hypotension following initiation of therapy with ACETEC
in heart failure, the dose should be increased gradually to the usual maintenance dose
of 20 mg, given in a single dose or 2 divided doses, as tolerated by the patient. This
dose titration may be performed over a 2 to 4 weeks period, or more rapidly if indicated
by the presence of residual signs and symptoms of heart failure. In patients with
symptomatic heart failure, this dosage regimen was effective in reducing mortality.
Blood pressure and renal function should be monitored closely both before and after
starting treatment with ACETEC because hypotension and consequent renal failure
have been reported. In patients treated with diuretics, the dose should be reduced if
possible before beginning treatment with ACETEC. The appearance of hypotension
after the initial dose of ACETEC does not imply that hypotension will recur during
chronic therapy with ACETEC and does not preclude continued use of the drug. Serum
potassium also should be monitored.
OVERDOSAGE-SYMPTOMS, TREATMENT, SUPPORTIVE THERAPY, ANTIDOTE (S)
The common symptom is hypotension. The recommended treatment of overdosage is
IV infusion of normal saline solution.
If ingestion is recent, induce emesis. ACETEC may be removed from the circulation