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CONTRAINDICATIONS
ACETEC is contraindicated in patients with a history of angioneurotic edema relating
to previous treatment with an ACE inhibitor.
Hypersensitivity to the product or any of its component.
PRECAUTIONS AND WARNINGS
1. ACETEC should be used with caution for the simultaneous intake with potassium
supplement or potassium sparing diuretics, all drugs which may increase the resistance
of blood vessels.
2. For the patients with renal dysfunctions, the dosage must be reduced.
3. For the patients with liver dysfunction, the active metabolite of Enalapril becomes
low and the dosage may be increased but there is no sufficient experience in these
patients.
4. Neutropenia, thrombocytopenia, bone marrow depression and agranulocytosis have
occurred rarely ; a causal relationship can not be excluded.
5. ACETEC should not be recommended for children because there is no sufficient
report of safety of the drug in children.
6. If increased BUN and creatinine concentration occur, reduction in dosage and/or
withdrawal of the diuretic may be required. The possibility of renovascular
hypertension should also be consider, especially in the presence of a solitary kidney,
transplanted kidney, or bilateral renal atery stenosis.
7. Symptomatic hypotension is likely to occur in volume-depleted patients, patients
with congestive heart failure. This is most likely to occur in those patients with more
severe degrees of heart failure, as reflected by the use of high doses of loop diuretics,
hyponatremia or functional renal impairment. In these patients, therapy should be
started under medical supervision and the patients should be followed closely
whenever the dose of ACETEC and/or diuretic is adjusted. Similar considerations
may apply to patients with ischemic heart or cerebrovascular disease in whom an
excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular
accident. If hypotension occurs, place patients in supine position and, if necessary,
give IV infusion of normal saline. A transient hypotensive response is not a
contraindication to further doses, which can be given usually without difficulty once
the blood pressure has increased after volume expansion. In some patients with
heart failure who have normal or low blood pressure, additional lowering of systemic
blood pressure may occur with ACETEC. This effect is anticipated and usually is
not a reason to discontinue treatment. If hypotension becomes symptomatic, a
reduction of dose and/or discontinuation of the diuretic and/or ACETEC may be
necessary. No differences in blood pressure response or adverse effects have been
noted in elderly patients receiving enalapril.
8. In patients undergoing major surgery or during anesthesia with agents that produce
hypotension, enalapril will block angiotensin II formation secondary to compensatory
renin release. If hypotension occurs and is considered to be due to this mechanism,
it can be corrected by volume expansion.
Use in pregnancy
When used in pregnancy during the second and third trimesters ACE inhibitors can
cause injury and even death to the developing fetus. When pregnancy is detected, this
drug should be discontinued as soon as possible.
Use in lactation
Enalapril and enalaprilat are secreted in human milk in trace amounts. Cautions should
be exercised if ACETEC is given to a nursing mother.
ADVERSE EFFECTS
-- Hypotensive especially with high dosage or simultaneous intake with diuretics or
dehydration states or salt-limited diet.
-- Renal function disturbances such as glycosuria or proteinuria and in some cases may
lead to acute renal failure.
-- Skin : Diaphoresis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson
syndrome, toxic epidermal necrolysis, pemphigus, pruritus, urticaria, alopecia.
-- Gastrointestinal : Ileus, pancreatitis, hepatic failure, hepatitis (either hepatocellular
or cholestatic), jaundice, abdominal pain, vomiting, dyspepsia, constipation,
anorexia, stomatitis.
-- Laboratory Test Findinds : Increases in blood urea and serum creatinine and
elevations of liver enzymes and/or serum bilirubin have been seen. These are usually
reversible upon discontinuation of ACETEC. Hyperkalemia and hyponatremia have
occurred. Decreases in hemoglobin and hematocrit have been reported, a small
number of cases of neutropenia, thrombocytopenia, bone marrow depression and
agranulocytosis have been reported.
-- Hypersensitivity/Angioneurotic Edema : Angioneurotic edema of the face, extremities,
lips, tongue, glottis and/or larynx has been reported rarely.
-- Respiratory : Pulmonary infiltrates, bronchospasm/asthma, dyspnea, rhinorrhea,
sore throat and hoarseness.
-- Nervous System/Psychiatric : Depression, confusion, somnolence, insomnia,
nervousness, paresthesia, vertigo.
DRUG INTERACTIONS
When administered concurrently, the following drugs may interact with Enalapril
:
Antihypertensive drug : Additive hypotensive effect may occur.
Potassium-sparing diuretics or
potassium preparation : Hyperkalemia may occur (particularly in patient with
impaired renal function).
Potassium-losing diuretics : The potassium-losing effect was attenuated.
Lithium : Lithium clearance may be reduced. Frequent monitoring
of serum lithium concentrations is recommended.
Digoxin : Increase plasma digoxin level
Allopurinol : High risk of hypersensitivity reaction possible.
Rifampin : Pharmocologic effects of enalapril may be decreased.
Phenothiazine : Pharmocologic effects of enalapril may be increased.
Indomethacin : Reduce hypotensive effect of enalapril.
STORAGE:
Store at room at temperature not exceed 30°C, protect from moisture.
The shelf-life period is 3 years.
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