The package insert of the medicine Eupressin

the package insert of the medicine Eupressin.

what For?

All grades of essential hypertension; hypertension-renovascular; in congestive heart failure (CHF). As an adjunct to conventional therapy, Eupressin is indicated to reduce mortality in patients with heart failure.

Contraindications

When should I not use?

Individuals who have demonstrated hypersensitivity to enalapril maleate or other components of the formula. In patients with a history of edema angioneurótico related to previous treatment with inhibitors of angiotensin converting enzyme.

Dosage

How to use?

As the absorption of Eupressin is not affected by food intake, the tablets may be administered before, during or after meals. The daily dose usual varies from 10 to 40 mg for all indications. Eupressin can be administered 1 or 2 times per day. In patients with chf, renal failure, or who are being treated with diuretics may be needed in an initial dose lower Eupressin. Up to the present time, the maximum dose studied in humans is 80 mg daily. Essential hypertension: initial dose 10 to 20 mg administered 1 time a day. Mild hypertension: initial dose 10 mg per day. Other degrees of hypertension: initial dose 20 mg per day. The maintenance dose usual is 1 20 mg pill a day. The dosage should be adjusted according to the needs of the patient. Hypertension, renovascular: start with 1 lower dose, 2.5 mg to 5 mg, and adjust according to the needs of the patient. The majority of patients respond to 20 mg a day. Caution in hypertensive patients treated recently with diuretics, due to the possibility of occur hypotension symptomatic after the initial dose of Eupressin. In these cases, discontinue the diuretic for 2 to 3 days before beginning therapy with Eupressin. Dosage in case of renal failure: generally this should prolong the interval between doses of Eupressin, or reduce the dosage. In case of renal impairment mild (creatinine clearance between 30 and 80 ml/min): initial dose 5 to 10 mg; dysfunction moderate (creatinine between 10 and 30 ml/min): 2.5 to 5 mg; dysfunction and severe (creatinine 10 ml/min): 2.5 mg on dialysis days.. As enalapril is dialyzable, one should adjust the dosage to the response of the blood pressure. Congestive heart failure: monitor blood pressure and renal function before and after starting treatment with Eupressin, due to the possibility of experiencing hypotension and renal failure in the ICC. The initial dose of Eupressin in patients with heart failure is 2.5 mg and should be administered under medical supervision, to verify the initial effect on blood pressure. The start of the action happens a few minutes after administration. The maximum effect on the blood pressure and hemodynamic parameters is noted, in general, in the first 4 hours. In the absence of, or after, the effective treatment of the hypotension symptomatic, consequent to the start of therapy with Eupressin, the doses should be gradually increased according to patient response, up to 10 or 20 mg daily. This period of dose titration will take place in a variable period of 2 to 4 weeks, or less, if necessary at the physician’s discretion. The usual dose of maintenance is of 10 to 20 mg daily in a single dose or divided. Note: the appearance of hypotension after the initial dose of Eupressin does not mean that this will occur during the therapy chronic. Such an occurrence does not contra-indicate the continued use of the Eupressin. – Overdose: limited data is available on overdosage in man. The most likely manifestation of overdosage would be hypotension, which can be treated, if necessary, by intravenous infusion of normal saline and/or angiotensin II.

Side Effects

What are the evils that can cause me?

Eupressin has been shown to be generally well tolerated. In clinical studies, the overall incidence of adverse reactions was not higher with Eupressin than the one verified with placebo. In most cases, the adverse reactions were mild and transient, not requiring discontinuation of treatment. Dizziness and headaches were the most commonly reported effects. Fatigue and asthenia. Other side effects: hypotension, orthostatic hypotension, syncope, nausea, diarrhea, muscle cramps, rash and cough. Have been reported rare cases of edema angioneurótico with edema of the face, tongue and glottis, associated with the dyspnea. In these circumstances, Eupressin should be discontinued, and clinical measures that are appropriate should be initiated immediately. Laboratory findings: infrequently occurring changes of laboratory parameters during treatment with Eupressin. They were, however, described in isolated cases, increases in urea and creatinine, particularly in patients with renal insufficiency. Equally rare were the observations of reduction in hemoglobin, hematocrit, platelets, and leukocytes or elevation of liver enzymes.

Warnings and Precautions

what should I know before using?

Hypotension symptomatic: has occurred rarely. It is more probable its occurrence in hypertensive patients with volume depletion, restriction of dietary salt, or subjected to dialysis. It is more frequent in patients with advanced degrees of chf, requiring high doses of diuretics and present with renal failure. Should the need arise, will be made replacement volume and treatment with Eupressin can be continued. Renal insufficiency: patients with renal insufficiency may require reduced dose and/or less frequent Eupressin. As some hypertensive patients without renal injury pre-existing apparent, have developed discrete and transient increases in urea and creatinine blood, when given concomitantly Eupressin and a diuretic; it is recommended to monitor previously the renal function of the patient. It may be necessary to reduce the dose of Eupressin and/or discontinuation of the diuretic. Hypersensitivity and edema angioneurótico: has been reported rarely in patients treated with ACE inhibitors. The treatment should be discontinued and the patient should be observed. Use in pregnancy: there are no studies adequate and well-controlled of enalapril in pregnant women. The same crosses the placental barrier and appears in cord blood. There is, therefore, the potential risk of hypotension in the fetus, reduced birth weight and decreased renal perfusion and/or anuria in the foetus from exposure in utero to ACE inhibitors. All the neonate who was exposed to enalapril in the womb, should be observed carefully as to the urinary output and blood pressure. If necessary, you must initiate appropriate clinical care, including administration of fluids or even dialysis to remove enalapril from its circulation. The use of ACE inhibitors during pregnancy is not, for the reasons exposed, absolutely recommended, unless there is no other treatment option. In this case, the pregnant woman should be properly cientificada of the fact. Lactating mothers: enalapril and the enalaprilato can potentially be secreted in breast milk. It is advised that all risks should be assessed, in the case of Eupressin to be prescribed to lactating women. Paediatric use: Eupressin has not been studied in children. – Drug interactions: antihypertensive therapy: can occur additive effect, when Eupressin is used with other anti-hypertensive medications. Serum potassium: usually remains within normal limits. In patients with renal insufficiency, the administration of Eupressin can raise the serum potassium.