The package insert of the medicine Eupressin-h

the package insert of the medicine Eupressin-h.

what For?

it Is indicated in the treatment of hypertension in patients in whom combination therapy is appropriate.


When should I not use?

Anuria. Hypersensitivity to any component of this product or to other drugs derived from the sulphonamides.


How to use?

Eupressin-H is presented as tablets for oral administration. The dosage of Eupressin H should be determined primarily by the experience with the enalapril maleate. The dose of each patient should be individualized. The dose of Eupressin H 10/25 mg or Eupressin-H 20/12,5 mg should be determined by titration of each component individually. It should be taken into account that the patients in treatment with anti-hypertensive combined usually do not require doses of hydrochlorothiazide greater than 50 mg/day or enalapril greater than 40 mg/day. Therefore the dose of Eupressin H in any of its two forms of presentation should not exceed 2 tablets a day. Hypertension: in hypertension, the usual dose is 1 tablet of 10/25 mg or 20/12,5 mg, as the case may be, administered 1 time a day. If necessary, the dosage can be increased to 2 tablets administered 1 time a day. Diuretic therapy previous: can occur hypotension symptomatic after the initial dose of Eupressin H; this is more likely in patients who are depletados salt or volume, as a result of diuretic therapy previously used. This should be discontinued 2 to 3 days before the start of the use of Eupressin-H. Dosage in renal failure: thiazide-type water pills are not diuretics are appropriate for use in patients with renal failure and are not effective with values of clearance creatinine below 30 ml/min. (that is, renal failure, moderate or severe). In patients with creatinine clearance between 30 and 80 ml/min., Eupressin-H should be used only after titration of the individual components. The recommended dose of enalapril maleate, when used alone, in renal insufficiency, is 5 to 10 mg. Overdosage: treatment of overdosage is symptomatic and of support. You must suspend therapy with Eupressin-H and observe the patient carefully.

Side Effects

What are the evils that can cause me?

Eupressin-H is usually well tolerated. In clinical studies, the side effects were usually mild and transient and, in most cases, not requiring discontinuation of therapy. The clinical effect of the most common was dizziness, which generally responded to the decrease of dosing, and rarely led to discontinuation of therapy. Other side effects less frequent were headache, weakness, muscle cramps, and asthenia. Still less common were the following events listed by system: cardiovascular: syncope, low blood pressure is not orthostatic, tachycardia, chest pain, palpitations. Gastrointestinal: diarrhea, vomiting, dyspepsia, abdominal pain, flatulence, constipation, nausea. Psychiatric: insomnia, somnolence, paraesthesia, vertigo, nervousness. Respiratory: dyspnea, cough. Other: decreased libido, rash, dry mouth, gout, hyperhidrosis, tinnitus, pruritus, arthralgia, impotence, skin rash. Hypersensitivity/edema angioneurótico: edema angioneurótico of the face, extremities, lips, tongue, glottis and/or larynx have been reported rarely. Effects in the laboratory: changes to clinically important laboratory parameters standards rarely been associated with the administration of Eupressin-H. Were noted occasionally, hyperglycemia, hyperuricemia, hypokalemia and hipopotassemia. Were also seen increases in the urea and creatinine from the blood, and elevations of liver enzymes and/or bilirrubinas serum. All were generally reversible with discontinuation of Eupressin-H. also Occurred hyperkalemia, and reductions of hemoglobin, hematocrit and white blood cells.

Warnings and Precautions

what should I know before using?

Hypotension and imbalance electrolyte: as with any antihypertensive therapy, can occur hypotension in some patients. Patients should be observed as to the clinical signs of imbalance electrolyte, for example: depletion of volume, hyponatremia, alcalose hipoclorêmica, hypomagnesemia or hypokalemia, that may occur during diarrhea or vomiting. Determinations and periodic serum electrolytes should be performed at appropriate intervals in such patients. Particular attention should be given when therapy is administered to patients with ischemic heart disease or vascular disease of the brain, as a reduction in excessive blood pressure could result in myocardial infarction or A. V. C. If hypotension, the patient should be placed in the supine position, and, if necessary, should receive infusion of normal saline. Hypotension transient is not a contraindication to doses later. After re-establishment of the PA and of the blood volume effective, the re-institution of therapy reduced doses may be possible, or you can opt for the appropriate use of any of the components alone. Deterioration of renal function: thiazide-type water pills are not the diuretics that are appropriate for use in patients with renal function deteriorated and are not effective with values of clearance creatinine below 30 ml/min. (that is, renal failure, moderate or severe). Eupressin-H should not be administered to patients with renal failure (clearance of creatinine 80 ml/min.) until titration of the individual components has established the need for the doses to be used with the combination. Some hypertensive patients without apparent damage to renal disease, have developed increases in discrete and transient urea and creatinine serum, when subjected to combination therapy of enalapril and a diuretic. If this occurs during treatment with Eupressin-H, the combination should be discontinued. You can restart treatment with lower doses or opt for one of the components alone. In some patients, with stenosis bilateral renal artery or stenosis of a renal artery in the kidney only, have been reported increases in urea and creatinine serum with the use of inhibitors of angiotensin converting. These increases are usually reversible upon discontinuation of therapy. Liver disorders: thiazides should be used with caution in patients with liver dysfunction and liver disorders progressive, because small changes of the water balance and electrolyte may precipitate coma hepatic. Surgery/Anesthesia: in patients who undergo major surgeries or during anesthesia with agents that produce hypotension, enalapril may block the formation of angiotensin II secondary to the release compensatory renin. If hypotension attributed to this mechanism, the correction can be made through the expansion of volume. Thiazides may increase the responsiveness to tubocurarine. Effects metabolic and endocrine: the thiazides may impair glucose tolerance. May be required adjustments in the dosage of agents hypoglycaemic, including insulin. Thiazides may decrease urinary calcium excretion and cause elevations in light and intermittent calcium in serum, hyperkalemia important may be evidence of hiperparatireoidismo subclinical. Therapy with thiazide should be discontinued before carrying out tests of function paratireoideana. Therapy with thiazide may precipitate hyperuricemia and/or gout in certain patients. However, enalapril may increase the level of uric acid in the urine and, therefore, mitigate the effect hiperuricemiante of hydrochlorothiazide. Hypersensitivity/Edema angioneurótico: edema angioneurótico of the face, extremities, lips, glottis and/or larynx has been reported rarely in patients treated with inhibitors of angiotensin-converting enzyme, including enalapril maleate. In such cases, enalapril maleate should be discontinued immediately and the patient should be observed closely until the disappearance of edema. In cases where swelling has been confined to the face and lips, the condition usually resolves without treatment, however, antihistamines have been useful in the relief of symptoms. The edema angioneurótico associated with edema of the larynx can be fatal. When there is involvement of tongue, glottis, or larynx, so as to produce obstruction of the airway, should be to immediately administer solution of epinephrine subcutaneous (1:1000 (0.3 to 0.5 ml) and to institute other therapies as appropriate. In patients receiving thiazide reactions, sensitivity can occur with or without history of allergy or bronchial asthma. Exacerbation or activity of lupus erythematosus has been reported with the use of thiazide-type water pills. It is recommended to abstain from the use of alcoholic beverages, as alcohol can enhance the effect of the medicine. Use in pregnancy: there are no studies adequate and well-controlled with the Eupressin-H in pregnant women. The routine use of diuretics in pregnant women, healthy is not recommended and exposes mother and fetus to unnecessary damage. Diuretics do not prevent development of toxemia gravídica and there is no satisfactory evidence that they are useful in the treatment of toxemia. Thiazides cross the placental barrier and appear in cord blood. Therefore, the use of products containing thiazide during or suspected pregnancy requires that the benefits of the drug be weighed against the possible harm to the unborn baby. One should consider discontinuation of treatment. These damages include jaundice, fetal or neonatal thrombocytopenia and possibly other adverse reactions that have occurred in adults; can cause death of the fetus. Enalapril crosses the placental barrier and appears in cord blood. There is potential risk of hypotension in the fetus, reduced birth weight and decreased renal perfusion or anuria in the foetus from exposure in utero to ACE inhibitors. All the neonate exposed to enalapril in the uterus 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 dialysis to remove enalapril from the circulation. The use of ACE inhibitors during the final stage of pregnancy, therefore, is not generally recommended. Lactation: it is not known if the enalaprilato is secreted in breast milk. It is known that thiazides do appear in human milk. If the drug use is absolutely essential, the patient should stop breastfeeding. Paediatric use: safety and effectiveness in children have not been established. Use in elderly: in clinical studies, the efficacy and tolerability of enalapril maleate and hydrochlorothiazide, administered concomitantly, were similar in hypertensive patients young and old. Drug interactions: potassium serum: the effect espoliador potassium of thiazide diuretics is usually attenuated by the effect-saver potassium enalapril. The levels of serum potassium usually remained within normal limits. The use of supplementation, potassium sparing agents potassium, or salt substitutes kitchen containing potassium, particularly in patients with renal function deteriorated, you may induce the increases are significant in the serum potassium. Lithium: lithium should generally not be administered with diuretics. Diuretics reduce the clearance renal lithium and lead to high risk of toxicity. The information of the preparations lithium should be consulted prior to use. Other anti-hypertensive drugs: the combination of enalapril maleate with beta-adrenergic blockers, metildopa, or calcium channel blockers have shown increased efficacy in the control blood pressure. Ganglioplégicos and blocker adrenergic receptors combined with enalapril, should only be administered under strict observation. Alcohol, barbiturates or narcotics: can occur potentiation of orthostatic hypotension. Amines vasopressoras (for example: adrenaline): possible decreased response to amines vasopressoras, but not enough to prevent its use. Nsaids: in some patients, the administration of nsaids can reduce the effects of diuretics, natriuretic and anti-hypertensive drugs diuretics.