The package insert of the medicine Redupress

the package insert of the medicine Redupress. Therapeutic class of Antihypertensives. Active principles Losartan Feldspar.

what For?

Treatment of hypertension.

Contraindications

When should I not use?

Patients hypersensitive to any of the components of the formula.

Dosage

How to use?

The usual dose for initial and maintenance treatment is 50 mg, 1 time a day, for the majority of patients. The maximum effect of anti-hypertensive is obtained 3 to 6 weeks after the start of treatment. Some patients may get additional benefit if the dose is increased to 100 mg, 1 time a day. For patients with intravascular volume depletion (treated with high doses of diuretics), should be considered an initial dose of 25 mg once a day. There is no need to adjust the starting dosage for elderly patients or for patients with renal dysfunction, including patients on dialysis. It should be considered to use a lower dose for patients with a history of liver dysfunction. Redupress can be administered with another agent anti-hypertensive. Redupress can be administered with or without food. Note: the data are available related to overdosage in humans are limited. The manifestations most likely to overdose are hypotension and tachycardia; bradycardia may occur by the stimulation of the parasympathetic (vagal). If hypotension symptomatic must establish supportive care. Nor Redupress nor the active metabolite can be removed from the circulation by hemodialysis.

Side Effects

What are the evils that can cause me?

Redupress is generally well tolerated. Adverse reactions have generally been mild in nature and transient and have not required discontinuation of treatment. The overall incidence of adverse reactions reported with Redupress was comparable to that of placebo. In controlled clinical studies in essential hypertension, dizziness was the only adverse reaction reported as related to the drug, that occurred with an incidence greater than placebo in 1% or more of patients treated with Redupress. Still, effects ortost├íticos related to dose were observed in less than 1% of patients. It was rarely reported skin rash, and the incidence in controlled clinical studies less than that of the placebo. – laboratory Findings: in controlled clinical studies, changes clinically important laboratory parameters standards were rarely associated with administration of the Redupress. Hyperkalemia (serum potassium > 5.5 mEq/l) occurred in 1.5% of patients, however, in these studies it was not necessary to discontinue treatment with Redupress due to hyperkalemia. Rarely occurred elevations in the values of ALT in general, returned to baseline with discontinuation of treatment.

Warnings and Precautions

what should I know before using?

In patients who have intravascular volume depletion (for example: those patients treated with high doses of diuretics), can occur hypotension symptomatic. These conditions should be corrected prior to administration of Redupress, or should use a lower starting dose. Based on pharmacokinetic data which demonstrate significant increases in plasma concentrations of Redupress in cirrhotic patients, one should consider lower doses in patients with a history of liver dysfunction. Other drugs that affect the renin-angiotensin system may increase the rates of urea and creatinine serum in patients with renal artery stenosis, bilateral or stenosis of the artery of the kidney only. While it is not confirmed, this situation can potentially occur with angiotensin receptor antagonists II. – Pregnancy: when used in pregnancy during the second and third trimesters of pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When there is confirmation of pregnancy, you should discontinue the treatment with Redupress as soon as possible. In humans, the renal perfusion the fetus, which depends on the development of the renin-angiotensin system, begins in the second trimester; thus risk to the foetus increases if Redupress is administered during the second or third trimester of pregnancy. – nursing mothers: it is not known if Redupress is excreted in human milk, because of the potential for serious adverse health reactions in infants, a decision must be made as to the interruption of breast-feeding or treatment with Redupress taking into consideration the importance of the drug to the mother. – paediatrics: have not yet been established the safety and efficacy in children. – Use in elderly: in clinical studies there was no difference in the safety profile and efficacy of Redupress, age related. Drug interactions: there were no identified drug interactions significant. The compounds that were evaluated in clinical studies of pharmacokinetics, which include hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital.