TRIATEC ® Ramipril

TRIATEC ® is a ramipril-based drug

THERAPEUTIC GROUP: Antihypertensives - ACE inhibitors not associated.

Indications TRIATEC ® Ramipril

TRIATEC ® is used - both monotherapy and together with other antihypertensive drugs - in the treatment of arterial hypertension. TRIATEC ® in addition to diuretics and cardiac glycosides, is also indicated in the treatment of congestive heart failure, and in monotherapy in slowing the progression renal insufficiency or in case of overt nephropathies in non-diabetic patients.

TRIATEC ® Ramipril mechanism of action

Ramipril, the active ingredient of TRIATEC ®, is rapidly absorbed following oral administration, so that the blood peak is reached after about an hour. However, ramipril is only an inactive precursor of the molecule with therapeutic activity. This substance, called ramiprilat, is synthesized in the liver following hydrolysis of its precursor (ramipril).

The maximum peak of the active form is observed approximately 2/4 hours after oral administration, with a bioavailability equal to approximately 20% of the starting dose.
Ramiprilat - both at systemic and tissue level - inhibits the enzyme dipeptidylcarboxypeptidase I, and prevents the conversion of angiotensin I into its active metabolite, angiotensin II, with the simultaneous increase in bradykinin values. The reduction in angiotensin II levels causes a significant decrease in the concentration of aldosterone, in the vasoconstriction process and in hydro-saline retention. The increased production of bradykinin, on the other hand, allows to mediate a sensitive vasodilatory action.The biological union between these two actions takes the form of a reduction in arteriolar vascular resistance, therefore in a significant pressure drop that begins around the third fourth hour, is optimized around the third fourth week of treatment and lasts up to 2 years, without any effect. rebound or adaptive (increased heart rate or rebound hypertension).
The antihypertensive action on the one hand, and the increase in bradykinin levels on the other, could be responsible for the vaso and cardioprotective action exerted by ramiprilat.
At the end of its action, ramiprilat is mainly removed by the kidney, with different timing due to a "variable half-life, between 3 hours and 4/5 days.

Studies carried out and clinical efficacy

1. RAMIPRIL IN THE "HYPERTENSION

Andersen K et al, J Hypertens 2008; 26: 589-599

Treatment with ramipril 5 mg daily for 4 weeks in patients with arterial hypertension showed a drop in systolic pressure of about 15mmHg, with no obvious side effects except for dry cough.

2. THE EFFECTS OF RAMIPRIL IN WOMEN AFTER PROLONGED TREATMENT

J Am Coll Cardiol. 2002 Aug 21; 40: 693-702.

Effect of long-term therapy with ramipril in high-risk women.

Lonn E, Roccaforte R, Yi Q, Dagenais G, Sleight P, Bosch J, Suhan P, Micks M, Probstfield J, Bernstein V, Yusuf S; HOPE Investigators. Heart Outcomes Prevention Evaluation.

2480 women, suffering from vascular pathologies or type II diabetes and treated with ramipril at doses of 10mg / day for prolonged time intervals, were monitored for the incidence of cardiovascular events. The careful critical evaluation showed how in the treated group the presence of cardiovascular accidents has been avoided and systolic function has been preserved.

3. RAMIPRIL AND RISK OF DIABETES

JAMA. 2001 Oct 17; 286: 1882-5.

Ramipril and the development of diabetes.

Yusuf S, Gerstein H, Hoogwerf B, Pogue J, Bosch J, Wolffenbuttel BH, Zinman B; HOPE Study Investigators.

Experimental models are elucidating the biological role of ramipril in protecting against diabetic disease, probably involved in the reduction of insulin resistance. This precursor study from 2001 laid the foundation for the experiment, observing how in 5,720 patients with vascular diseases, familiarity with diabetes and overweight, therapy with ramipril 10 mg daily significantly reduced the incidence of diabetic disease in high-risk individuals. However, it is necessary to clarify that there are no other studies in the literature that disprove these results.

Method of use and dosage

TRIATEC ® Ramipril 1.25, 2.5, 5 and 10 mg tablets: for the treatment of hypertension, the most effective and most used dose seems to be that of 2.5 milligrams per day, although at intervals generally biweekly it can be increased up to a maximum daily dose of 10mg.
In the latter cases, and in case of refractory to monotherapy, it is preferable to combine TRIATEC ® with another antihypertensive drug. In the treatment of congestive heart failure, the starting dose is 1.25 mg per day, to grow up to 5/10 mg provided that they are administered in different doses.
In the treatment of overt nephropathy of non-diabetic origin, the suggested dosage is 1.25 mg per day, possibly to be increased twice a week up to a maximum of 5 mg per day.
All appropriate corrections and any different therapeutic plans should be evaluated exclusively by the doctor, after a "careful evaluation of the patient's physio-pathological conditions, objectives and severity of the disease, taking into account that for particular risk categories it would be advisable not to exceed the maximum daily dose of 2.5 mg.
It can be taken either before, during or after meals, since food intake does not seem to interfere with the pharmacokinetics of the active ingredient.

Warnings TRIATEC ® Ramipril

When the use of ACE inhibitors such as rimapril is accompanied by angioedema of the face, head and neck, the administration of this drug should be discontinued immediately.
It would also be necessary to undergo continuous medical supervision and the relative blood pressure and electrolyte monitoring, in patients suffering from heart failure, from significant haemodynamic alterations, from previous therapy with diuretics, undergoing therapy with ACE inhibitors or suffering from gastrointestinal tract diseases that facilitate the loss. of fluids, such as diarrhea and vomiting.
Furthermore, given the excretion of ramiprilat mainly by the kidney, alterations in renal function or anuria, could delay the elimination of the drug and enhance the biological effects of the active ingredient.
Dosage adjustment may be necessary in case of concomitant administration of antihypertensive drugs or in case of patients with renal insufficiency or liver disease.
The administration of antihypertensive drugs generally exposes the patient to potential hypotensive episodes, dizziness and drowsiness, which could compromise normal perceptive and reactive abilities, making the use of vehicles or machinery particularly dangerous.

IN ANY CASE, BEFORE TAKING TRIATEC ® Ramipril - YOU MUST BE PRESCRIBED AND CHECKED BY YOUR DOCTOR.

PREGNANCY AND BREASTFEEDING

It would be necessary to avoid taking TRIATEC ® during the whole pregnancy, in order to avoid even irreversible damage to the fetus. In case of real need, it is good to prefer other antihypertensive drugs with a reduced risk profile for the health of the fetus.
Ramipril is excreted to a small extent in breast milk; therefore it would be necessary to stop breastfeeding in case of taking TRIATEC ®

Interactions

There are several pharmacological and non-pharmacological interactions described for TRIATEC ®

• Interactions with negatively charged membranes, such as those caused by hemodialysis, could lead to an increase in anaphylactic episodes;
• The concomitant administration of potassium supplements or potassium-sparing diuretics could lead to an increase in kalaemia;
• The simultaneous intake of hypoglycemic drugs could cause a significant glycemic drop, given the increased sensitivity to insulin induced by ramipril;
• Corticosteroids and non-steroidal anti-inflammatory drugs could cause an increase in hydro-saline retention with a reduction in the hypotensive effect;
• Lithium salts could accumulate and increase the cytotoxic effect.

Contraindications TRIATEC ® Ramipril

The use of TRIATEC ® is not recommended in case of innate hypersensitivity - or induced by hemodialysis filters - towards one of its components, in case of angioedema, clinically significant renal disorders with haemodynamic alterations, and hypotension.

Undesirable Effects - Side Effects

Most of the undesirable effects associated with taking TRIATEC ® are related to the hypotensive effect of rimapril. More precisely, hypovolaemic episodes can be quite frequent, especially in the initial stages of treatment, sleep disturbances, dizziness, sweating, dry cough, palpitations, fatigue, nausea and diarrhea.
Rarer and generally associated with the concomitant administration of diuretics, are instead side effects such as hyponatremia and hyperkalaemia, peripheral angioedema, increased levels of creatinine and urea, and alterations in blood counts and plasma values ​​of liver enzymes.
In case of hypersensitivity, mainly skin and respiratory reactions are described.

Note

TRIATEC ® can only be sold under medical prescription.

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