PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Rasitrio - Aliskiren / amlodipine / hydrochlorothiazide?
Rasitrio is a medicine that contains the active substances aliskiren, amlodipine and hydrochlorothiazide. It is available in tablets with the following concentrations: 150/5 / 12.5 mg; 300/5 / 12.5 mg; 300/5/25 mg; 300/10/12.5 mg; and 300/10/25 mg.
What is Rasitrio used for?
Rasitrio is used for the treatment of essential hypertension (high blood pressure) in adult patients whose blood pressure is already adequately controlled with the combination of aliskiren, amlodipine and hydrochlorothiazide administered concomitantly at the same dose. The term "essential" indicates that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
How is Rasitrio - Aliskiren / amlodipine / hydrochlorothiazide used?
The patient should take one tablet once a day with a light meal, preferably at the same time each day. The tablet should be swallowed whole with water and should not be taken with grapefruit juice.
The concentration of the Rasitrio tablet taken by the patient depends on the previously administered doses of aliskiren, amlodipine and hydrochlorothiazide. Patients should be switched to the fixed combination Rasitrio tablet containing the same doses as the previously used components alone.
How does Rasitrio - Aliskiren / amlodipine / hydrochlorothiazide work?
Rasitrio contains three active substances: aliskiren, amlodipine and hydrochlorothiazide.
Aliskiren is a renin inhibitor that blocks the activity of an enzyme called renin, which is involved in the production of a substance called angiotensin I in the body. Angiotensin I is converted to the hormone angiotensin II, which is a potent vasoconstrictor (a substance that causes blood vessels to narrow.) By blocking renin activity, angiotensin I and angiotensin II levels are reduced. This involves vasodilation (dilation of blood vessels) resulting in a reduction in blood pressure.
Amlodipine is a calcium channel blocker that blocks particular channels on the surface of cells called calcium channels, through which calcium ions normally pass. Entering the muscle cells of the blood vessel walls, calcium ions cause a contraction. By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thereby reducing blood pressure.
Hydrochlorothiazide is a diuretic that increases urine production by reducing the volume of fluid in the blood and lowering blood pressure.
The combination of these three active substances reduces blood pressure more than one of the medicines given individually.
How has Rasitrio been studied?
In a main study involving 1,191 patients with moderate or severe hypertension, combinations of Rasitrio containing the three active substances and combinations containing only two active substances were compared: aliskiren and amlodipine, amlodipine and hydrochlorothiazide, aliskiren and hydrochlorothiazide. Patients underwent treatment for eight weeks. The main measure of effectiveness was the reduction in the average systolic pressure (blood pressure during contraction of the heart) measured with patients in a sitting position.
The company also presented studies showing that the tablet containing all three substances is absorbed by the body in the same way as the separate tablets.
What benefit has Rasitrio shown during the studies?
Rasitrio combination was more effective than double combinations for reducing systolic blood pressure. After eight weeks, patients treated with Rasitrio experienced an average reduction in sitting systolic pressure of 37.4 mmHg. They were observed. reductions of 28.2 mmHg, 30.6 mmHg and 30.8 mmHg for aliskiren and hydrochlorothiazide, aliskiren and amlodipine, and amlodipine and hydrochlorothiazide, respectively.
What is the risk associated with Rasitrio?
The most frequent adverse reactions for Rasitrio are hypotension, peripheral edema and dizziness. For the full list of side effects reported with Rasitrio, see the package leaflet.
Rasitrio must not be used in people who are hypersensitive (allergic) to aliskiren, amlodipine or hydrochlorothiazide, to any of the ingredients of the medicine or to other substances derived from dihydropyridine (a group including amlodipine) or sulphonamide (which includes hydrochlorothiazide). It must not be used in patients who have experienced angioedema (swelling under the skin), who have severe liver or kidney problems, or who have blood potassium levels that are too low or blood calcium levels that are too high. It must not be taken concomitantly with cyclosporine or itraconazole (medicine that reduces the activity of the immune system) or with medicines that can slow down the breakdown of aliskiren in the body such as quinidine (used to correct an irregular heart rhythm). to people with very low blood pressure, who suffer from shock, who have narrowing of the aortic valve or who suffer from heart failure following an acute heart attack. It should not be given to women who are more than 3 months pregnant or while breastfeeding. Use of the medicine in the first three months of pregnancy is not recommended. For the full list of restrictions, see the package leaflet.
Why has Rasitrio - Aliskiren / amlodipine / hydrochlorothiazide been approved?
The main study showed a greater reduction in blood pressure with Rasitrio than with combinations of two active substances. Studies have also shown that the active ingredients contained in Rasitrio are absorbed by the body in the same way as the active ingredients given in separate tablets. The CHMP noted that taking the three active substances in one tablet, as opposed to taking them as separate tablets, may lead to greater compliance with treatment.
The CHMP therefore decided that Rasitrio's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.
More information about Rasitrio - Aliskiren / amlodipine / hydrochlorothiazide
On November 22, 2011, the European Commission issued a "marketing authorization" for Rasitrio valid throughout the European Union.
For more information about Rasitrio therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
The information on Rasitrio - Aliskiren / amlodipine / hydrochlorothiazide published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
