What is CoAprovel?
CoAprovel is a medicine containing two active substances, irbesartan and hydrochlorothiazide. It is available as oval-shaped tablets (peach-colored: 150 mg or 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide; pink-colored 300 mg of irbesartan and 25 mg of hydrochlorothiazide).
What is CoAprovel used for?
CoAprovel is used in adults with essential hypertension (high blood pressure) not adequately controlled by irbesartan or hydrochlorothiazide alone. The term "essential" indicates that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
How is CoAprovel used?
CoAprovel should be taken by mouth, with or without food. The dose of CoAprovel to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient has previously taken. Doses above 300 mg of irbesartan and 25 mg of hydrochlorothiazide once daily are not recommended. CoAprovel can be taken as an adjunct to other treatments for hypertension.
How does CoAprovel work?
CoAprovel contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan is an "angiotensin II receptor antagonist", which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan blocks the effect of the hormone, allowing the blood vessels to dilate.
Hydrochlorothiazide is a diuretic, another type of hypertension treatment. It works by increasing the excretion of urine, reducing the amount of fluid in the blood and lowering blood pressure.
The combination of the two active ingredients has an additional effect, reducing blood pressure to a greater extent than the two medicines taken individually. With reduced blood pressure, the risks associated with high blood pressure, such as having a stroke, decrease.
How has CoAprovel been studied?
Irbesartan alone obtained authorization in the European Union (EU) in 1997, with the names Karvea and Aprovel. It can be used together with hydrochlorothiazide in the treatment of hypertension. Studies of Karvea / Aprovel taken together with hydrochlorothiazide in separate tablets were used to support the use of CoAprovel. Further studies were also conducted with 300 mg doses of irbesartan in combination with 25 mg of hydrochlorothiazide. The main efficacy index was based on the reduction of diastolic blood pressure (the blood pressure measured in the interval between two heartbeats).
What benefit has CoAprovel shown during the studies?
CoAprovel was more effective than placebo (a dummy treatment) and hydrochlorothiazide taken on its own to reduce diastolic blood pressure. Increasing the dose to 300 mg of irbesartan and 25 mg of hydrochlorothiazide may further lower blood pressure.
What is the risk associated with CoAprovel?
The most common side effects seen with CoAprovel (seen in between 1 and 10 patients in 100) are vertigo, nausea or vomiting, abnormal urination, fatigue (fatigue) and increased concentrations of urea nitrogen in the blood (BUN, protein degradation product), creatinine (degradation product of muscle metabolism) and creatine kinase (enzyme present in muscles). For the full list of all side effects reported with CoAprovel, see the Package Leaflet.
CoAprovel should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfa drugs or any of the other ingredients. It must not be used in women who have been pregnant for more than three months. Not recommended for use during the first three months of pregnancy. Furthermore, CoAprovel should not be used in patients with severe kidney, liver or bile disorders, with too low levels of potassium in the blood or too high levels of calcium in the blood.
Particular attention should be paid if CoAprovel is taken with other drugs that affect blood potassium levels. For the full list of these medicines, see the package leaflet.
Why has CoAprovel been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that CoAprovel's benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with irbesartan or hydrochlorothiazide alone. The committee recommended the granting of the marketing authorization for CoAprovel.
More information on CoAprovel:
On 15 October 1998, the European Commission issued a marketing authorization valid throughout the European Union for CoAprovel to Sanofi Pharma Bristol-Myers Squibb SNC. The marketing authorization was renewed on 15 October 2003 and 15 October 2008.
For the full EPAR of CoAprovel, click here.
Last update of this summary: 03-2009.
