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) that is not adequately controlled by irbesartan or hydrochlorothiazide taken 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 is to be taken by mouth, with or without meals. The dose of CoAprovel to be used depends on the dose of irbesartan or hydrochlorothiazide the patient has previously taken. Doses greater than 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 potent vasoconstrictor (a substance that constricts blood vessels). angiotensin II normally binds, irbesartan blocks the effect of the hormone, allowing blood vessels to widen.
Hydrochlorothiazide is a diuretic, another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and lowering blood pressure.
The combination of the two active substances has an additional effect, reducing blood pressure to a greater extent than the two medicines taken alone. By lowering blood pressure, the risks associated with high blood pressure, such as that of have a stroke.
How has CoAprovel been studied?
Irbesartan alone obtained authorization in the European Union (EU) in 1997, under the names of Karvea and Aprovel. It can be used together with hydrochlorothiazide in the treatment of hypertension. Studies of Karvea / Aprovel taken together with hydrochlorothiazide as separate tablets have been used to support the use of CoAprovel. Further studies were also conducted with doses of 300 mg of irbesartan in combination with 25 mg of hydrochlorothiazide. The main measure of effectiveness was based on the reduction in 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 alone in lowering the diastolic blood pressure. Increasing the dose to 300 mg of irbesartan and 25 mg of hydrochlorothiazide may result in further lowering of blood pressure. .
What is the risk associated with CoAprovel?
The most common side effects seen with CoAprovel (seen in 1 to 10 patients in 100) are dizziness, nausea or vomiting, abnormal urination, fatigue (tiredness) and increased blood urea nitrogen concentrations (BUN, a protein breakdown product). , creatinine (breakdown product of muscle metabolism) and creatine kinase (enzyme present in the muscles). For the full list of side effects reported with CoAprovel, see the package leaflet.
CoAprovel should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides or any of the other ingredients. It must not be used in women who are more than three months pregnant. It is not recommended for use during the first three months of pregnancy. CoAprovel should also not be used in patients with severe kidney, liver or bile disorders, too low blood potassium levels or too high blood calcium levels.
Particular attention should be paid if CoAprovel is taken with other drugs that affect blood potassium levels. For the complete 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 on irbesartan or hydrochlorothiazide alone. Committee recommended the granting of a marketing authorization for CoAprovel.
Other information about CoAprovel:
On October 15, 1998, the European Commission granted Sanofi Pharma Bristol-Myers Squibb SNC a "Marketing Authorization" for CoAprovel, valid throughout the European Union. The "Marketing Authorization" was renewed on October 15. 2003 and October 15, 2008.
For the full version of CoAprovel's EPAR, click here.
Last update of this summary: 03-2009.
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