What is Karvezide?
Karvezide 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 Karvezide used for?
Karvezide 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 Karvezide used?
Karvezide should be taken by mouth, with or without food. The dose of Karvezide to use 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. Karvezide can be taken in addition to other therapies for hypertension.
How does Karvezide work?
Karvezide 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 treatment for hypertension. It works by increasing urine excretion, 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.
What studies have been carried out on Karvezide?
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 in separate tablets were used to support the use of Karvezide. 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 Karvezide shown during the studies?
Karvezide 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 Karvezide?
The most common side effects seen with Karvezide (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 Karvezide, see the Package Leaflet.
Karvezide should not be used in patients 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. Karvezide should also not be used in patients with severe liver, kidney 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 Karvezide is taken together with other medicines that affect blood potassium levels. For the full list of these medicines, see the package leaflet.
Why has Karvezide been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Karvezide'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 therefore recommended that Karvezide be given marketing authorization.
More information on Karvezide:
On October 16, 1998, the European Commission granted Karvezide a marketing authorization valid throughout the European Union to Bristol-Myers Squibb Pharma EEIG. The marketing authorization was renewed on 16 October 2003 and 16 October 2008.
For the full EPAR of Karvezide, click here.
Last update of this summary: 03-2009.
