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) 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 Karvezide used?
Karvezide is taken by mouth, with or without meals. The dose of Karvezide 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. Karvezide can be taken as an adjunct to other treatments 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 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 Karvezide been studied?
Irbesartan alone obtained authorization in the European Union (EU) in 1997 under 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 as separate tablets were used to support the use of Karvezide. Further studies with doses of 300 mg were also conducted. of irbesartan in combination with hydrochlorothiazide 25 mg. The main measure of effectiveness was based on the reduction in diastolic blood pressure (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 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 Karvezide?
The most common side effects seen with Karvezide (seen in 1 to 10 out of 100 patients) are dizziness, nausea or vomiting, abnormal urination, fatigue (tiredness) and increased blood urea nitrogen (BUN, protein breakdown product) concentrations. , creatinine (breakdown product of muscle metabolism) and creatine kinase (enzyme present in the muscles). For the full list of side effects reported with Karvezide, see the package leaflet.
Karvezide should not be used in patients 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. Karvezide should also not be used in patients with severe liver, kidney or bile disorders, too low blood potassium levels or too high blood calcium levels. .
Particular attention should be paid if Karvezide is taken together with other medicines that affect the levels of potassium in the blood. For the complete 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 on irbesartan or with hydrochlorothiazide alone. therefore recommended the granting of marketing authorization for Karvezide.
Other information about Karvezide:
On 16 October 1998, the European Commission granted Bristol-Myers Squibb Pharma EEIG a "Marketing Authorization" for Karvezide, valid throughout the European Union. The "Marketing Authorization" was renewed on 16 October 2003 and on October 16, 2008.
For the full version of Karvezide's EPAR, click here.
Last update of this summary: 03-2009.
The information on Karvezide 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.
