What is Irbesartan Hydrochlorothiazide Winthrop?
Irbesartan Hydrochlorothiazide Winthrop 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: 300 mg of irbesartan and 25 mg of hydrochlorothiazide).
This medicine is similar to CoAprovel, already authorized in the European Union (EU). The company that makes CoAprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Winthrop.
What is Irbesartan Hydrochlorothiazide Winthrop used for?
Irbesartan Hydrochlorothiazide Winthrop is used in adults with essential hypertension (high blood pressure) not adequately controlled with irbesartan and hydrochlorothiazide alone. The term "essential" indicates that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
How is Irbesartan Hydrochlorothiazide Winthrop used?
Irbesartan Hydrochlorothiazide Winthrop should be taken by mouth, with or without food. The dose of Irbesartan Hydrochlorothiazide Winthrop 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. Irbesartan Hydrochlorothiazide Winthrop can be taken as an adjunct to other treatments for hypertension.
How does Irbesartan Hydrochlorothiazide Winthrop work?
Irbesartan Hydrochlorothiazide Winthrop 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.
How has Irbesartan Hydrochlorothiazide Winthrop 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. The studies of Karvea / Aprovel taken together with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Winthrop. 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 Irbesartan Hydrochlorothiazide Winthrop shown during the studies?
Irbesartan Hydrochlorothiazide Winthrop 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 Irbesartan Hydrochlorothiazide Winthrop?
The most common side effects seen with Irbesartan Hydrochlorothiazide Winthrop (seen in between 1 and 10 patients in 100) are vertigo, nausea or vomiting, abnormal urination, fatigue (tiredness) and increased concentrations of urea nitrogen in the blood (BUN, degradation product of proteins), creatinine (degradation product of muscle metabolism) and creatine kinase (enzyme present in muscles). For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Winthrop, see the Package Leaflet.
Irbesartan Hydrochlorothiazide Winthrop 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. Furthermore, Irbesartan Hydrochlorothiazide Winthrop should not be used in patients with severe liver, kidney or bile related disorders, with too low levels of potassium in the blood or with too high levels of calcium in the blood.
Particular attention should be paid if Irbesartan Hydrochlorothiazide Winthrop is taken with other drugs that affect blood potassium levels. For the full list of these medicines, see the package leaflet.
Why has Irbesartan Hydrochlorothiazide Winthrop been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide Winthrop's benefits are greater than its risks for the treatment of essential hypertension in adults with blood pressure not adequately controlled with irbesartan or hydrochlorothiazide alone. The Committee recommended the granting of a marketing authorization for Irbesartan Hydrochlorothiazide Winthrop.
Other information on Irbesartan Hydrochlorothiazide Winthrop:
On 19 January 2007, the European Commission granted an EU-wide marketing authorization for Irbesartan Hydrochlorothiazide Winthrop to Sanofi Pharma Bristol-Myers Squibb SNC.
The full EPAR for Irbesartan Hydrochlorothiazide Winthrop can be found here.
Last update of this summary: 04-2009.
