What is Irbesartan Hydrochlorothiazide Winthrop?
Irbesartan Hydrochlorothiazide Winthrop is a medicine that contains 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, which is already authorized in the European Union (EU). The company that makes CoAprovel has agreed that its scientific data are 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) that is not adequately controlled with irbesartan and hydrochlorothiazide taken individually. 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 is taken by mouth, with or without meals. The dose of Irbesartan Hydrochlorothiazide Winthrop 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. 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 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 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. Studies of Karvea / Aprovel taken together with hydrochlorothiazide as separate tablets have been used to support the use of Irbesartan Hydrochlorothiazide Winthrop. 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 (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 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. blood pressure.
What is the risk associated with Irbesartan Hydrochlorothiazide Winthrop?
The most common side effects seen with Irbesartan Hydrochlorothiazide Winthrop (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 breakdown product of blood urea). proteins), creatinine (breakdown product of muscle metabolism) and creatine kinase (enzyme present in the muscles). For the full list of 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, 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. Irbesartan Hydrochlorothiazide Winthrop should also not be used in patients with severe liver, kidney or bile problems, 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 complete 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 on irbesartan or hydrochlorothiazide alone. The committee recommended the granting of the marketing authorization for Irbesartan Hydrochlorothiazide Winthrop.
Other information about Irbesartan Hydrochlorothiazide Winthrop:
On 19 January 2007, the European Commission granted Sanofi Pharma Bristol-Myers Squibb SNC an EU-wide "Marketing Authorization" for Irbesartan Hydrochlorothiazide Winthrop.
For the full version of Irbesartan Hydrochlorothiazide Winthrop EPAR, click here.
Last update of this summary: 04-2009.
The information on Irbesartan Hydrochlorothiazide Winthrop 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.
