What is Ifirmasta?
Ifirmasta is a medicine that contains the active substance irbesartan. It is available in white oval tablets (75, 150 and 300 mg).
Ifirmasta is a "generic medicine". This means that Ifirmasta is similar to a "reference drug" already authorized in the European Union (EU) called Aprovel. For more information on generic medicines, see the questions and answers by clicking here.
What is Ifirmasta used for?
Ifirmasta is used in patients with essential hypertension (high blood pressure). Hypertension is called "essential" when it is not caused by other disorders. Ifirmasta is also used to treat kidney disease in hypertensive patients and with type 2 (non-insulin-dependent) diabetes mellitus. Ifirmasta is not recommended in patients under the age of 18 years.
The medicine can only be obtained with a prescription.
How is Ifirmasta used?
Ifirmasta should be taken orally, with or without food. The usual recommended dose is 150 mg once a day. If blood pressure is not adequately controlled, the dosage can be increased to 300 mg a day, or other drugs for hypertension, such as hydrochlorothiazide, can be given. A starting dose of 75 mg can be used in patients undergoing hemodialysis (a blood clearance technique) or in patients over 75 years of age.
In hypertensive patients with type 2 diabetes, Ifirmasta is added to other treatments for hypertension. Therapy starts with a dose of 150 mg once a day, which is usually increased up to 300 mg once a day.
How does Ifirmasta work?
The active substance in Ifirmasta, irbesartan, is an "angiotensin II receptor antagonist", which implies that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (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. This allows the blood pressure to decrease, reducing the risk caused by high blood pressure such as a stroke.
How has Ifirmasta been studied?
Because Ifirmasta is a generic medicine, studies have been limited to tests to determine that the drug is bioequivalent to the reference medicine. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the risks and benefits associated with Ifirmasta?
Because Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are assumed to be the same as the latter.
Why has Ifirmasta been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Ifirmasta has been shown to have comparable quality and to be bioequivalent to Aprovel. It is therefore the opinion of the CHMP that, as in the case of Aprovel, the benefits outweigh the risks identified. The Committee recommended that Ifirmasta be given marketing authorization
More information on Ifirmasta
On 1 December 2008, the European Commission issued a marketing authorization for Irbetesan Krka, valid throughout the European Union, to Krka, dd, Novo Mesto. The name of the medicine was changed to Ifirmasta on 24 September 2009. The marketing authorization is valid for five years, after which it can be renewed
For the full EPAR for Ifirmasta, click here.
Last update of this summary: 10-2009.
