Product Details
What is this medicine used for?
Irbesartan is a medicine widely used to treat high blood pressure. Irbesartan helps to prevent future strokes, heart attacks and kidney problems. This medicine is only available on prescription.
How much and how often should you use this medicine?
DOSAGE AND ADMINISTRATION
Hypertension
150 mg to 300 mg once daily.
The usual recommended initial and maintenance dose is 150 mg once daily.
In hypertensive type 2 diabetic patients: 150 mg-300 mg once daily.
Or, as prescribed by the physician.
Contraindications
Known hypersensitivity to the active substance or to any of the excipients.
Warning and Precautions
Precautions:
The drug can cause serious fetal harm (possibly death) if used during the last six months of pregnancy.
So when pregnancy is diagnosed, treatment with Irbesartan should be stopped immediately and if
appropriate, alternative therapy should be started.
When Irbesartan is used in patients with impaired renal function, a periodic monitoring of potassium and
creatinine serum levels is recommended. There is no experience regarding the administration of
irbesartan in patients with a recent kidney transplantation.
The combination of lithium and irbesartan is not recommended.
PREGNANCY
Because of the possibility that irbesartan may have a harmful effect on the fetus, it should not be used
during pregnancy.
Warnings:
Hypotension-Volume-Depleted Patients: Irbesartan has been rarely associated with hypotension in
hypertensive patients without other co-morbid conditions. Symptomatic hypotension, as with ACE
inhibitors, may be expected to occur in sodium/volume depleted patients such as those treated
vigorously with diuretics and/or salt restriction, or on haemodialysis. Volume and/or sodium depletion
should be corrected before initiating therapy with irbesartan or a lower starting dose should be
considered.
Fetal/Neonatal Morbidity and Mortality: Although there is no experience with Irbesartan in pregnant
women, in utero exposure to ACE.
Inhibitors given to pregnant women during the second and third trimesters has been reported to cause
injury and death to the developing fetus. Thus, as for any drug that also acts directly on the
renin- angiotensin-aldosterone system, irbesartan should not be used during pregnancy. If pregnancy is
detected during therapy, Irbesartan should be discontinued as soon as possible.
General: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal
function may be anticipated in susceptible individuals. In patients whose renal function depends on the
activity of the renin-angiotensin-aldosterone system (e.g., hypertensive patients with renal artery
stenosis in one or both kidneys, or patients with severe congestive heart failure), treatment with drugs
that affect this system has been associated with oliguria and/or progressive azotemia and (rarely) with
acute renal failure and/or death. The possibility of a similar effect occurring with the use of an angiotensin
II receptor antagonist, including Irbesartan cannot be excluded.
In hypertensive type 2 diabetic patients with proteinuria (>900 mg/day), a population which has a high
risk or renal artery stenosis, no patient treated with Irbesartan in IDNT had an early acute rise in serum
creatinine attributable to renal artery stenosis.
Availability
RM Irbesatan 300 mg box of 20s