PRESCRIPTION NOTICE: Irovel 300 mg is a Prescription Only Medicine (POM). It cannot legally be dispensed without a valid prescription from a licensed healthcare provider in Kenya. Do not use this medicine without medical supervision. Do not share this medicine with others even if they appear to have the same condition.
Irovel 300 mg Tablets are indicated in adults for the treatment of essential hypertension and for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen. Each pack contains 30 film-coated tablets providing a one-month supply at standard once-daily dosing.
Irbesartan is a potent, selective, and long-acting angiotensin II type 1 (AT1) receptor blocker (ARB) that lowers blood pressure by blocking the principal hormonal driver of vasoconstriction and sodium retention in hypertensive patients. The 300 mg strength represents the maximum standard maintenance dose — typically used in patients whose blood pressure is not adequately controlled on the 150 mg starting dose, and as the recommended maintenance dose for patients with hypertensive diabetic nephropathy. If you have been prescribed Irovel 300 mg for hypertension treatment in Kenya or diabetic nephropathy management, this medicine must be taken strictly as directed by your healthcare provider. The price of Irovel 300 mg in Kenya varies by pharmacy and is dispensed only on presentation of a valid prescription.
Key Benefits
- Potent, selective AT1 receptor blockade — provides effective and sustained 24-hour blood pressure control with once-daily dosing
- Proven diabetic nephropathy protection — irbesartan significantly reduces the rate of progression of kidney disease in hypertensive patients with type 2 diabetes and proteinuria, based on the landmark IDNT trial
- Renal and cardiovascular organ protection — ARB-class RAAS blockade reduces proteinuria, slows progression of hypertensive and diabetic nephropathy, and provides cardiovascular organ protection
- No ACE inhibitor-associated dry cough — irbesartan does not inhibit bradykinin degradation, providing excellent tolerability particularly in Black African patients who have a significantly higher incidence of ACE inhibitor-induced cough
- No dose adjustment required in renal impairment — irbesartan can be used across a wide range of renal function without routine dose modification, a clinically practical advantage in hypertensive patients with concurrent kidney disease
- Hepatically eliminated — predominantly biliary excretion reduces accumulation risk in mild to moderate renal impairment
- Once-daily dosing — supports long-term treatment adherence and consistent blood pressure control
- Well-established global and Kenyan clinical use with a robust safety and efficacy profile
- Suitable for use across a broad patient population including the elderly and those with concurrent diabetes or kidney disease
What It Is & How It Works
Active Ingredient
Each film-coated tablet contains:
| Active Ingredient | Strength | Role |
|---|---|---|
| Irbesartan | 300 mg | Selective non-competitive AT1 receptor antagonist (ARB) — blocks angiotensin II-mediated vasoconstriction and aldosterone secretion to lower blood pressure and protect the kidneys |
How It Works
AT1 Receptor Blockade — Primary Mechanism
The renin-angiotensin-aldosterone system (RAAS) is the primary hormonal regulator of blood pressure and fluid homeostasis. In hypertensive states, excessive RAAS activation drives sustained angiotensin II production — a potent vasoconstrictor that also stimulates aldosterone secretion, promoting sodium and water retention. Irbesartan selectively and non-competitively antagonises the angiotensin II type 1 (AT1) receptor — the receptor subtype through which angiotensin II exerts its pathological cardiovascular and renal effects. By blocking AT1 receptors with high affinity and slow dissociation kinetics, irbesartan:
- Prevents angiotensin II-mediated vasoconstriction of arterial smooth muscle — directly reducing peripheral vascular resistance and systemic blood pressure
- Inhibits angiotensin II-stimulated aldosterone secretion from the adrenal cortex — reducing sodium and water retention and intravascular volume
- Blocks angiotensin II-driven cardiac hypertrophy and vascular remodelling — providing long-term protection against hypertensive end-organ damage
- Reduces intraglomerular capillary pressure — by blocking angiotensin II-mediated efferent arteriolar constriction in the kidney, irbesartan reduces haemodynamic stress on glomerular capillaries that drives proteinuria and progressive renal damage in diabetic and hypertensive nephropathy
- Allows AT2 receptor stimulation by the resulting elevated circulating angiotensin II — producing complementary vasodilatory and antiproliferative effects
Non-Competitive AT1 Receptor Binding
A key pharmacological feature of irbesartan is its non-competitive (insurmountable) binding at the AT1 receptor — meaning that even rising concentrations of endogenous angiotensin II cannot fully displace irbesartan from the receptor. This pharmacological property contributes to sustained and consistent AT1 receptor blockade throughout the 24-hour dosing interval, even during periods of high RAAS activity.
Renal Protective Mechanism in Diabetic Nephropathy
In hypertensive patients with type 2 diabetes, the combination of systemic hypertension and intraglomerular hypertension — driven by angiotensin II-mediated efferent arteriolar constriction — causes progressive glomerular injury, increasing proteinuria and accelerating the decline of kidney function towards end-stage renal disease. Irbesartan’s AT1 blockade reduces both systemic blood pressure and intraglomerular pressure simultaneously, directly addressing both major haemodynamic drivers of diabetic nephropathy progression. Clinical trial evidence from the landmark IDNT trial demonstrated that irbesartan 300 mg significantly reduced the primary composite endpoint of doubling of serum creatinine, end-stage renal disease, and all-cause mortality in hypertensive patients with type 2 diabetes and nephropathy — a benefit independent of its blood pressure-lowering effect.
Unlike ACE Inhibitors
Irbesartan works by interfering with the angiotensin system, which plays a key role in regulating blood pressure and fluid balance in the body. Unlike ACE inhibitors, irbesartan achieves this RAAS blockade without inhibiting the breakdown of bradykinin — thereby avoiding the persistent dry cough that affects a significant proportion of patients on ACE inhibitors such as enalapril. This is clinically significant in the Kenyan population, where ACE inhibitor-induced cough has a substantially higher incidence in Black African patients.
Classification
Irovel 300 mg is classified as a Prescription Only Medicine (POM) in Kenya. It must only be initiated, monitored, and adjusted by a licensed healthcare provider. A valid prescription is required for dispensing at any registered pharmacy in Kenya.
Formulation
Film-coated tablets. Each pack contains 30 tablets. Tablets should be swallowed whole with water, with or without food, at the same time each day.
Uses & Indications
Irovel 300 mg Tablets are indicated for:
Essential Hypertension
- Primary high blood pressure in adults — as a maintenance dose following initiation at 150 mg, or as the starting dose in patients where more potent blood pressure lowering is clinically appropriate from initiation
Diabetic Nephropathy
- Hypertension with type 2 diabetes mellitus and proteinuria — irbesartan 300 mg is the recommended maintenance dose for reducing the rate of progression of renal disease in hypertensive adult patients with type 2 diabetes and evidence of nephropathy; the IDNT trial demonstrated statistically significant reductions in end-stage renal disease risk with irbesartan 300 mg
IMPORTANT: The decision to initiate, adjust, or discontinue Irovel therapy must be made exclusively by a licensed healthcare provider based on individual clinical assessment, blood pressure targets, renal function monitoring, and electrolyte levels. A lower starting dose of 75 mg should be considered for patients undergoing haemodialysis. Do not self-prescribe or alter your dose without medical advice.
Dosage & Administration
This medicine requires a valid prescription. Use only as prescribed by your healthcare provider. The following dosage information is provided for general reference only and does not constitute prescribing advice.
| Indication | Starting Dose | Usual Maintenance Dose | Maximum Daily Dose |
|---|---|---|---|
| Essential hypertension | As directed by physician | As directed by physician | As directed by physician |
| Diabetic nephropathy | As directed by physician | As directed by physician | As directed by physician |
| Volume-depleted patients | As directed by physician | As directed by physician | As directed by physician |
| Patients on haemodialysis | As directed by physician | As directed by physician | As directed by physician |
| Renal impairment (mild to severe) | As directed by physician | As directed by physician | As directed by physician |
| Hepatic impairment (mild to moderate) | 150 mg once daily | As directed by physician | As directed by physician |
| Elderly patients (65+ years) | As directed by physician | As directed by physician | As directed by physician |
| Paediatric patients (under 18 years) | As directed by physician | As directed by physician | As directed by physician |
Administration Instructions
- Take this medicine exactly as prescribed — do not increase, decrease, or skip doses without medical advice
- Take once daily at the same time each day — consistent timing maintains stable drug levels and sustained blood pressure control
- May be taken with or without food — food does not significantly affect the absorption of irbesartan
- Swallow tablets whole with a full glass of water — do not crush, chew, or split
- Do not stop taking this medicine suddenly without consulting your doctor — abrupt discontinuation may result in rebound blood pressure elevation
- If a dose is missed, take it as soon as you remember on the same day — if the next day has begun, skip the missed dose and continue as normal; do not double dose
- Maintain adequate hydration — particularly in hot weather, during physical activity, or during illness with vomiting or diarrhoea — to reduce the risk of excessive blood pressure lowering and electrolyte disturbances
- Attend all scheduled follow-up appointments for blood pressure monitoring, renal function tests, and serum electrolyte checks — particularly serum potassium and creatinine monitoring
Possible Side Effects
Like all medicines, Irovel 300 mg may cause side effects in some patients. Adverse effects of irbesartan have been reported to be usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension. Hypotension may occur particularly in patients with volume depletion. Impaired renal function and, rarely, rash, urticaria, pruritus, angioedema, and raised liver enzyme values may occur. Hyperkalaemia, myalgia, and arthralgia have been reported. Other adverse effects include respiratory tract disorders, back pain, gastrointestinal disturbances, fatigue, and neutropenia. Report any new or worsening symptoms to your healthcare provider promptly.
Common
- Dizziness or light-headedness — particularly upon standing (orthostatic hypotension); rise slowly from sitting or lying positions; most common after the first dose or following dose increases
- Headache — usually mild and transient
- Fatigue or weakness
- Hyperkalaemia (elevated serum potassium) — ARB class effect; aldosterone inhibition reduces urinary potassium excretion; particularly significant in patients with renal impairment, diabetes, or those taking potassium supplements or potassium-sparing diuretics; regular serum potassium monitoring is essential
- Nausea or gastrointestinal discomfort
Less Common
- Hypotension (low blood pressure) — particularly in volume-depleted patients or those on concurrent diuretics; may cause dizziness, fainting, or falls
- Elevated creatinine or blood urea nitrogen — a modest rise on initiation of ARB therapy is expected due to reduced intraglomerular pressure; significant or progressive rises warrant medical review
- Myalgia or arthralgia — muscle and joint pain; usually mild
- Skin rash, urticaria, or pruritus
- Elevated liver enzymes — rare; monitor in patients with pre-existing hepatic conditions
- Neutropenia — very rare reduction in white blood cell count; report persistent infections or fever promptly
WARNING: Rare but serious — seek immediate medical attention if you experience: angioedema (sudden swelling of the face, lips, tongue, or throat — a potentially life-threatening emergency; although less common with ARBs than ACE inhibitors, irbesartan-induced angioedema has been reported), severe hypotension causing loss of consciousness (particularly after first dose in volume-depleted patients), acute kidney injury (significant reduction in urine output or rapidly rising creatinine — particularly in patients with bilateral renal artery stenosis), severe hyperkalaemia (muscle weakness, paralysis, or cardiac arrhythmias), or signs of serious liver reactions (jaundice, severe abdominal pain, dark urine).
This is not a complete list of side effects. Report all side effects to your healthcare provider.
Warnings & Precautions
CONTRAINDICATION: Do NOT use Irovel 300 mg if you are pregnant (second or third trimester), have known hypersensitivity to irbesartan or any excipient in this formulation, or are taking aliskiren and have diabetes or renal impairment.
Do Not Use If You:
- Are in the second or third trimester of pregnancy — irbesartan is unsafe to use during pregnancy; consult your doctor immediately regarding alternative antihypertensive therapy
- Are breastfeeding — consult a doctor before use
- Have known hypersensitivity to irbesartan or any excipient in this formulation
- Are taking aliskiren and have diabetes or an eGFR below 60 mL/min — dual RAAS blockade in this setting significantly increases the risk of hypotension, hyperkalaemia, and renal failure
Use With Caution If You Have:
- Aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy — as with other vasodilators, special caution is indicated in patients suffering from these conditions
- Bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney — ARBs can precipitate acute kidney injury; use only under specialist supervision with close monitoring
- Volume or sodium depletion — correct dehydration before initiating to reduce the risk of first-dose hypotension; consider initiating at 75 mg in volume-depleted patients
- Renal impairment — no dosage adjustment is necessary in patients with impaired renal function — however, monitor renal function, electrolytes, and blood pressure closely; irbesartan may cause further reduction in renal function in patients with pre-existing kidney disease
- Hepatic impairment — use with caution; initiate at 150 mg; monitor liver function
- Primary hyperaldosteronism — ARBs are generally less effective in this condition
- Heart failure — use under specialist supervision; monitor renal function and electrolytes closely
- Diabetes mellitus — both diabetes and ARBs independently predispose to hyperkalaemia; close monitoring of serum potassium in patients at risk is recommended
- Elderly patients — increased susceptibility to hypotension, falls, and renal impairment; monitor blood pressure and renal function carefully
Do Not Combine With (Selected Key Interactions — Consult Pharmacist for Full Review):
- Other RAAS blockers (ACE inhibitors, aliskiren, other ARBs) — dual RAAS blockade significantly increases the risk of hypotension, hyperkalaemia, and acute renal failure; avoid
- Potassium-sparing diuretics (spironolactone, amiloride, eplerenone) or potassium supplements — additive hyperkalaemia risk; monitor serum potassium closely and frequently
- Lithium — the combination of lithium and irbesartan is not recommended due to reduced renal lithium clearance and risk of lithium toxicity; if concurrent use is unavoidable, monitor lithium levels very closely
- NSAIDs (ibuprofen, diclofenac, aspirin at anti-inflammatory doses) — reduce antihypertensive efficacy of irbesartan and significantly increase the risk of acute kidney injury; the ARB-diuretic-NSAID combination is particularly dangerous and must be avoided
- Antidiabetic agents (insulin, sulphonylureas including glimepiride) — ARBs may enhance the glucose-lowering effect; monitor blood glucose closely and adjust antidiabetic therapy if necessary
- Other antihypertensive agents and diuretics — additive hypotensive effects; monitor blood pressure closely and adjust doses accordingly
- Alcohol — enhances the hypotensive effect; advise patients to limit alcohol intake
CLINICAL NOTE (Kenya-specific): Irovel 300 mg (Irbesartan) is an important and clinically versatile ARB in the Kenyan antihypertensive formulary. Several Kenya-specific considerations are essential in its safe and effective use. Irbesartan’s diabetic nephropathy indication is of critical importance in Kenya, where type 2 diabetes prevalence is rapidly increasing and diabetic kidney disease represents a leading and largely preventable cause of end-stage renal disease — a condition for which dialysis access remains severely limited across most of Kenya. Early and consistent irbesartan 300 mg therapy in hypertensive Kenyan patients with type 2 diabetes and any degree of proteinuria is one of the most evidence-based and impactful interventions available for preventing dialysis-dependent renal failure. The absence of ACE inhibitor-induced dry cough — which has a significantly higher incidence in Black African patients — makes irbesartan a well-tolerated and adherence-friendly alternative ARB for Kenyan patients intolerant of enalapril or other ACE inhibitors. NSAIDs — particularly ibuprofen and diclofenac — are very widely and frequently used without supervision in Kenya; pharmacists must explicitly counsel all patients on irbesartan about the need to avoid concurrent NSAID use given the significant and well-documented risk of acute kidney injury and reduced antihypertensive efficacy. The absolute contraindication in the second and third trimesters of pregnancy must be clearly communicated to all women of childbearing potential given the severe and potentially fatal fetal consequences of ARB exposure during pregnancy — effective contraception and immediate reporting of pregnancy are essential.
Keep out of reach of children. Store all medicines safely and securely.
Storage Instructions
- Store below 30°C in a cool, dry place
- Protect from direct sunlight, moisture, and excessive heat
- Keep tablets in their original packaging
- Store out of reach and sight of children
- Do not use after the expiry date printed on the packaging
- Do not transfer tablets to another container
- Dispose of unused or expired tablets safely at your local registered pharmacy — do not flush down the toilet or discard in household waste
Mandatory Disclaimer
This medicine requires a valid prescription. Do not use without medical advice. Irovel 300 mg (Irbesartan) is a Prescription Only Medicine (POM) that must be initiated, monitored, and adjusted exclusively by a licensed healthcare provider. Do not self-prescribe, purchase without a valid prescription, share this medicine with others, or stop treatment without consulting your doctor. Irbesartan is contraindicated in the second and third trimesters of pregnancy — women of childbearing potential must use effective contraception during treatment and must inform their doctor immediately if they become or plan to become pregnant. Regular medical follow-up including blood pressure monitoring, renal function tests, and serum electrolyte checks is a non-negotiable and essential component of safe Irovel 300 mg therapy. This product information is provided for general educational reference only and does not constitute medical advice or replace the guidance of a qualified healthcare professional.
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