CoAprovel (Irbesartan / Hydrochlorothiazide)
Combination angiotensin II receptor blocker and thiazide diuretic for the treatment of high blood pressure
Quick Facts About CoAprovel
Key Takeaways About CoAprovel
- Combination medicine: CoAprovel combines two blood pressure-lowering mechanisms (ARB + diuretic) for more effective control than either drug alone
- Do not use in pregnancy: CoAprovel can cause serious harm to an unborn baby and must be stopped immediately if pregnancy occurs
- Monitor electrolytes: The hydrochlorothiazide component can affect potassium, sodium, and other electrolyte levels, requiring regular blood tests
- Stay hydrated: The diuretic component increases urination; drink adequate fluids and avoid dehydration, especially in hot weather
- Full effect takes weeks: While blood pressure starts to decrease within hours, the maximum effect is usually reached within 4 to 6 weeks of regular use
What Is CoAprovel and What Is It Used For?
CoAprovel is a fixed-dose combination medicine containing irbesartan 150 mg or 300 mg and hydrochlorothiazide 12.5 mg or 25 mg. It is primarily used to treat essential hypertension (high blood pressure) when monotherapy with either irbesartan or hydrochlorothiazide alone does not achieve adequate blood pressure control.
CoAprovel belongs to a class of medications known as combination antihypertensives. It contains two active substances that work through complementary mechanisms to lower blood pressure. Irbesartan is an angiotensin II receptor blocker (ARB) that prevents the hormone angiotensin II from binding to its receptors on blood vessels. This action relaxes and widens the blood vessels, reducing resistance to blood flow. Hydrochlorothiazide is a thiazide diuretic that works on the kidneys to increase the excretion of sodium and water, thereby reducing blood volume and lowering blood pressure.
The combination of these two mechanisms provides additive blood pressure reduction. Clinical trials have demonstrated that the irbesartan/hydrochlorothiazide combination produces greater reductions in both systolic and diastolic blood pressure compared with either component used as monotherapy. The European Society of Cardiology (ESC) and European Society of Hypertension (ESH) 2023 guidelines recommend initial combination therapy for most patients with hypertension, recognizing that achieving blood pressure targets often requires two or more medications.
CoAprovel is approved for use in adults and is typically prescribed when a patient has already been taking irbesartan or hydrochlorothiazide alone without achieving satisfactory blood pressure control. It may also be considered as initial therapy for patients whose blood pressure is significantly above target values. The medicine is marketed by Sanofi and was first approved in the European Union (EU) by the European Medicines Agency (EMA).
Indications
CoAprovel is indicated for the treatment of essential hypertension in adults. The European Medicines Agency (EMA) has approved it specifically for use as substitution therapy in patients whose blood pressure is adequately controlled on irbesartan and hydrochlorothiazide given concurrently as separate tablets, or for patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. It is also used in patients with hypertension and type 2 diabetes with kidney disease (diabetic nephropathy) as part of a comprehensive treatment approach.
How Does CoAprovel Work?
The dual mechanism of action of CoAprovel provides synergistic blood pressure lowering. Irbesartan selectively blocks the angiotensin II type 1 (AT1) receptor, which is responsible for the vasoconstrictive and aldosterone-secreting effects of angiotensin II. By blocking this receptor, irbesartan causes vasodilation (widening of blood vessels) and reduces aldosterone secretion, which in turn decreases sodium and water retention. The blood pressure-lowering effect of irbesartan begins within 1 to 2 hours of dosing and reaches its maximum at 4 to 6 hours.
Hydrochlorothiazide inhibits the sodium-chloride cotransporter in the distal convoluted tubule of the kidney. This prevents the reabsorption of sodium and chloride, leading to increased excretion of these electrolytes along with water. The resulting reduction in blood volume contributes to lower blood pressure. Importantly, the compensatory activation of the renin-angiotensin system that occurs with diuretic use is counteracted by the ARB component, making the combination particularly effective.
What Should You Know Before Taking CoAprovel?
Before taking CoAprovel, it is essential to inform your doctor about all medical conditions, especially kidney disease, liver disease, heart failure, diabetes, gout, and any history of allergic reactions. CoAprovel must not be used during pregnancy and is contraindicated in patients with severe kidney or liver impairment.
Contraindications
CoAprovel must not be used in the following situations:
- Pregnancy: CoAprovel can cause serious harm to the unborn baby. It must not be used at any stage of pregnancy. If pregnancy is detected, treatment must be stopped immediately
- Hypersensitivity: Known allergy to irbesartan, hydrochlorothiazide, any sulfonamide-derived substance, or any of the excipients
- Severe kidney impairment: Creatinine clearance below 30 ml/min or patients undergoing dialysis
- Severe liver impairment: Including biliary cirrhosis and cholestasis
- Refractory hypokalaemia or hypercalcaemia: Persistently low potassium or high calcium levels that do not respond to treatment
- Concomitant use with aliskiren: In patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²)
CoAprovel must not be used during pregnancy. Use during the second and third trimesters has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. If you become pregnant while taking CoAprovel, stop the medication immediately and contact your doctor. Alternative blood pressure medicines that are safe during pregnancy should be discussed with your healthcare provider.
Warnings and Precautions
Special caution is required in patients with the following conditions:
- Volume or sodium depletion: Patients who are dehydrated or have low sodium levels (e.g., from intensive diuretic therapy, dietary salt restriction, dialysis, diarrhoea, or vomiting) may experience symptomatic hypotension, especially after the first dose. Volume depletion should be corrected before starting CoAprovel
- Renovascular hypertension: Patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney are at increased risk of severe hypotension and renal insufficiency
- Renal impairment and kidney transplant: Periodic monitoring of potassium, creatinine, and uric acid levels is recommended. There is no experience in patients with recent kidney transplant
- Hepatic impairment: Thiazide diuretics should be used with caution in patients with impaired hepatic function, as minor alterations of fluid and electrolyte balance may precipitate hepatic coma
- Heart failure: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals
- Aortic and mitral valve stenosis / hypertrophic cardiomyopathy: CoAprovel should be used with caution in these patients
- Metabolic and endocrine effects: Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol, triglycerides, and uric acid. It may precipitate hyperuricaemia and/or gout in susceptible patients
- Electrolyte imbalance: Periodic monitoring of serum electrolytes is recommended. Hydrochlorothiazide can cause hypokalaemia, hyponatraemia, and hypochloraemic alkalosis
- Lithium: The combination of lithium and CoAprovel is generally not recommended due to the risk of lithium toxicity
- Photosensitivity: Cases of photosensitivity reactions have been reported with thiazide diuretics. If photosensitivity occurs, treatment should be stopped. If re-administration is necessary, it is recommended to protect exposed areas from sun or artificial UVA rays
Pregnancy and Breastfeeding
CoAprovel is absolutely contraindicated during pregnancy. The angiotensin II receptor blocker component (irbesartan) can cause fetal renal dysfunction, oligohydramnios (reduced amniotic fluid), skull ossification retardation, and pulmonary hypoplasia when used during the second and third trimesters. Use during the first trimester is also not recommended based on epidemiological evidence. Women planning pregnancy should be switched to alternative antihypertensive treatments with an established safety profile for use in pregnancy, such as methyldopa, labetalol, or nifedipine.
Breastfeeding is not recommended during treatment with CoAprovel. Hydrochlorothiazide is excreted in human breast milk in small amounts, and intensive diuresis with high doses of thiazides may inhibit milk production. There is limited information on the excretion of irbesartan in breast milk. If CoAprovel is essential for the mother, an alternative method of feeding the infant should be considered.
CoAprovel may cause dizziness or fatigue, particularly at the start of treatment or when the dose is increased. If you experience these effects, do not drive or operate machinery until you know how the medicine affects you. These effects usually diminish as your body adjusts to the medication.
How Does CoAprovel Interact with Other Drugs?
CoAprovel can interact with several medications, including lithium, NSAIDs (such as ibuprofen and naproxen), potassium supplements, other blood pressure medicines, and diabetes medications. Always inform your doctor and pharmacist about all medicines you are taking, including over-the-counter drugs and herbal supplements.
Drug interactions with CoAprovel can be clinically significant and may affect the efficacy or safety of either CoAprovel or the concomitant medication. The interactions arise from both the irbesartan and hydrochlorothiazide components. Understanding these interactions is essential for safe prescribing and medication management. Below is a comprehensive overview of the most important drug interactions, categorized by severity.
Major Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Lithium | Increased lithium blood levels and toxicity risk. Both ARBs and diuretics reduce renal lithium clearance | Combination generally not recommended. If essential, closely monitor lithium levels |
| Aliskiren | Dual blockade of the RAAS increases risk of hypotension, hyperkalaemia, and renal impairment | Contraindicated in patients with diabetes or renal impairment (GFR <60). Avoid in all patients |
| ACE inhibitors (e.g., enalapril, ramipril) | Dual RAAS blockade increases risk of hypotension, hyperkalaemia, and renal impairment | Avoid combination. Do not co-administer with CoAprovel in patients with diabetic nephropathy |
| Potassium supplements / potassium-sparing diuretics (e.g., spironolactone, amiloride) | Risk of hyperkalaemia (elevated potassium levels), potentially causing cardiac arrhythmias | Monitor potassium levels closely if combination cannot be avoided |
| NSAIDs (e.g., ibuprofen, naproxen, diclofenac) | May reduce the antihypertensive effect of CoAprovel and increase the risk of renal impairment and hyperkalaemia | Use with caution, especially in elderly or volume-depleted patients. Monitor renal function and blood pressure |
Minor Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Digoxin | Diuretic-induced hypokalaemia may increase sensitivity to digitalis toxicity | Monitor potassium and digoxin levels regularly |
| Diabetes medicines (insulin, oral antidiabetics) | Hydrochlorothiazide may alter glucose tolerance. Dose adjustments of antidiabetic medications may be needed | Monitor blood glucose more frequently when starting or adjusting CoAprovel |
| Carbamazepine | Risk of symptomatic hyponatraemia (low sodium). Hydrochlorothiazide may exacerbate carbamazepine-induced hyponatraemia | Monitor sodium levels. Be alert for symptoms such as confusion, headache, and nausea |
| Cholestyramine / colestipol | May reduce the absorption of hydrochlorothiazide | Take CoAprovel at least 1 hour before or 4 hours after these medicines |
| Alcohol | May enhance the blood pressure-lowering effect, increasing the risk of orthostatic hypotension and dizziness | Limit alcohol consumption. Be cautious when standing up quickly |
| Corticosteroids / ACTH | May increase electrolyte depletion, particularly hypokalaemia | Monitor electrolytes when used concomitantly |
What Is the Correct Dosage of CoAprovel?
The usual dose of CoAprovel is one tablet once daily, taken with or without food. The specific strength (150/12.5 mg, 300/12.5 mg, or 300/25 mg) depends on the individual patient's blood pressure response and previous treatment. Your doctor will determine the appropriate dose for you.
CoAprovel is taken orally once daily, at approximately the same time each day. The tablets should be swallowed whole with a glass of water and can be taken with or without food. Consistent daily dosing is important for maintaining stable blood pressure control throughout the 24-hour period. Below are the standard dosage recommendations for different patient groups.
Adults
Standard Adult Dosing
The recommended dose is one tablet of CoAprovel once daily. The choice of strength depends on the patient's current treatment and blood pressure response:
- CoAprovel 150/12.5 mg: For patients not adequately controlled on irbesartan 150 mg or hydrochlorothiazide 12.5 mg alone
- CoAprovel 300/12.5 mg: For patients not adequately controlled on irbesartan 300 mg or CoAprovel 150/12.5 mg
- CoAprovel 300/25 mg: For patients not adequately controlled on CoAprovel 300/12.5 mg (maximum recommended dose)
The maximum daily dose is 300 mg irbesartan / 25 mg hydrochlorothiazide. The antihypertensive effect is substantially present within 1 to 2 weeks, with the maximum effect occurring by 6 to 8 weeks.
Children
Paediatric Use
CoAprovel is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of CoAprovel have not been established in this population. Alternative antihypertensive treatments suitable for paediatric use should be considered.
Elderly
Elderly Patients (65 years and older)
No dose adjustment is generally required in elderly patients. However, treatment should be initiated with caution, as elderly patients may be more susceptible to the blood pressure-lowering effects, especially those who are volume- or sodium-depleted. Starting with the lowest available strength (150/12.5 mg) is advisable, with careful monitoring of blood pressure, renal function, and electrolytes.
Renal and Hepatic Impairment
Special Populations
- Mild to moderate renal impairment (GFR 30–60 ml/min): No dose adjustment is required, but monitoring of renal function is recommended
- Severe renal impairment (GFR <30 ml/min): CoAprovel is contraindicated. Thiazide diuretics are generally ineffective in severe renal impairment
- Mild to moderate hepatic impairment: No dose adjustment is required, but use with caution
- Severe hepatic impairment: CoAprovel is contraindicated
Missed Dose
If you miss a dose of CoAprovel, take it as soon as you remember on the same day. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take a double dose to make up for the one you missed. If you frequently forget doses, consider using a pill organizer or setting a daily alarm to help you remember.
Overdose
Overdose with CoAprovel may cause marked hypotension (dangerously low blood pressure), tachycardia or bradycardia, electrolyte imbalances (especially hypokalaemia and hyponatraemia), dehydration, and impaired consciousness. If you suspect an overdose, seek immediate medical attention or contact your local poison control centre. Treatment is supportive and may include intravenous fluid replacement and electrolyte correction. Irbesartan is not removed by haemodialysis.
What Are the Side Effects of CoAprovel?
Like all medicines, CoAprovel can cause side effects, although not everybody gets them. The most commonly reported side effects include dizziness, fatigue, nausea, and increased urination. Serious but rare side effects include severe allergic reactions, significant electrolyte imbalances, and acute kidney injury. Contact your doctor if you experience any concerning symptoms.
The side effects of CoAprovel reflect the known safety profiles of both irbesartan and hydrochlorothiazide. In clinical trials, the combination was generally well tolerated, with most side effects being mild to moderate in severity. The following side effects have been reported, categorized by frequency according to international conventions.
Common
- Dizziness or lightheadedness
- Nausea or vomiting
- Fatigue or tiredness
- Increased urination (polyuria)
- Abnormal urination patterns
- Muscle or joint pain (musculoskeletal pain)
- Elevated blood urea nitrogen (BUN) and creatinine levels
Uncommon
- Orthostatic hypotension (dizziness when standing up)
- Increased heart rate (tachycardia)
- Flushing
- Swelling of the ankles or feet (oedema)
- Numbness or tingling sensation
- Sexual dysfunction
- Changes in blood electrolyte levels (hypokalaemia, hyponatraemia)
- Elevated uric acid levels (hyperuricaemia), which may precipitate gout
- Elevated liver enzymes
- Rash or itching
Rare
- Severe allergic reactions (angioedema, anaphylaxis)
- Hepatitis (inflammation of the liver)
- Jaundice (yellowing of the skin or eyes)
- Pancreatitis (inflammation of the pancreas)
- Interstitial nephritis (kidney inflammation)
- Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Blood disorders (thrombocytopenia, leukopenia, agranulocytosis)
- Photosensitivity reaction (severe sensitivity to sunlight)
Not Known
- Hyperkalaemia (elevated potassium levels)
- Acute angle-closure glaucoma
- Choroidal effusion
- Acute myopia (sudden short-sightedness)
Contact your doctor immediately or go to the nearest emergency department if you experience: severe allergic reaction (swelling of face, lips, tongue, or throat; difficulty breathing), chest pain, rapid or irregular heartbeat, signs of severely low blood pressure (extreme dizziness, fainting), signs of liver problems (persistent nausea, abdominal pain, dark urine, yellowing of skin), or unexplained muscle weakness with dark-coloured urine (which may indicate rhabdomyolysis).
How Should You Store CoAprovel?
Store CoAprovel at room temperature below 30°C (86°F) in the original packaging to protect from moisture. Keep out of reach and sight of children. Do not use after the expiry date printed on the packaging.
Proper storage of CoAprovel ensures the medicine remains effective and safe to use throughout its shelf life. The tablets should be stored in their original blister packaging until you are ready to take them, as this protects them from moisture and light. Do not remove tablets from the blister pack in advance.
Store the medicine at room temperature, ideally below 30°C (86°F). Do not store CoAprovel in the bathroom or near a sink, as humidity can degrade the tablets. Do not freeze the medicine. Keep all medicines out of the reach and sight of children, preferably in a locked cabinet.
Check the expiry date on the blister pack and outer carton before taking the medicine. Do not use CoAprovel after the expiry date (month/year). The expiry date refers to the last day of that month. If you notice any change in the appearance of the tablets (discolouration, crumbling, unusual odour), do not use them and consult your pharmacist.
Do not dispose of medicines via household waste or wastewater. Ask your pharmacist about how to properly dispose of medicines you no longer use. These measures help to protect the environment and ensure that unused or expired medicines do not cause harm.
What Does CoAprovel Contain?
Each CoAprovel 150/12.5 mg film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide as active ingredients, along with several inactive ingredients (excipients) that help form and stabilize the tablet.
Active Ingredients
- Irbesartan: 150 mg or 300 mg (depending on the strength). An angiotensin II receptor blocker (ARB) that relaxes blood vessels
- Hydrochlorothiazide: 12.5 mg or 25 mg (depending on the strength). A thiazide diuretic that helps the body eliminate excess fluid
Inactive Ingredients (Excipients)
The excipients in CoAprovel include:
- Tablet core: Microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch
- Film coating: Lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 3000, iron oxide red (E172) and iron oxide yellow (E172) (for coloured tablets), carnauba wax
CoAprovel tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The amount of lactose is small and is unlikely to cause problems for most people with lactose intolerance, but you should discuss this with your healthcare provider if you have concerns.
Frequently Asked Questions About CoAprovel
CoAprovel is a combination medicine containing irbesartan (an angiotensin II receptor blocker) and hydrochlorothiazide (a thiazide diuretic). It is used to treat high blood pressure (hypertension) when treatment with irbesartan or hydrochlorothiazide alone has not provided adequate blood pressure control. It is also used to treat hypertension in patients with type 2 diabetes and kidney disease (diabetic nephropathy). The combination works by relaxing blood vessels and removing excess fluid from the body.
No. CoAprovel must not be used during pregnancy. It can cause serious harm to the unborn baby, including kidney damage, low amniotic fluid, skull bone defects, and even fetal death. If you become pregnant while taking CoAprovel, stop taking it immediately and contact your doctor. You should discuss alternative blood pressure treatments that are safe during pregnancy, such as methyldopa, labetalol, or nifedipine.
The most common side effects include dizziness, nausea, fatigue, and increased urination (due to the diuretic component). Uncommon side effects include orthostatic hypotension (dizziness when standing up), increased uric acid levels, and changes in blood electrolyte levels. Serious but rare side effects include severe allergic reactions, significant electrolyte imbalances, and acute kidney injury. If you experience any unusual symptoms, contact your healthcare provider.
Alcohol can enhance the blood pressure-lowering effect of CoAprovel and may increase the risk of dizziness, lightheadedness, and fainting, especially when standing up quickly. It is advisable to limit alcohol consumption while taking CoAprovel. Discuss your alcohol use with your doctor for personalized advice on safe limits.
If you miss a dose, take it as soon as you remember on the same day. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one. If you frequently forget doses, consider setting a daily reminder or using a pill organizer. Consistent daily dosing is important for effective blood pressure control.
CoAprovel starts to lower blood pressure within a few hours of taking the first dose. However, the full blood pressure-lowering effect typically develops over 4 to 6 weeks of regular use. It is important to continue taking CoAprovel as prescribed even if you feel well, as high blood pressure often has no noticeable symptoms. Do not stop taking the medicine without consulting your doctor.
References
- European Medicines Agency (EMA). CoAprovel (irbesartan/hydrochlorothiazide) – Summary of Product Characteristics. Available at: ema.europa.eu. Accessed January 2026.
- Mancia G, Kreutz R, Brunström M, et al. 2023 ESH Guidelines for the management of arterial hypertension. Journal of Hypertension. 2023;41(12):1874–2071. doi:10.1097/HJH.0000000000003480
- Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal. 2018;39(33):3021–3104. doi:10.1093/eurheartj/ehy339
- Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. Journal of the American College of Cardiology. 2018;71(19):e127–e248. doi:10.1016/j.jacc.2017.11.006
- World Health Organization (WHO). Guideline for the pharmacological treatment of hypertension in adults. Geneva: WHO; 2021. Available at: who.int
- British National Formulary (BNF). Irbesartan with hydrochlorothiazide. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk. Accessed January 2026.
- Sica DA. Rationale for fixed-dose combinations in the treatment of hypertension: the cycle repeats. Drugs. 2002;62(3):443–462. doi:10.2165/00003495-200262030-00003
- Bobrie G, Delonca J, Moulin C, et al. A home blood pressure monitoring study comparing the antihypertensive efficacy of two angiotensin II receptor antagonist fixed combinations. American Journal of Hypertension. 2005;18(11):1482–1488. doi:10.1016/j.amjhyper.2005.05.024
About the Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of licensed physicians specializing in cardiology, internal medicine, and clinical pharmacology. All medical content follows international guidelines from the European Society of Cardiology (ESC), American Heart Association (AHA), and the World Health Organization (WHO).
Medical Review Process
- Initial research and drafting by medical writers
- Clinical review by board-certified physicians
- Fact-checking against current clinical guidelines
- Regular updates when new evidence emerges
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- GRADE framework for recommendation strength
- ESC/ESH, AHA/ACC, WHO guideline adherence
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