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APROVEL TABLETS (Each tablet contains Ibesartan 150mg)

Ibesartan

FDA/SD.245-071101 Ibesartan 150mg

What it does

Ibesartan is a medicine used to help lower high blood pressure and protect kidney function in people with diabetes.

Commonly used for: high blood pressure (hypertension), heart failure, kidney protection in diabetes

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.245-071101
Registration date
2024-07-09
Expiry date
2027-09-01
Status
Valid
Active ingredient
Ibesartan
Dosage form
Ibesartan
Strength
150mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Sanofi Winthrop
Country of origin
France
Manufacturer location
1 Rue de la Vierge, 33440 Ambarès-et-Lagrave, France

Source: Food and Drugs Authority · fetched 2026-04-18 08:32:59 · updated 2026-10-20 04:00:05

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ibesartan is a medicine used to help lower high blood pressure and protect kidney function in people with diabetes.

What it treats

  • high blood pressure (hypertension)
  • heart failure
  • kidney protection in diabetes

How it works

Ibesartan works by blocking certain substances in the body that can raise blood pressure, helping to relax blood vessels so blood can flow more easily.

Who it's for

Ibesartan is for adults who need help managing their blood pressure or protecting their kidneys due to diabetes.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: ibesartan

Ibesartan is an angiotensin II receptor antagonist (ARB) used primarily in the management of hypertension and certain heart conditions. It works by blocking the action of angiotensin II, a substance in the body that causes blood vessels to constrict, thereby lowering blood pressure and reducing the workload on the heart. Ibesartan is typically well tolerated, with common side effects including dizziness, fatigue, and gastrointestinal disturbances.

Indications

  • Hypertension
  • Heart failure
  • Left ventricular dysfunction
  • Chronic kidney disease
  • Diabetic nephropathy

Dosage

Children: Refer to BNF for Children for appropriate dosing information in pediatric patients.

Adults: Refer to BNF for specific dosing guidelines based on individual patient needs and conditions.

Mechanism of action

Ibesartan selectively antagonizes the angiotensin II type 1 (AT1) receptor. By inhibiting this receptor, it prevents angiotensin II from exerting its vasoconstrictive effects, leading to vasodilation, decreased blood pressure, and reduced secretion of aldosterone, which in turn decreases sodium and water retention.

Pharmacodynamics

Ibesartan exhibits dose-dependent antihypertensive effects, with its peak action occurring approximately 1 to 2 hours after oral administration. The duration of action can persist for 24 hours, allowing for once-daily dosing in most cases. It also shows cardioprotective effects, making it beneficial for patients with heart failure or left ventricular dysfunction.

Pharmacokinetics

Ibesartan is rapidly absorbed following oral administration, with a bioavailability of approximately 60-80%. Peak plasma concentrations occur within 1-2 hours. It is highly protein-bound (about 95%) and is primarily excreted via the feces. The elimination half-life ranges from 2 hours to 15 hours, depending on individual patient factors. Renal impairment may affect the clearance of ibesartan.

Contra-indications

  • Hypersensitivity to ibesartan or any of its excipients
  • Severe hepatic impairment
  • Pregnancy
  • Severe renal impairment or conditions associated with hyperkalemia

Adverse effects

  • Dizziness
  • Headache
  • Fatigue
  • Hypotension
  • Hyperkalemia
  • Renal impairment
  • Angioedema

Interactions

  • Other antihypertensives may potentiate the hypotensive effect of ibesartan
  • Potassium supplements or potassium-sparing diuretics may increase the risk of hyperkalemia
  • Non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect of ibesartan

Precautions

  • Monitor renal function, particularly in patients with renal artery stenosis
  • Use with caution in patients with a history of angioedema
  • Assess potassium levels periodically, especially in patients with renal impairment or those taking concomitant medications that increase potassium levels

Pregnancy

Ibesartan is contraindicated in pregnancy due to the risk of fetal harm.

Breast-feeding

It is not known whether ibesartan is excreted in human milk. Caution should be exercised when administering to breastfeeding mothers.

Storage

Store in a cool, dry place away from direct light. Keep out of reach of children.

Formulations

  • Tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.