Canceled South Africa · SAHPRA

ZANTIPRES 30 mg

Zofenopril calcium

55/7.1/0015 INN generic

What it does

Zofenopril is a medication used to help manage certain heart and blood vessel conditions.

Commonly used for: high blood pressure (hypertension), heart failure

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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.
55/7.1/0015
Registration date
2023/01/24
Expiry date
-
Status
Canceled
Active ingredient
Zofenopril calcium
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:27:37 · updated 2026-09-16 04:01:09

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Zofenopril is a medication used to help manage certain heart and blood vessel conditions.

What it treats

  • high blood pressure (hypertension)
  • heart failure

How it works

Zofenopril helps relax blood vessels, making it easier for the heart to pump blood and lowering blood pressure.

Who it's for

This medication is for adults dealing with high blood pressure or heart-related issues.

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

Clinical monograph: zofenopril

BNF-referenced

Zofenopril is an angiotensin-converting enzyme (ACE) inhibitor used primarily for the treatment of hypertension and heart failure. It works by inhibiting the conversion of angiotensin I to angiotensin II, leading to vasodilation, reduced blood pressure, and decreased workload on the heart. Zofenopril is also noted for its potential renal protective effects in patients with diabetic nephropathy.

Indications

  • Hypertension
  • Heart failure
  • Left ventricular dysfunction following myocardial infarction
  • Diabetic nephropathy

Dosage

Children: Zofenopril is not generally recommended for use in children. Refer to the BNF for Children for specific guidance on any potential pediatric use.

Adults: The usual starting dose for hypertension is 15 mg once daily, which may be adjusted based on the patient's response. For heart failure, the initial dose may be lower, around 7.5 mg once daily, titrated as necessary.

Mechanism of action

Zofenopril inhibits the enzyme ACE, which is responsible for the conversion of angiotensin I to angiotensin II. This inhibition results in decreased levels of angiotensin II, a potent vasoconstrictor, leading to vasodilation, reduced secretion of aldosterone, and ultimately lower blood pressure. Additionally, it enhances bradykinin levels, which also contributes to vasodilation.

Pharmacodynamics

The pharmacodynamic effects of zofenopril include significant reductions in systemic vascular resistance and blood pressure. It also improves cardiac output in patients with heart failure by reducing afterload and preload. The onset of action is typically observed within a few hours, with peak effects occurring within 2 to 4 weeks of therapy.

Pharmacokinetics

Zofenopril is well absorbed after oral administration. It undergoes hepatic metabolism to its active metabolite, zofenoprilat, which has a longer half-life. The elimination half-life of zofenoprilat ranges from 8 to 12 hours. Both the drug and its metabolites are primarily excreted via the kidneys. Renal impairment may necessitate dosage adjustments.

Contra-indications

  • Hypersensitivity to zofenopril or any of its excipients
  • History of angioedema associated with previous ACE inhibitor therapy
  • Severe renal impairment
  • Pregnancy
  • Concomitant use with aliskiren in patients with diabetes

Adverse effects

  • Cough
  • Dizziness
  • Fatigue
  • Hypotension
  • Hyperkalemia
  • Renal impairment
  • Angioedema
  • Rash
  • Gastrointestinal disturbances

Interactions

  • Potassium-sparing diuretics may increase the risk of hyperkalemia
  • Non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect
  • Lithium levels may increase, requiring monitoring
  • Concomitant use of other antihypertensives may enhance hypotensive effects

Precautions

  • Monitor renal function before and during treatment
  • Use with caution in patients with hepatic impairment
  • Caution in patients with a history of angioedema
  • Consider risk factors for hypotension in volume-depleted patients

Pregnancy

Zofenopril is contraindicated in pregnancy due to potential harm to the fetus.

Breast-feeding

It is not known whether zofenopril is excreted in human milk. Caution is advised.

Storage

Store at room temperature, away from moisture and light.

Formulations

  • Tablets: 7.5 mg, 15 mg, 30 mg

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

Molecular reference: zofenopril

PubChem CID 92400

Molecular formula: C22H23NO4S2

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.