Benazepril

Registered South African indications: 

• Hypertension

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• History of angioedema
• Pregnancy
• Coadministration with with aliskiren agents in patient with diabetes mellitus or renal impairment

Cautions

• Breastfeeding
• Moderate to severe renal impairment
• Elderly
• Volume-depleted patients
• Risk factors for hyperkalaemia
• Collagen vascular disease
• Dialysis with high-flux dialysis membranes
• Low density lipoprotein apheresis with dextran sulfate
• Ischaemic heart disease
• Cerebrovascular disease
• Renal artery stenosis
• Hymenoptera venom desensitising treatment
• Decompensated congestive cardiac failure
• Diabetes mellitus
• Left ventricular outflow tract obstruction

Forms avail. in SA and covered in this monograph: tab

Hypertension - mild to moderate

• Oral (tab): Initial: 10mg, dly; Maintenance: 10-40mg, 12-24hrly; Max: 80mg/24hrs

If possible, diuretic should be discontinued 2-3 days before initiation of benazepril

If currently on diuretic when starting drug, initiate benazepril at lower dose: 5mg, dly  

If once daily dosing does not provide adequate control, consider increasing dose or divided administration

Dose adjustment should be based on peak (2-6hrs after dosing) and trough (pre-dosing) blood pressures

Not approved for use in South Africa for children

Pregnancy

• Contraindicated: Second-, and third-trimester
• Avoid: First-trimester
• Second and third trimester: Foetal toxic effects may include anuria, oligohydramnios, foetal hypocalvaria, intrauterine growth restriction (IUGR), prematurity, and patent ductus arteriosus. Stillbirth or neonatal death may occur
• Benazepril has the ability to cross the placenta. ACE inhibitor exposure during pregnancy is known to induce human fetotoxicity. Use of ACE inhibitors has been associated with adverse effects such as, anuria, hypotension, renal failure, skull hypoplasia, and death in the foetus/neonate. Infants born from mothers who had ACE inhibitor therapy during their pregnancy should be monitored for hyperkalemia, hypotension, and oliguria
• Benazepril treatment should be discontinued, if pregnancy is dectected and alternative agents used

Breastfeeding

• Caution; not recommended
• No human data available
• Benazepril and its metabolite, benazeprilat are excreted into breast milk
• The drug is concentrated in low amounts in milk and with a minum/ no adverse effect on nursing infants

Renal Impairment

• CrCl≥30 ml/min/1.73m²: No dose adjustment recommended
• CrCl<30ml/min/1.73m²: Caution; dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution;  no dose adjustment recommended
  Consider lower initial doses

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Fatigue
• Somnolence
• Insomnia
• Nervousness
• Paraesthesia
• Inco-ordination

Cardiovascular Disorders

• Palpitations
• Orthostatic symptoms
• Symptomatic hypotension
• Chest pain
• Angina pectoris
• Arrthymias
• Myocardial infarction

Respiratory Disorders

• Cough
• Sinusitis

Gastrointestinal Disorders

• Non-specific gastro-intestinal disorders
• Diarrhoea
• Nausea and vomiting
• Constipation
• Abdominal pain
• Pancreatitis

Hepatobiliary Disorders

• Hepatitis
• Cholestatic jaundice

Genitourinary Disorders

• Urinary infrequency
• Increase in serum urea nitrogen
• Increased serum creatinine
• Impaired renal function

Musculoskeletal Disorders

• Arthralgia
• Arthritis
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash
• Flushing
• Photosensitivity
• Pemphigus
• Stevens-Johnson syndrome

Immune, Blood and Lymphatic System Disorders

• Haemolytic anaemia
• Thrombocytopenia
• Angioedema
• Lip and facial oedema

Sensory Disorders

• Tinnitus
• Dysgeusia

• Agents that act on the angiotensin-renin-aldosterone system
• Diuretics
• Agents that increase serum potassium
• Agents that alter serum sodium
• Lithium
• Anaesthetic agents
• Aliskiren-containing agents

• Electrolytes
• Renal function 

Specific cases may require

• Full blood count

Benazepril is a angiotensin-converting enzyme (ACE) inhibitor. This enzyme functions to convert angiotensin I to angiotensin II which is involved in vascular control and function through many different mechanisms, including stimulation of aldosterone secretion. By inhibiting the ACE, benazepril prevents the downstream vasopressor activity and aldosterone secretion effected by angiotensin II

Tablet 10mg

• Cibace (Novartis) originator

COMBINATION PREPARATIONS

Benazepril/ Hydrochlorothiazide

Tablet 10mg/12.5mg

• Cibadrex Fct (Novartis) originator