Cilazapril

Registered South African indications:

• Hypertension
• Cardiac failure

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Severe renal impairment
• Hereditary or idiopathic angioneurotic oedema
• History of angioedema associated with previous angiotensin converting enzyme inhibitors therapy
• Hypertrophic obstructive cardiomyopathy
• Bilateral renal artery stenosis
• Renal artery stenosis in patients with a single kidney 
• Aortic stenosis
• Cirrhosis with ascites
• Porphyria
• Coadministration with potassium sparing diuretics
• Coadministration with lithium
• Coadministration with aliskiren containing agents in patient with diabetes mellitus or renal impairment

Cautions

• Mild to moderate renal impairment
• Severe hepatic impairment
• Elderly
• Black patients
• Risk factors for hyperkalaemia
• Hypovolaemic patients
• Collagen vascular disease
• Ischaemia heart disease
• Cerebrovascular disease
• Galactose intolerance
• Glucose-galactose malabsorption
• Lapp lactase deficiency

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

Hypertension - mild, moderate

• Oral (tab): Initial: 0.5-1.25mg, dly; Maintenance: 2.5-5mg, dly; Max: 10mg/24hrs

All diuretics should be discontinued 2-3 days prior to starting cilazapril

May administer total daily dose in 2 divided doses if antihypertensive effect diminishes over 24 hour dosing interval

Chronic cardiac failure

• Oral (tab): Initial: 0.5mg, dly; Maintenance dose: 1-2.5mg, dly; Max: 5mg/24hrs

Not established for use in children

Pregnancy

• FDA Pregnancy Category Not Rated (NR) 

Breastfeeding

• Contraindicated 

Renal Impairment

• Mild to moderate: Caution; dose adjustment recommended 
• Severe: Contraindicated 

Hepatic Impairment

• Severe: Caution; dose adjustment recommended

Elderly

• Caution; dose adjustment recommended

Central Nervous System Disorders

• Headache
• Dysgeusia
• Fatigue

Cardiovascular Disorders

• Angina pectoris
• Tachycardia
• Palpitations
• Dizziness
• Hypotension

Respiratory Disorders

• Cough

Gastrointestinal Disorders

• Nausea

Skin and Subcutaneous Tissue Disorders

• Rash

Immune, Blood and Lymphatic System Disorders

• Angioedema

• Antihypertensives
• Lithium 
• Agents that increase serum potassium
• Diuretics
• Non-steroidal anti-inflammatory drugs
• Aliskiren containing agents
• Sympathomimetics
• Tricyclic antidepressants
• Antipsychotics
• Anaesthetics
• Narcotics
• Antidiabetic agents
• Gold

• Renal function
• Hepatic function
• Electrolytes

Specific cases may require

• Full blood count
• Blood glucose

Cilazapril is an angiotensin-converting enzyme inhibitor. It blocks the conversion of angiotensin I to angiotensin II, which is a potent vasoconstrictor. This results in a decrease in blood pressure, an increase in renin activity and stimulation of baroreceptor reflex mechanisms.

Tablet 5mg

• Inhibace (Roche) originator

COMBINATION PREPARATIONS

Cilazapril/ Hydrochlorothiazide

Tablet 5mg/12.5mg

• Inhibace plus (Roche) originator