Cilazapril/ Hydrochlorothiazide

Registered South African indications:

• Hypertension

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other ACE inhibitors or other sulphonamide-derived medicines
• A history of angioedema related to previous therapy with ACE inhibitors or angiotensin receptor blockers (ARBs). These patients must never again be given these medicines
• Hereditary or idiopathic angioedema
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Aortic stenosis or outflow tract obstruction
• Severe renal function impairment (creatinine clearance less than 30 mℓ/min) or anuria
• Bilateral renal artery stenosis and renal artery stenosis in patients with a single kidney
• Concomitant therapy with potassium sparing diuretics such as spironolactone, triamterene, amiloride
• Porphyria
• Hydrochlorothiazide as in this combination product should not be given to patients with Addison’s disease
• Lithium therapy: Concomitant administration may lead to toxic blood concentrations of lithium
• The safety and efficacy in children have not been established, therefore administration to children is not recommended
• Pregnancy
• Breastfeeding

Cautions

• Woman contemplating pregnancy
• Mild to moderate renal impairment
• Hepatic impairment or progressive liver disease
• Elderly
• Sodium or volume-depleted patients
• Cardiac disorders
• Heart failure
• Ischaemic heart disease
• Cerebrovascular disease
• Risk factors for hypotension
• Angina pectoris
• Diabetes mellitus
• Risk factors for hyperkalaemia
• African descent
• Desensitisation therapy
• Low-density lipoproteins (LDL)-apheresis
• Haemodialysis  with high flux membranes
• Combination with anaesthetic medicines
• Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Ability to drive and use machines

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

Hypertension - mild to moderate

Cilazapril/ Hydrochlorothiazide
5/12.5 (mg)

• Oral (tab): 1 tab, dly

Do not cut/crush/chew/dissolve

Not established for use in children

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated 

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Cilazapril

• Lithium
• Other antihypertensive agents
• Potassium sparing diuretics
• Spironolactone
• Triamterene
• Amiloride
• Potassium supplements
• Potassium-containing salt substitutes
• Diuretics
• Thiazide diuretics
• Loop diuretics
• Tricyclic antidepressants
• Antipsychotics
• Anaesthetics
• Narcotics
• NSAIDs including aspirin ≥ 3 g/day
• COX-2 inhibitors
• Non-selective NSAIDs
• Sympathomimetics
• Anti-diabetics
• Insulin
• Oral hypoglycaemic agents
• Gold

Hydrochlorothiazide

• Digoxin
• Agents that could induce torsades de pointes
• Class Ia antidysrhythmics
• Quinidine
• Hydroquinidine
• Disopyramide
• Class III antidysrhythmics
• Amiodarone
• Sotalol
• Some antipsychotics
• Thioridazine
• Chlorpromazine
• Trifluoperazine
• Sulpiride
• Tiapride
• Haloperidol
• Droperidol
• Bepridil
• Cisapride
• Diphemanil
• Halofantrine
• Ketanserin
• Pentamidine
• Calcium salts
• Vitamin D
• Cholestyramine
• Colestipol
• Anticholinergics
• Atropine
• Biperiden
• Non-depolarising muscle relaxants
• Amantadine
• Cytotoxic medicines
• Methotrexate
• Cyclophosphamide
• Iodine containing contrast media
• Ciclosporin
• Allopurinol
• Tetracyclines

• Renal function
• Hepatic function
• Electrolytes

Specific cases may require

• Serum potassium
• Full blood count
• Blood glucose

Cilazapril
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.

Hydrochlorothiazide
Hydrochlorothiazide acts primarily in the distal convoluted tubule where it inhibits sodium chloride transport. It competes for the chloride site and affects the electrolyte reabsorption by increasing sodium and chloride excretion. This reduces plasma volume indirectly and increases plasma renin activity, aldosterone secretion and urinary potassium loss.

COMBINATION PREPARATIONS

Cilazapril/ Hydrochlorothiazide

Tablet 5mg/12.5mg

• Inhibace Plus (Roche) originator