cilazapril/hydrochlorothiazide

Action and Spectrum

Actions and Spectrum 

cilazapril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking the action of ACE, an enzyme that converts angiotensin I to angiotensin II. 

hydrochlorothiazide is a thiazide diuretic which acts on the kidneys, specifically on the distal convoluted tubules, to increase the excretion of water and electrolytes.

Drug Interaction

Adverse Reaction

Frequency defined  

1-10% 

Increased uric acid (≥1%) 

Urinary frequency (1%) 

Increased serum glucose (≥1%) 

Decreased HDL cholesterol (≥1%) 

Decreased serum potassium (≥1%) 

Nausea (1%) 

Leukocyturia (≥1%), neutropenia (1%) 

Dizziness (4%) 

Drowsiness (1%) 

Fatigue (3%) 

Headache (6%) 

Cough (3%) 

<1% 

Peripheral edema, peripheral ischemia, angina pectoris 

Atrial fibrillation, bradycardia 

Flatulence, melena, vomiting, xerostomia 

Diplopia, visual disturbance 

Dermatitis, diaphoresis 

Pruritus, skin rash, xeroderma 

Decreased libido, hot flash 

Increased libido, increased thirst, weight gain 

Abdominal pain, anorexia, constipation, diarrhea, dyspepsia  

Acute myocardial infarction, extrasystoles  

Hypotension, orthostatic hypotension, palpitations 

Blockage of external ear, tinnitus 

Impotence, leukorrhea, nocturia 

Abnormal dreams, anxiety, asthenia, cerebrovascular disease  

Confusion, depersonalization, depression, emotional lability 

Prolonged bleeding time, purpuric disease 

Increased serum alanine aminotransferase 

Angioedema, facial edema  

Hypersensitivity reaction 

Flushing sensation, hypoesthesia, hypothermia, insomnia 

Malaise, nervousness, neurosis, nightmares, pain, paresthesia 

Arthralgia, back pain, gout  

Lower limb cramp, myalgia 

Increased blood urea nitrogen, polyuria 

Bronchitis, dyspnea, pharyngitis 

Rhinitis, sinusitis 

Upper respiratory tract infection 

Post marketing report  

Increased gamma-glutamyl transferase 

Cholestatic hepatitis  

Increased serum alkaline phosphatase  

Increased serum bilirubin 

Black Box Warning

Black Box Warning 

None

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• cilazapril are contraindicated in patients with a history of angioedema related to previous ACE inhibitor use. 
• hydrochlorothiazide is contraindicated in patients with known hypersensitivity or allergy to thiazide-type diuretics. 

Caution: 

• cilazapril/hydrochlorothiazide should be used with caution in patients with impaired renal function.  
• cilazapril/hydrochlorothiazide may cause low blood pressure particularly in patients with volume depletion, caution is advised in these individuals. 
• Close monitoring of electrolyte levels is recommended especially in patients at higher risk, such as those with heart failure or hepatic cirrhosis. 

Pregnancy / Lactation

Pregnancy consideration: 

Pregnancy category: N/A 

Lactation: Excretion into human milk is known for hydrochlorothiazide drug. 

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 

Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology  

cilazapril reduces the production of angiotensin II, a potent vasoconstrictor leading to vasodilation. This action decreases peripheral resistance and lowers blood pressure. 

hydrochlorothiazide acts on the distal convoluted tubules of the kidneys, inhibiting the reabsorption of sodium and chloride ions. This leads to increased excretion of water and electrolytes, including sodium and chloride. 

Pharmacodynamics 

cilazapril decreases the levels of angiotensin II, which results in reduced aldosterone secretion. This leads to a decrease in sodium and water retention and an increase in potassium retention. 

hydrochlorothiazide can also cause increased excretion of potassium and magnesium. The diuretic effect reduces blood volume, which contributes to the reduction of blood pressure. 

Pharmacokinetics 

Absorption   

cilazapril undergoes extensive first-pass metabolism in the liver.  

hydrochlorothiazide is absorbed after oral administration. The peak plasma concentration is reached within 1 to 2 hours. 

Distribution 

cilazapril have high protein binding around 96% and distribute extensively throughout the body. 

hydrochlorothiazide is distributed throughout the body. 

Metabolism 

cilazapril is metabolized in the liver by esterase enzymes.  

hydrochlorothiazide undergoes minimal metabolism in the liver. 

Elimination and excretion 

cilazapril/hydrochlorothiazide both are eliminated through the kidneys.

Adminstartion

Administration 

cilazapril/hydrochlorothiazide is administered orally, in the form of tablets or capsules. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: cilazapril/hydrochlorothiazide 

Why do we use cilazapril/ hydrochlorothiazide? 

cilazapril/hydrochlorothiazide is primarily used for the treatment of hypertension.  

cilazapril is also used in the management of heart failure and to improve survival following a heart attack.