Benazepril/ Hydrochlorothiazide

Registered South African indications:

• Hypertension

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

Benazepril
Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• History of angioedema
• 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

Hydrochlorothiazide
Contraindications 

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe renal impairment
• Refractory hypokalaemia, hyponatremia, hypercalcaemia, hyperuricaemia
• Addison’s disease
• Pre-existing hypercalcaemia

Cautions

• Breastfeeding
• Mild to moderate renal impairment
• Hepatic impairment
• Elderly
• Renal artery stenosis
• Gout
• Hyperglycaemia
• Systemic lupus erythematosus

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

Hypertension - mild to moderate

Benazepril/ Hydrochlorothiazide
10/12.5 (mg)

• Oral (tab): 1 tab, dly

Not established for use in children

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

Pregnancy

• FDA Pregnancy Category D (Benazepril)

Breastfeeding

• Caution; not recommended (Hydrochlorothiazde)

Renal Impairment

• Mild to moderate: Caution; dose adjustment recommended (Benazepril)
• Severe: Contraindicated (Hydrochlorothiazide)

Hepatic Impairment

• Caution; no dose adjustment recommended (Hydrochlorothiazide)

Elderly

• Caution; no dose adjustment recommended (Benazepril, Hydrochlorothiazide)

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Prohibited - At all times

  
  

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

Benazepril
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

Hydrochlorothiazide
Central Nervous System Disorders

• Weakness
• Lethargy
• Drowsiness
• Restlessness
• Seizures
• Headache
• Paraesthesia
• Dizziness

Cardiovascular Disorders

• Postural hypotension

Gastrointestinal Disorders

• Nausea and vomiting
• Constipation
• Diarrhoea
• Intestinal ulceration

Hepatobiliary Disorders

• Cholestatic jaundice
• Pancreatitis

Genitourinary Disorders

• Oliguria
• Impotence

Endocrine and Metabolic Disorders

• Hypochloraemic alkalosis
• Hyponatremia
• Hypokalaemia
• Hyperglycaemia
• Hyperuricaemia
• Gout
• Hypomagnesaemia
• Anorexia

Musculoskeletal Disorders

• Muscle pain
• Cramps

Skin and Subcutaneous Tissue Disorders

• Hypersensitivity reactions

Immune, Blood and Lymphatic System Disorders

• Thrombocytopaenia
• Granulocytopaenia
• Leucopenia
• Aplastic anaemia
• Haemolytic anaemia

Sensory Disorders

• Dry mouth
• Thirst
• Yellow vision

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

Benazepril

• 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

Hydrocholorthiazide

• Digoxin
• Neuromuscular blocking agents
• Central nervous system depressants
• Corticosteroids
• Corticotrophin
• Beta-2 agonists
• Adrenaline
• Lithium

• Renal function
• Electrolytes

Specific cases may require

• Full blood count
• Blood glucose

Benazepril
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.

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

Benazepril/ Hydrochlorothiazide

Tablet 10mg/12.5mg

• Cibadrex fct (Novartis) originator