Cilazapril

Cilazapril

[1 tablet 15 cents]

ADMINISTRATION ROUTES:

  • PO

ALTERNATIVE NAMES:

  • inhibace

ICU INDICATIONS:

  1. Hypertension
  2. Congestive heart failure or left ventricular dysfunction after myocardialinfarction
  3. Diabetic nephropathy

PRESENTATION AND ADMINISTRATION:

  • PO
    Inhibace 0.5mg (white), 2.5mg (pink), 5mg (reddish-brown)

DOSAGE:

  • PO:
    0.5-5mg daily

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:

  • Dose in renal impairment [GFR (ml/min)]
    <10: dose as in normal renal function
    10-40: initially 0.5mg once daily (usual maximum 2.5mg daily)
    >40-50: 1mg once daily
  • Dose in renal replacement therapy
    CAPD: 0.25-0.5mg once daily
    HD: 0.25-0.5mg once daily
    CVVHDF: initially 0.5mg once daily (usual maximum 2.5mg daily)

    Note: Recent clinical observations have shown an association of hypersensitivity-like (anaphylactoid) reactions during hemodialysis with high-flux dialysis membranes (e.g., AN69) in patients receiving ACE inhibitors.

DOSAGE IN PAEDIATRICS:

  • PO:
    0.02-0.1mg/kg daily.

CLINICAL PHARMACOLOGY:

  • Cilazapril is an angiotensin I-converting enzyme (ACE) inhibitor

CONTRAINDICATIONS:

  1. hypersensitivity to cilazapril or any other angiotensin-converting enzyme inhibitor (e.g. a patient who has experienced angioedema during therapy with any other ACE inhibitor).
  2. cardiogenic shock

WARNINGS

  • Anaphylactoid and Possibly Related Reactions:
    Cilazapril can cause anaphylactoid reactions
  • Head and Neck Angioedema:
    Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with ACE inhibitors, including cilazapril. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Swelling confined to the face, mucous membranes of the mouth, lips and extremities has usually resolved with discontinuation of cilazapril; some cases required medical therapy.
  • Intestinal Angioedema:
    Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.
  • Neutropenia/Agranulocytosis:
    Neutropenia (<1000/mm3) with myeloid hypoplasia has resulted from use of cilazapril.
  • Hypotension in Heart Failure Patients:
    Caution should be observed when initiating therapy in patients with heart failure. Patients with heart failure given cilazapril commonly have some reduction in blood pressure. In patients with symptomatic hypotension this may require temporarily reducing the dose of cilazapril, or diuretic, or both, and volume repletion
  • Hepatic Failure:
    Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor.

PRECAUTIONS

  • General:
    Some patients with renal disease, particularly those with severe renal artery stenosis, have developed increases in serum creatinine after reduction of blood pressure with cilazapril. Cilazapril dosage reduction and/or discontinuation of diuretic may be required. Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including cilazapril.
    Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.
  • Laboratory Tests:
    No tests in addition to routine ICU tests are required.
  • Drug/Laboratory Test Interactions :
    None of note

IMPORTANT DRUG INTERACTIONS FOR THE ICU

  • Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. The risk of hypotension increases if cilazapril is coadministered with other antihypertensives

ADVERSE REACTIONS:

  • Body as a Whole:
    Gynaecomastia, anaphylactoid reactions, angioedema
  • Cardiovascular:
    Cardiac arrest, cerebrovascular accident / insufficiency, rhythm disturbances, orthostatic hypotension, syncope
  • Dermatological:
    Bullous pemphigus, erythema multiforme (Stevens Johnson syndrome), exfoliatice dermatitis
  • Gastrointestinal:
    Pancreatitis, glossitis, dyspepsia, jaundice, hepatitis, rare causes of hepatic necrosis, cholestasis
  • Haematological:
    Anaemia (including cases of haemolytic anaemia), thrombocytopenia, neutropenia
  • Metabolic:
    Hyponatraemia
  • Musculoskeletal:
    Myalgia, myasthenia
  • Nervous system:
    Ataxia, confusion, depression, nervousness, somnolence
  • Respiratory system:
    Bronchospasm, eosinophilic pneumonia, angioedema
  • Urogenital system:
    Renal failure, proteinuria

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