Prinivil Label Updated with Oral Suspension Prep Details
Merck has updated the labeling for Prinivil (lisinopril) to include details on the preparation of an oral suspension.
Prinivil, an angiotensin converting enzyme (ACE) inhibitor, is indicated to treat hypertension in adults and pediatric patients ≥6yrs of age, for the treatment of acute myocardial infarction, and as an adjunctive therapy for heart failure.
The label update states:
To make 200mL of a suspension at 1.0mg/mL, add 10mL of Purified Water USP to a polyethylene terephthalate (PET) bottle containing ten 20mg tablets of PRINIVIL and shake for at least one minute. Add 30mL of Sodium Citrate and Citric Acid Oral Solution or Cytra-2 diluent and 160mL of Ora-Sweet SF to the concentrate in the PET bottle and gently shake for several seconds to disperse the ingredients.The suspension should be stored at or below 25°C (77°F) and can be stored for up to four weeks. Shake the suspension before each use.
The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion.
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