FRUSOL Oral solution Ref.[27733] Active ingredients: Furosemide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: High-Ceiling Diuretic Sulfonamide
ATC code: CO3CA01

Furosemide is a potent loop diuretic which inhibits sodium and chloride reabsorption at the Loop of Henlรฉ. The drug eliminates both positive and negative free water production. Furosemide acts at the luminal face of the epithelial cells by inhibiting co-transport mechanisms for the entry of sodium and chloride. Furosemide gains access to its site of action by being transported through the secretory pathway for organic acids in the proximal tubule. It reduces the renal excretion of uric acid. Furosemide causes an increased loss of potassium in the urine and also increases the excretion of ammonia by the kidney.

5.2. Pharmacokinetic properties

When oral doses of Furosemide are given to normal subjects the mean bioavailability of the drug is approximately 52% but the range is wide. In plasma, Furosemide is extensively bound to proteins mainly to albumin. The unbound fraction in plasma averages 2-4% at therapeutic concentrations. The volume of distribution ranges between 170-270ml/Kg. The half life of the ฮฒ phase ranges from 45-60 min. The total plasma clearance is about 200ml/min. Renal excretion of unchanged drug and elimination by metabolism plus faecal excretion contribute almost equally to the total plasma clearance. Furosemide is in part cleared by the kidneys in the form of the glucuronide conjugate.

5.3. Preclinical safety data

Furosemide is a widely used diuretic which has been available for over thirty years and its safety profile in man is well established.

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