FIBSOL

What it is

Fibsol contains lisinopril dihydrate, a white to off-white crystalline powder that is soluble in water, sparingly soluble in methanol and practically insoluble in ethanol. Fibsol tablets come in three strengths and contain lisinopril dihydrate equivalent to 5 mg, 10 mg or 20 mg of lisinopril. Lisinopril is a peptidyl dipeptidase inhibitor that inhibits the angiotensin converting enzyme (ACE), which catalyses the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II.

Approved indications

— Treatment of hypertension. — Treatment of heart failure. — Treatment of acute myocardial infarction in haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmHg.

Dosing overview Lisinopril should be administered in a single daily dose.

Key safety warnings

Serum potassium concentrations exceeding 5.5 mEq/L may occur because ACE inhibitors decrease the formation of angiotensin II and subsequent production of aldosterone. Hyperkalaemia is more likely in patients with renal impairment, those treated with potassium-sparing diuretics or potassium supplements, and in those consuming potassium-containing salt substitutes. Severe life-threatening angioedema has been reported rarely with ACE inhibitors. Most commonly, angioedema occurs during the first week of therapy but it has also been reported after long-term therapy. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported. Angioedema associated with laryngeal oedema is potentially life-threatening. Very rarely, fatalities have been reported due to angioedema associated with laryngeal oedema or tongue oedema. ACE inhibitors cause a higher rate of angioedema in Afro-Caribbean black patients than in non-Afro-Caribbean black patients. A persistent dry irritating cough has been reported with ACE inhibitors. The cough is most likely due to stimulation of the pulmonary cough reflex by kinins (bradykinin) and/or prostaglandins, which accumulate because of ACE inhibition. Hypotension may occur in patients commencing treatment with ACE inhibitors. Excessive hypotension is rarely seen in patients with uncomplicated hypertension but can develop in patients with impaired renal function, in those who are salt or volume depleted because of renovascular disease, diuretic therapy, vomiting or diarrhoea, and in patients undergoing dialysis.

Contraindications

Hypersensitivity to lisinopril or any other component of lisinopril. History of hereditary and/or idiopathic angioedema, anaphylactic/anaphylactoid reactions or angioedema associated with previous treatment with an ACE inhibitor. Pregnancy. Patients undergoing haemodialysis with polyacrylonitrile metalylsulfonate high flux membranes, as there is a risk of anaphylactoid reaction with simultaneous use of an ACE inhibitor and polyacrylonitrile metalylsulfonate high flux dialysis membranes or during low-density lipoprotein apharesis with dextran sulphate within dialysis treatment.

PBS listing

No information available in the provided sources regarding PBS listing details for Fibsol, including strengths listed, item numbers, restriction type or ex-manufacturer price.

Regulatory history

Fibsol 5 mg, 10 mg and 20 mg tablets were first listed on the ARTG on 7 May 2004.