Prinivil - Indications & Dosage

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If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS, Hypotension and PRECAUTIONS, Drug Interactions).

A lower starting dose is required in the presence of renal impairment, in patients in whom diuretic therapy cannot be discontinued, patients who are volume-and/ or salt-depleted for any reason, and in patients with renovascular hypertension.

Dosage Adjustment in Renal Impairment

Dosage in patients with renal impairment should be based on creatinine clearance as outlined in the Table below:

Creatinine Clearance Starting Dose

70 30 mL/ min ( 1.17 0.5 mL/ s) 5.0 -10.0 mg/ day

30 10 mL/ min ( 0.5 0.17 mL/ s) 2.5 -5.0 mg/ day

< 10 mL/ min (< 0.17 mL/ s) 2.5 mg/ day x

(including patients on dialysis)

x Dosage and/ or frequency of administration should be adjusted depending on the blood pressure response.

The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.

Anaphylactoid reactions have been reported in patients dialysed with high-flux membranes (e. g., polyacrylonitrile [PAN] and treated concomitantly with an ACE inhibitor) (see PRECAUTIONS, Anaphylactoid Reactions during Membrane Exposure).

Dosage in the Elderly

In general, blood pressure response and adverse experiences were similar in younger and older patients given similar doses of PRINIVIL ® . Pharmacokinetic studies, however, indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients so that dosage adjustments should be made with particular caution.

Renovascular Hypertension

Some patients with renovascular hypertension, especially those with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, may develop an exaggerated response to the first dose of PRINIVIL ® . Therefore, a lower starting dose of 2.5 or 5 mg is recommended. Thereafter, the dosage may be adjusted according to the blood pressure response.