Maximum Daily Dose of Hydralazine for Dialysis Patients
The maximum daily dose of hydralazine for a dialysis patient is 300 mg per day in divided doses, which is the same as for patients without renal disease, as hydralazine does not require dose adjustment in end-stage renal disease (ESRD). 1, 2
Standard Dosing Guidelines
- The FDA-approved maximum dose is 300 mg daily in divided doses for all patients, including those with ESRD 2
- The ACC/AHA Heart Failure Guidelines specify hydralazine dosing as 25-50 mg three or four times daily initially, with a maximum of 300 mg daily in divided doses 1
- No dose reduction is required for renal insufficiency or dialysis patients 1
Practical Dosing Strategy
- Start with 10 mg four times daily for 2-4 days, then increase to 25 mg four times daily for the first week 2
- For the second week onward, increase to 50 mg four times daily as tolerated 2
- The typical maintenance dose ranges from 100-200 mg daily in divided doses, though up to 300 mg daily may be needed in resistant cases 2
- Hydralazine should be given 3-4 times daily due to its short duration of action 1, 2
Special Considerations for Dialysis Patients
- Timing relative to dialysis sessions is not clinically relevant, as hydralazine is not significantly removed by hemodialysis 3
- A pilot trial in maintenance hemodialysis patients successfully titrated combination hydralazine/isosorbide dinitrate to 75 mg hydralazine three times daily (225 mg total daily) with good tolerability 3
- Intradialytic hypotension may actually be less frequent with hydralazine therapy (0.47 events/patient-year with hydralazine vs 1.83 events/patient-year with placebo) 3
Important Safety Warnings
- The incidence of drug-induced lupus syndrome and ANCA-associated vasculitis is dose-dependent and increases significantly at doses above 200 mg daily 2, 4
- Hydralazine can cause severe acute kidney injury and ANCA-positive crescentic glomerulonephritis, even in patients already on dialysis 4
- Monitor for lupus-like symptoms (arthralgias, fever, rash) and consider checking ANA and ANCA antibodies if symptoms develop, particularly at higher doses 4
- Common side effects include headache, nausea, and diarrhea, which occur more frequently than with placebo 3
Monitoring Recommendations
- Blood pressure should be monitored closely during dose titration, particularly for symptomatic hypotension 3
- Given the increased risk of drug-induced lupus at doses >200 mg daily, consider combination therapy with other antihypertensives rather than pushing hydralazine to maximum doses 2
- The combination of hydralazine with a thiazide diuretic and/or beta blocker allows for lower hydralazine doses while maintaining efficacy 2