Usual Adult Dose for Hypotension

Initial dose: 100 mg orally 3 times daily upon arising in the morning, at midday, and in the late afternoon at least 3 hours prior to bedtime (to reduce the potential for supine hypertension during sleep)
Titration: Titrate to symptomatic response, in increments of 100 mg 3 times daily every 24 to 48 hours.
Maximum dose: 600 mg orally 3 times daily (i.e., a maximum total daily dose of 1800 mg)

Duration of therapy: Effectiveness beyond 2 weeks of treatment has not been established.

Comments:

• Supine blood pressure should be monitored prior to initiating and after increasing the dose of droxidopa.
• Droxidopa must be administered consistently, either with food or without food.
• Capsules should be swallowed whole, not chewed or crushed.

General Use: For the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy.

Renal Dose Adjustments

Mild or moderate renal impairment (CrCl greater than 30 mL/min): No adjustment recommended
Severe renal function impairment (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

No adjustment recommended

Precautions

US BOXED WARNINGS:

• SUPINE HYPERTENSION: Droxidopa therapy may cause or exacerbate supine hypertension in patients with neurogenic orthostatic hypotension (NOH). Patients should be advised to elevate the head of the bed when resting or sleeping. Blood pressure should be monitored, both in the supine position and in the recommended head-elevated sleeping position. Droxidopa should be reduced or discontinued if supine hypertension persists. Droxidopa may increase the risk of cardiovascular events if supine hypertension is not well-managed.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

• Droxidopa may be taken with or without food but should be taken the same way each time because a high fat meal changes the pharmacokinetics of the drug.
• General: Effectiveness beyond 2 weeks of treatment has not been established. The effectiveness of droxidopa should be assessed periodically.