Droxidopa - Droxidopa capsule Prescribing Information
Droxidopa capsules are indicated 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 [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.
• Starting dose is 100 mg three times during the day (2.1)• Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily (2.1)• Take consistently with or without food (2.1)• To reduce the potential for supine hypertension, elevate the head of the bed and give the last dose at least 3 hours prior to bedtime (2.1)• Take droxidopa capsule whole (2.1)
Droxidopa capsules are available in 100 mg, 200 mg, and 300 mg strengths as specified below.
• 100 mg: Hard gelatin capsule, light blue opaque cap and white opaque body, imprinted with “RM” on cap and “78” with band on body in black ink containing white to off-white powder.• 200 mg: Hard gelatin capsule, light yellow opaque cap and white opaque body, imprinted with “RM” on cap and “79” with band on body in black ink containing white to off-white powder.• 300 mg: Hard gelatin capsule, light green opaque cap and white opaque body, imprinted with “RM” on cap and “80” with band on body in black ink containing white to off-white powder.
• Lactation:Breastfeeding not recommended (8.2)• Patients with Renal Impairment:Dosing recommendations cannot be provided for patients with GFR less than 30 mL/min (8.6)
Droxidopa capsules are contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients