droxidopa

Adult Dosing

Neurogenic Orthostatic Hypotension

100 mg PO tid
Titrate to symptomatic response, in increments of 100 mg PO tid q24-48 hrs
Max: 1800 mg/day

Note:

Effectiveness beyond 2 weeks of treatment has not been demonstrated
Administer 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
Swallow capsule whole; do now chew, open, or dissolve contents
Monitor supine blood pressure before initiating and after increasing the dose
Patients who miss a dose should take their next scheduled dose; do not double the dose to make up for a missed dose

Pediatric Dosing

Safety and efficacy in pediatric patients have not been established

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product

Black Box Warnings ⬆ ⬇

Monitor blood pressure, both in the supine position and in the recommended head elevated sleeping position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce dose or discontinue droxidopa

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment (Based on CrCl)

>30 mL/min: No dosage adjustment
<30 mL/min: Caution advised

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

Therapy may worsen supine hypertension in patients with NOH. Advise patient to elevate the head of the bed when resting or sleeping
Monitor blood pressure, both in the supine position and in the recommended head elevated sleeping position Reduce or discontinue therapy if supine hypertension persists. Therapy may increase risk of cardiovascular events If supine hypertension is not well managed
Hyperpyrexia and confusion may occur with droxidopa
Therapy may worsen symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure. Consider potential risk prior to initiating therapy in patients with these conditions
Therapy may cause allergic type reactions, including bronchial asthma, it is more frequently seen in patients who have aspirin hypersensitivity

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown. Because of serious adverse reactions in nursing infants decision should be made to either discontinue nursing, or drug taking into account the importance of the drug to the mother.

Adverse Reactions ⬆ ⬇

CNS: Headache, dizziness, syncope
GU: Urinary tract infections
GI: Nausea
CV: Hypertension
MISC: Hyperpyrexia, confusion

Clinical Pharmacology ⬆ ⬇

Alpha/Beta adrenergic agonists; norepinephrine precursor; directly metabolized to norepinephrine by dopa-decarboxylase which is extensively distributed throughout the body, it elicits beta 1 and alpha-adrenergic effects and moderate beta2 effects, which increase cardiac output and heart rate, decrease renal perfusion and PVR, and cause variable BP effects
Metabolized by aromatic L-amino acid decarboxylase
Excreted in the urine, with the main metabolite being 3-O-methyldihydroxyphenylserine
Half-life: 2-3 hours

Brands and Availability ⬆ ⬇