(drox i DOE pa)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Northera: 100 mg, 200 mg [contains fd&c blue #2 (indigotine)]
Northera: 300 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, tartrazine (fd&c yellow #5)]
Brand Names: U.S.
- Alpha/Beta Agonist
A synthetic amino acid analog that is directly metabolized to norepinephrine by dopadecarboxylase. Droxidopa is believed to exert its pharmacological effects through norepinephrine. Norepinephrine increases blood pressure by inducing peripheral arterial and venous vasoconstriction.
High-fat meals reduce the Cmax and area under the plasma concentration-time curve (AUC) by 35% and 20%, respectively, and delay the Cmax by approximately 2 hours.
Vd: ~200 L
The metabolism of droxidopa is mediated by catecholamine pathway. Droxidopa is initially converted to methoxylated dihydroxyphenylserine (3-OM-DOPS), a major metabolite, by catechol-O-methyltransferase (COMT), to norepinephrine by DOPA decarboxylase (DDC), or to protocatechualdehyde by DOPS aldolase.
Time to Peak
Plasma: 1 to 4 hours
26% to 75%
Use: Labeled Indications
Neurogenic orthostatic hypotension: Treatment of orthostatic dizziness, light-headedness, or the “feeling that you are about to black out” in adults with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson disease [PD], multiple system atrophy [MSA], and pure autonomic failure [PAF]), dopamine beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy.
Hypersensitivity to droxidopa or any component of the formulation.
Neurogenic orthostatic hypotension: Oral: Initial: 100 mg 3 times daily; titrate in increments of 100 mg 3 times daily every 24 to 48 hours to symptomatic response (maximum dose: 1,800 mg/day).
Refer to adult dosing.
Dosing: Renal Impairment
GFR >30 mL/minute: No dose adjustments necessary.
GFR ≤30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
Administer capsule whole, consistently with or without food, 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).
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
Carbidopa: May diminish the therapeutic effect of Droxidopa. Carbidopa may decrease serum concentrations of the active metabolite(s) of Droxidopa. Carbidopa may increase the serum concentration of Droxidopa. Monitor therapy
Ephedra: May enhance the hypertensive effect of Droxidopa. Monitor therapy
EPHEDrine (Systemic): May enhance the hypertensive effect of Droxidopa. Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Droxidopa. Exceptions: Rasagiline; Selegiline. Avoid combination
Midodrine: May enhance the hypertensive effect of Droxidopa. Monitor therapy
Norepinephrine: May enhance the hypertensive effect of Droxidopa. Monitor therapy
Serotonin 5-HT1D Receptor Agonists: May enhance the hypertensive effect of Droxidopa. Monitor therapy
>10%: Central nervous system: Headache (6% to 13%)
1% to 10%:
Cardiovascular: Hypertension (2% to 7%)
Central nervous system: Dizziness (4% to 10%)
Gastrointestinal: Nausea (9%)
Postmarketing and/or case reports: Abdominal pain, agitation, blurred vision, chest pain, confusion, delirium, diarrhea, fatigue, hallucination, hyperpyrexia, hypersensitivity reaction (including anaphylaxis, angioedema, bronchospasm, skin rash, urticaria), memory impairment, pancreatitis, psychosis, vomiting
Concerns related to adverse effects:
• Anaphylaxis/allergic reactions: Hypersensitivity reactions have been reported. Reactions may include anaphylaxis, angioedema, bronchospasm, rash, and urticaria; emergency treatment may be necessary. Discontinue use and initiate immediate medical support if a hypersensitivity reaction occurs.
• Hypertension: [US Boxed Warning]: Droxidopa may cause or exacerbate supine hypertension. Advise patients to elevate the head of bed when resting or sleeping. Monitor blood pressure in supine position and in recommended head-elevated sleeping position. Reduce or discontinue droxidopa if supine hypertension persists. Risk of cardiovascular events may be increased if supine hypertension is not well managed.
• Neuroleptic malignant syndrome: A symptom complex resembling neuroleptic malignant syndrome has been reported; symptoms have included hyperpyrexia and confusion. Observe patients carefully with dose changes or when concomitant levodopa is reduced abruptly or discontinued, especially if patient is receiving neuroleptics.
• Cardiovascular disease: Droxidopa may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure; consider potential risk prior to initiating therapy.
Dosage form specific issues:
• Tartrazine: May contain FD+C Yellow No. 5 (tartrazine), which may cause allergic reactions, including bronchial asthma in susceptible individuals, especially in patients with aspirin hypersensitivity.
Monitor supine blood pressure prior to and during treatment and more frequently when increasing the dose.
Adverse events have been observed in some animal reproduction studies.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea. Have patient report immediately to prescriber severe headache, severe dizziness, passing out, vision changes, or signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, severe headache, confusion, change in thinking, tachycardia, abnormal heartbeat, or sweating a lot) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about droxidopa
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- During Pregnancy
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- Drug class: vasopressors
Other brands: Northera