droxidopa

Therapeutic Classification: antihypotensives

Pharmacologic Classification: adrenergics

Indications ⬆ ⬇

REMS

Treatment of orthostatic dizziness, lightheadedness or feeling of impending blackout associated with symptomatic neurogenic orthostatic hypotension due to primary autonomic failure (Parkinson's disease, multiple system atrophy), dopamine beta-hydroxylase deficiency or non-diabetic autonomic neuropathy.

Action ⬆ ⬇

Acts as a synthetic precursor that is converted by dopa decarboxylase to norepinephrine which produces peripheral arterial and venous vasoconstriction. Result is increased BP.

Therapeutic effects:

Increased BP with decreased symptoms of orthostatic dizziness.

Pharmacokinetics ⬆ ⬇

Absorption: Systemic absorption follows oral administration.

Distribution: Crosses the blood-brain barrier.

Metabolism/Excretion: Metabolized via catecholamine pathway; metabolites other than norepinephrine do not contribute to activity. 75% excreted by kidneys as parent drug and metabolites.

Half-Life: 2.5 hr.

Time/Action Profile ⬆ ⬇

(↑ BP)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1–4 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to droxidopa or tartrazine (FD+C No. 5 [cross sensitivity between aspirin and FD+C No. 5 may occur]);
CCr <30 mL/min;
Lactation: Lactation.

Use Cautiously in:

Hypertension (should be controlled prior to treatment);
Mild to moderate renal impairment (↑ risk of adverse reactions);
History of cardiovascular disease (may exacerbate hypertension, ischemic heart disease, arrhythmias or HF);
OB: Safety not established in pregnancy;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may be more sensitive to drug effects.

Adv. Reactions/Side Effects ⬆ ⬇

CV: HF, ARRHYTHMIAS, MYOCARDIAL ISCHEMIA, supine hypertension

GI: nausea

Neuro: confusion, dizziness, fatigue, headache

Misc: hyperpyrexia, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

↑risk of supine hypertension with other agents that BP including ephedrine, norepinephrine, midodrine, pseudoephedrine, and triptans.
Concurrent use of DOPA decarboxylase inhibitors may require dose adjustments.

Route/Dosage ⬆ ⬇

PO (Adults ): 100 mg three times daily, may be ↑ by 100 mg three times daily up to 600 mg three times daily (last dose should be given at least 3 hr prior to bedtime).

Availability ⬆ ⬇

(Generic available)

Capsules (contain tartrazine): 100 mg; 200 mg; 300 mg

Assessment ⬆ ⬇

Monitor BP prior to and during therapy; more frequently during dose increases. Measure BP in supine position and while head of bed is elevated; lessens risks of supine hypertension. If supine hypertension cannot be managed by elevating head of bed, reduce or discontinue droxidopa. Poorly managed supine hypertension may increase risk for cardiovascular events.
Monitor for symptom complex resembling neuroleptic malignant syndrome (fever, muscle rigidity, involuntary movements, altered consciousness, mental status changes) when dose is changed or when concomitant levodopa is abruptly reduced or discontinued, especially if patient is receiving neuroleptics. Syndrome is rare but potentially fatal.
Monitor for signs and symptoms of hypersensitivity reactions (anaphylaxis, angioedema, bronchospasm, urticaria, rash) during therapy. If symptoms offer, discontinue droxidopa and treat symptomatically.

Implementation ⬆ ⬇

PO: Administer upon arising in the morning, midday, and in late afternoon at least 3 hr prior to bedtime to reduce risk of supine hypertension during sleep. DNC: Swallow capsule whole; do not open, crush or chew.
- May be administered without regard to food, but should be consistent each dose.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take droxidopa as directed. If dose is missed, omit and take next dose at scheduled time; do not double doses.
Advise patient to raise head of bed when resting or sleeping.
Instruct patient how to take BP and manage elevations.
Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reactions (anaphylaxis, facial swelling, difficulty breathing, itching, rash) or neuroleptic malignant syndrome occur.
Rep: Advise female patient to notify health care professional if pregnancy is planned or suspected or and to avoid breastfeeding during therapy.

Evaluation/Desired Outcomes ⬆ ⬇

Increased BP with decreased symptoms of orthostatic dizziness.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

67386- Lundbeck Pharmaceuticals LLC
- 67386-820- Northera
  - 67386-820-19- 90 CAPSULE in 1 BOTTLE (67386-820-19)

67386- Lundbeck Pharmaceuticals LLC
- 67386-821- Northera
  - 67386-821-19- 90 CAPSULE in 1 BOTTLE (67386-821-19)

67386- Lundbeck Pharmaceuticals LLC
- 67386-822- Northera
  - 67386-822-19- 90 CAPSULE in 1 BOTTLE (67386-822-19)

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Pronunciation ⬇

Classifications ⬆ ⬇