DROXIDOPA

Other

Brand names: droxidopa

Oral

Mechanism of Action

12.1 Mechanism of Action The exact mechanism of action of droxidopa in the treatment of neurogenic orthostatic hypotension is unknown. Droxidopa is a synthetic amino acid analog that is directly metabolized to norepinephrine by dopa-decarboxylase, which is extensively distributed throughout the body. Droxidopa is believed to exert its pharmacological effects through norepinephrine and not through the parent molecule or other metabolites. Norepinephrine increases blood pressure by inducing peripheral arterial and venous vasoconstriction. Droxidopa in humans induces small and transient rises in plasma norepinephrine.

Indications

1 INDICATIONS AND USAGE Droxidopa capsules 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

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Droxidopa may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed (5
If supine hypertension is not well-managed, droxidopa may increase the risk of cardiovascular events, particularly stroke
Careful consideration should be given to this potential risk prior to initiating therapy in patients with these conditions

Known Side Effects

9 documented side effects by frequency

Dizziness

>10%

Drug Not Working

1-10%

Headache

1-10%

Falls

1-10%

Low Blood Pressure

1-10%

Fatigue

1-10%

High Blood Pressure

1-10%

Nausea

1-10%

General Unwellness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral