Droxidopa

What is Droxidopa?

• Droxidopa (NORTHERA) which is a synthetic amino acid precursor of norepinephrine used in the treatment of symptomatic orthostatic hypotension due to neurogenic causes of autonomic failure.

What are the uses of this medicine?

• This medicine is used 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 NORTHERA should be assessed periodically.

How does this medicine work?

• Droxidopa (drox" i doe' pa) is a prodrug of norepinephrine (noradrenaline) a major adrenergic neurotransmitter important in maintenance of sympathetic autonomic tone and normal blood pressure.
• Unlike norepinephrine, however, droxidopa does not cross the blood-brain barrier, so that its effects are restricted to the periphery where it acts on the smooth muscle of arteries and arterioles to maintain blood pressure, particularly in response to standing.
• In short term clinical trials, droxidopa showed modest effects in improving symptoms of postural hypotension in patients with neurogenic causes.
• The neurogenic causes of primary autonomic failure include Parkinson disease and multiple systemic atrophy (Shy Drager syndrome).

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a history of hypersensitivity to the drug or its ingredients

What drug interactions can this medicine cause?

• Administering NORTHERA in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension.
• Dopa-decarboxylase inhibitors may require dose adjustments for NORTHERA.
• Mechanism of action, the use of non-selective MAO inhibitors and linezolid should be avoided as there is a potential for increased blood pressure when taken with NORTHERA.

Is this medicine FDA approved?

• It was approved for use in the United States in 2014.

How should this medicine be used?

Recommended Dosage:

• The recommended starting dose of NORTHERA is 100 mg, taken orally three times daily: 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).

Administration

• Administer NORTHERA consistently, either with food or without food.
• Take NORTHERA capsule whole.
• Titrate to symptomatic response, in increments of 100 mg three times daily every 24 to 48 hours up to a maximum dose of 600 mg three times daily (i.e., a maximum total daily dose of 1,800 mg).
• Monitor supine blood pressure prior to initiating NORTHERA and after increasing the dose.
• Patients who miss a dose of NORTHERA should take their next scheduled dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As 100 mg, 200 mg, and 300 mg capsules This medicine is available in fallowing brand namesː

• NORTHERA

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• dizziness
• nausea
• hypertension

What special precautions should I follow?

• NORTHERA may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed. Monitor blood pressure, both in the supine position and in the recommended head-elevated sleeping position. Reduce or discontinue NORTHERA if supine hypertension persists. If supine hypertension is not well-managed, NORTHERA may increase the risk of cardiovascular events, particularly stroke.
• Neuroleptic malignant syndrome (NMS) have been reported with NORTHERA. Observe patients carefully when the dosage of NORTHERA is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.
• NORTHERA may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure.
• Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria and rash have been reported in postmarketing experience. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypertensive crisis
• hypertension
• intracranial hemorrhage

Management of overdosage:

• There is no known antidote for NORTHERA overdosage.
• In case of an overdose that may result in an excessively high blood pressure, discontinue NORTHERA and treat with appropriate symptomatic and supportive therapy.
• Counsel patients to remain in a standing or seated position until their blood pressure drops below an acceptable limit.

Can this medicine be used in pregnancy?

• There are no available data on use of NORTHERA in pregnant women and risk of major birth defects or miscarriage.

Can this medicine be used in children?

• The safety and effectiveness of NORTHERA in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient: DROXIDOPA

Inactive Ingredients: MANNITOL STARCH, CORN MAGNESIUM STEARATE GELATIN TITANIUM DIOXIDE FD&C BLUE NO. 2 FERRIC OXIDE RED FERROSOFERRIC OXIDE

Who manufactures and distributes this medicine?

Manufactured by:

• Lundbeck Pharmaceuticals LLC

What should I know about storage and disposal of this medication?

• NORTHERA capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Droxidopa
• FDA Droxidopa

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