Northera

Generic Name: droxidopa
Date of Approval: February 18, 2014
Company: Chelsea Therapeutics

Treatment for: Neurogenic Orthostatic Hypotension

FDA Approves Northera

The U.S. Food and Drug Administration (FDA) has granted accelerated approval of Northera (droxidopa) 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), a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure.

What is Northera?

Northera is a synthetic amino acid analog that is directly metabolized to norepinephrine, a vasopressor. Norepinephrine causes constriction (tightening) of the blood vessels which leads to an increase in blood pressure.

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Northera is used to treat neurogenic orthostatic hypotension, reat a rare, chronic condition characterized by a sudden drop in blood pressure when a person stands.

What is the most important information I should know?

Northera may cause an excessive increase in blood pressure when lying down (supine hypertension), which could lead to strokes, heart attacks and death. You must rest and sleep with your upper-body in an elevated position while you are taking this medicine. You should also monitor your blood pressure regularly.

Contact your doctor immediately or seek emergency medical attention if you experience an unusual awareness of heartbeats, pounding in the ears, headache, or blurred vision. These may be signs of increased blood pressure.

In some cases, increased blood pressure may cause a slowed heart rate. Contact your doctor immediately or seek emergency medical attention if you experience decreased pulse rate, increased dizziness, fainting, or an unusual awareness of heartbeats. These may be signs of a slowed heart rate.

Northera can cause elevated blood pressure when lying down. The last dose should be taken at least three hours before bedtime. If you are going to be lying down for any length of time during the day, you may need to skip a dose. Talk to your doctor about how to take Northera if you lie down during the day.

Other prescription and over-the-counter medicines may cause an increase in blood pressure , which may be dangerous when taken with Northera. Do not take any other prescription or over-the-counter medicines or herbal products especially cough, cold, or allergy products, weight loss products, asthma or respiratory medicines, migraine headache medicines, heart or blood pressure medicines, or antidepressants without first talking to your doctor.

What should I discuss with my healthcare provider?

Do not take Northera without first talking to your doctor if you have

  • heart or blood vessel problems (other than low blood pressure);
  • high blood pressure;
  • heart disease;
  • a heart rhythm disorder;
  • heart failure;
  • kidney problems;
  • difficulty urinating; or
  • an allergy to tartrazine (FD+C Yellow No. 5).

Northera is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medicine without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Northera passes into breast-milk and should not be taken if you are breast-feeding a baby.

How should I take Northera?

Take exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.

Northera is usually taken three times aa day: upon arising in the morning, at midday, and in the late afternoon at least three hours prior to bedtime.

Take each dose with a full glass of water.

Swallow capsules whole. Capsules can be taken with or without food, but should be taken the same way each time.

Take doses at regular intervals as directed by your doctor.

Northera can cause increased blood pressure when lying down. The last dose should be taken at least three hours before bedtime. If you are going to be lying down for any length of time during the day, you may need to skip a dose. Talk to your doctor about how to take this medicine if you lie down during the day.

Your doctor may want you to have regular blood pressure monitoring or other medical evaluations during treatment with Northera to monitor progress and side effects.

Store Northera capsules at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose, you should take the next dose at the regularly scheduled time. You should not double the dose.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected. You should remain in a standing or seated position until your blood pressure drops below an acceptable limit.

Symptoms of an overdose may include increased blood pressure (flushing, headache, pounding heartbeat, blurred vision), goosebumps, difficulty urination, a feeling of being cold, and loss of consciousness.

What should I avoid?

Northera can cause increased blood pressure when lying down. The last dose should be taken at least three hours before bedtime. If you are going to be lying down for any length of time during the day, you may need to skip a dose. Talk to your doctor.

Other prescription and over-the-counter medicines may cause an increase in blood pressure, which may be dangerous when taken with Northera. Do not take any other prescription or over-the-counter medicines or herbal products especially cough, cold, or allergy products, weight loss products, asthma or respiratory medicines, migraine headache medicines, heart or blood pressure medicines, or antidepressants without first talking to your doctor.

Northera side effects

Northera may cause an excessive increase in blood pressure when lying down. Contact your doctor immediately or seek emergency medical attention if you experience an unusual awareness of heartbeats, pounding in the ears, headache, or blurred vision. These may be signs of increased blood pressure.

In some cases, increased blood pressure may cause a slowed heart rate. Contact your doctor immediately or seek emergency medical attention if you experience decreased pulse rate, increased dizziness, fainting, or an unusual awareness of heartbeats. These may be signs of a slowed heart rate.

If you experience any of the following serious side effects, stop taking this medicine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
  • irregular heartbeats, fluttering feeling in the chest, or chest pain;
  • fever or hyperthermia;
  • muscle rigidity or involuntary movements; or
  • confusion.

Other, less serious side effects may be more likely to occur. Continue to take prescribed doses and talk to your doctor if you experience

  • headache;
  • dizziness; or
  • fatigue.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Northera?

Before taking Northera, talk to your doctor if you are taking any other medicines especially any of the following:

  • drugs that increase blood pressure such as pseudoephedrine, phenylephrine, ephedrine, norepinephrine, or dihydroergotamine;
  • midodrine (ProAmatine);
  • triptans used in the treatment of migraine such as sumatriptan (Imitrex and others), zolmitriptan (Zomig), rizatriptan (Maxalt), frovatriptan (Frova), and naratriptan (Amerge); and
  • medicines used in the treatment of Parkinson's disease.
  • You may not be able to take Northera, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

    Other prescription and over-the-counter medicines may cause an increase in blood pressure, which may be dangerous when taken with Northera. Do not take any other prescription or over-the-counter medicines or herbal products especially cough, cold, or allergy products, weight loss products, asthma or respiratory medicines, migraine headache medicines, heart or blood pressure medicines, irregular heartbeat medicines, or antidepressants without first talking to your doctor.

    Drugs other than those listed here may also interact with Northera. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

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