Northera works by constricting (narrowing) the blood vessels and increasing blood pressure.

Northera is used to treat low blood pressure that causes severe dizziness or a light-headed feeling, like you might pass out.

Northera is for use in people with conditions of the nervous system that can cause low blood pressure (such as Parkinson's disease, multiple system atrophy, autonomic failure, and others).

Northera can increase your blood pressure even while you are lying down. You may need to keep your head elevated during sleep to help prevent high blood pressure. Follow your doctor's instructions about how to position your body while you are lying down or sleeping.

Your blood pressure will need to be checked before and during treatment with Northera, or whenever your dose is changed. Check your blood pressure while you are lying down, and check it again with your head elevated.

Before taking this medicine

You should not use Northera if you are allergic to droxidopa.

To make sure Northera is safe for you, tell your doctor if you have:

• heart disease;

• history of heart attack or stroke;

• high blood pressure;

• kidney disease;

• asthma, or a history of severe allergic reaction to aspirin, especially aspirin triad syndrome; or

• if you are allergic to yellow food dye.

It is not known whether Northera will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether droxidopa passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Northera is not approved for use by anyone younger than 18 years of age.

Take Northera exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Northera is usually taken 3 times per day, as follows. First dose in the morning when you wake up; second dose at mid-day; third dose in the late afternoon or at least 3 hours before you go to bed. The timing of your doses is very important in helping to maintain a healthy blood pressure while you are taking this medicine. Follow your doctor's dosing instructions very carefully.

You may take Northera with or without food, but take it the same way each time.

Do not crush, chew, break, or open a capsule. Swallow it whole.

Northera can increase your blood pressure even while you are lying down or sleeping (when blood pressure is usually lowest). Long-term high blood pressure (hypertension) can lead to heart attack or stroke, which may be fatal.

Follow your doctor's instructions about the best way to position your body while you are laying down or sleeping. You may need to keep your head elevated to help prevent high blood pressure.

Your blood pressure will need to be checked before and during treatment with Northera, or whenever your dose is changed. Check your blood pressure while you are lying down, and check it again with your head elevated.

Your doctor will need to check your progress at regular visits if you use Northera for longer than 2 weeks.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypotension:

Initial dose: 100 mg orally 3 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)
Titration: Titrate to symptomatic response, in increments of 100 mg 3 times daily every 24 to 48 hours.
Maximum dose: 600 mg orally 3 times daily (i.e., a maximum total daily dose of 1800 mg)

Duration of therapy: Effectiveness beyond 2 weeks of treatment has not been established.

Comments:
-Supine blood pressure should be monitored prior to initiating and after increasing the dose of droxidopa.
-Northera must be administered consistently, either with food or without food.
-Capsules should be swallowed whole, not chewed or crushed.

General Use: 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, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy.

You should not use Northera if you are allergic to droxidopa.

To make sure Northera is safe for you, tell your doctor if you have:

• heart disease;

• history of heart attack or stroke;

• high blood pressure;

• kidney disease;

• asthma, or a history of severe allergic reaction to aspirin, especially aspirin triad syndrome; or

• if you are allergic to yellow food dye.

It is not known whether Northera will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether droxidopa passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Northera is not approved for use by anyone younger than 18 years of age.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose, or if your bedtime is less than 3 hours away. Do not take extra medicine to make up the missed dose.

Do not take the medicine less than 3 hours before bedtime.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking the medicine less than 3 hours before bedtime.

Stop taking Northera and get emergency medical help if you have any of these signs of an allergic reaction to droxidopa: hives; wheezing, chest tightness, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe dizziness or light-headed feeling;

• confusion, fever;

• pain or burning when you urinate;

• dangerously high blood pressure - severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Northera side effects may include:

• headache, dizziness;

• nausea; or

• increased blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• linezolid.

This list is not complete. Other drugs may interact with droxidopa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.