Northera

Before taking droxidopa,

• tell your doctor and pharmacist if you are allergic to droxidopa, aspirin, tartrazine (a yellow dye in some processed foods and medications), other medications, or any of the ingredients in the capsule. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbidopa (Lodosyn, in Parcopa, in Sinemet, in Stalevo); ephedrine; medications for mental illness or nausea; medications for migraines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and sumatriptan (Imitrex) and zolmitriptan (Zomig); and midodrine (Orvaten). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had asthma, coronary artery disease (blockage or narrowing of the blood vessels that lead to the heart), irregular heartbeat, heart failure, or heart or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking droxidopa, call your doctor.

Northera is a prescription medication approved 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
• non-diabetic autonomic neuropathy

​This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before taking Northera, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any medications or FD+C Yellow No. 5 (tartrazine)
• have kidney disease
• have heart disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.

• Northera comes in capsule form. 
• It is usually taken three times daily; first thing 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).
• Your doctor may start you at a low dose and gradually increase your dose as necessary to achieve maximum benefit.
• Swallow Northera capsules whole.
• You may take it with or without food. More importantly, it is best taken the same way each time, either with or without food.
• If a dose is missed, take the next dose at the regularly scheduled time and should not double the dose.

Avoid taking the medicine less than 3 hours before bedtime.

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.

General

Restricted Distribution

• Available only through a specialty pharmacy.10 For more information, contact manufacturer at 844-601-0101 or .10

Administration

Oral Administration

Administer orally 3 times daily: upon arising in the morning, at midday, and in the late afternoon at least 3 hours before bedtime.1 Take consistently, either with food or without food.1 Swallow capsules whole.1

Monitor supine BP prior to initiating droxidopa, periodically during treatment, and after dosage increases.1 (See Supine Hypertension under Cautions.)

If a dose is missed, skip the dose and take the next dose at the regularly scheduled time.1

Dosage

Adults

Initially, 100 mg 3 times daily.1 May increase dosage based on symptomatic response and tolerance in increments of 100 mg 3 times daily at intervals of 24–48 hours.1

Efficacy beyond 2 weeks not established; periodically reassess continued benefit.1

Prescribing Limits

Adults

600 mg 3 times daily (1.8 g daily).1

Special Populations

Renal Impairment

Mild or moderate renal impairment when GFR >30 mL/minute: Dosage adjustment not necessary.1

Limited experience in patients with severe renal impairment (GFR <30 mL/minute); no dosage recommendations provided by manufacturer.1

Geriatric Patients

Manufacturer makes no special dosage recommendations.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of droxidopa is restricted.10 (See Restricted Distribution under Dosage and Administration.)

Droxidopa is used to treat neurogenic orthostatic hypotension (lightheadedness, dizziness, or fainting) caused by primary autonomic failure (eg, Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bladder pain
• bloody or cloudy urine
• blurred vision
• difficult, burning, or painful urination
• dizziness
• fainting
• frequent urge to urinate
• lower back or side pain
• nervousness
• pounding in the ears
• slow or fast heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dosing Information

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). 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.

How Supplied

Northera capsules are supplied in the following dosage strengths:

100 mg:  Hard gelatin, size 3 capsule, with an opaque light blue cap and an opaque white body, printed with “Northera” on body and “100” on cap, filled with a white to light brown powder.

200 mg:  Hard gelatin, size 2 capsule, with an opaque light yellow cap and an opaque white body, printed with “Northera” on body and “200” on cap, filled with a white to light brown powder.

300 mg:  Hard gelatin, size 1 capsule, with an opaque light green cap and an opaque white body, printed with “Northera” on body and “300” on cap, filled with a white to light brown powder.

100 mg 90-count bottle (NDC code# 67386-820-19)

200 mg 90-count bottle (NDC code# 67386-821-19)

300 mg 90-count bottle (NDC code# 67386-822-19)

Storage and Handling

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) [see USP Controlled Room Temperature].

NDC 67386-820-19
90 Capsules
Northera™
(droxidopa) capsules
100 mg
Rx Only

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.

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

More frequent side effects include: hypertension. See below for a comprehensive list of adverse effects.

Applies to droxidopa: oral capsule

Along with its needed effects, droxidopa (the active ingredient contained in Northera) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking droxidopa:

• Bladder pain
• bloody or cloudy urine
• blurred vision
• difficult, burning, or painful urination
• dizziness
• fainting
• frequent urge to urinate
• lower back or side pain
• nervousness
• pounding in the ears
• slow or fast heartbeat

Some side effects of droxidopa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• nausea