Droxidopa, Oral

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KEY POINTS

• This medicine is taken by mouth to treat severe dizziness or lightheadedness caused by certain conditions. Take it exactly as directed.
• Carefully follow your healthcare provider's instructions for how and when to check your blood pressure while you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: synthetic amino acid analog

Generic and brand names: droxidopa, oral; Northera

What is this medicine used for?

This medicine is taken by mouth to treat severe dizziness or lightheadedness that people with low blood pressure, caused by some nervous system problems, have when they stand up.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to tartrazine dye
• Heart disease, irregular heartbeat, or a heart attack
• Liver or kidney disease

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is usually taken 3 times per day. You should take the last dose at least 3 hours before bedtime. You may take this medicine with or without food, but you should take it the same way each time. Swallow the capsules whole with a full glass of water.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: irregular or fast heartbeat, lightheadedness, dizziness, weakness, fainting, confusion, twitching, restlessness.

What should I watch out for?

This medicine may cause your blood pressure to be too high when you are lying down, which could lead to strokes, heart attacks, and death. To decrease the risk of this, you should rest and sleep with the head of the bed raised while you are taking this medicine. It is also important to take your last dose of the day 3 hours before bedtime. Talk with your healthcare provider about this.

You should regularly check your blood pressure while taking this medicine. Carefully follow your healthcare provider's instructions for how and when to check your blood pressure.

You will need to have regular checkups to see how this medicine affects you. Keep all appointments.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe dizziness; fainting; high blood pressure; fast or irregular heartbeat; chest pain; high fever; stiff muscles; uncontrolled movements; severe headache; vision changes; severe sweating; trouble breathing; confusion.

Other: Mild nausea; mild dizziness; drowsiness; headache.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Caffeine
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Ephedrine
• Midodrine
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), isometheptene/dichloralphenazone/acetaminophen, rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Natural remedies such as bayberry, bitter orange, blue cohosh, cayenne, ephedra, ginger, ginseng, gotu kola, and licorice
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Parkinson’s disease medicines such as carbidopa (Lodosyn), levodopa/carbidopa (Duopa, Rytary, Sinemet), and levodopa/carbidopa/entacapone (Stalevo)
• Stimulants and diet pills such as dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.