Pronunciation:

drox-i-DOE-pa

Brand Names:

• Northera

Dosage Forms:

• Capsule

Warnings:

Monitor supine blood pressure before and during treatment, and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevating the head of the bed, reduce or discontinue droxidopa .

Classifications:

Therapeutic—

Vasopressor

Pharmacologic—

Adrenergic System

Uses of This Medicine:

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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of droxidopa in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of droxidopa in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amphetamine
• Dextroamphetamine
• Lisdexamfetamine
• Midodrine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbidopa

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to aspirin or
• Asthma—This medicine contains tartrazine, which can make these conditions worse.

• Congestive heart failure or
• Heart or blood vessel problems (eg, ischemic heart disease) or
• Heart rhythm problems (eg, arrhythmia) or
• Supine hypertension—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Take this medicine the same way every day. This means take it at the same time and take it consistently, either with or without food.

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

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For neurogenic orthostatic hypotension:
    • Adults—At first, 100 milligrams (mg) three times a day (taken upon waking up in the morning, at noon, and in the late afternoon at least 3 hours before bedtime). Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects caused by this medicine. You may also need to monitor your blood pressure at home before, during, and after treatment.

This medicine may increase your risk of having supine hypertension, which can lead to stroke or heart attack. You doctor will tell you to rest or sleep in an upper body elevated position and monitor your blood pressure. If you notice changes in your blood pressure, tell your doctor right away.

This medicine may cause confusion, fever, and worsening of heart or blood vessel problems. Tell your doctor right away if you have these conditions.

If your condition does not improve within 2 weeks, or if it become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

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:

More common

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.