Droxidopa

Droxidopa is a prescription medication used for the treatment of neurogenic orthostatic hypertension.

• Droxidopa is available under the following different brand names: Northera

Common side effects of Droxidopa include:

• headache,
• nausea, and
• dizziness

Serious side effects of Droxidopa include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• muscle stiffness,
• severe confusion,
• sweating,
• fast or irregular heartbeat, and
• severe dizziness

Rare side effects of Droxidopa include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 100 mg
• 200 mg
• 300 mg

Neurogenic Orthostatic Hypotension

Adult dosage

• 100 mg orally thrice daily  initially
• Titrate to symptomatic response, in increments of 100 mg thrice daily every 24-48 hours; not to exceed 600 mg thrice daily (i.e., 1800 mg/day)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Droxidopa has severe interactions with no other drugs.
• Droxidopa has serious interactions with the following drugs:
  • iobenguane I 131
  • ozanimod
• Droxidopa has moderate interactions with at least 31 other drugs.
• Droxidopa has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Known hypersensitivity to the drug or ingredients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Droxidopa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Droxidopa?”

Cautions

• May cause or exacerbate supine hypertension in patients with NOH; advise patients to elevate the head of the bed when resting or sleeping (see Black Box Warnings); if supine hypertension is not well-managed, therapy may increase risk of cardiovascular events, particularly stroke
• Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria, and rash (see Contraindications); if hypersensitivity reaction occurs, discontinue drug and initiate appropriate therapy
• Sympathomimetic effect may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure; give careful consideration to this potential risk prior to initiating therapy in patients with these conditions
• Coadministration with other drugs that increase blood pressure are expected to increase risk of hypertension
• Coadministration with dopa-decarboxylase inhibitors may decrease the conversion of droxidopa to norepinephrine
• Contains FD+C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons; although overall incidence of this sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity
• Hyperpyrexia and confusion
  • Symptom complex resembling neuroleptic malignant syndrome (NMS) reported; monitor closely when dosage is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics
  • NMS is an uncommon, but life-threatening syndrome characterized by fever or hyperthermia, muscle rigidity, involuntary movements, altered consciousness, and mental status changes

Pregnancy and Lactation

• There are no available data on use of droxidopa in pregnant women and risk of major birth defects or miscarriage
• Lactation
  • There is no information regarding presence of drug or its active metabolite(s) in human milk, effects on breastfed child, nor effects on milk production/excretion; because of potential for serious adverse reactions, including reduced weight gain in breastfed infants, advise a woman not to breastfeed during treatment