Droxidopa is a generic form of the brand-name drug called Northera. This prescription medication was first approved by the FDA in 2014 for treating the symptoms of neurogenic orthostatic hypotension (NOH), which involves fainting, dizziness, or lightheadedness when standing after sitting or lying down. Droxidopa is a type of prodrug (a drug that is converted into an active form once it reaches its target area) and belongs to the class of alpha and beta-adrenergic agonists.
Hable con un especialista sobre la asistencia con los copagos
Este medicamento está indicado para regular la presión arterial en reposo mediante el aumento temporal del nivel de norepinefrina en el organismo. La norepinefrina, también conocida como noradrenalina, es un tipo de neurotransmisor (sustancia química cerebral) necesario para regular la presión arterial.
Droxidopa is available in oral capsule form and can only be obtained via a doctor’s prescription.
¿Para qué se utiliza el Droxidopa?
Droxidopa is used to treat symptomatic neurogenic orthostatic hypotension – a chronic and potentially debilitating condition characterized by a sustained drop of blood pressure upon standing due to low production or release of norepinephrine. This condition may arise as a result of autonomic failure and mainly occurs in patients suffering from certain neurologic disorders such as pure autonomic failure (PAF), multiple system atrophy (MSA), and Parkinson’s disease (PD).
These neurologic disorders mainly affect the patient’s sistema nervioso autónomo (típicamente implicada en la regulación de diversas funciones involuntarias, como la frecuencia cardíaca, la respiración y la presión arterial), lo que provoca una liberación inadecuada de noradrenalina. Esta desregulación de la liberación de noradrenalina provoca hipotensión en pacientes con OH neurogénica al ponerse de pie.
Debido a una caída de la presión arterial, los pacientes con OH neurogénica experimentan mareos intensos, aturdimiento, síncope, visión borrosa, desmayos (sensación de desmayo) y pérdida del conocimiento.
Between 80,000 – 150,000 people are thought to suffer from the symptoms of neurogenic OH in the United States.
How Does Droxidopa Work?
Droxidopa works to improve the symptoms of NOH by increasing the norepinephrine level in the body. Norepinephrine, upon release, normalizes the blood pressure by constricting (narrowing) the peripheral blood vessels.
Mecanismo de acción
Once inside the body, droxidopa prodrug is converted into norepinephrine by an enzyme called dopa-decarboxylase. Norepinephrine then exhibits its pharmacological action throughout the body and increases blood flow to the brain, which prevents the symptoms of NOH.
Forma farmacéutica y concentraciones
Droxidopa is available in capsule form with strengths of 100 mg, 200 mg, and 300 mg.
Get Droxidopa Copay Assistance
Dosis de Droxidopa
Información de dosificación
The recommended initial (starting) dose is 100 mg 3 times a day during waking hours (in the morning, at midday, and in the late afternoon at least 3 hours before bedtime). The dose of droxidopa is titrated (adjusted) according to symptomatic response (where the patient’s symptoms respond to the drug).
Depending on the symptomatic response, the droxidopa dose can be increased by increments of 100 mg 3 times a day, up to a maximum dose of 600 mg three times a day. The maximum recommended total daily dose of droxidopa is 1,800 mg. Dose titration and adjustment must be done by the treating doctor.
La dosis de droxidopa puede variar de paciente a paciente y se realiza de manera muy estricta para mejorar los síntomas de OH neurogénica y evitar un aumento excesivo de la presión arterial.
Qué hacer si se olvida una dosis
Take your dose consistently as prescribed by your doctor. In case of a missed dose, avoid taking a double dose of droxidopa to compensate for the missed dose.
If you accidentally took your dose less than 3 hours before bedtime, consult your healthcare provider immediately to reduce the risk of supine hypertension.
How Is Droxidopa Used?
Droxidopa capsules are taken orally (by mouth). Since the elimination half-life of this medication is 2 to 3 hours, it is prescribed to be taken three times a day to maintain a consistent effect.
Droxidopa capsules should be taken consistently with or consistently without food upon waking up in the morning, at midday, and in the late afternoon at least 3 hours prior to bedtime. The capsules should be swallowed whole without opening, crushing, chewing, or breaking them.
Possible Side Effects of Droxidopa
Algunos efectos secundarios comunes informados por pacientes que toman droxidopa incluyen, entre otros:
- Náuseas
- Mareo
- Dolor de cabeza
- Hipertensión (aumento de la presión arterial)
These symptoms are temporary and can be managed easily. However, if the symptoms persist and do not go away within two weeks during therapy, you should report to your healthcare provider immediately.
Además, algunos efectos secundarios pueden ser graves y requerir atención médica inmediata, como:
Hipertensión supina
Droxidopa can cause or worsen supine hypertension in NOH patients. Supine hypertension is a condition in which a patient’s blood pressure rises when they lie flat on their back. Supine hypertension increases the risk of stroke if not appropriately managed.
Doctors recommend that patients should check their blood pressure before going to bed, and while resting or sleeping, they should elevate the head of the bed to avoid the risk of supine hypertension. Blood pressure should also be monitored whenever changing the dose.
Arritmias, insuficiencia cardíaca congestiva y cardiopatía isquémica
Droxidopa therapy may exacerbate existing arritmias, congestive heart failure, and ischemic heart disease. It is recommended to discuss your health status with your doctor before initiating droxidopa.
Reacción alérgica grave
Droxidopa contains tartrazine (a lemon yellow azo dye used in food coloring and medication), which may cause a severe allergic reaction (including bronchial asthma) in some patients with NOH.
Hiperpirexia y confusión
También se informan hiperpirexia (una condición en la que la temperatura corporal supera los 106,7 grados Fahrenheit) y síntomas de confusión en pacientes que reciben terapia con droxidopa durante la vigilancia posterior a la comercialización.
Therefore, it is recommended to carefully observe the patients when the dosage is changed.
Pregúntele a un especialista sobre los efectos secundarios
Droxidopa Interaction With Other Drugs
There is a high possibility that other drugs may interact with droxidopa and increase the risk of supine hypertension in patients with NOH. Some of the medications that need to be avoided or adjusted include:
- Norepinephrine
- Ephedrine
- Midodrine
- Triptans
- Dopa-decarboxylase inhibitors
- MAO inhibitors and linezolid
- Vitamins and herbal products
Before taking droxidopa, consult your healthcare provider if you take the medications mentioned above. You should always inform your doctor and pharmacist about all the medications you’re currently taking before starting any new medications.
Precauciones
It is recommended to consult your doctor before taking droxidopa. You should not take droxidopa in the following cases:
- You have a history of asthma, irregular heartbeat, heart failure, and kidney disease.
- Está embarazada o planea quedar embarazada.
- You are breastfeeding a child or plan to breastfeed.
- You are less than 18 years old.
US Boxed Warning – Supine Hypertension
Monitor supine blood pressure prior to 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 elevation of the head of the bed, reduce or discontinue droxidopa.
REFERENCIAS:
- Kaufmann, H., Norcliffe-Kaufmann, L., & Palma, J. A. (2015). Droxidopa in neurogenic orthostatic hypotension. Expert review of cardiovascular therapy, 13(8), 875-891.
- Kaufmann, H., Freeman, R., Biaggioni, I., Low, P., Pedder, S., Hewitt, L. A., … & Mathias, C. J. (2014). Droxidopa for neurogenic orthostatic hypotension: a randomized, placebo-controlled, phase 3 trial. Neurología, 83(4), 328-335.
- US. Food and Drug Administration. Droxidopa prescribing information https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203202lbl.pdf
Spanish 
English 
Chinese 
Vietnamese