Northera 200mg Capsules
WARNING: This drug may cause high blood pressure, especially when lying down. You will need to watch your blood pressure closely before you start this drug and during treatment. Do this also with any increase in dose. Be sure to rest and sleep with your upper body raised. If high blood pressure is not controlled well, the risk of stroke, heart attack, and death may be raised. @ COMMON USES: It is used to treat dizziness or the feeling that you are about to black out.
Drug Class
Alpha/beta-adrenergic agonist; Agent for Orthostatic Hypotension
Pharmacologic Class
Synthetic amino acid precursor
Pregnancy Category
Not available
FDA Approved
Feb 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Northera (droxidopa) is a medication used to treat very low blood pressure that occurs when you stand up (called neurogenic orthostatic hypotension). It works by increasing a natural chemical in your body called norepinephrine, which helps to tighten blood vessels and raise blood pressure.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Take your medication whole, without chewing, opening, or crushing the tablets.
You can take your medication with or without food, but be consistent and take it the same way each time. Choose to always take it with food or always take it on an empty stomach.
To minimize the risk of high blood pressure during sleep, take your last dose of the day at least 3 hours before bedtime.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms and areas with high humidity.
* Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or overdose.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Take your medication whole, without chewing, opening, or crushing the tablets.
You can take your medication with or without food, but be consistent and take it the same way each time. Choose to always take it with food or always take it on an empty stomach.
To minimize the risk of high blood pressure during sleep, take your last dose of the day at least 3 hours before bedtime.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms and areas with high humidity.
* Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or overdose.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take Northera consistently with food.
- Take the last dose of the day at least 3 hours before bedtime to reduce the risk of high blood pressure while lying down (supine hypertension).
- Avoid sudden changes in position (e.g., standing up too quickly).
- Stay well-hydrated unless otherwise advised by your doctor.
- Avoid overheating and prolonged standing, which can worsen orthostatic hypotension.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 100 mg orally 3 times daily. Titrate by 100 mg 3 times daily increments every 1-2 days. Administer doses at least 3 hours prior to bedtime.
Dose Range:
100 - 600 mg
Condition-Specific Dosing:
neurogenicOrthostaticHypotension:
Initial: 100 mg 3 times daily. Max: 600 mg 3 times daily (1800 mg/day). Administer doses at least 3 hours prior to bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No specific dose adjustment recommendations; use with caution due to potential for increased exposure.
Dialysis:
Not available; unknown if dialyzable.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No specific dose adjustment recommendations; use with caution.
Pharmacology
Mechanism of Action
Droxidopa is a synthetic amino acid precursor of norepinephrine. It is converted to norepinephrine by the enzyme DOPA decarboxylase. Norepinephrine acts on alpha-1 adrenergic receptors to cause vasoconstriction, increasing blood pressure. It also has minor effects on beta-adrenergic receptors.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
1.7-2.0 hours
FoodEffect:
High-fat meal decreases Cmax by 30% and AUC by 10%, delays Tmax by 2 hours. Administer consistently with food.
Distribution:
Vd:
1.2 L/kg
ProteinBinding:
Approximately 10%
CnssPenetration:
Limited
Elimination:
HalfLife:
Droxidopa: 2-3 hours; Norepinephrine (active metabolite): 2-3 minutes
Clearance:
Not available
ExcretionRoute:
Primarily renal (60-70% as metabolites, <1% unchanged)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
1-2 hours
DurationOfAction:
Up to 4 hours
Safety & Warnings
BLACK BOX WARNING
Droxidopa can cause supine hypertension. Monitor supine blood pressure prior to and during treatment and more frequently when titrating dosage. Manage supine hypertension by reducing the dose or discontinuing droxidopa.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness or fainting
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Falls
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or irregular heartbeat
+ Excessive sweating
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dizziness
Headache
* Upset stomach
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness or fainting
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Falls
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or irregular heartbeat
+ Excessive sweating
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dizziness
Headache
* Upset stomach
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Symptoms of supine hypertension: severe headache, blurred vision, chest pain, dizziness, palpitations, nausea, shortness of breath.
- Symptoms of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking or have recently taken any of the following medications:
+ Isocarboxazid, phenelzine, or tranylcypromine (monoamine oxidase inhibitors, or MAOIs)
+ Linezolid or methylene blue
* If you are breast-feeding, as you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking or have recently taken any of the following medications:
+ Isocarboxazid, phenelzine, or tranylcypromine (monoamine oxidase inhibitors, or MAOIs)
+ Linezolid or methylene blue
* If you are breast-feeding, as you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To monitor your condition, follow the instructions provided by your healthcare provider for checking your blood pressure regularly.
If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor before taking this medication, as some formulations may contain this ingredient.
Patients with pre-existing heart conditions, such as abnormal heartbeat or heart failure, should be aware that this medication may exacerbate these conditions. If you have a history of heart problems, discuss the potential risks with your doctor. Immediately contact your doctor if you experience any new or worsening symptoms, including abnormal heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs.
If you are pregnant or planning to become pregnant, it is crucial to discuss the benefits and risks of using this medication during pregnancy with your doctor to make an informed decision.
To monitor your condition, follow the instructions provided by your healthcare provider for checking your blood pressure regularly.
If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor before taking this medication, as some formulations may contain this ingredient.
Patients with pre-existing heart conditions, such as abnormal heartbeat or heart failure, should be aware that this medication may exacerbate these conditions. If you have a history of heart problems, discuss the potential risks with your doctor. Immediately contact your doctor if you experience any new or worsening symptoms, including abnormal heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs.
If you are pregnant or planning to become pregnant, it is crucial to discuss the benefits and risks of using this medication during pregnancy with your doctor to make an informed decision.
Overdose Information
Overdose Symptoms:
- Excessive supine hypertension (severe headache, blurred vision, chest pain)
- Bradycardia (slow heart rate)
- Palpitations
- Arrhythmias
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive, focusing on managing blood pressure (e.g., alpha-adrenergic blocking agents if severe hypertension occurs).
Drug Interactions
Contraindicated Interactions
- Non-selective monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, isocarboxazid, selegiline, rasagiline, linezolid, methylene blue)
Major Interactions
- Tricyclic antidepressants (e.g., amitriptyline, imipramine, desipramine) - may potentiate pressor effects
- Alpha-adrenergic blocking agents (e.g., prazosin, terazosin, doxazosin) - may antagonize effects of droxidopa
- Beta-adrenergic blocking agents (e.g., propranolol, metoprolol) - may potentiate pressor effects of norepinephrine
- Other vasopressors (e.g., phenylephrine, midodrine) - additive pressor effects
- Digoxin - increased risk of cardiac arrhythmias
Moderate Interactions
- Carbidopa - reduces conversion of droxidopa to norepinephrine, requiring higher droxidopa doses
- Centrally acting alpha-2 adrenergic agonists (e.g., clonidine) - may reduce pressor response to droxidopa
Monitoring
Baseline Monitoring
Supine and standing blood pressure
Rationale: To establish baseline and assess severity of orthostatic hypotension.
Timing: Prior to initiation of therapy.
Heart rate
Rationale: To establish baseline.
Timing: Prior to initiation of therapy.
Routine Monitoring
Supine and standing blood pressure
Frequency: Regularly, especially during dose titration and periodically thereafter.
Target: Individualized to achieve symptomatic relief without excessive supine hypertension.
Action Threshold: If supine systolic blood pressure consistently >180 mmHg or diastolic >110 mmHg, consider dose reduction or discontinuation.
Heart rate
Frequency: Regularly, especially during dose titration.
Target: Not available
Action Threshold: Not available
Symptom Monitoring
- Symptoms of orthostatic hypotension (dizziness, lightheadedness, syncope, fatigue)
- Symptoms of supine hypertension (headache, blurred vision, chest pain, dizziness, palpitations, nausea, shortness of breath)
Special Patient Groups
Pregnancy
Based on animal data, droxidopa may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Animal studies showed adverse developmental effects (e.g., skeletal abnormalities, reduced fetal weight) at doses higher than human therapeutic doses.
Second Trimester:
Not available
Third Trimester:
Not available
Lactation
It is not known whether droxidopa is excreted in human milk, or if it has effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for droxidopa and any potential adverse effects on the breastfed infant from droxidopa or from the underlying maternal condition.
Infant Risk:
Not available
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between older and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should generally start at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- The most significant adverse effect is supine hypertension. Patients must be educated on symptoms and the importance of taking the last dose at least 3 hours before bedtime.
- Droxidopa should be taken consistently with food to ensure predictable absorption.
- Monitor supine and standing blood pressure regularly, especially during dose titration.
- Patients should avoid activities that could exacerbate orthostatic hypotension (e.g., prolonged standing, hot environments) and be advised on non-pharmacological measures (e.g., increased fluid intake, compression stockings).
Alternative Therapies
- Midodrine (another alpha-1 agonist)
- Fludrocortisone (mineralocorticoid, increases blood volume)
- Pyridostigmine (cholinesterase inhibitor, off-label use)
- Non-pharmacological interventions (e.g., increased fluid and salt intake, compression stockings, head-up tilt sleeping)
Cost & Coverage
Average Cost:
Highly variable, typically $1500-$3000+ per 30 capsules (200mg)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.