Northera 300 mg/1
droxidopa · CAPSULE · Lundbeck Pharmaceuticals LLC
Northera is a capsule containing droxidopa at 300 mg/1, taken oral. Manufactured by Lundbeck Pharmaceuticals LLC.
Key Facts
- Brand Name
- Northera
- Generic Name
- droxidopa
- NDC Code (Product)
67386-822- Manufacturer
- Lundbeck Pharmaceuticals LLC
- Strength
- 300 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA203202
- Marketing Start
- 09/01/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of NORTHERA should be assessed periodically. NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of NORTHERA should be assessed periodically ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Starting dose is 100 mg three times during the day ( 2.1 ) Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily ( 2.1 ) Take consistently with or without food ( 2.1 ) To reduce the potential for supine hypertension, elevate the head of the bed and give the last dose at least 3 hours prior to bedtime ( 2.1 ) Take NORTHERA capsule whole ( 2.1 ) 2.1 Dosing Information The recommended starting dose of NORTHERA is 100 mg, taken orally three times daily: upon arising in the morning, at midday, and in the late afternoon at least 3 hours prior to bedtime (to reduce the potential for supine hypertension during sleep). Administer NORTHERA consistently, either with food or without food. Take NORTHERA capsule whole. Titrate to symptomatic response, in increments of 100 mg three times daily every 24 to 48 hours up to a maximum dose of 600 mg three times daily (i.e., a maximum total daily dose of 1,800 mg). Monitor supine blood pressure prior to initiating NORTHERA and after increasing the dose. Patients who miss a dose of NORTHERA should take their next scheduled dose.
Contraindications
4 CONTRAINDICATIONS NORTHERA is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions ( 5.4 )]. History of hypersensitivity to the drug or its ingredients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Use of DOPA decarboxylase inhibitors may require dose adjustments for NORTHERA ( 7.2 ) 7.1 Drugs that Increase Blood Pressure Administering NORTHERA in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension. 7.2 Parkinson's Medications Dopa-decarboxylase inhibitors may require dose adjustments for NORTHERA. 7.3 Non-selective MAO Inhibitors The concomitant use of selective MAO-B inhibitors, such as rasagiline or selegiline, was permitted in the NORTHERA clinical trials. However, based on mechanism of action, the use of non-selective MAO inhibitors and linezolid should be avoided as there is a potential for increased blood pressure when taken with NORTHERA.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions with NORTHERA are included in more detail in the Warnings and Precautions section of the label: Supine Hypertension [see Warnings and Precautions ( 5.1 )] Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.2 )] May exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (>5% and ≥3% compared to placebo) are headache, dizziness, nausea, and hypertension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety evaluation of NORTHERA is based on two placebo-controlled studies 1 to 2 weeks in duration (Studies 301 and 302), one 8-week placebo-controlled study (Study 306), and two long-term, open-label extension studies (Studies 303 and 304).…
Frequently Asked Questions
What is Northera used for?
Northera contains droxidopa. It is a capsule taken oral. Consult your doctor for specific uses.
Is Northera a controlled substance?
Northera is not classified as a controlled substance by the DEA.
What is the generic name for Northera?
The generic name for Northera is droxidopa. There are 11 other brand versions of droxidopa.
What is the NDC code for Northera 300 mg/1?
The NDC (National Drug Code) for Northera 300 mg/1 is 67386-822, listed by Lundbeck Pharmaceuticals LLC.