"The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associate"...
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 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.
DOSAGE AND ADMINISTRATION
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 24-48 hours up to a maximum dose of 600 mg three times daily (i.e., a maximum total daily dose of 1800 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.
Dosage Forms And Strengths
NORTHERA capsules are available in 100 mg, 200 mg, and 300 mg strengths as specified below.
- 100 mg: Hard gelatin capsules with “Northera” on the white body and “100” on the light blue cap
- 200 mg: Hard gelatin capsules with “Northera” on the white body and “200” on the light yellow cap
- 300 mg: Hard gelatin capsules with “Northera” on the white body and “300” on the light green cap
NORTHERA capsules are supplied in the following dosage strengths:
100 mg: Hard gelatin, size 3 capsule, with an opaque light blue cap and an opaque white body, printed with “Northera” on the body and “100” on cap, filled with a white to light brown powder.
200 mg: Hard gelatin, size 2 capsule, with an opaque light yellow cap and an opaque white body, printed with “Northera” on body and “200” on cap, filled with a white to light brown powder.
300 mg: Hard gelatin, size 1 capsule, with an opaque light green cap and an opaque white body, printed with “Northera” on body and “300” on cap, filled with a white to light brown powder.
100 mg 90-count bottle (NDC code# 76320-100 90)
200 mg 90-count bottle (NDC code# 76320-200-90)
300 mg 90-count bottle (NDC code# 76320-300-90)
Storage And Handling
NORTHERA capsules should be stored at room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature].
Manufactured for: Chelsea Therapeutics, Inc., Charlotte, NC 28277. Revised: 02/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/27/2014
Additional Northera Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.