DROXIDOPA capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DROXIDOPA (UNII: J7A92W69L7) (DROXIDOPA - UNII:J7A92W69L7)

Available from:

Novadoz Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Droxidopa capsules are 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 droxidopa capsules should be assessed periodically. Droxidopa is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [ see Warnings and Precautions (5.4)]. Risk Summary There are no available data on use of droxidopa in pregnant women and risk of major birth defects or miscarriage. Droxidopa did not produce significant reproductive toxicity in pregnant female rats or rabbits or in their fetuses. However, when pregnant female rats were dosed during days 7-17

Product summary:

Droxidopa capsules are supplied in the following dosage strengths: 100 mg: White to light brown powder filled in Size"4" hard gelatin capsules with white opaque body with black color band and Light blue opaque cap imprinted with "MD 10" in black ink. 200 mg: White to light brown powder filled in Size "2" hard gelatin capsules with white opaque body with black color band and Light yellow opaque cap imprinted with "MD 9" in black ink. 300 mg: White to light brown powder filled in Size "1" hard gelatin capsules with white opaque body with black color band and Light green opaque cap imprinted with "MD 8" in black ink. 100 mg 90-count bottle (NDC code # 72205-072-90) 100 mg 500-count bottle (NDC code # 72205-072-05) 200 mg 90-count bottle (NDC code # 72205-073-90) 200 mg 500-count bottle (NDC code # 72205-073-05) 300 mg 90-count bottle (NDC code # 72205-074-90) 300 mg 500-count bottle (NDC code # 72205-074-05). Droxidopa capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DROXIDOPA - DROXIDOPA CAPSULE
NOVADOZ PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DROXIDOPA CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DROXIDOPA
CAPSULES.
DROXIDOPA CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
WARNING: SUPINE HYPERTENSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 _[ SEE WARNINGS AND PRECAUTIONS (5.1)]_
INDICATIONS AND USAGE
Droxidopa capsules are 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 droxidopa capsules should be assessed periodically
(1).
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 droxidopa capsule whole (2.1)
DOSAGE FORMS AND STRENGTHS
100 mg, 200 mg and 300 mg capsules (3)
CONTRAINDICATIONS
History of hypersensitivity to the drug or its ingredients (4)
WARNINGS AND PRECAUTIONS
• Droxidopa may cause supine hypertension and may increase
c