Droxidopa
Generic Name: droxidopa
Brand Names:
Droxidopa
11 DESCRIPTION Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (-)-threo-3-(3, 4-Dihydroxyphenyl)-L-serine. It has the following structural formula: Droxidopa is an odorless, tasteless, white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether and chloroform.
Overview
11 DESCRIPTION Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (-)-threo-3-(3, 4-Dihydroxyphenyl)-L-serine. It has the following structural formula: Droxidopa is an odorless, tasteless, white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether and chloroform.
Uses
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.
Dosage
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 droxidopa capsule whole ( 2.1 ) 2.1 Dosing Information The recommended starting dose of droxidopa capsules are 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 droxidopa capsules consistently, either with food or without food.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions with droxidopa 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 Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 DRUG INTERACTIONS Use of DOPA decarboxylase inhibitors may require dose adjustments for droxidopa ( 7.2 ) 7.1 Drugs that Increase Blood Pressure Administering droxidopa 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 droxidopa. 7.3 Non-selective MAO Inhibitors The concomitant use of selective MAO-B inhibitors, such as rasagiline or selegiline, was permitted in the droxidopa clinical trials.
Warnings
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 [ see Warnings and Precautions (5.1)]. WARNING: SUPINE HYPERTENSION See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS • Droxidopa may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed ( 5.1 ) • Hyperpyrexia and confusion ( 5.2 ) • May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure ( 5.3 ) • Allergic reactions ( 5.4 ) 5.1 Supine Hypertension Droxidopa therapy may cause or exacerbate supine hypertension in patients with nOH. Patients should be advised to elevate the head of the bed when resting or sleeping. Monitor blood pressure, both in the supine position and in the recommended head-elevated sleeping position. Reduce or discontinue droxidopa if supine hypertension persists. 4 CONTRAINDICATIONS Droxidopa 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 )
Pregnancy
8.1 Pregnancy 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 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.
Frequently Asked Questions
What is Droxidopa used for?▼
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.
What are the side effects of Droxidopa?▼
6 ADVERSE REACTIONS The following adverse reactions with droxidopa 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 Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Droxidopa during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Droxidopa?▼
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 [ see Warnings and Precautions (5.1)]. WARNING: SUPINE HYPERTENSION See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS • Droxidopa may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed ( 5.1 ) • Hyperpyrexia and confusion ( 5.2 ) • May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure ( 5.3 ) • Allergic reactions ( 5.4 ) 5.1 Supine Hypertension Droxidopa therapy may cause or exacerbate supine hypertension in patients with nOH. Patients should be advised to elevate the head of the bed when resting or sleeping. Monitor blood pressure, both in the supine position and in the recommended head-elevated sleeping position. Reduce or discontinue droxidopa if supine hypertension persists. 4 CONTRAINDICATIONS Droxidopa 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.