DROXIDOPA 100 mg/1
DROXIDOPA · CAPSULE · Lupin Pharmaceuticals, Inc.
DROXIDOPA is a capsule containing droxidopa at 100 mg/1, taken oral. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- DROXIDOPA
- Generic Name
- DROXIDOPA
- NDC Code (Product)
68180-987- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211652
- Marketing Start
- 09/24/2021
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 Droxidopa capsules 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 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 & 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 droxidopa capsule whole (2.1) 2.1 Dosing Information The recommended starting dose of droxidopa capsules 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 droxidopa capsules consistently, either with food or without food. Take droxidopa 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 droxidopa capsules and after increasing the dose. Patients who miss a dose of droxidopa capsules should take their next scheduled dose.
Contraindications
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
Drug 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. 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 droxidopa.
Adverse Reactions
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 Slate Run Pharmaceuticals, LCC at 1-888-341-9214 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 droxidopa 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 studi…
Frequently Asked Questions
What is DROXIDOPA used for?
DROXIDOPA contains DROXIDOPA. It is a capsule taken oral. Consult your doctor for specific uses.
Is DROXIDOPA a controlled substance?
DROXIDOPA is not classified as a controlled substance by the DEA.
What is the generic name for DROXIDOPA?
The generic name for DROXIDOPA is DROXIDOPA. There are 10 other brand versions of DROXIDOPA.
What is the NDC code for DROXIDOPA 100 mg/1?
The NDC (National Drug Code) for DROXIDOPA 100 mg/1 is 68180-987, listed by Lupin Pharmaceuticals, Inc..