droxidopa (Rx)

Brand and Other Names:Northera
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 100mg
  • 200mg
  • 300mg

Neurogenic Orthostatic Hypotension

Indicated for symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy

100 mg PO TID initially

Titrate to symptomatic response, in increments of 100 mg TID every 24-48 hr; not to exceed 600 mg TID (ie, 1800 mg/day)

Dosage Modifications

Renal impairment

  • Mild-to-moderate (GFR >30 mL/min): No dosage adjustment required
  • Severe (GFR <30 mL/min): Limited data; caution advised

Dosing Considerations

Effectiveness beyond 2 weeks of treatment has not been demonstrated

Continued effectiveness of droxidopa should be assessed periodically

Safety and efficacy not established

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Interactions

Interaction Checker

and droxidopa

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (2)

              • iobenguane I 131

                droxidopa will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.

              • ozanimod

                ozanimod increases toxicity of droxidopa by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Because the active metabolite of ozanimod inhibits MAO-B in vitro, there is a potential for serious adverse reactions, including hypertensive crisis. Therefore, coadministration of ozanimod with drugs that can increase norepinephrine or serotonin is not recommended. Monitor for hypertension with concomitant use.

              Monitor Closely (30)

              • almotriptan

                almotriptan and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • benzphetamine

                benzphetamine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • caffeine

                caffeine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • carbidopa

                carbidopa decreases effects of droxidopa by decreasing metabolism. Use Caution/Monitor. Carbidopa, a peripheral dopa-decarboxylase inhibitor, could prevent the conversion of droxidopa to norepinephrine; increased droxidopa dose may be required.

              • cocaine

                cocaine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • dexmethylphenidate

                dexmethylphenidate and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • dextroamphetamine

                dextroamphetamine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • eletriptan

                eletriptan and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • ephedrine

                ephedrine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • epinephrine

                epinephrine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • frovatriptan

                frovatriptan and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • insulin degludec

                droxidopa decreases effects of insulin degludec by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Sympathomimetics increase blood glucose by stimulating alpha and beta receptors; this action results in increased hepatic glucose production, glycogenolysis, and decreased insulin secretion.

              • insulin degludec/insulin aspart

                droxidopa decreases effects of insulin degludec/insulin aspart by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Sympathomimetics increase blood glucose by stimulating alpha and beta receptors; this action results in increased hepatic glucose production, glycogenolysis, and decreased insulin secretion.

              • insulin inhaled

                droxidopa decreases effects of insulin inhaled by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Sympathomimetics increase blood glucose by stimulating alpha and beta receptors; this action results in increased hepatic glucose production, glycogenolysis, and decreased insulin secretion.

              • isometheptene

                isometheptene and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • lisdexamfetamine

                lisdexamfetamine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • methamphetamine

                methamphetamine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • midodrine

                midodrine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • naratriptan

                naratriptan and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • norepinephrine

                norepinephrine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • oxymetazoline topical

                oxymetazoline topical and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • phentermine

                phentermine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • phenylephrine

                phenylephrine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • phenylephrine PO

                phenylephrine PO and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • pseudoephedrine

                pseudoephedrine and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • rizatriptan

                rizatriptan and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • solriamfetol

                droxidopa and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • sumatriptan

                sumatriptan and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • sumatriptan intranasal

                sumatriptan intranasal and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              • zolmitriptan

                zolmitriptan and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

              Minor (0)

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                Adverse Effects

                >10%

                8-10 week administration

                • Headache (13.2%)

                1-10%

                1-2 week administration

                • Headache (6.1%)
                • Dizziness (3.8%)
                • Nausea (1.5%)
                • Hypertension (1.5%)

                8-10 week administration

                • Dizziness (9.6%)
                • Nausea (8.8%)
                • Hypertension (7%)

                Postmarketing Reports

                Hypersensitivity

                Gastrointestinal Disorders: Pancreatitis, abdominal pain, vomiting, diarrhea

                General Disorders and Administration Site Conditions: Fatigue

                Psychiatric Disorders: Psychosis, hallucination, delirium, agitation, memory disorder

                Eye disorders: Blurred vision

                Nervous system disorders: Cerebrovascular accident

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                Warnings

                Black Box Warnings

                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 dose or discontinue droxidopa

                Contraindications

                Known hypersensitivity to the drug or ingredients

                Cautions

                May cause or exacerbate supine hypertension in patients with NOH; advise patients to elevate the head of the bed when resting or sleeping (see Black Box Warnings); if supine hypertension is not well-managed, therapy may increase risk of cardiovascular events, particularly stroke

                Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria, and rash (see Contraindications); if hypersensitivity reaction occurs, discontinue drug and initiate appropriate therapy

                Sympathomimetic effect may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure

                Coadministration with other drugs that increase blood pressure are expected to increase risk of hypertension

                Coadministration with dopa-decarboxylase inhibitors may decrease the conversion of droxidopa to norepinephrine

                Contains FD+C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons; although overall incidence of this sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity

                Hyperpyrexia and confusion

                • Symptom complex resembling neuroleptic malignant syndrome (NMS) reported; monitor closely when dosage is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics
                • NMS is an uncommon, but life-threatening syndrome characterized by fever or hyperthermia, muscle rigidity, involuntary movements, altered consciousness, and mental status changes
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                Pregnancy & Lactation

                Pregnancy: There are no available data on use of dorxidopa in pregnant women and risk of major birth defects or miscarriage

                Lactation: There is no information regarding presence of drug or its active metabolite(s) in human milk, effects on breastfed child, nor effects on milk production/excretion; because of potential for serious adverse reactions, including reduced weight gain in breastfed infants, advise a woman not to breastfeed during treatment

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Norepinephrine precursor; directly metabolized to norepinephrine by dopa-decarboxylase which is extensively distributed throughout the body

                Peak droxidopa plasma concentrations are associated with increases in systolic and diastolic blood pressures

                Droxidopa has no clinically significant effect on standing or supine heart rates in patients with autonomic failure

                Absorption

                Peak plasma concentration: 1-4 hr

                High-fat meals have a moderate impact on droxidopa exposure (decreased Cmax and AUC by ~35% and 20% respectively); Cmax delayed by ~2 hr

                Distribution

                Can cross the BBB

                Protein bound: 75% (100 ng/mL); 26% (10,000 ng/mL)

                Vd: 200 L

                Metabolism

                The metabolism of droxidopa is mediated by catecholamine pathway and not through the cytochrome P450 system

                Initially converted to methoxylated dihydroxyphenylserine (3-OM-DOPS), a major metabolite, by catechol-O-methyltransferase (COMT), to norepinephrine by DOPA decarboxylase (DDC), or to protocatechualdehyde by DOPS aldolase

                After oral dosing in humans, plasma norepinephrine levels peak within 3-4 hr but are generally very low (<1 ng/mL) and variable with no consistent relationship with dose

                The contribution of droxidopa metabolites (other than norepinephrine) to its pharmacological effects is not well understood

                Elimination

                Half-life: 2.5 hr

                Excretion: 75% urine

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                Administration

                Oral Administration

                Administer upon arising in the morning, at midday, and in the late afternoon at least 3 hr prior to bedtime (to reduce the potential for supine hypertension during sleep)

                Administer consistently, either with food or without food

                Swallow capsule whole; do not chew, open, or dissolve contents

                Monitor supine blood pressure prior to initiating and after increasing the dose

                Patients who miss a dose should take their next scheduled dose; do not double the dose to make up for a missed dose

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Northera oral
                -
                300 mg capsule
                Northera oral
                -
                200 mg capsule
                Northera oral
                -
                100 mg capsule
                droxidopa oral
                -
                300 mg capsule
                droxidopa oral
                -
                200 mg capsule
                droxidopa oral
                -
                100 mg capsule

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                droxidopa oral

                DROXIDOPA - ORAL

                (DROX-i-DOE-pa)

                COMMON BRAND NAME(S): Northera

                WARNING: This medication can increase your blood pressure when you are lying on your back (supine hypertension). Raising the head of the your bed lessens this risk. Your doctor will carefully monitor your blood pressure in this position before and during treatment, especially after a dosage increase. Your doctor may adjust or stop treatment with this medication if supine hypertension happens and cannot be managed by raising the head of your bed. If supine hypertension cannot be managed, it could lead to a stroke, heart attack, or even death. Talk with your doctor for details.

                USES: Droxidopa is used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH). This medication can lessen symptoms of low blood pressure when standing (orthostatic hypotension), such as dizziness, lightheadedness, or the "feeling that you are about to black out." Droxidopa is used by people whose daily activities are severely affected by this condition, even after other treatments are used (such as support stockings, water bolus). It is thought to work by making the blood vessels become more narrow, which increases blood pressure.

                HOW TO USE: Take this medication by mouth as directed by your doctor, usually 3 times a day (morning, midday, and late afternoon). Swallow the capsules whole. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. This drug is taken during daytime hours, when people stand most often. It should not be taken after the evening meal or less than 3 hours before bedtime.The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Since it is unknown if this medication will work longer than 2 weeks, it should be continued only if symptoms continue to get better during treatment. Do not take this medication for longer than 2 weeks unless your doctor directs you to do so. Learn how to monitor your own blood pressure and share the results with your doctor. Tell your doctor if your condition does not improve or if it worsens.

                SIDE EFFECTS: See also Warning section.Headache, nausea, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can increase your blood pressure, especially when you are lying down (supine hypertension). Monitor and share your blood pressure results with your doctor. Tell your doctor if you have symptoms of high blood pressure, such as pounding heartbeat, pounding sound in your ears, headache, or blurred vision.This medication may rarely cause very serious symptoms that are like a condition called neuroleptic malignant syndrome (NMS). These symptoms may be more likely to happen when your dose of this drug or other medications (such as levodopa) is changed. Get medical help right away if you have any of the following symptoms: fever, muscle stiffness, severe confusion, sweating, fast/irregular heartbeat.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: See also Warning section.Before taking droxidopa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as irregular heartbeat, congestive heart failure, previous heart attack), kidney disease.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication increases your blood pressure. Raise the head of your bed to lessen the risk of high blood pressure that happens when lying down (supine hypertension).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Learn about other ways to help manage symptoms of neurogenic orthostatic hypotension-NOH, such as drinking plenty of fluids, taking salt supplements/table salt, or wearing an abdominal binder and leg stockings. Also, certain physical movements (such as toe-raise, leg-crossing, thigh contraction) can help make you be able to stay upright a longer time. Ask your doctor for more details.Laboratory and/or medical tests (such as blood pressure measured while standing/sitting/lying down) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

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                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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