today Droxidopa Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pronunciation (drox i DOE pa) Index Terms L-Dihydroxyphenylserine L-DOPS L-Threo-Dihydroxyphenylserine SM-5688 Slideshow Treatment of Opioid-Induced Constipation: The Hard Facts Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Capsule, Oral: Northera: 100 mg, 200 mg [contains fd&c blue #2 (indigotine)] Northera: 300 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, tartrazine (fd&c yellow #5)] Brand Names: U.S. Northera Pharmacologic Category Alpha/Beta Agonist Pharmacology A synthetic amino acid analog that is directly metabolized to norepinephrine by dopadecarboxylase. Droxidopa is believed to exert its pharmacological effects through norepinephrine. Norepinephrine increases blood pressure by inducing peripheral arterial and venous vasoconstriction. Absorption High-fat meals reduce the C max and area under the plasma concentration-time curve (AUC) by 35% and 20%, respectively, and delay the C max by approximately 2 hours. Distribution V d : ~200 L Metabolism The metabolism of droxidopa is mediated by catecholamine pathway. Droxidopa is 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. Excretion Urine (~75%) Time to Peak Plasma: 1 to 4 hours Half-Life Elimination ~2.5 hours Protein Binding 26% to 75% Use: Labeled Indications Neurogenic orthostatic hypotension: Treatment of orthostatic dizziness, light-headedness, or the feeling that you are about to black out in adults with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson disease [PD], multiple system atrophy [MSA], and pure autonomic failure [PAF]), dopamine beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy. Contraindications Hypersensitivity to droxidopa or any component of the formulation. Dosing: Adult Neurogenic orthostatic hypotension: Oral: Initial: 100 mg 3 times daily; titrate in increments of 100 mg 3 times daily every 24 to 48 hours to symptomatic response (maximum dose: 1,800 mg/day). Dosing: Geriatric Refer to adult dosing. Dosing: Renal Impairment GFR >30 mL/minute: No dose adjustments necessary. GFR 30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Dosing: Hepatic Impairment There are no dosage adjustments provided in the manufacturer's labeling. Administration Administer capsule whole, consistently with or without food, 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). Storage Store at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F) Drug Interactions Carbidopa: May diminish the therapeutic effect of Droxidopa. Carbidopa may decrease serum concentrations of the active metabolite(s) of Droxidopa. Carbidopa may increase the serum concentration of Droxidopa. Monitor therapy Ephedra: May enhance the hypertensive effect of Droxidopa. Monitor therapy EPHEDrine (Systemic): May enhance the hypertensive effect of Droxidopa. Monitor therapy Ifenprodil: May diminish the therapeutic effect of Droxidopa. Monitor therapy Midodrine: May enhance the hypertensive effect of Droxidopa. Monitor therapy Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Droxidopa. Exceptions: Rasagiline; Safinamide; Selegiline. Avoid combination Norepinephrine: May enhance the hypertensive effect of Droxidopa. Monitor therapy Serotonin 5-HT1D Receptor Agonists: May enhance the hypertensive effect of Droxidopa. Monitor therapy Adverse Reactions >10%: Central nervous system: Headache (6% to 13%) 1% to 10%: Cardiovascular: Hypertension (2% to 7%) Central nervous system: Dizziness (4% to 10%) Gastrointestinal: Nausea (9%) Postmarketing and/or case reports: Abdominal pain, agitation, blurred vision, cerebrovascular accident, chest pain, confusion, delirium, diarrhea, fatigue, hallucination, hyperpyrexia, hypersensitivity reaction (including anaphylaxis, angioedema, bronchospasm, skin rash, urticaria), memory impairment, pancreatitis, psychosis, vomiting ALERT: U.S. Boxed 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. Warnings/Precautions Concerns related to adverse effects: Anaphylaxis/allergic reactions: Hypersensitivity reactions have been reported. Reactions may include anaphylaxis, angioedema, bronchospasm, rash, and urticaria; emergency treatment may be necessary. Discontinue use and initiate immediate medical support if a hypersensitivity reaction occurs. Hypertension: [US Boxed Warning]: Droxidopa may cause or exacerbate supine hypertension. Advise patients to elevate the head of bed when resting or sleeping. Monitor blood pressure in supine position and in recommended head-elevated sleeping position. Reduce or discontinue droxidopa if supine hypertension persists. Risk of cardiovascular events may be increased if supine hypertension is not well managed. Neuroleptic malignant syndrome: A symptom complex resembling neuroleptic malignant syndrome has been reported; symptoms have included hyperpyrexia and confusion. Observe patients carefully with dose changes or when concomitant levodopa is reduced abruptly or discontinued, especially if patient is receiving neuroleptics. Disease-related concerns: Cardiovascular disease: Droxidopa may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure; consider potential risk prior to initiating therapy. Dosage form specific issues: Tartrazine: May contain FD+C Yellow No. 5 (tartrazine), which may cause allergic reactions, including bronchial asthma in susceptible individuals, especially in patients with aspirin hypersensitivity. Monitoring Parameters Monitor supine blood pressure prior to and during treatment and more frequently when increasing the dose. Pregnancy Considerations Adverse events have been observed in some animal reproduction studies. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience nausea. Have patient report immediately to prescriber severe headache, severe dizziness, passing out, vision changes, or signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, severe headache, confusion, change in thinking, tachycardia, abnormal heartbeat, or sweating a lot) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Interactions Print this page Add to My Med List More about droxidopa Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: vasopressors Consumer resources Droxidopa Droxidopa (Advanced Reading) Professional resources Droxidopa (AHFS Monograph) Other brands: Northera Related treatment guides Hypotension} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Droxidopa Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Vasopressors Related Drugs vasopressors EpiPen , epinephrine , phenylephrine , dopamine , dobutamine , Levophed Hypotension midodrine , phenylephrine , Levophed , ephedrine , norepinephrine , ProAmatine , Northera , Orvaten , Akovaz , Corphedra , More...} } agency
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