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Fenoldopam (United States and Canada: Not available): Drug information

Fenoldopam (United States and Canada: Not available): Drug information
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Brand Names: US
  • Corlopam [DSC]
Pharmacologic Category
  • Antihypertensive;
  • Dopamine Agonist
Dosing: Adult

Dosage guidance:

Dosage form information: Corlopam has been discontinued in the United States for >1 year.

Hypertensive emergency

Hypertensive emergency:

Note: In general, reduce mean arterial blood pressure gradually by ~10% to 20% over the first hour, then by an additional 5% to 15% over the next 23 hours. Invasive blood pressure monitoring is recommended for appropriate dose titration (Ref).

Continuous IV infusion: Initial: 0.1 mcg/kg/minute; may increase in increments of 0.05 to 0.1 mcg/kg/minute every 15 minutes until target blood pressure is reached; usual initial dosing range: 0.01 to 0.3 mcg/kg/minute; maximum dose: 1.6 mcg/kg/minute; limit use to 48 hours (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; the effects of hemodialysis have not been evaluated.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Fenoldopam (United States and Canada: Not available): Pediatric drug information")

Dosage guidance:

Dosage form information: Corlopam has been discontinued in the United States for >1 year.

Hypertension, acute severe

Hypertension, acute severe: Infants, Children, and Adolescents: IV: Continuous IV infusion: Initial: 0.2 mcg/kg/minute; may be increased every 20 to 30 minutes to 0.3 to 0.5 mcg/kg/minute; maximum dose: 0.8 mcg/kg/minute (higher doses have been shown to worsen tachycardia without any additional blood pressure benefits) (Ref).

Dosing: Kidney Impairment: Pediatric

All patients: There are no dosage adjustments provided in the manufacturer’s labeling; the effects of hemodialysis have not been evaluated.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Nausea (12%)

Nervous system: Headache (24%)

1% to 10%:

Cardiovascular: Acute myocardial infarction (≤5%), angina pectoris (≤5%), chest pain (≤5%), extrasystoles (≤5%), flushing (>5%), heart failure (≤5%), hypotension (>5%), inversion T wave on ECG (6%), ischemic heart disease (≤5%), palpitations (≤5%), tachycardia (≤5%)

Dermatologic: Hyperhidrosis (≤5%)

Endocrine & metabolic: Hypokalemia (≤5%), increased lactate dehydrogenase (≤5%), increased serum glucose (≤5%)

Gastrointestinal: Abdominal pain (≤5%), vomiting (6%)

Genitourinary: Oliguria (≤5%)

Hepatic: Increased serum transaminases (≤5%)

Local: Injection-site reaction (7%)

Nervous system: Anxiety (≤5%), dizziness (≤5%), insomnia (≤5%), nervousness (≤5%)

Neuromuscular & skeletal: Muscle spasm (≤5%)

Renal: Increased blood urea nitrogen (≤5%), increased serum creatinine (≤5%)

Miscellaneous: Fever (≤5%)

Frequency not defined: Ophthalmic: Increased intraocular pressure

Postmarketing:

Cardiovascular: Cardiogenic shock, depression of ST segment on ECG

Gastrointestinal: Abdominal distention

Respiratory: Oxygen saturation decreased

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Hypokalemia: Hypokalemia has been observed within 6 hours of fenoldopam infusion; monitor potassium concentrations appropriately.

• Tachycardia: Dose-related tachycardia can occur, especially at infusion rates >0.1 mcg/kg/minute (adults) and >0.8 mcg/kg/minute (pediatric). Doses lower than 0.1 mcg/kg/minute and slow up-titration is associated with less reflex tachycardia.

Disease-related concerns:

• Angina: Use with extreme caution in patients with obstructive coronary disease or ongoing angina pectoris; can increase myocardial oxygen demand due to tachycardia leading to angina pectoris.

• Glaucoma: Dose-dependent increase in intraocular pressure (IOP) has been reported in patients with glaucoma or intraocular hypertension; upon discontinuation, IOP returned to baseline within 2 hours.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

• Sulfites: Contains sulfites; may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in susceptible individuals. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Warnings: Additional Pediatric Considerations

A dose related tachycardia can occur, especially at infusion rates >0.1 mcg/kg/minute; in pediatric patients at doses >0.8 mcg/kg/minute, tachycardia has been shown to persist for at least 4 hours. Close monitoring of blood pressure is necessary; hypotension can occur.

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP, 1997; Shehab, 2009).

Product Availability

Corlopam has been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Corlopam: 10 mg/mL (1 mL [DSC]); 20 mg/2 mL (2 mL [DSC]) [contains propylene glycol, sodium metabisulfite]

Generic Equivalent Available: US

No

Pricing: US

Solution (Corlopam Intravenous)

10 mg/mL (per mL): $597.48

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: For continuous IV infusion only.

Administration: Pediatric

Continuous IV infusion: Administer using an infusion pump

Usual Infusion Concentrations: Adult

IV infusion: 10 mg in 250 mL (concentration: 40 mcg/mL) of D5W or NS

Usual Infusion Concentrations: Pediatric

IV infusion: 60 mcg/mL

Use: Labeled Indications

Hypertensive emergency: Short-term treatment of hypertensive emergency (up to 48 hours in adults while in hospital), including patients with malignant hypertension with deteriorating end-organ function; short-term (up to 4 hours while in hospital) BP reduction in pediatric patients while in hospital.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification

Amphetamines: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Indoramin: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Isocarboxazid: May increase antihypertensive effects of Antihypertensive Agents. Risk X: Avoid

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification

Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Prazosin: Antihypertensive Agents may increase hypotensive effects of Prazosin. Risk C: Monitor

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Terazosin: Antihypertensive Agents may increase hypotensive effects of Terazosin. Risk C: Monitor

Urapidil: Antihypertensive Agents may increase hypotensive effects of Urapidil. Risk C: Monitor

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Fenoldopam was administered orally to rats and rabbits during the period of organogenesis; although maternal toxicity occurred at the highest dose, teratogenic or fetotoxic effects were not observed.

Severe maternal hypertension is associated with adverse pregnancy outcomes, including maternal stroke, pulmonary edema, myocardial ischemia, or maternal/fetal death.

Breastfeeding Considerations

It is not known if fenoldopam is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

Blood pressure, heart rate, ECG; serum potassium concentrations

Mechanism of Action

A selective postsynaptic dopamine agonist (D1-receptors) which exerts hypotensive effects by decreasing peripheral vasculature resistance with increased renal blood flow, diuresis, and natriuresis; 6 times as potent as dopamine in producing renal vasodilatation; has minimal adrenergic effects

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: IV: Children: 5 minutes; Adults: 10 minutes; Note: Majority of effect of a given infusion rate is attained within 15 minutes.

Duration: IV: 1 hour

Distribution: Vd: 0.6 L/kg

Half-life elimination: IV: Children: 3 to 5 minutes; Adults: ~5 minutes

Metabolism: Hepatic via methylation, glucuronidation, and sulfation; the 8-sulfate metabolite may have some activity; extensive first-pass effect

Excretion: Urine (90%); feces (10%)

Clearance: Children: 3 L/hour/kg

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (IT) Italy: Corlopam;
  • (PL) Poland: Corlopam
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