Class: Non-selective alpha-Adrenergic Blocking Agents
VA Class: AU200
CAS Number: 65-28-1
Brands: Regitine, Vasomax, Z-Max
Introduction
α-adrenergic blocking agent, an imidazoline.177 a
Uses for Phentolamine Mesylate
Diagnosis of Pheochromocytoma
Used as an aid in the diagnosis of pheochromocytoma.a 177
Determination of blood catecholamine concentrations, urinary assay of catecholamines, or other biochemical assays are the safest and most reliable diagnostic methods and they have largely replaced phentolamine and other pharmaceutical tests.177 a No test, however, is completely reliable.177 a
May be used when additional confirmatory evidence of pheochromocytoma is required and potential benefits outweigh the possible risks.177 a
Test is more reliable with sustained than with paroxysmal hypertension; no diagnostic value in absence of hypertension at the time of the test.177 a
Sudden and marked reduction in BP following parenteral administration of phentolamine suggests pheochromocytoma;a however, false-negative and false-positive responses are frequent.177 a
Hypertension in Pheochromocytoma
May be administered immediately prior to or during pheochromocytomectomy to prevent or control paroxysmal hypertension resulting from anesthesia, stress, or operative manipulation of the tumor.a
Has been used to manage pheochromocytoma until surgery is performed and for prolonged treatment of hypertension when the tumor is not operable; however, phenoxybenzamine is considered the drug of choice because it has a longer duration of action.a
Hypertensive Crises
Has been used to treat hypertensive crises caused by sympathomimetic amines† (e.g., methoxamine, phenylephrine) or catecholamine excess by certain foods or drugs in patients taking MAO inhibitors† (e.g., isocarboxazid [no longer commercially available in the US], tranylcypromine), or by clonidine withdrawal syndrome†.a 180
If used, the initial goal is to reduce mean arterial BP by no more than 25% within minutes to 1 hour, followed by further reduction if stable toward 160/100 to 110 mm Hg within the next 2–6 hours, avoiding excessive declines in pressure that could precipitate renal, cerebral, or coronary ischemia.164
If this BP is well tolerated and the patient is clinically stable, may implement further gradual reductions toward normal in the next 24–48 hours.a In patients with aortic dissection, reduce systolic BP to <100 mm Hg if tolerated.a
Extravasation of Catecholamines
Used to prevent dermal necrosis and sloughing following IV administration or extravasation of norepinephrine.177 180 a
Has been used to prevent necrosis after extravasation of dopamine†.a
MI
Has been used to decrease impedance to left ventricular ejection and the infarct size in patients with MI associated with left ventricular failure†.a
However, contraindicated in patients with MI,177 a and investigators do not recommend for routine use, since left ventricular function and the ECG must be monitored continuously.a
Erectile Dysfunction
Self-injection of small doses combined with papaverine hydrochloride into the corpus cavernosum has been effective for the treatment of erectile dysfunction† (ED, impotence).103 105 106 107 108 110 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127
Combination has been effective in patients with neurogenic103 105 106 108 110 112 113 115 116 118 119 120 122 123 124 127 and/or limited vasculogenic impotence103 105 106 108 110 112 113 115 116 120 122 123 124 127 or with psychogenic impotence,105 106 108 123 124 127 but efficacy in those with a vasculogenic component of their impotence may be variable depending on the extent and type of vascular dysfunction.103 108 110 115 120 123 124
Erection, which can be potentiated by sexual arousal, usually occurs within 10 minutes after injection of the drugs and may persist for 1 to several hours;105 106 108 113 114 116 118 119 124 tolerance to the drugs may occur during long-term use;105 114 124 priapism may occur.103 105 106 107 108 110 113 115 116 124 125 126 127
Cocaine-induced Acute Coronary Syndrome
Used as an adjunct in the management of cocaine overdose† to reverse coronary vasoconstriction175 180 following use of oxygen, benzodiazepines (e.g., diazepam, lorazepam), and nitroglycerin.175
Phentolamine Mesylate Dosage and Administration
General
Diagnosis of Pheochromocytoma
Withhold sedatives, analgesics (e.g., opiates), and all other medications except essential drugs (e.g., digitalis, insulin) for at least 24 hours (preferably 48-72 hours) prior to the test.177
Withhold antihypertensive drugs until BP returns to untreated hypertensive levels.177
Before injection, the patient should rest in a supine position (preferably in a quiet, darkened room) until the BP is stabilized; read BP every 10 minutes for at least 30 minutes to establish basal BP.177 a
After insertion of needle, delay IV injection until venipuncture effect on blood pressure has passed; then inject rapidly.177 a
After IV injection, record BP immediately (at 30-second intervals for the first 3 minutes, then 1-minute intervals for the next 7 minutes).177 a
After IM administration, determine BP at 5-minute intervals for 30-45 minutes.a
Typical BP response in patients with pheochromocytoma is a decrease of 60 mm Hg systolic and 25 mm Hg diastolic within 2 minutes after IV administration or 20 minutes after IM administration.177 a BP usually returns to pretest levels within 15–30 minutes or 3–4 hours, following IV177 or IM administration, respectively.a
Positive response/test is a BP decrease ≥35 mm Hg systolic and 25 mm Hg diastolic;a negative response is when BP is unchanged, elevated, or lowered <35 mm Hg systolic and 25 mm Hg diastolic.177 a
Confirm positive response by other diagnostic procedures, preferably by measurement of urinary catecholamines or their metabolites.177
Administration
Administer usually by IV or IM injection; also may be administered by IV infusion.177 a Has been administered by intracavernous injection† for the treatment of impotence.103 105 106 107 108 110 112 113 114 115
IV administration
Reconstitution
Reconstitute vial containing 5 mg of lyophilized drug with 1 mL of sterile water to provide solution containing 5 mg of phentolamine mesylate per mL.177 a
Dilution
IV infusion: for prevention of tissue necrosis and sloughing following extravasation or IV administration of norepinephrine, may add reconstituted phentolamine mesylate to each L of solution containing norepinephrine.177 a
Rate of Administration
IV injection for pheochromocytoma test: inject rapidly.177 a
IM Administration
Reconstitution
Reconstitute vial containing 5 mg of lyophilized drug with 1 mL of sterile water to provide solution containing 5 mg of phentolamine mesylate per mL.177 a
Local Infiltration
Reconstitution
Reconstitute vial containing 5 mg of lyophilized drug with 1 mL of sterile water to provide solution containing 5 mg of phentolamine mesylate per mL.177 a
Dilution
For treatment or prevention of tissue necrosis and sloughing following extravasation of catecholamines, dilute the appropriate amount of reconstituted phentolamine mesylate in 10–15 mL of 0.9% sodium chloride injection.177 a
Dosage
Available as phentolamine mesylate; dosage expressed in terms of phentolamine mesylate.177 a
Pediatric Patients
Diagnosis of Pheochromocytoma
IV (Preferred Route)
1 mg,177 a 0.1 mg/kg, or 3 mg/m2.a
IM
3 mg.177 a
Hypertension in Pheochromocytoma
Pheochromocytomectomy
IV
Preoperative: 1 mg,177 a 0.1 mg/kg, or 3 mg/m2, 1–2 hours before surgery; may repeat if necessary.a
During surgery: 1mg,177 a 0.1 mg/kg, or 3 mg/m2.a
Postoperative: may administer norepinephrine to control hypotension (usually following complete pheochromocytoma removal);177 however, hypotension is prevented more frequently by administration of blood, plasma, or 5% albumin in 0.9% sodium chloride injection to correct the reduced blood volume.a
IM
Preoperative: 1mg,177 a 0.1 mg/kg, or 3 mg/m2, 1–2 hours before surgery; may repeat if necessary.a
Extravasation of Catecholamines
Dopamine Extravasation
Local Infiltration
Prevention of tissue necrosis and sloughing: 0.1–0.2 mg/kg (maximum 10 mg per dose).a
Immediate and conspicuous local hyperemic changes occur if the area is infiltrated within 12 hours.a
Adults
Diagnosis of Pheochromocytoma
IV (Preferred Route) or IM
5 mg.177 a
Hypertension in Pheochromocytoma
Hypertensive Crises Secondary to Catecholamine Excess
IV
Usually 5–15 mg.a
Pheochromocytomectomy
IV
Preoperative: 5 mg, 1-2 hours before surgery; repeat if necessary.177 a
During surgery, to prevent or control paroxysms of hypertension, tachycardia, respiratory depression, convulsions, or other effects of excessive epinephrine secretion due to manipulation of the tumor: 5 mg as needed.177 a
IM
Preoperative: 5 mg, 1-2 hours before surgery; repeat if necessary.177 a
Hypertensive Crises†
IV
5–15 mg has been used.a
Extravasation of Catecholamines
IV Administration or Extravasation of Norepinephrine
Local Infiltration
Treatment of tissue necrosis and sloughing: 5–10 mg (in 10–15 mL of 0.9% sodium chloride) into affected area.177 180 a
Immediate and conspicuous local hyperemic changes occur if the area is infiltrated within 12 hours; ineffective if used >12 hours after extravasation.177 a
IV Infusion
Prevention of tissue necrosis and sloughing: 10 mg added to each liter of IV fluid containing norepinephrine; pressor effect of norepinephrine is unaffected.177 a
Extravasation of Dopamine Injection†
Local Infiltration
Prevention of tissue necrosis and sloughing: 5–10 mg (in 10–15 mL of 0.9% sodium chloride) infiltrated (using a syringe with a fine hypodermic needle) liberally throughout the affected area.a
Immediate and conspicuous local hyperemic changes occur if the area is infiltrated within 12 hours.a
MI†
IV Infusion
For treatment of left ventricular failure secondary to acute MI†, dosages of 0.17–0.4 mg/minute have been used.a
Erectile Dysfunction†
Intracavernosal Self-injection
Usually 0.5–1 mg (range: 0.08–1.25 mg) combined with papaverine hydrochloride 2.5–37.5 mg has been effective. a
Tolerance with long-term use may require dosage increase.105 114 124
Prescribing Limits
Pediatric Patients
Extravasation of Catecholamines
Dopamine Extravasation
Local Infiltration
Maximum 10 mg per dose.a
Cautions for Phentolamine Mesylate
Contraindications
MI or history of MI.177 a However, results of some studies indicate that the drug may have a beneficial effect in patients with MI.a
Coronary insufficiency, angina, or other evidence suggestive of CAD.177 a
Known hypersensitivity to phentolamine, related compounds, or any ingredient in the formulation.177 a
Warnings/Precautions
Warnings
Cardiovascular Effects
Risk of MI, cerebrovascular spasm or occlusion, usually in association with marked hypotension.177 a
Risk of tachycardia, cardiac arrhythmias; defer cardiac glycoside administration until cardiac rhythm returns to normal.177
Risk of severe hypotension or other signs and symptoms of shock; treat with prompt supportive measures and norepinephrine (if necessary).a Do not administer epinephrine for hypotension since it may cause a paradoxical fall in BP.a
Diagnostic Tests for Pheochromocytoma
Phentolamine and other pharmaceutical tests no longer procedures of choice for diagnosis of pheochromocytoma; may be used when additional confirmatory evidence of pheochromocytoma is required and the potential benefits of the tests outweigh the possible risks.177 a Urinary assay of catecholamines or other biochemical assays are the safest and most reliable methods.177 a Consider that no test is completely reliable.177 a
Possible false-negative responses to phentolamine test (e.g., in patients with paroxysmal hypertension or with a pheochromocytoma not secreting enough epinephrine or norepinephrine to elevate BP or sustain an elevation).a
False-positive reactions (occurring more commonly than false-negative) reported in patients with essential hypertension, uremia, or in those who received sedatives, opiates, or antihypertensive drugs.a (See Specific Drugs under Interactions.)
Do not perform test on normotensive patients.a
Major Toxicities
Intracavernosal Therapy
Intracavernosal therapy for impotence could result in persistent priapism (a medical emergency) which requires immediate medical and/or surgical intervention.103 105 106 107 108 110 113 115 116 120 124 125 126 127 128 If not treated immediately, penile tissue damage and permanent loss of potency may occur.142 152 161 162 163
Intracavernosal therapy (administered by self-injection) may be problematic in patients receiving anticoagulants, those who cannot tolerate transient hypotension, and those with poor manual dexterity, poor vision, or severe psychiatric disease.125
General Precautions
GI Conditions
Use with caution in patients with gastritis or peptic ulcer.a
MI
Monitor left ventricular function and ECG continuously during IV infusion of the drug.a
Specific Populations
Pregnancy
Category C.177
Lactation
Not known whether phentolamine is distributed into milk.177 Discontinue nursing or the drug.177
Common Adverse Effects
Abdominal pain, nausea, vomiting, diarrhea, exacerbation of peptic ulcer, weakness, dizziness, flushing, orthostatic hypotension, and nasal congestion.177 a
Interactions for Phentolamine Mesylate
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Antihypertensive Agents | Possible false-positive test for pheochromocytomaa | Withdraw antihypertensive agents and do not perform phentolamine test until blood pressure returns to pretreatment hypertensive levelsa |
Epinephrine | Possible paradoxical fall in blood pressurea | Do not administer for phentolamine-associated hypotensiona |
Opiate analgesics | Possible false-positive test for pheochromocytomaa | Withdraw opiates ≥24 hours (preferably 48–72 hours) prior to phentolamine testa |
Rauwolfia alkaloids | Possible false-positive test for pheochromocytomaa | Withdraw rauwolfia drugs at least 4 weeks prior to phentolamine testa |
Sedatives | Possible false-positive test for pheochromocytomaa | Withdraw sedatives ≥24 hours (preferably 48–72 hours) prior to phentolamine test.a |
Phentolamine Mesylate Pharmacokinetics
Absorption
Onset
IV injection: maximum effect (in positive pheochromocytoma test) within 2 minutes.177 a
IM injection: maximum effect usually within 20 minutes.177 a
Intracavernous injection: (penile erection) within 10 minutes.105 106 108 113 114 116 118 119 124
Duration
IV injection: return to pretest BP usually within 15–30 minutes or less.a
IM injection: return to pretest BP within 3–4 hours.a
Intracavernous injection: penile erection may persist for 1 to several hours.105 106 108 113 114 116 118 119 124
Distribution
Extent
Not known whether phentolamine is distributed into milk.177 a
Elimination
Elimination Route
Excreted in urine (10–13%) as unchanged drug; the fate of the remainder is not known.177 a
Half-life
19 minutes following IV administration.177
Stability
Storage
Parenteral
Powder for Injection
15–30°C.177 a
Use reconstituted solution at time of preparation; do not store.177 a
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Drug Compatibility
Compatible |
|---|
Dobutamine HCl |
Verapamil HCl |
Compatible |
|---|
Amiodarone HCl |
ActionsActions
Competitively blocks α-adrenergic receptors (primarily excitatory responses of smooth muscle and exocrine glands), but action is transient and incomplete.a
More effective in antagonizing responses to circulating epinephrine and/or norepinephrine than in antagonizing responses to mediator released at the adrenergic nerve ending.a
Causes peripheral vasodilation and decreases peripheral resistance, primarily by direct relaxation of vascular smooth muscle, but α-adrenergic blockade also contributes to vasodilation.a
Stimulates β-adrenergic receptors and produces a positive inotropic and chronotropic effect on the cardiac muscle (increasing cardiac output)a and vascular effects on vascular smooth muscle.177
Usual doses lower BP maintained by circulating epinephrine or norepinephrine, but have little effect on the BP of healthy individuals or patients with essential hypertension.a
In patients with AMI associated with hypertension and/or left ventricular failure, administration of IV phentolamine results in improvement in left ventricular performance; cardiac output, stroke index, heart rate, and cardiac index are increased and left ventricular filling pressure is decreased.a
Advice to Patients
Advise patients (using intracavernosal therapy for impotence) to contact their clinician if they develop a persistent (e.g., longer than 4 hours) erection during such therapy.132 133
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.177 a
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection | 5 mg* | Phentolamine Mesylate for Injection |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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