FOR INJECTION, USP
Phentolamine Mesylate for Injection USP, is an antihypertensive, available in vials for intravenous and intramuscular administration.
Phentolamine Mesylate for Injection is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision.
Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.
Phentolamine Mesylate for Injection is also indicated for the diagnosis of pheochromocytoma by the phentolamine blocking test.
Published Studies Related to Phentolamine
Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients. [2008.08]
BACKGROUND: The authors evaluated the safety and efficacy of a formulation of phentolamine mesylate (PM) as a local anesthesia reversal agent for pediatric patients... CONCLUSIONS: PM was well-tolerated and safe in children 4 to 11 years of age, and it accelerated the reversal of soft-tissue local anesthesia after a dental procedure in children 6 to 11 years of age. CLINICAL IMPLICATIONS: PM can help dental clinicians shorten the post-treatment duration of soft-tissue anesthesia and can reduce the number of posttreatment lip and tongue injuries in children.
Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. [2008.08]
BACKGROUND: The authors conducted two multicenter, randomized, double-blinded, controlled Phase III clinical trials to study the efficacy and safety of phentolamine mesylate (PM) in shortening the duration and burden of soft-tissue anesthesia. The study involved 484 subjects who received one of four commercially available local anesthetic solutions containing vasoconstrictors for restorative or scaling procedures... CONCLUSIONS: PM was efficacious and safe in reducing the duration of local anesthetic- induced soft-tissue numbness and its associated functional deficits. CLINICAL IMPLICATIONS: Clinicians can use PM to accelerate reversal of soft-tissue anesthesia and the associated functional deficits.
Pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with phentolamine mesylate. [2008.06]
Phentolamine mesylate accelerates recovery from oral soft tissue anesthesia in patients who have received local anesthetic injections containing a vasoconstrictor. The proposed mechanism is that phentolamine, an alpha-adrenergic antagonist, blocks the vasoconstriction associated with the epinephrine used in dental anesthetic formulations, thus enhancing the systemic absorption of the local anesthetic from the injection site...
Injection therapy for the treatment of erectile dysfunction: a comparison between alprostadil and a combination of vasoactive intestinal polypeptide and phentolamine mesilate. [2007.10]
OBJECTIVE: To compare two injectable treatments, alprostadil 5-20 microg powder for injection and a combination of vasoactive intestinal polypeptide (VIP) and phentolamine in patients with erectile dysfunction (ED)... CONCLUSIONS: VIP/phentolamine and alprostadil were effective treatments for ED, however the VIP/phentolamine combination was preferred by more patients, which may be because it was much less likely to cause pain.
Assessment of the efficacy of phentolamine to prevent radial artery spasm during cardiac catheterization procedures: a randomized study comparing phentolamine vs. verapamil. [2005.10]
The objective of this study was to evaluate phentolamine as radial artery spasmolytic in transradial catheterization procedures.
Clinical Trials Related to Phentolamine
Study of OraVerse� for Safety and Efficacy in Pediatric Dental Patients [Recruiting]
The purpose of this study is to determine whether OraVerse is safe and effective for the
reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) [Recruiting]
ENCHANTED is an independent, investigator initiated, international collaborative,
quasi-factorial randomised controlled trial involving a package of 2 linked comparative
randomised treatment arms, which aims to address 4 key questions in patients eligible for
thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0. 6 mg/kg)
intravenous (i. v.) recombinant tissue plasminogen activator (rtPA) provide equivalent
benefits compared to standard-dose (0. 9 mg/kg) rtPA? (2) Does intensive blood pressure (BP)
lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline
recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0. 6 mg/kg)
intravenous (i. v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of
symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering
to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial [Recruiting]
The purpose of this academic lead study is to determine if a treatment strategy of early
intensive blood pressure (BP) lowering compared to conservative BP lowering policy in
patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage
(ICH) improves the outcome of death and disability at 3 months after onset.
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer [Active, not recruiting]
RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard
therapies for erectile dysfunction may be effective in helping patients with prostate cancer
improve sexual satisfaction and quality of life. It is not yet known whether erectile
dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve
PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to
see how well they work compared to standard therapy alone in treating erectile dysfunction in
patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.
Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage [Completed]
The purpose of the study is to determine whether lowering high blood pressure levels after
the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce
the chances of a person dying or surviving with a long term disability. The study will be
undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000