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Oraverse (Phentolamine Mesylate) - Summary



Phentolamine mesylate is phenol,3-[[(4,5-dihydro-1 H -imidazol-2-yl)methyl](4-methyl-phenyl)amino]-,methanesulfonate (salt), a non-specific alpha adrenergic blocker. OraVerse (phentolamine mesylate) Injection is a clear, colorless, sterile, non pyrogenic, isotonic, preservative free solution. Each 1.7 mL cartridge contains 0.4 mg phentolamine mesylate, D-mannitol, edetate disodium, and sodium acetate. Either acetic acid or sodium hydroxide is used as necessary to adjust the pH.

OraVerse is indicated for reversal of the soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).
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Published Studies Related to Oraverse (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.

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Clinical Trials Related to Oraverse (Phentolamine)

Study of OraVerse´┐Ż for Safety and Efficacy in Pediatric Dental Patients [Completed]
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.

The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Complaints [Completed]
Night vision complaints such as glare, starburst and halo are often a result of peripheral corneal aberrations that cause light scatter when the pupil dilates in mesopic or scotopic conditions. Modest reductions in pupil size achieved pharmacologically may reduce the light scatter in dim light situations.

Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer [Completed]
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 grafting. 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.

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)?

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 patients.

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Page last updated: 2008-11-03

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