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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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Media Articles Related to Oraverse (Phentolamine)

Studies reveal how anesthesia's brain effects differ in older adults and in children
Source: Pain / Anesthetics News From Medical News Today [2015.08.14]
Age-related EEG patterns correspond with neurophysiological changes associated with development, agingRecent Massachusetts General Hospital (MGH) investigations into the neurobiology underlying...

Surgery Patients Might Not Need Sedative Before Anesthesia
Source: MedicineNet lorazepam Specialty [2015.03.04]
Title: Surgery Patients Might Not Need Sedative Before Anesthesia
Category: Health News
Created: 3/3/2015 12:00:00 AM
Last Editorial Review: 3/4/2015 12:00:00 AM

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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 [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.

The Effect of Alfa-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure [Recruiting]
The activity of the sympathetic nervous system seems to influence the uptake (and handling) of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is increased seem to inhibit/reduce forearm glucose uptake. Inversely a decrease in sympathetic activity seems to increase glucose uptake. This study analyzes the effect of alfa-adrenergic receptor blockade (counteracting sympathetic influence) on insulin-stimulated forearm glucose uptake in patients with increased sympathetic activity (patients with chronic heart failure).

Assessment of the Functional Significance of Accessory Pudendal Arteries [Recruiting]
For patients with Prostate Cancer advances in medical technology have enabled us to identify "accessory" (additional) pudendal arteries (called APA) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). APAs running near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These arteries are preserved more than 80% of the time, depending on their size and location. With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied.

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Page last updated: 2015-08-14

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