REGITINE SUMMARY
Regitine®
Regitine, phentolamine mesylate for injection, USP, is an antihypertensive, available in vials for intravenous and intramuscular administration.
Regitine 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.
Regitine is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.
Regitine is also indicated for the diagnosis of pheochromocytoma by the Regitine blocking test.
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NEWS HIGHLIGHTS
Published Studies Related to Regitine (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 Regitine (Phentolamine)
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).
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
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.
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.
Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures [Completed]
This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled
study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11
years of age. NV-101 or sham injection is administered at the completion of a dental
procedure requiring local anesthesia with 2% lidocaine with 1: 100,000 epinephrine. The dental
procedure(s) shall be performed in a single quadrant of the mouth and include cavity
preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing),
or crowns.
Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Maxillary Procedures [Completed]
This Phase 3 clinical study is designed as a multicenter, randomized, blinded, controlled
study to evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a
submucosal injection following completion of a restorative or periodontal maintenance
procedure requiring local anesthesia with an agent containing a vasoconstrictor. Local
vasodilatation that results in more rapid clearance of the anesthetic is the proposed
mechanism of action.
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