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John A Yagiela - One of the best experts on this subject based on the ideXlab platform.

  • what s new with Phentolamine Mesylate a reversal agent for local anaesthesia
    SAAD digest, 2011
    Co-Authors: John A Yagiela
    Abstract:

    Abstract Phentolamine Mesylate (OraVerse), a nonselective a-adrenergic blocking drug, is the first therapeutic agent marketed for the reversal of soft-tissue anaesthesia and the associated functional deficits resulting from an intraoral submucosal injection of a local anaesthetic containing a vasoconstrictor. In clinical trials, Phentolamine injected in doses of 0.2 to 0.8 mg (0.5 to 2 cartridges), as determined by patient age and volume of local anaesthetic administered, significantly hastened the return of normal soft-tissue sensation in adults and children 6 years of age and older. Median lip recovery times were reduced by 75 to 85 minutes. Functional deficits, such as drooling and difficulty in drinking, smiling, or talking--and subjects' perception of altered function or appearance--were consistently resolved by the time sensation to touch had returned to normal. Adverse effects of Phentolamine injected in approved doses for reversal of local anaesthesia in patients ranging in age from 4 to 92 years were similar in incidence to those of sham injections, and no serious adverse events caused by such use were reported. The clinical use of Phentolamine is viewed favorably by dentists who have administered the drug and by patients who have received it. Optimal use may require some modifications of the technique described in the package insert; cost of the agent may be influencing its widespread adoption into clinical practice. Phentolamine Mesylate, in the form of OraVerse (Novalar Pharmaceuticals, San Diego, USA) represents a new therapeutic class of drugs in dentistry intended to reverse soft-tissue anaesthesia after nonsurgical dental procedures (e.g., restorative or deep scaling/root planing procedures). As shown in Figure 1, OraVerse is manufactured in 1.7 mL dental cartridges, each of which contains 0.4 mg active drug. This review describes the development of Phentolamine as a dental drug, its pharmacologic characteristics, and how it may be used in clinical practice to improve patient care.

  • reversal of soft tissue local anesthesia with Phentolamine Mesylate in pediatric patients
    Journal of the American Dental Association, 2008
    Co-Authors: Mary Tavares, Laura Navalta, John A Yagiela, Max J Goodson, Bruce Rutherford, Deborah Studenpavlovich, Siegfried Rogy, Sharon M Gordon, Athena Papas
    Abstract:

    ABSTRACT Background The authors evaluated the safety and efficacy of a formulation of Phentolamine Mesylate (PM) as a local anesthesia reversal agent for pediatric patients. Methods A total of 152 pediatric subjects received injections of local anesthetic with 2 percent lidocaine and 1:100,000 epinephrine before undergoing dental procedures. The authors then randomized subjects to receive a PM injection or a control injection (sham injection in which a needle does not penetrate the tissue) in the same sites as the local anesthetic was administered in a 1:1 cartridge ratio after the procedure was completed. Over a two- to-four-hour period, they measured the duration of soft-tissue anesthesia and evaluated vital signs, pain and adverse events. Results The median recovery time to normal lip sensation was 60 minutes for the subjects in the PM group versus 135 minutes for subjects in the control group. The authors noted no differences in adverse events, pain, analgesic use or vital signs, and no subjects failed to complete the study. 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
    Journal of the American Dental Association, 2008
    Co-Authors: Elliot V Hersh, John A Yagiela, Paul A Moore, Athena Papas, Max J Goodson, Bruce Rutherford, Siegfried Rogy, Laura A Mavalta, Jeffrey Bennett, Hafsteinn Eggertsson
    Abstract:

    ABSTRACT 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. Methods On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection. The investigators measured the duration of soft-tissue anesthesia by using standardized lip- and tongue-tapping procedures every five minutes for five hours. They also evaluated functional measures and subject-perceived altered function, sensation, appearance and safety. Results Median recovery times in the lower lip and tongue for subjects in the PM group were 70 minutes and 60 minutes, respectively. Median recovery times in the lower lip and tongue for subjects in the sham group were 155 minutes and 125 minutes, respectively. Upper lip median recovery times were 50 minutes for subjects in the PM group and 133 minutes for subjects in the sham group. These differences were significant ( P 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.

  • randomized study of Phentolamine Mesylate for reversal of local anesthesia
    Journal of Dental Research, 2008
    Co-Authors: M Laviola, S K Mcgavin, G A Freer, G Plancich, S C Woodbury, S Marinkovich, R Morrison, A Reader, R B Rutherford, John A Yagiela
    Abstract:

    Local anesthetic solutions frequently contain vasoconstrictors to increase the depth and/or duration of anesthesia. Generally, the duration of soft-tissue anesthesia exceeds that of pulpal anesthesia. Negative consequences of soft-tissue anesthesia include accidental lip and tongue biting as well as difficulty in eating, drinking, speaking, and smiling. A double-blind, randomized, multicenter, Phase 2 study tested the hypothesis that local injection of the vasodilator Phentolamine Mesylate would shorten the duration of soft-tissue anesthesia following routine dental procedures. Participants (122) received one or two cartridges of local anesthetic/vasoconstrictor prior to dental treatment. Immediately after treatment, 1.8 mL of study drug (containing 0.4 mg Phentolamine Mesylate or placebo) was injected per cartridge of local anesthetic used. The Phentolamine was well-tolerated and reduced the median duration of soft-tissue anesthesia in the lip from 155 to 70 min (p < 0.0001).

  • pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with Phentolamine Mesylate
    Anesthesia Progress, 2008
    Co-Authors: Paul A Moore, Bruce I Rutherford, Elliot V Hersh, John A Yagiela, Athena Papas, Max J Goodson, Laura Navalta
    Abstract:

    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. Assessments of the pharmacokinetics of lidocaine and Phentolamine, and the impact of Phentolamine on the pharmacokinetics of lidocaine with epinephrine were performed to characterize this potentially valuable strategy. The blood levels of Phentolamine were determined following its administration intraorally and intravenously. Additionally, the effects of Phentolamine Mesylate on the pharmacokinetics of intraoral injections of lidocaine with epinephrine were evaluated. Sixteen subjects were enrolled in this phase 1 trial, each receiving 4 drug treatments: 1 cartridge lidocaine/epinephrine followed after 30 minutes by 1 cartridge Phentolamine (1L1P), 1 cartridge Phentolamine administered intravenously (1Piv), 4 cartridges lidocaine/epinephrine followed after 30 minutes by 2 cartridges Phentolamine (4L2P), and 4 cartridges lidocaine/epinephrine followed by no Phentolamine (4L). Pharmacokinetic parameters estimated for Phentolamine, lidocaine, and epinephrine included peak plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the plasma concentration-time curve from 0 to the last time point (AUClast) or from time 0 to infinity (AUCinf), elimination half-life (t1/2), clearance (CL), and volume of distribution (Vd). The Phentolamine Tmax occurred earlier following the intravenous administration of 1Piv (7 minutes than following its submucosal administration in treatment 1L1P (15 minutes) or 4L2P (11 minutes). The Phentolamine t1/2, CL, and Vd values were similar for 1L1P, 1Piv, and 4L2P. The Tmax for lidocaine occurred later and the Cmax for lidocaine was slightly higher when comparing the 4L2P treatment and the 4L treatment. The Phentolamine-induced delay of the lidocaine Tmax likely represents Phentolamine's ability to accelerate the systemic absorption of lidocaine from oral tissues into the systemic circulation.

Elliot V Hersh - One of the best experts on this subject based on the ideXlab platform.

  • phase four randomized double blinded controlled trial of Phentolamine Mesylate in two to five year old dental patients
    Pediatric Dentistry, 2017
    Co-Authors: Elliot V Hersh, R Lindemeyer, J H Berg, Adrian Marberger, J. Chin, Paul S. Casamassimo, Matthew Hutcheson, Paul A Moore
    Abstract:

    The purpose of this study was to evaluate, using a randomized, double-blind methodology: (1) the safety of Phentolamine Mesylate (Oraverse) in accelerating the recovery of soft tissue anesthesia following the injection of two percent lidocaine plus 1:100,000 epinephrine in two- to five-year-olds; and (2) efficacy in four- to five-year-olds only.One hundred fifty pediatric dental patients underwent routine dental restorative procedures with two percent lidocaine plus 1:100,000 epinephrine with doses based on body weight. Phentolamine Mesylate or a sham injection (two to one ratio) was then administered. Subjects were monitored for safety and, in four- to five-year-olds, for efficacy during the two-hour evaluation period.There were no significant differences in adverse events between the Phentolamine and sham injections. Compared to sham, Phentolamine was not associated with nerve injury, increased analgesic use, or abnormalities of the oral cavity. Phentolamine was associated with transient decreased blood pressure in some children. In four- and five-year-olds, Phentolamine induced more rapid recovery of lip anesthesia by 48 minutes (P<0.0001).Phentolamine was well tolerated and safe in three- to five-year-olds; in four- to five-year-olds, a statistically significant more rapid recovery of lip sensation compared to sham injections was determined.

  • Phase Four, Randomized, Double-Blinded, Controlled Trial of Phentolamine Mesylate in Two- to Five-year-old Dental Patients.
    Pediatric Dentistry, 2017
    Co-Authors: Elliot V Hersh, R Lindemeyer, Adrian Marberger, Paul S. Casamassimo, Matthew Hutcheson, Joel Berg, Judith R Chin, Paul A Moore
    Abstract:

    PURPOSE: The purpose of this study was to evaluate, using a randomized, double-blind methodology: (1) the safety of Phentolamine Mesylate (Oraverse) in accelerating the recovery of soft tissue anesthesia following the injection of two percent lidocaine plus 1:100,000 epinephrine in two- to five-year-olds; and (2) efficacy in four- to five-year-olds only. METHODS: One hundred fifty pediatric dental patients underwent routine dental restorative procedures with two percent lidocaine plus 1:100,000 epinephrine with doses based on body weight. Phentolamine Mesylate or a sham injection (two to one ratio) was then administered. Subjects were monitored for safety and, in four- to five-year-olds, for efficacy during the two-hour evaluation period. RESULTS: There were no significant differences in adverse events between the Phentolamine and sham injections. Compared to sham, Phentolamine was not associated with nerve injury, increased analgesic use, or abnormalities of the oral cavity. Phentolamine was associated with transient decreased blood pressure in some children. In four- and five-year-olds, Phentolamine induced more rapid recovery of lip anesthesia by 48 minutes (P

  • Phentolamine Mesylate for accelerating recovery from lip and tongue anesthesia
    Dental Clinics of North America, 2010
    Co-Authors: Elliot V Hersh, R Lindemeyer
    Abstract:

    : Phentolamine Mesylate, at dosages from 0.4 to 0.8 mg in adults and adolescents and at dosages from 0.2 to 0.4 mg in children aged 4 to 11 years, has been proven to be safe and effective for the reversal of soft tissue anesthesia (lip and tongue numbness) and the associated functional deficits resulting from a local dental anesthetic injection containing a vasoconstrictor. Its ability to block a-adrenergic receptors on blood vessels induces vasodilation and enhances the redistribution of the local anesthetic away from the injection site. The low dosages administered for dental local anesthetic reversal in all likelihood accounts for the lack of significant cardiovascular effects that are associated with the medical use of the drug for hypertensive conditions associated with catecholamine excess.

  • Phentolamine Mesylate for accelerating recovery from lip and tongue anesthesia
    Dental Clinics of North America, 2010
    Co-Authors: Elliot V Hersh, R Lindemeyer
    Abstract:

    Phentolamine Mesylate, marketed under the proprietary name OraVerse, was granted Food and Drug Administration (FDA) approval on May 12, 2008 with an indication for the reversal of soft tissue anesthesia (lip and tongue numbness) and the associated functional deficits resulting from a local dental anesthetic containing a vasoconstrictor. This approved FDA indication does not include the use of this drug in children younger than 6 years or weighing less than 15 kg (33 lb) because of a lack of research in this younger age group. Phentolamine was originally developed for the treatment of hypertension and is still used off-label to treat hypertensive crises (characterized by catecholamine excess) by administering an intravenous bolus dose of 5 to 15 mg. Such hypertensive emergencies include drug (indirect sympathomimetics such as pseudoephedrine) and food interactions (those containing tyramine) with monoamine oxidase inhibitors, cocaine toxicity, and amphetamine overdose. The

  • reversal of soft tissue local anesthesia with Phentolamine Mesylate in adolescents and adults
    Journal of the American Dental Association, 2008
    Co-Authors: Elliot V Hersh, John A Yagiela, Paul A Moore, Athena Papas, Max J Goodson, Bruce Rutherford, Siegfried Rogy, Laura A Mavalta, Jeffrey Bennett, Hafsteinn Eggertsson
    Abstract:

    ABSTRACT 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. Methods On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection. The investigators measured the duration of soft-tissue anesthesia by using standardized lip- and tongue-tapping procedures every five minutes for five hours. They also evaluated functional measures and subject-perceived altered function, sensation, appearance and safety. Results Median recovery times in the lower lip and tongue for subjects in the PM group were 70 minutes and 60 minutes, respectively. Median recovery times in the lower lip and tongue for subjects in the sham group were 155 minutes and 125 minutes, respectively. Upper lip median recovery times were 50 minutes for subjects in the PM group and 133 minutes for subjects in the sham group. These differences were significant ( P 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.

Athena Papas - One of the best experts on this subject based on the ideXlab platform.

  • reversal of soft tissue local anesthesia with Phentolamine Mesylate in adolescents and adults
    Journal of the American Dental Association, 2008
    Co-Authors: Elliot V Hersh, John A Yagiela, Paul A Moore, Athena Papas, Max J Goodson, Bruce Rutherford, Siegfried Rogy, Laura A Mavalta, Jeffrey Bennett, Hafsteinn Eggertsson
    Abstract:

    ABSTRACT 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. Methods On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection. The investigators measured the duration of soft-tissue anesthesia by using standardized lip- and tongue-tapping procedures every five minutes for five hours. They also evaluated functional measures and subject-perceived altered function, sensation, appearance and safety. Results Median recovery times in the lower lip and tongue for subjects in the PM group were 70 minutes and 60 minutes, respectively. Median recovery times in the lower lip and tongue for subjects in the sham group were 155 minutes and 125 minutes, respectively. Upper lip median recovery times were 50 minutes for subjects in the PM group and 133 minutes for subjects in the sham group. These differences were significant ( P 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.

  • reversal of soft tissue local anesthesia with Phentolamine Mesylate in pediatric patients
    Journal of the American Dental Association, 2008
    Co-Authors: Mary Tavares, Laura Navalta, John A Yagiela, Max J Goodson, Bruce Rutherford, Deborah Studenpavlovich, Siegfried Rogy, Sharon M Gordon, Athena Papas
    Abstract:

    ABSTRACT Background The authors evaluated the safety and efficacy of a formulation of Phentolamine Mesylate (PM) as a local anesthesia reversal agent for pediatric patients. Methods A total of 152 pediatric subjects received injections of local anesthetic with 2 percent lidocaine and 1:100,000 epinephrine before undergoing dental procedures. The authors then randomized subjects to receive a PM injection or a control injection (sham injection in which a needle does not penetrate the tissue) in the same sites as the local anesthetic was administered in a 1:1 cartridge ratio after the procedure was completed. Over a two- to-four-hour period, they measured the duration of soft-tissue anesthesia and evaluated vital signs, pain and adverse events. Results The median recovery time to normal lip sensation was 60 minutes for the subjects in the PM group versus 135 minutes for subjects in the control group. The authors noted no differences in adverse events, pain, analgesic use or vital signs, and no subjects failed to complete the study. 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.

  • pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with Phentolamine Mesylate
    Anesthesia Progress, 2008
    Co-Authors: Paul A Moore, Bruce I Rutherford, Elliot V Hersh, John A Yagiela, Athena Papas, Max J Goodson, Laura Navalta
    Abstract:

    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. Assessments of the pharmacokinetics of lidocaine and Phentolamine, and the impact of Phentolamine on the pharmacokinetics of lidocaine with epinephrine were performed to characterize this potentially valuable strategy. The blood levels of Phentolamine were determined following its administration intraorally and intravenously. Additionally, the effects of Phentolamine Mesylate on the pharmacokinetics of intraoral injections of lidocaine with epinephrine were evaluated. Sixteen subjects were enrolled in this phase 1 trial, each receiving 4 drug treatments: 1 cartridge lidocaine/epinephrine followed after 30 minutes by 1 cartridge Phentolamine (1L1P), 1 cartridge Phentolamine administered intravenously (1Piv), 4 cartridges lidocaine/epinephrine followed after 30 minutes by 2 cartridges Phentolamine (4L2P), and 4 cartridges lidocaine/epinephrine followed by no Phentolamine (4L). Pharmacokinetic parameters estimated for Phentolamine, lidocaine, and epinephrine included peak plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the plasma concentration-time curve from 0 to the last time point (AUClast) or from time 0 to infinity (AUCinf), elimination half-life (t1/2), clearance (CL), and volume of distribution (Vd). The Phentolamine Tmax occurred earlier following the intravenous administration of 1Piv (7 minutes than following its submucosal administration in treatment 1L1P (15 minutes) or 4L2P (11 minutes). The Phentolamine t1/2, CL, and Vd values were similar for 1L1P, 1Piv, and 4L2P. The Tmax for lidocaine occurred later and the Cmax for lidocaine was slightly higher when comparing the 4L2P treatment and the 4L treatment. The Phentolamine-induced delay of the lidocaine Tmax likely represents Phentolamine's ability to accelerate the systemic absorption of lidocaine from oral tissues into the systemic circulation.

R Lindemeyer - One of the best experts on this subject based on the ideXlab platform.

  • phase four randomized double blinded controlled trial of Phentolamine Mesylate in two to five year old dental patients
    Pediatric Dentistry, 2017
    Co-Authors: Elliot V Hersh, R Lindemeyer, J H Berg, Adrian Marberger, J. Chin, Paul S. Casamassimo, Matthew Hutcheson, Paul A Moore
    Abstract:

    The purpose of this study was to evaluate, using a randomized, double-blind methodology: (1) the safety of Phentolamine Mesylate (Oraverse) in accelerating the recovery of soft tissue anesthesia following the injection of two percent lidocaine plus 1:100,000 epinephrine in two- to five-year-olds; and (2) efficacy in four- to five-year-olds only.One hundred fifty pediatric dental patients underwent routine dental restorative procedures with two percent lidocaine plus 1:100,000 epinephrine with doses based on body weight. Phentolamine Mesylate or a sham injection (two to one ratio) was then administered. Subjects were monitored for safety and, in four- to five-year-olds, for efficacy during the two-hour evaluation period.There were no significant differences in adverse events between the Phentolamine and sham injections. Compared to sham, Phentolamine was not associated with nerve injury, increased analgesic use, or abnormalities of the oral cavity. Phentolamine was associated with transient decreased blood pressure in some children. In four- and five-year-olds, Phentolamine induced more rapid recovery of lip anesthesia by 48 minutes (P<0.0001).Phentolamine was well tolerated and safe in three- to five-year-olds; in four- to five-year-olds, a statistically significant more rapid recovery of lip sensation compared to sham injections was determined.

  • Phase Four, Randomized, Double-Blinded, Controlled Trial of Phentolamine Mesylate in Two- to Five-year-old Dental Patients.
    Pediatric Dentistry, 2017
    Co-Authors: Elliot V Hersh, R Lindemeyer, Adrian Marberger, Paul S. Casamassimo, Matthew Hutcheson, Joel Berg, Judith R Chin, Paul A Moore
    Abstract:

    PURPOSE: The purpose of this study was to evaluate, using a randomized, double-blind methodology: (1) the safety of Phentolamine Mesylate (Oraverse) in accelerating the recovery of soft tissue anesthesia following the injection of two percent lidocaine plus 1:100,000 epinephrine in two- to five-year-olds; and (2) efficacy in four- to five-year-olds only. METHODS: One hundred fifty pediatric dental patients underwent routine dental restorative procedures with two percent lidocaine plus 1:100,000 epinephrine with doses based on body weight. Phentolamine Mesylate or a sham injection (two to one ratio) was then administered. Subjects were monitored for safety and, in four- to five-year-olds, for efficacy during the two-hour evaluation period. RESULTS: There were no significant differences in adverse events between the Phentolamine and sham injections. Compared to sham, Phentolamine was not associated with nerve injury, increased analgesic use, or abnormalities of the oral cavity. Phentolamine was associated with transient decreased blood pressure in some children. In four- and five-year-olds, Phentolamine induced more rapid recovery of lip anesthesia by 48 minutes (P

  • Phentolamine Mesylate for accelerating recovery from lip and tongue anesthesia
    Dental Clinics of North America, 2010
    Co-Authors: Elliot V Hersh, R Lindemeyer
    Abstract:

    : Phentolamine Mesylate, at dosages from 0.4 to 0.8 mg in adults and adolescents and at dosages from 0.2 to 0.4 mg in children aged 4 to 11 years, has been proven to be safe and effective for the reversal of soft tissue anesthesia (lip and tongue numbness) and the associated functional deficits resulting from a local dental anesthetic injection containing a vasoconstrictor. Its ability to block a-adrenergic receptors on blood vessels induces vasodilation and enhances the redistribution of the local anesthetic away from the injection site. The low dosages administered for dental local anesthetic reversal in all likelihood accounts for the lack of significant cardiovascular effects that are associated with the medical use of the drug for hypertensive conditions associated with catecholamine excess.

  • Phentolamine Mesylate for accelerating recovery from lip and tongue anesthesia
    Dental Clinics of North America, 2010
    Co-Authors: Elliot V Hersh, R Lindemeyer
    Abstract:

    Phentolamine Mesylate, marketed under the proprietary name OraVerse, was granted Food and Drug Administration (FDA) approval on May 12, 2008 with an indication for the reversal of soft tissue anesthesia (lip and tongue numbness) and the associated functional deficits resulting from a local dental anesthetic containing a vasoconstrictor. This approved FDA indication does not include the use of this drug in children younger than 6 years or weighing less than 15 kg (33 lb) because of a lack of research in this younger age group. Phentolamine was originally developed for the treatment of hypertension and is still used off-label to treat hypertensive crises (characterized by catecholamine excess) by administering an intravenous bolus dose of 5 to 15 mg. Such hypertensive emergencies include drug (indirect sympathomimetics such as pseudoephedrine) and food interactions (those containing tyramine) with monoamine oxidase inhibitors, cocaine toxicity, and amphetamine overdose. The

Mary Tavares - One of the best experts on this subject based on the ideXlab platform.

  • Phentolamine Mesylate may be a safe and effective option to reduce discomfort and time to recovery after dental care with local anesthesia
    Journal of Evidence Based Dental Practice, 2018
    Co-Authors: Mohammad Helmi, Muath Aldosari, Mary Tavares
    Abstract:

    Article Title and Bibliographic Information Effectiveness and safety of Phentolamine Mesylate in routine dental care. Daublander M, Liebaug F, Niedeggen G, Theobald K, Kurzinger M-L. J Am Dent Assoc 2017; 148(3):149-56. Source of Funding The study was funded by Sanofi-Aventis Deutschland, Berlin, Germany Type of Study/Design Two study designs were used: a prospective noninterventional, postauthorization efficacy (controlled observational) study, and a prospective noninterventional uncontrolled observational study

  • reversal of soft tissue local anesthesia with Phentolamine Mesylate in pediatric patients
    Journal of the American Dental Association, 2008
    Co-Authors: Mary Tavares, Laura Navalta, John A Yagiela, Max J Goodson, Bruce Rutherford, Deborah Studenpavlovich, Siegfried Rogy, Sharon M Gordon, Athena Papas
    Abstract:

    ABSTRACT Background The authors evaluated the safety and efficacy of a formulation of Phentolamine Mesylate (PM) as a local anesthesia reversal agent for pediatric patients. Methods A total of 152 pediatric subjects received injections of local anesthetic with 2 percent lidocaine and 1:100,000 epinephrine before undergoing dental procedures. The authors then randomized subjects to receive a PM injection or a control injection (sham injection in which a needle does not penetrate the tissue) in the same sites as the local anesthetic was administered in a 1:1 cartridge ratio after the procedure was completed. Over a two- to-four-hour period, they measured the duration of soft-tissue anesthesia and evaluated vital signs, pain and adverse events. Results The median recovery time to normal lip sensation was 60 minutes for the subjects in the PM group versus 135 minutes for subjects in the control group. The authors noted no differences in adverse events, pain, analgesic use or vital signs, and no subjects failed to complete the study. 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.