OraVerse

ORAVERSE- phentolamine mesylate injection, solution
Novalar Pharmaceuticals

1 INDICATIONS AND USAGE

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).

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

The recommended dose of OraVerse is based on the number of cartridges of local anesthetic with vasoconstrictor administered:

Amount of Local
Anesthetic Administered
Dose of OraVerse
[mg]
Dose of OraVerse
[Cartridge]
½ Cartridge 0.2 ½
1 Cartridge 0.4 1
2 Cartridges 0.8 2

OraVerse should be administered following the dental procedure using the same location(s) and technique(s) (infiltration or block injection) employed for the administration of the local anesthetic.

Note: Do not administer OraVerse if the product is discolored or contains particulate matter.

2.2 Dosing in Special Populations

In pediatric patients weighing 15-30 kg, the maximum dose of OraVerse recommended is 1/2 cartridge (0.2 mg).

(Note: Use in pediatric patients under 6 years of age or weighing less than 15 kg (33 lbs) is not recommended. A dose of more than 1 cartridge [0.4 mg] of OraVerse has not been studied in children less than 12 years of age.)

3 DOSAGE FORMS AND STRENGTHS

0.4 mg/1.7 mL solution per cartridge

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Events

Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the parenteral administration of phentolamine. These events usually occurred in association with marked hypotensive episodes producing shock-like states.

Tachycardia and cardiac arrhythmias may occur with the use of phentolamine or other alpha-adrenergic blocking agents. Although such effects are uncommon after administration of OraVerse, clinicians should be alert to the signs and symptoms of these events, particularly in patients with a prior history of cardiovascular disease.

6 ADVERSE REACTIONS

In clinical trials, the most common adverse reaction with OraVerse that was greater than the control group was injection site pain.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Dental patients were administered a dose of either 0.2, 0.4 or 0.8 mg of OraVerse. The majority of adverse reactions were mild and resolved within 48 hours. There were no serious adverse reactions and no discontinuations due to adverse reactions.

Table 1 lists adverse reactions where the frequency was greater than or equal to 3% in any OraVerse dose group and was equal to or exceeded that of the control group.

Table 1: Adverse Reactions with Frequency Greater Than or Equal to 3% and Equal to or Exceeding Control
Adverse Event OraVerse Control
0.2 mg
(N = 83)
0.4 mg
(N = 284)
0.8 mg
(N = 51)
Total
(N = 418)
Total
(N = 359)
N (%) N (%) N (%) N (%) N (%)
Patients with AEs 15 (18) 82 (29) 20 (39) 117 (28) 96 (27)
Tachycardia 0 (0) 17 (6) 2 (4) 19 (5) 20 (6)
Bradycardia 0 (0) 5 (2) 2 (4) 7 (2) 1 (0.3)
Injection site pain 5 (6) 15 (5) 2 (4) 22 (5) 14 (4)
Post procedural pain 3 (4) 17 (6) 5 (10) 25 (6) 23 (6)
Headache 0 (0) 10 (4) 3 (6) 13 (3) 14 (4)

An examination of population subgroups did not reveal a differential adverse reaction incidence on the basis of age, gender, or race.

Results from the pain assessments in Study 1 and Study 2, involving mandibular and maxillary procedures, respectively, indicated that the majority of dental patients in both OraVerse and control groups experienced no or mild oral pain, with less than 10% of patients in each group reporting moderate oral pain with a similar distribution between the OraVerse and control groups. No patient experienced severe pain in these studies.

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