ORAVERSE Solution for injection (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Septodont, Inc.

Λέξεις κλειδιά

0362-0101

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1. Indications and Usage

OraVerse an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated ...

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 ...

3. Dosage Forms and Strengths

0.4 mg/1.7 mL solution per cartridge.

4. Contraindications

OraVerse is contraindicated in patients with: hypersensitivity to the active substance or to any ingredients in the formulation.

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 ...

6. Adverse Reactions

In clinical trials, the most common adverse reaction with OraVerse that was greater than the control group was injection site pain. 6.2 Adverse Reactions in Clinical Trials Adverse reactions reported by ...

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 ...

7. Drug Interactions

There are no known drug interactions with OraVerse. 7.1 Lidocaine and Epinephrine When OraVerse was administered as an intraoral submucosal injection 30 minutes after injection of a local anesthetic, 2% ...

8.1. Pregnancy

Pregnancy Category C. Risk summary There are no available data with OraVerse in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal toxicology studies, phentolamine ...

8.2. Lactation

Risk Summary There is no information regarding the presence of phentolamine in human milk, the effects on the breastfed infant or the effects on milk production. The developmental and health benefits of ...

8.4. Pediatric Use

The safety and efficacy of OraVerse has not been established in patients younger than 3 years. The safety and effectiveness of OraVerse in pediatric patients ages 3 years and older is supported by evidence ...

8.5. Geriatric Use

Of the total number of patients in clinical studies of OraVerse, 55 were 65 and over, while 21 were 75 and over. No overall differences in safety or effectiveness were observed between these patients and ...

10. Overdosage

No deaths due to acute poisoning with phentolamine have been reported. Overdosage with parenterally administered phentolamine is characterized chiefly by cardiovascular disturbances, such as arrhythmias, ...

11. Description

Phentolamine mesylate is phenol,3-[[(4,5-dihydro-1<em>H</em>-imidazol-2-yl)methyl](4-methyl-phenyl)amino]-,methanesulfonate (salt), a non-specific alpha adrenergic blocker. Phentolamine mesylate USP is ...

12.1. Mechanism of Action

The mechanism by which OraVerse accelerates reversal of soft-tissue anesthesia and the associated functional deficits is not fully understood. Phentolamine mesylate, the active ingredient in OraVerse, ...

12.3. Pharmacokinetics

Following OraVerse administration, phentolamine is 100% available from the submucosal injection site and peak concentrations are achieved 10-20 minutes after injection. Phentolamine systemic exposure increased ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Carcinogenic studies with OraVerse have not been conducted. Mutagenesis Phentolamine was not mutagenic in the in-vitro bacterial reverse mutation (Ames) assay. In the in-vitro chromosomal ...

14. Clinical Studies

The safety and efficacy of OraVerse when used for reversal of soft-tissue anesthesia (STA), i.e., anesthesia of the lips and tongue following a dental procedure that required local anesthesia containing ...

16.1. How Supplied

OraVerse (phentolamine mesylate) Injection 0.4 mg/1.7 mL is supplied in a dental cartridge, in cartons of 10 and 50 cartridges. Each cartridge is individually packaged in a separate compartment of a 10 ...

16.2. Storage and Handling

Store at controlled room temperature, 20-25°C (68-77°F) with brief excursions permitted between 15-30°C (59-86°F) (see USP Controlled Room Temperature) Protect from direct heat and light. Do not permit ...

17. Patient Counseling Information

Patients should be instructed not to eat or drink until normal sensation returns.