ORAVERSE- phentolamine mesylate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Phentolamine Mesylate (UNII: Y7543E5K9T) (Phentolamine - UNII:Z468598HBV)

Available from:

Septodont, Inc.

INN (International Name):

Phentolamine Mesylate

Composition:

Phentolamine Mesylate 0.235 mg in 1 mL

Administration route:

SUBMUCOSAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OraVerse is contraindicated in patients with: Hypersensitivity to the active substance or to any ingredients in the formulation 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 administered orally to pregnant mice and rats during the period of organogenesis resulted in skeletal immaturity and decreased growth in the offspring at doses at least 24-times the recommended dose. Additionally, a lower rate of implantation was seen in pregnant rats treated with phentolamine at least 60-times the recommended dose. No malformations or embryofetal deaths were observed in the offspring of pregnant mice, rats, and rabbits administered phentolamine during the period of organogenesis at doses 24-, 60-, and 20-times, respectively, the recommended dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is

Product summary:

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 cartridge blister pack. NDC 0362-0101-50 NDC 0362-0101-10 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 to freeze.

Authorization status:

New Drug Application

Summary of Product characteristics

ORAVERSE- PHENTOLAMINE MESYLATE INJECTION, SOLUTION
SEPTODONT, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORAVERSE™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ORAVERSE.
ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION
INITIAL U.S. APPROVAL: 1952
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 functional deficits resulting from an
intraoral submucosal injection of a local anesthetic containing a
vasoconstrictor. (1)
DOSAGE AND ADMINISTRATION
AMOUNT OF LOCAL ANESTHETIC
ADM INISTE RE D
DOSE OF ORAVERSE
/
Cartridge
/
Cartridge (0.1 mg)
½ Cartridge
½ Cartridge (0.2 mg)
1 Cartridge
1 Cartridge (0.4 mg)
2 Cartridges
2 Cartridges (0.8 mg)
OraVerse is administered using the same location(s) and same
technique(s) (infiltration or block injection) used for the
administration of local anesthetic. (2.1)
DOSAGE FORMS AND STRENGTHS
0.4 mg/1.7 mL solution per cartridge (3)
CONTRAINDICATIONS
OraVerse is contraindicated in patients with:
Hypersensitivity to the active substance or to any ingredients in the
formulation. (4)
WARNINGS AND PRECAUTIONS
Myocardial infarction, cerebrovascular spasm, and cerebrovascular
occlusion have been reported to occur following the
intravenous or intramuscular administration of phentolamine, usually
in association with marked hypotensive episodes or
shock-like states which occasionally follow parenteral administration.
Tachycardia and cardiac arrhythmiasmay occur with the use of
phentolamine or other alpha-adrenergic blocking agents.
(5.1)
ADVERSE REACTIONS
The most common adverse reaction with OraVerse (incidence ≥5% and >
control) is injection-site pain. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SEPTODONT AT
1-888-888-1441 OR FDA AT 1-800-FDA-
1088 OR _WWW.FDA.GOV/MEDWATCH_.
USE IN SPECIFIC POPULATIONS
Use in pedi