oraverse- Phentolamine mesylate injection, solution for submucosal use

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Phentolamine mesylate (UNII: Y7543E5K9T) (phentolamine - UNII:Z468598HBV)

Disponible depuis:

Novalar Pharmaceuticals

DCI (Dénomination commune internationale):

Phentolamine mesylate

forme pharmaceutique:

INJECTION, SOLUTION

Composition:

0.4 mg in 1.7 mL

Mode d'administration:

SUBMUCOSAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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). None. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. OraVerse should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of phentolamine to pregnant rats and mice at doses at least 24 times the recommended dose (based on a 60 kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses. Immaturity was manifested by increased incidence of incomplete or unossified calcaneal and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral phentolamine doses at least 60 times the recommended dose (ba

Descriptif du produit:

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 1500-0101-01 NDC 1500-0101-02 Store at controlled room temperature, 20-25C (68-77F) with brief excursions permitted between 15-30C (59-86F) (see USP Controlled Room Temperature). Protect from direct heat and light. Do not permit to freeze. Manufactured by Novocol Pharmaceutical of Canada, Incorporated Cambridge, Ontario, Canada for Novalar Pharmaceuticals, Inc. San Diego, CA, 92130 US Patent Nos.: 6,764,678; 6,872,390; 7,229,630 Trademark of Novalar Pharmaceuticals, Inc.

Résumé des caractéristiques du produit

ORAVERSE- PHENTOLAMINE MESYLATE INJECTION, SOLUTION
NOVALAR PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
INDICATIONS AND USAGE
OraVerse is indicated 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.
OraVerse is not recommended for use in children less than 6 years of
age or weighing less than 15 kg (33 lbs). ( 1)
DOSAGE AND ADMINISTRATION
AMOUNT OF LOCAL
ANESTHETIC ADMINISTERED
DOSE OF
ORAVERSE
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
None ( 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 arrhythmias may 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)
USE IN SPECIFIC POPULATIONS
Use in pediatric patients less than 6 years of age or <15 kg (33 lbs)
is not recommended. (8.4)
In pediatric patients weighing less than 30 kg (66 lbs), the maximum
dose of OraVerse recommended is 1/2 cartridge
(0.2 mg). (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2008
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Dosing in Special Populations
3 DOSAGE FORMS AND STRENGTHS
4 CONT