ORABLOC- articaine hydrochloride and epinephrine bitartrate injection

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ARTICAINE HYDROCHLORIDE (UNII: QS9014Q792) (ARTICAINE - UNII:D3SQ406G9X), EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH)

Verfügbar ab:

Pierrel S.p.A.

INN (Internationale Bezeichnung):

ARTICAINE HYDROCHLORIDE

Zusammensetzung:

ARTICAINE HYDROCHLORIDE 40 mg in 1 mL

Verabreichungsweg:

SUBMUCOSAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

ORABLOC is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older. ORABLOC is contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people [see Warnings and Precautions (5.5)] . Teratogenic Effects-Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women with articaine with epinephrine. Articaine hydrochloride and epinephrine (1:100,000) has been shown to increase fetal deaths and skeletal variations in rabbits when given in doses approximately 4 times the maximum recommended human dose (MRHD). ORABLOC should be used during pregnancy only if the potential benefit justifies the potentia

Produktbesonderheiten:

ORABLOC® (articaine hydrochloride and epinephrine) injection is a clear, colorless solution available in 1.8 mL single-dose glass cartridges, packaged in boxes of 50 and 100 cartridges in the following two strengths (less than a full cartridge or more than one cartridge may be used for an individual patient): Both products are formulated with a 10% overage of epinephrine. Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Do not freeze.

Berechtigungsstatus:

New Drug Application

Fachinformation

ORABLOC- ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION
PIERREL S.P.A.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORABLOC® SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ORABLOC®.
ORABLOC® (ARTICAINE HCL AND EPINEPHRINE) INJECTION, FOR INTRAORAL
SUBMUCOSAL INFILTRATION USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Methemoglobinemia (5.4) 11/2018
INDICATIONS AND USAGE
ORABLOC is a combination of articaine HCl, an amide local anesthetic,
and epinephrine, a vasoconstrictor, indicated for
local, infiltrative, or conductive anesthesia in both simple and
complex dental procedures in adults and pediatric patients 4
years of age and older (1).
DOSAGE AND ADMINISTRATION
For dental procedures by intraoral submucosal infiltration or nerve
block (2.1):
For infiltration: 0.5 mL-2.5 mL (20 mg-100 mg articaine HCl) (2.1)
For nerve block: 0.5 mL-3.4 mL (20 mg-136 mg articaine HCl) (2.1)
For oral surgery: 1 ml-5.1 mL (40 mg-204 mg articaine HCl) (2.1)
For most routine dental procedures, ORABLOC containing epinephrine
1:200,000 is preferred. However, when more
pronounced homeostasis or improved visualization of the surgical field
are required, ORABLOC containing epinephrine
1:100,000 may be used. (2.1)
Maximum recommended dosages (2.2):
Healthy adults: 7 mg/kg of articaine HCl and 0.0017mg/kg of
epinephrine (equivalent to 0.175 mL/kg for either
product presentation, articaine HCl and epinephrine 1:100,000 or
1:200,000)
Pediatric patients 4-16 years: 7 mg/kg of articaine HCl and
0.0017mg/kg of epinephrine (equivalent to 0.175 mL/kg
for either product presentation, articaine HCl and epinephrine
1:100,000 or 1:200,000)
DOSAGE FORMS AND STRENGTHS
Injection provided in glass cartridges (single-dose) containing:
Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000 (as
epinephrine bitartrate 0.009 mg/mL) (3)
Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000 (as
epinephrine bitart