ARTICAINE HYDROCHLORIDE AND EPINEPHRINE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Articaine Hydrochloride (UNII: QS9014Q792) (Articaine - UNII:D3SQ406G9X), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)

Tilgjengelig fra:

Henry Schein

INN (International Name):

Articaine Hydrochloride

Sammensetning:

Articaine Hydrochloride 40 mg in 1 mL

Administreringsrute:

SUBCUTANEOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Articaine HCl and Epinephrine, an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. Articaine HCl and Epinephrine 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 HCl and 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). Articaine HCl and Epinephrine should be used

Produkt oppsummering:

Articaine HCl and Epinephrine Injection is available in 1.7 mL single use glass cartridges, packaged in boxes of 50 cartridges in the following two strengths: Articaine HCl 4% and Epinephrine, 1:100,000 with Monoject Disposable Dental Injector (Articaine Hydrochloride and Epinephrine) Injection Solution is available in cardbord boxes containing 30 disposable single use injectors, each containing a single 1.7 mL cartridge (NDC 0404-6620-30) Storage and Handling Store at controlled room temperature 25°C (77°F) with brief excursions permitted between 15° and 30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from light. Do Not Freeze. Limited only to cartridges when sold without dental injector: For chemical disinfection of the carpule, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. Many commercially available brands of isopropyl (rubbing) alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and therefore are not to be used. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Autorisasjon status:

New Drug Application

Preparatomtale

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE- ARTICAINE HYDROCHLORIDE AND
EPINEPHRINE INJECTION, SOLUTION
HENRY SCHEIN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARTICAINE HCL AND EPINEPHRINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARTICAINE HCL AND
EPINEPHRINE.
ARTICAINE HYDROCHLORIDE 4% AND EPINEPHRINE 1:200,000
ARTICAINE HYDROCHLORIDE 4% AND EPINEPHRINE 1:100,000
(ARTICAINE HCL AND EPINEPHRINE) INJECTION; INTRAORAL SUBMUCOSAL
INJECTION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Articaine HCl and Epinephrine, an amide local anesthetic containing a
vasoconstrictor, is indicated for local, infiltrative, or
conductive anesthesia in both simple and complex dental procedures.
(1)
DOSAGE AND ADMINISTRATION
For dental injection by submucosal infiltration or nerve block. (2.1)
For infiltration: 0.5-2.5 mL (20-100 mg articaine HCl) (2.1)
For nerve block: 0.5-3.4 mL (20-136 mg articaine HCl) (2.1)
For oral surgery: 1.0-5.1 mL (40-204 mg articaine HCl) (2.1)
For most routine dental procedures, Articaine HCl and Epinephrine
containing 1:200,000 is preferred. However, when
more pronounced hemostasis or improved visualization of the surgical
field are required, Articaine HCl and Epinephrine
containing epinephrine 1:100,000 may be used. (2.1)
Dosages should be reduced in pediatric patients, elderly patients, and
patients with cardiac or liver disease. (2.1)
Maximum recommended dosages (2.2):
Adults: 7 mg/kg (0.175 mL/kg)
Children 4-16 years: 7 mg/kg (0.175 mL/kg), depending on the age,
weight and magnitude of the operation.
DOSAGE FORMS AND STRENGTHS
Injection (clear colorless solution), 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 bitartrate 0.018 mg/mL) (3)
CONTRAINDICATIONS
KNOWN HYPERSENSITIVITY TO SULFITE. (4)
WARNINGS AND PRECAUTIONS
ACCIDENTAL INTRAVASCULAR INJECTION: May b