ARTICAINE HYDROCHLORIDE AND EPINEPHRINE- articaine hydrochloride, epinephrine bitartrate injection, solution ARTICAINE HYDROCHL

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:

Midway Dental Supply, LLC

Administreringsrute:

SUBMUCOSAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. 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 with epinephrine. Articaine hydrochloride and epinephrine (1:100,000) has been shown to increase fetal deaths and skeletal variations in rabbits when gi

Produkt oppsummering:

Articaine HCl 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): • Articaine HCl 4% (40 mg/mL) and epinephrine 1:200,000 (as epinephrine bitartrate 0.09 mg/mL): - NDC 72304-016-00 (50 cartridges/box) • Articaine HCl 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL): - NDC 72304-015-00 (50 cartridges/box), 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.

Autorisasjon status:

New Drug Application

Preparatomtale

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE- ARTICAINE HYDROCHLORIDE,
EPINEPHRINE BITARTRATE INJECTION, SOLUTION
MIDWAY DENTAL SUPPLY, LLC
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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 1:100,000 INJECTION
ARTICAINE HYDROCHLORIDE 4% AND EPINEPHRINE 1:200,000 INJECTION
(ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION), FOR INTRAORAL
SUBMUCOSAL INFILTRATION USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS, Methemoglobinemia (5.4)
INDICATIONS AND USAGE
Articaine HCl and Epinephrine is a combination of articaine HCl, an
amide local anesthetic, and
epinephrine, a vasoconstrictor, is indicated for local, infiltrative,
or conductive anesthesia in both simple
and complex dental procedures in adults and pediatric patients 4 years
of age or older (1). (1)
DOSAGE AND ADMINISTRATION
• For dental procedures by intraoral submucosal infltration or nerve
block (2.1):
- For infltration: 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, Articaine HCl and Epinephrine
containing epinephrine 1:200,000 is
preferred. However, when more pronounced homeostasis or improved
visualization of the surgical field are
required, Articaine HCl and Epinephrine 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