ARTICAINE HCL AND EPINEPHRINE- articaine hydrochloride and epinephrine bitartrate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Safco Dental Supply Co.

INN (International Name):

ARTICAINE HYDROCHLORIDE

Composition:

ARTICAINE HYDROCHLORIDE 40 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 and 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 given in doses approximately 4 times the maximum recommended human dose (MRHD). Articaine HCl and Epinephrine should be used dur

Product summary:

Articaine HCl and Epinephrine (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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ARTICAINE HCL AND EPINEPHRINE- ARTICAINE HYDROCHLORIDE AND EPINEPHRINE
BITARTRATE INJECTION
SAFCO DENTAL SUPPLY CO.
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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 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
Articaine HCl and Epinephrine 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, 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 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
e