ZORCAINE- articaine hydrochloride and epinephrine bitartrate injection, solution

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:

Carestream Health, Inc.

INN (International Name):

Articaine hydrochloride

Composition:

Articaine hydrochloride 40 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZorcaineTM , an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. Zorcaine 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 Zorcaine. 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). Zorcaine should be used during pregnancy only if the potential benefit justifies the potential risk to th

Product summary:

Zorcaine™ (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: • Zorcaine™ containing articaine HCl 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL) (NDC 31382-830-50) 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. 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.

Authorization status:

New Drug Application

Summary of Product characteristics

ZORCAINE- ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
CARESTREAM HEALTH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZORCAINE
SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZORCAINE™.
INITIAL U.S. APPROVAL: 2000
ZORCAINE™ (ARTICAINE HCL AND EPINEPHRINE) INJECTION;
INTRAORAL SUBMUCOSAL INJECTION
ARTICAINE HYDROCHLORIDE 4% AND EPINEPHRINE 1:100,000
ARTICAINE HYDROCHLORIDE 4% AND EPINEPHRINE 1:200,000
INDICATIONS AND USAGE
Zorcaine
, 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 hydrochloride 4%
containing epinephrine 1:200,000 is preferred.
However, when more pronounced hemostasis or improved visualization of
the surgical field are required, Zorcaine™
containing epinehrine 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 be associated with convulsions
followed by coma and respiratory arr