ULTACAN- articaine hydrochloride, epinephrine bitartrate injection, solution ULTACAN FORTE- articaine hydrochloride, epinephrin

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:

HANSAmed, Inc.

INN (International Name):

ARTICAINE HYDROCHLORIDE

Sammensetning:

ARTICAINE HYDROCHLORIDE 40 mg in 1 mL

Administreringsrute:

SUBMUCOSAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ultacan® and Ultacan® forte, an amide local anesthetic containing a vasoconstrictor, are indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. Ultacan®  and Ultacan® forte are 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 4% with epinephrine. Articaine hydrochloride 4% 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). Ultacan® or Ultacan® forte should be us

Produkt oppsummering:

Ultacan®  and Ultacan® forte (articaine HCl 4% and epinephrine injection, USP) are available in 1.7 mL single use glass cartridges, packaged in boxes of 10 cartridges in the following two strengths: Or, packaged in boxes of 50 cartridges in the following two strengths: Or, packaged in boxes of 100 cartridges in the following two strengths: Storage and Handling Store at 20° to 25°C (68° to 77°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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ULTACAN- ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION,
SOLUTION
ULTACAN FORTE- ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
HANSAMED, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULTACAN® AND ULTACAN® FORTE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ULTACAN® AND
ULTACAN® FORTE.
ULTACAN® AND ULTACAN® FORTE (ARTICAINE HCL 4% AND EPINEPHRINE
INJECTION, USP); INTRAORAL SUBMUCOSAL
INJECTION
ARTICAINE HYDROCHLORIDE 4% AND EPINEPHRINE 1:200,000
ARTICAINE HYDROCHLORIDE 4% AND EPINEPHRINE 1:100,000
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Ultacan® and Ultacan® forte, an amide local anesthetic containing a
vasoconstrictor, are 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, Ultacan® containing epinephrine
1:200,000 is preferred. However, when more
pronounced hemostasis or improved visualization of the surgical field
are required, Ultacan® 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