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Duranest

Drug Description
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DURANEST INJECTIONS FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also ADVERSE REACTIONS and PRECAUTIONS). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST, AND POSSIBLY DEATH.

DRUG DESCRIPTION

Duranest (Etidocaine HCl) Injections are sterile aqueous solutions that contain a local anesthetic agent and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The specific quantitative composition of each available solution is shown in Table 1.

Duranest Injections contain Etidocaine HCl, which is chemically designated as butanamide, N-(2,6-dimethylphenyl)-2-(ethylpropylamine)-, monohydrochloride and Epinephrine which is (-)-3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl alcohol. Chemical structure is as follows:

The PKa of etidocaine (7.74) is similar to that of lidocaine (7.86). However, etidocaine possesses a greater degree of lipid solubility and protein binding capacity than does lidocaine. Duranest Injections are sterile and, except for the 1.5% concentration, are available with or without epinephrine 1:200,000. Single dose containers of Duranest Injection without epinephrine may be reautoclaved it necessary.

See Table 1 for composition of available injections.

Table1. Composition of Available Injections

Product Identification
Formula

Duranest (etidocaine HCl) Concentration % (mg/mL) 

Epinephrine Dilution (as the bitartrate) (mg/mL)

pH

Sodium chloride (mg/mL)

Single Dose Vials/Dental Cartridge Sodium metabisulfite (mg/mL)

Citric acid (mg/mL)

1.0

(10)

None

4.0- 5.0 

7.1

None

 

1.0

(1.0)

1 :200,000 (0.005 mg/mL)

3.0- 4.5

7.1

0.5

0.2

1.5

(1.5)

1 :200,000 (0.005 mg/mL)

3.0- 4.5

6.2

0.5

0.2


NOTE: pH of all solutions adjusted with sodium hydroxide and/ or hydrochloric acid. Duranest dental cartridges are only available as 1.5% solution with epinephrine 1:200,000. Filled under nitrogen.

Brand Name: Duranest
Generic Name: Etidocaine HCl

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