XYLOCAINE- lidocaine hydrochloride and epinephrine bitartrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH)

Available from:

Dentsply Pharmaceutical

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Administration route:

SUBMUCOSAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended. 2% Xylocaine DENTAL is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations.

Product summary:

- 2% Xylocaine DENTAL with Epinephrine 1:50,000 (Lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges (NDC 66312-181-16). - 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges (NDC 66312-176-16). Store at controlled room temperature, below 25°C (77°F). Protect from light. Do not permit to freeze. BOXES : For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the end flap. Do not use if color is pinkish or darker than slightly yellow or if it contains a precipitate.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

XYLOCAINE- LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
INJECTION,
SOLUTION
DENTSPLY PHARMACEUTICAL
----------
2% XYLOCAINE
DENTAL WITH EPINEPHRINE 1:50,000
(LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP)
LIDOCAINE HCL 2% (34 MG/1.7 ML) (20 MG/ML) AND EPINEPHRINE 1:50,000
INJECTION
2% XYLOCAINE
DENTAL WITH EPINEPHRINE 1:100,000
(LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP)
LIDOCAINE HCL 2% (34 MG/1.7 ML) (20 MG/ML) AND EPINEPHRINE 1:100,000
INJECTION
RX ONLY
SOLUTIONS FOR LOCAL ANESTHESIA IN DENTISTRY
DESCRIPTION
2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL
with
Epinephrine 1:100,000 are sterile isotonic solutions containing a
local anesthetic agent,
Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as
bitartrate) and are
administered parenterally by injection. Both solutions are available
in single dose
cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses).
2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is
chemically
designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride,
and has the following structural formula:
C
H
N O • HCI • H O
M.W. 288.8
Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl
alcohol and has the
following structural formula:
14
22
2
2
C H
NO M.W.
183.21
The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits
with sodium
hydroxide.
COMPOSITION OF THE 2% XYLOCAINE DENTAL INJECTIONS
BRAND NAME
PRODUCT
IDENTIFICATION
FORMULA
SINGLE DOSE CARTRIDGE
Lidocaine
hydrochloride
Epinephrine
(as the
bitartrate)
Sodium
Chloride
Potassium
metabisulfite
Edetate
Disodium
Concentration
%
Dilution
(mg/mL)
(mg/mL)
(mg/mL)
2% Xylocaine Dental with
Epinephrine 1:50,000
2
1:50,000
6.5
1.2
0.25
2% Xylocaine Dental with
Epinephrine 1:100,000
2
1:100,000
6.5
1.2
0.25
The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits
with sodium
hydroxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic