LIGNOSPAN STANDARD- lidocaine hydrochloride and epinephrine injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)

थमां उपलब्ध:

Septodont, Inc.

INN (इंटरनेशनल नाम):

Lidocaine Hydrochloride

रचना:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

प्रशासन का मार्ग:

SUBMUCOSAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

LIGNOSPAN 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. LIGNOSPAN 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.

उत्पाद समीक्षा:

- LIGNOSPAN FORTE (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 0362-1096-70). - LIGNOSPAN STANDARD (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 0362-1095-60). 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

LIGNOSPAN STANDARD- LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION,
SOLUTION
SEPTODONT, INC.
----------
LIGNOSPAN  (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION,
U.S.P.)
LIGNOSPAN FORTE (LIDOCAINE HCL 2% (34 MG/1.7 ML) (20 MG/ML) AND
EPINEPHRINE 1:50,000 INJECTION)
LIGNOSPAN STANDARD (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
LIGNOSPAN FORTE and LIGNOSPAN STANDARD 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). LIGNOSPAN 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 • HCl •
H 0 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
COMPOSITION OF THE LIGNOSPAN 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)
LIGNOSPAN
FORTE
2
1:50,000
6.5
1.2
0.25
LlGNOSPAN
STANDARD
2
1:100,000
6.5
1.2
0.25
The pH of the LIGNOSPAN FORTE and the LIGNOSPAN STANDARD solutions are
adjusted to USP limits with sodium hydroxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the
initiation and conduction of nerve impulses, thereby effecting local
anesthetic action.
ONSET AND DURATION OF ANESTHESIA
When used for infiltration anesthesia in dental patients, the time of
onset averages less
than two minutes for each of the two forms of LIGNOSPAN. LIGNOSPAN
FOR