CARBOCAINE- mepivacaine hydrochloride injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

MEPIVACAINE HYDROCHLORIDE (UNII: 4VFX2L7EM5) (MEPIVACAINE - UNII:B6E06QE59J)

Tillgänglig från:

Hospira, Inc.

INN (International namn):

MEPIVACAINE HYDROCHLORIDE

Sammansättning:

MEPIVACAINE HYDROCHLORIDE 10 mg in 1 mL

Administreringssätt:

EPIDURAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

CARBOCAINE is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. The routes of administration and indicated concentrations for CARBOCAINE are: local infiltration 0.5% (via dilution) or 1% peripheral nerve blocks 1% and 2% epidural block 1%, 1.5%, 2% caudal block 1%, 1.5%, 2% See DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of CARBOCAINE. CARBOCAINE is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of solutions of CARBOCAINE.

Produktsammanfattning:

Single-dose vials and multiple-dose vials of CARBOCAINE may be sterilized by autoclaving at 15 pound pressure, 121°C (250°F) for 15 minutes. Solutions of CARBOCAINE may be reautoclaved when necessary. Do not administer solutions which are discolored or which contain particulate matter. THESE SOLUTIONS ARE NOT INTENDED FOR SPINAL ANESTHESIA OR DENTAL USE For single-dose vials: Discard unused portion. Store at 20 to 25°C (68 to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0996-4.0 11/2018

Bemyndigande status:

New Drug Application

Produktens egenskaper

CARBOCAINE- MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
CARBOCAINE
MEPIVACAINE HYDROCHLORIDE INJECTION, USP
These solutions are not intended for spinal anesthesia or dental use
Rx only
_DESCRIPTION_
Mepivacaine hydrochloride is 2-Piperidinecarboxamide,
_N_-(2,6-dimethylphenyl)-1-methyl,
monohydrochloride and has the following structural formula:
C
H
N O • HCl
It is a white crystalline odorless powder, soluble in water, but very
resistant to both acid
and alkaline hydrolysis.
CARBOCAINE is a local anesthetic available as sterile isotonic
solutions (clear, colorless)
in concentrations of 1%, 1.5%, and 2% for injection via local
infiltration, peripheral nerve
block, and caudal and lumbar epidural blocks.
Mepivacaine hydrochloride is related chemically and pharmacologically
to the amide-type
local anesthetics. It contains an amide linkage between the aromatic
nucleus and the
amino group.
COMPOSITION OF AVAILABLE SOLUTIONS
1%
Single-Dose
30 mL Vial
mg/mL
1%
Multiple-Dose
50 mL Vial
mg/mL
1.5%
Single-Dose
30 mL Vial
mg/mL
2%
Single-Dose
20 mL Vial
mg/mL
2%
Multiple-Dose
50 mL Vial
mg/mL
TM
15
22
2
*
*
Mepivacaine
hydrochloride
10
10
15
20
20
Sodium chloride
6.6
7
5.6
4.6
5
Potassium chloride
0.3
0.3
0.3
Calcium chloride
0.33
0.33
0.33
Methylparaben
1
1
_CLINICAL PHARMACOLOGY_
Local anesthetics block the generation and the conduction of nerve
impulses,
presumably by increasing the threshold for electrical excitation in
the nerve, by slowing
the propagation of the nerve impulse and by reducing the rate of rise
of the action
potential. In general, the progression of anesthesia is related to the
diameter,
myelination, and conduction velocity of affected nerve fibers.
Clinically, the order of loss
of nerve function is as follows: pain, temperature, touch,
proprioception, and skeletal
muscle tone.
Systemic absorption of local anesthetics produces effects on the
cardiovascular and
central nervous systems (CNS). At blood concentrations achieved with
normal
therapeutic doses, changes in cardiac cond