8024-20 CONTINUOUS EPIDURAL 17G TUOHY- anesthesia conduction kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Available from:

Smiths Medical ASD, Inc.

INN (International Name):

EPINEPHRINE

Composition:

EPINEPHRINE 1 mg in 1 mL

Therapeutic indications:

Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal conge

Product summary:

Lidocaine Hydrochloride and Epinephrine Injection, USP is supplied in single-dose and multiple-dose containers as shown below: NDC No. Container Size Drug Concentration Lidocaine HCl Epinephrine Single-dose 0409-3181-01 Fliptop Vial 30 mL 1.5% 1:200,000 0409-3183-01 Fliptop Vial 20 mL 2% 1:200,000 Epidural Test Dose (single-dose) 0409-1209-01 Ampul 5 mL 1.5% 1:200,000 0409-1209-05 Ampul 5 mL 1.5% 1:200,000 0409-1209-65 Ampul 5 mL 1.5% 1:200,000 Multiple-dose 0409-3177-01 Fliptop Vial 50 mL 0.5% 1:200,000 0409-3178-01 Fliptop Vial 20 mL 1% 1:100,000 0409-3178-02 Fliptop Vial 30 mL 1% 1:100,000 0409-3178-03 Fliptop Vial 50 mL 1% 1:100,000 0409-3182-01 Fliptop Vial 20 mL 2% 1:100,000 0409-3182-02 Fliptop Vial 30 mL 2% 1:100,000 0409-3182-03 Fliptop Vial 50 mL 2% 1:100,000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Revised: 9/2015                                                                           EN-4048 Hospira, Inc., Lake Forest, IL 60045 USA          Unit of Sale Total Strength/ Total Volume (Concentration) Each NDC 0409-7241-61  Case of 800 1 mg/mL NDC 0409-7241-60 1 mL single dose Ampule Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Revised: 11/2015                                                                                  EN-4114                                                                    Hospira, Inc., Lake Forest, IL 60045 USA              Lidocaine Hydrochloride Injection, USP is supplied as follows: Unit of Sale Concentration Each Single-dose NDC 0409-4278-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4278-16 Glass Teartop Vial NDC 0409-4713-02 Carton of 25 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-12 Glass Ampul NDC 0409-4713-32 Carton of 50 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-42 Glass Ampul NDC 0409-4713-62 Case of 800 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-72 Glass Ampul NDC 0409-4713-65 Case of 800 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-75 Glass Ampul NDC 0409-4279-02 Carton of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4279-16 Glass Teartop Vial NDC 0409-4270-01 Case of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4270-11 Sterile Glass Teartop Vial NDC 0409-4776-01 Carton of 25 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4776-10 Glass Ampul NDC 0409-4056-01 Carton of 5 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4056-11 Sterile Glass Ampul NDC 0409-4282-01 Bundle of 25 2% 40 mg/2 mL (20mg/mL) NDC 0409-4282-11 Glass Ampul NDC 0409-4282-02 Carton of 25 2% 200 mg/10 mL (20 mg/mL) NDC 0409-4282-12 Glass Ampul Unit of Sale Concentration Each Multiple-dose: NDC 0409-4275-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4275-16 Plastic Fliptop Vial NDC 0409-4276-01 Tray of 25 1% 200 mg/20 mL (10 mg/mL) NDC 0409-4276-16 Plastic Fliptop Vial NDC 0409-4276-02 Tray of 25 1% 500 mg/50 mL (10 mg/mL) NDC 0409-4276-17 Plastic Fliptop Vial NDC 0409-4277-01 Tray of 25 2% 400 mg/20 mL (20 mg/mL) NDC 0409-4277-16 Plastic Fliptop bottle NDC 0409-4277-02 Tray of 25 2% 1000 mg/50 mL (20 mg/mL) NDC 0409-4277-17 Plastic Fliptop Vial Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: 1/2015                                                                               EN-3679 Hospira, Inc., Lake Forest, IL 60045 USA      5 mL ampuls packaged in box of 25 each (NDC-65282-1505-1) 10 mL ampuls packaged in box of 25 each (NDC-65282-1510-1)

Authorization status:

Premarket Notification

Summary of Product characteristics

8024-20 CONTINUOUS EPIDURAL 17G TUOHY- ANESTHESIA CONDUCTION KIT
SMITHS MEDICAL ASD, INC.
----------
For Infiltration and Nerve Block.
Ampul
Fliptop Vial
Multiple-dose Fliptop Vial
Protect from light.
Rx only
Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile,
nonpyrogenic solution of
lidocaine hydrochloride and epinephrine in water for injection for
parenteral administration in
various concentrations with characteristics as follows:
Concentration
Lidocaine HCl
Epinephrine
Lidocaine HCl
(anhyd.) mg/mL
Epinephrine
mcg/mL
Sodium Chloride
mg/mL
0.5%
1:200,000
5
5
8
1%
1:200,000
10
5
7
1.5%
1:200,000
15
5
6.5
2%
1:200,000
20
5
6
1%
1:100,000
10
10
7
2%
1:100,000
20
10
6
Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL
added as stabilizers. The
headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen
gassed. May contain sodium
hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to
5.5). See HOW SUPPLIED section
for various sizes and strengths.
Multiple-dose vials contain methylparaben 1 mg/mL added as
preservative.
Single-dose ampuls and vials contain no bacteriostat or antimicrobial
agent. Discard unused portion.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated
2-(diethyl-amino)-2’,6’-acetoxylidide
monohydrochloride monohydrate, a white powder freely soluble in water.
It has the following
structural formula:
Epinephrine, USP is a sympathomimetic (adrenergic) agent designated
chemically as 4-[1-hydroxy-2
(methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline
powder. It has the following structural
formula:
Mechanism of action: Lidocaine stabilizes the neuronal membrane by
inhibiting the ionic fluxes required
for the initiation and conduction of impulses, thereby effecting local
anesthetic action.
Hemodynamics: Excessive blood levels may cause changes in cardiac
output, total peripheral
resistance, and mean arterial pressure. With central neural blockade
these changes may be attributable to