8284-20 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:

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 congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine Injection can be utilized to prolong the action of anesthetics used in local and regional anesthesia. Epinephrine is co

Product summary:

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                 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) 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                      

Authorization status:

Premarket Notification

Summary of Product characteristics

8284-20 CONTINUOUS EPIDURAL 17G TUOHY- ANESTHESIA CONDUCTION KIT
SMITHS MEDICAL ASD, INC.
----------
EPINEPHRINE
Injection, USP
1 mg/mL
Ampul
Protect from light until ready to use.
Rx only
Epinephrine Injection, USP 1 mg/mL is a sterile, nonpyrogenic
solution. Each mL contains epinephrine 1
mg; sodium chloride 9 mg; sodium metabisulfite 0.9 mg added. May
contain hydrochloric acid for pH
adjustment.
The solution contains no bacteriostat or antimicrobial agent. It is
administered by the following routes:
intravenous, intracardiac (left ventricular chamber), via endotracheal
tube into the bronchial tree,
subcutaneous or intramuscular.
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:
Sodium Chloride, USP is chemically designated NaCl, a white,
crystalline compound freely soluble in
water.
The actions of epinephrine resemble the effects of stimulation of
adrenergic nerves. To a variable
degree it acts on both alpha and beta receptor sites of sympathetic
effector cells. Its most prominent
actions are on the beta receptors of the heart, vascular and other
smooth muscle. When given by rapid
intravenous injection, it produces a rapid rise in blood pressure,
mainly systolic, by (1) direct
stimulation of cardiac muscle which increases the strength of
ventricular contraction, (2) increasing the
heart rate and (3) constriction of the arterioles in the skin, mucosa
and splanchnic areas of the
circulation.
When given by slow intravenous injection epinephrine usually produces
only a moderate rise in systolic
and a fall in diastolic pressure. Although some increase in pulse
pressure occurs, there is usually no
great elevation in mean blood pressure. Accordingly, the compensatory
reflex mechanisms that come
into play with a pronounced increase in blood pressure do not
antagonize the direct cardiac actions of
epinephrine as much as with catecholamines that have a predominan