Label: A1285 PEDIATRIC/CAUDAL/EPIDURAL 20G TUOHY - regional anesthesia kit   

  • NDC Code(s): 0409-7241-61, 51688-8295-2, 52380-0001-3
  • Packager: Smiths Medical ASD, Inc.
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 11/12

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  • DESCRIPTION

    EPINEPHRINE injection, USP

    1:1000 (1 mg/mL)

    Ampul
    Protect from light until ready to use.

    Rx only

    Description

    Epinephrine Injection, USP 1:1000 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:

    Epinephrine Structural Formula

    Sodium Chloride, USP is chemically designated NaCl, a white, crystalline compound freely soluble in water.

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  • CLINICAL PHARMACOLOGY

    Clinical Pharmacology

    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 predominant action on alpha receptors.
    Total peripheral resistance decreases by action of epinephrine on beta receptors of the skeletal muscle vasculature and blood flow is thereby enhanced. Usually this vasodilator effect of the drug on the circulation predominates so that the modest rise in systolic pressure which follows slow injection or absorption is mainly the result of direct cardiac stimulation and increase in cardiac output. In some instances peripheral resistance is not altered or may even rise owing to a greater ratio of alpha to beta activity in different vascular areas. Epinephrine relaxes the smooth muscles of the bronchi and iris and is a physiologic antagonist of histamine. The drug also produces an increase in blood sugar and glycogenolysis in the liver. Intravenous injection produces an immediate and intensified response. Following intravenous injection epinephrine disappears rapidly from the blood stream. Epinephrine is rapidly inactivated in the body and is degraded by enzymes in the liver and other tissues. The large portion of injection doses is excreted in the urine as inactivated compounds. The remainder is excreted in the urine as unchanged or conjugated compounds.

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  • INDICATIONS & USAGE

    Indications and Usage

    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.

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  • CONTRAINDICATIONS

    Contraindications

    Epinephrine is contraindicated in patients with known hypersensitivity to sympathomimetic amines, in patients with angle closure glaucoma, and patients in shock (nonanaphylactic). It should
    not be used in patients anesthetized with agents such as cyclopropane or halothane as these may sensitize the heart to the arrhythmic action of sympathomimetic drugs. Addition of epinephrine to local anesthetics for injection of certain areas (e.g., fingers, toes, ears, etc.) is contraindicated because of danger that vasoconstriction may result in sloughing of tissue.
    Except as diluted for admixture with local anesthetics to reduce absorption and prolong action, epinephrine should not ordinarily be used in those cases where vasopressor drugs may be
    contraindicated, e.g., in thyrotoxicosis, diabetes, in obstetrics when maternal blood pressure is in excess of 130/80 and in hypertension and other cardiovascular disorders.

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  • WARNINGS

    Warnings

    Inadvertently induced high arterial blood pressure may result in angina pectoris, aortic rupture or cerebral hemorrhage. Epinephrine may induce potentially serious cardiac arrhythmias in patients not suffering from heart disease and in patients with organic heart disease or who are receiving drugs that sensitize the myocardium. Parenterally administered epinephrine initially may produce constriction of renal blood vessels and decrease urine formation. Epinephrine Injection, USP is subject to oxidation and should be protected against exposure to light and stored in light-resistant containers. Epinephrine is the preferred treatment for serious allergic or other emergency situations even though this product contains sodium metabisulfite, a sulfite that may in other products cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations.

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  • PRECAUTIONS

    Precautions

    Do not use the Injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Do not administer unless solution is clear and container is intact. Discard unused portion. Although epinephrine can produce ventricular fibrillation, its actions in restoring electrical activity in asystole and in enhancing defibrillation of the fibrillating ventricle are well documented. The drug, however, should be used with caution in patients with ventricular fibrillation. Epinephrine should be used cautiously in patients with hyperthyroidism, hypertension and
    cardiac arrhythmias. All vasopressors should be used cautiously in patients taking monoamine oxidase (MAO) inhibitors. Epinephrine should not be administered concomitantly with other sympathomimetic drugs (such as isoproterenol) because of possible additive effects and increased toxicity. Combined effects may induce serious cardiac arrhythmias. They may be administered alternately when the preceding effect of other such drugs has subsided. Administration of epinephrine to patients receiving cyclopropane or halogenated hydrocarbon general anesthetics such as halothane which sensitize the myocardium, may induce cardiac arrhythmia. (See CONTRAINDICATIONS.) When encountered, such arrhythmias may respond to administration of a beta-adrenergic blocking drug. Epinephrine also should be used cautiously with other drugs (e.g., digitalis glycosides) that sensitize the myocardium to the actions of
    sympathomimetic agents. Diuretic agents may decrease vascular response to pressor drugs such as epinephrine. Epinephrine may antagonize the neuron blockade produced by guanethidine resulting in decreased antihypertensive effect and requiring increased dosage of the latter.

    Pregnancy Category C. Animal reproduction studies have not been conducted with epinephrine. It is also not known whether epinephrine can cause fetal harm when administered to a
    pregnant woman or can affect reproduction capacity. Epinephrine should be given to a pregnant woman only if clearly needed.

    Labor and Delivery. Parenteral administration of epinephrine if used to support blood pressure during low or other spinal anesthesia for delivery can cause acceleration of fetal heart rate and
    should not be used in obstetrics when maternal blood pressure exceeds 130/80. (See CONTRAINDICATIONS.)

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  • ADVERSE REACTIONS

    Adverse Reactions

    Transient and minor side effects of anxiety, headache, fear and palpitations occur only with systemic therapeutic doses, especially in hyperthyroid individuals. Adverse effects such as cardiac arrhythmias and excessive rise in blood pressure may occur with systemic therapeutic doses or with inadvertent overdosage. Other adverse reactions include cerebral hemorrhage, hemiplegia, subarachnoid hemorrhage, anginal pain in patients with angina pectoris, anxiety, restlessness, headache, tremor, weakness, dizziness, pallor and respiratory difficulty. Such reactions are unlikely when epinephrine is diluted to 1:200,000 for injection with local anesthetic agents.

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  • OVERDOSAGE

    Overdosage

    Erroneous administration of large doses of epinephrine may lead to precordial distress, vomiting, headache, dyspnea, as well as unusually elevated blood pressure. (See WARNINGS.) Toxic effects of overdosage can be counteracted by injection of an alpha-adrenergic blocker and a betaadrenergic blocker. In the event of a sharp rise in blood pressure, rapid-acting vasodilators such as the nitrites, or alpha-adrenergic blocking agents can be given to counteract the marked pressor effect of large doses of epinephrine.

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  • DOSAGE & ADMINISTRATION

    Dosage and Administration

    Subcutaneously or intramuscularly – 0.2 to 1 mL (mg). Start with a small dose and increase if required.
    Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

    Hypersensitivity Reactions
    For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. The adult intravenous dose for
    hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.
    Cardiac Resuscitation
    A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility. Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.
    Ophthalmologic Use
    Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure) – use a concentration of 1:10,000 (0.1 mg/mL) to
    1:1000 (1 mg/mL).
    Regional Anesthesia
    A final concentration of 1:200,000 of epinephrine injection is recommended for infiltration injection, nerve block, caudal or other epidural blocks. From 0.3 to 0.4 mg of epinephrine (0.3 to
    0.4 mL of 1:1000 solution) may be mixed with spinal anesthetic agents. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (See PRECAUTIONS.)

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  • HOW SUPPLIED

    How SuppliedEpinephrine Injection, USP 1:1000 (1 mg/mL) is supplied in a 1 mL ampul single-dose container (NDC 0409-7241-61).
     
    Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

    Protect from light.

    Revised: October, 2008

    Printed in USA EN-1927

    Hospira, Inc., Lake Forest, IL 60045 USA Close
  • PRINCIPAL DISPLAY PANEL

    Epinephrine Pack Label

    Epinephrine Pack Label


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  • PRINCIPAL DISPLAY PANEL


    3/4 Fluid Ounce Povidone Iodine

    Povidone-iodine 10%

    Antiseptic

    Warnings

                Do not use

    • if allergic to iodine
    • in the eyes

                For external use only

                Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

                Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

                Avoid pooling beneath patient

                Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.


    Povidone Iodine Solution




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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    A1285

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  • INGREDIENTS AND APPEARANCE
    A1285 PEDIATRIC/CAUDAL/EPIDURAL 20G TUOHY 
    regional anesthesia kit kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-8295
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:51688-8295-2 10 in 1 CASE
    1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 AMPULE 1 mL
    Part 2 1 PACKET 22.5 mL
    Part 1 of 2
    EPINEPHRINE 
    epinephrine injection, solution
    Product Information
    Item Code (Source) NDC:0409-7241
    Route of Administration EPIDURAL, INTRASPINAL, INTRATHECAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE 9 mg  in 1 mL
    SODIUM METABISULFITE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0409-7241-61 1 mL in 1 AMPULE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/03/2010
    Part 2 of 2
    APLICARE POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Item Code (Source) NDC:52380-0001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) POVIDONE-IODINE 0.10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    SODIUM PHOSPHATE, DIBASIC  
    SODIUM HYDROXIDE  
    NONOXYNOL-9  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-0001-3 22.5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/01/1984
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K965017 12/14/2005
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    Name Address ID/FEI Business Operations
    Smiths Medical ASD, Inc. 137835299 relabel, manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Hospira, Inc. 030606222 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aplicare, Inc. 107255002 manufacture
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