Label: ATROPINE SULFATE- atropine sulfate injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 3, 2017

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  • DESCRIPTION

    Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic.  It is administered parenterally by subcutaneous, intramuscular or intravenous injection.

    Each milliliter (mL) contains atropine sulfate, monohydrate 0.1mg (adult strength) or 0.05mg (pediatric strength), and sodium chloride, 9mg.  May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.) pH 4.2 (3.0 to 6.5).

    The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection.  When smaller doses are required the unused portion should be discarded.

    Atropine sulfate Injection is a parenteral anticholinergic agent and muscarinic antagonist.

    Atropine Sulfate, USP is chemically designated 1 α H, 5 α H-Tropan-3-α ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 • H2SO4 • H2O, colorless crystals or white cyrstalline powder very soluble in water.

    It has the following structural formula:

    Formula1.jpg

    Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug.

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

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  • Clinical Pharmacology Section

    Atropine is commonly classified as an anticholinergic or antiparasympathetic (parasympatholytic)
    drug. More precisely, however, it is termed an antimuscarinic agent since it antagonizes the
    muscarine-like actions of acetyl-choline and other choline esters.
    Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by
    postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous
    acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of
    atropine is a competitive or surmountable antagonism which can be overcome by increasing the
    concentration of acetylcholine at receptor sites of the effector organ (e.g., by using
    anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine). The receptors
    antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine
    (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic
    nerve stimulation also may be inhibited by atropine but this occurs less readily than with responses
    to injected (exogenous) choline esters.
    Atropine-induced parasympathetic inhibition may be preceded by a transient phase of
    stimulation, especially on the heart where small doses first slow the rate before characteristic
    tachycardia develops due to paralysis of vagal control. Atropine exerts a more potent and prolonged
    effect on heart, intestine and bronchial muscle than scopolamine, but its action on the iris, ciliary
    body and certain secretory glands is weaker than that of scopolamine. Unlike the latter, atropine in
    clinical doses does not depress the central nervous system but may stimulate the medulla and
    higher cerebral centers. Although mild vagal excitation occurs, the increased respiratory rate and
    (sometimes) increased depth of respiration produced by atropine are more probably the result of
    bronchiolar dilatation. Accordingly, atropine is an unreliable respiratory stimulant and large or
    repeated doses may depress respiration.
    Adequate doses of atropine abolish various types of reflex vagal cardiac slowing or asystole.
    The drug also prevents or abolishes bradycardia or asystole produced by injection of choline esters,
    anticholinesterase agents or other parasympathomimetic drugs, and cardiac arrest produced by
    stimulation of the vagus. Atropine also may lessen the degree of partial heart block when vagal
    activity is an etiologic factor. In some patients with complete heart block, the idioventricular rate
    may be accelerated by atropine; in others, the rate is stabilized. Occasionally a large dose may
    cause atrioventricular (A-V) block and nodal rhythm.
    Atropine Sulfate Injection, USP in clinical doses counteracts the peripheral dilatation and
    abrupt decrease in blood pressure produced by choline esters. However, when given by itself,
    atropine does not exert a striking or uniform effect on blood vessels or blood pressure. Systemic
    doses slightly raise systolic and lower diastolic pressures and can produce significant postural
    hypotension. Such doses also slightly increase cardiac output and decrease central venous pressure.
    Occasionally, therapeutic doses dilate cutaneous blood vessels, particularly in the “blush” area
    (atropine flush), and may cause atropine “fever” due to suppression of sweat gland activity in
    infants and small children.
    Atropine disappears rapidly from the blood following injection and is distributed throughout the
    body. Much of the drug is destroyed by enzymatic hydrolysis, particularly in the liver; from 13 to
    50% is excreted unchanged in the urine. Traces are found in various secretions, including milk.
    Atropine readily crosses the placental barrier and enters the fetal circulation.
    Sodium chloride added to render the solution isotonic for injection of the active ingredient is
    present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride
    (Cl¯ ) ions.

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  • Indications & Usage Section

    Atropine Sulfate Injection, USP is indicated (1) as an antisialogogue for preanesthetic medication
    to prevent or reduce secretions of the respiratory tract, (2) to restore cardiac rate and arterial
    pressure during anesthesia when vagal stimulation produced by intra-abdominal surgical traction
    causes a sudden decrease in pulse rate and cardiac action, (3) to lessen the degree of
    atrioventricular (A-V) heart block when increased vagal tone is a major factor in the conduction
    defect as in some cases due to digitalis, (4) to overcome severe bradycardia and syncope due to a
    hyperactive carotid sinus reflex, (5) as an antidote (with external cardiac massage) for
    cardiovascular collapse from the injudicious use of a choline ester (cholinergic) drug, (6) in the
    treatment of anticholinesterase poisoning from organophosphorus insecticides, and (7) as an
    antidote for the “rapid” type of mushroom poisoning due to the presence of the alkaloid, muscarine,
    in certain species of fungus such as Amanita muscaria.

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  • Contraindications

    Atropine generally is contraindicated in patients with glaucoma, pyloric stenosis or prostatic
    hypertrophy, except in doses ordinarily used for preanesthetic medication.

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  • Warnings

    Atropine is a highly potent drug and due care is essential to avoid overdosage, especially with
    intravenous administration. Children are more susceptible than adults to the toxic effects of
    anticholinergic agents.

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  • Precautions

    Do not administer unless solution is clear and seal is intact. Discard unused portion.
    Atropine Sulfate Injection, USP should be used with caution in all individuals over 40 years of
    age. Conventional systemic doses may precipitate acute glaucoma in susceptible patients, convert
    partial organic pyloric stenosis into complete obstruction, lead to complete urinary retention in
    patients with prostatic hypertrophy or cause inspissation of bronchial secretions and formation of
    dangerous viscid plugs in patients with chronic lung disease.
    Pregnancy Category C. Animal reproduction studies have not been conducted with atropine. It
    also is not known whether atropine can cause fetal harm when given to a pregnant woman or can
    affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed.

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  • Adverse Reactions

    Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the
    mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration
    of therapeutic doses. Anhidrosis also may occur and produce heat intolerance or impair temperature
    regulation in persons living in a hot environment. Constipation and difficulty in micturition may
    occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin
    rashes which in some instances progressed to exfoliation.
    Adverse effects following single or repeated injections of atropine are most often the result of
    excessive dosage. These include palpitation, dilated pupils, difficulty in swallowing, hot dry skin,
    thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to marked palpitation,
    restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse
    occur only with severe intoxication. In such cases, blood pressure declines and death due to
    respiratory failure may ensue following paralysis and coma.

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  • Overdosage

    In the event of toxic overdosage (See ADVERSE REACTIONS), a short acting barbiturate or
    diazepam may be given as needed to control marked excitement and convulsions. Large doses for
    sedation should be avoided because central depressant action may coincide with the depression
    occurring late in atropine poisoning. Central stimulants are not recommended. Physostigmine,
    given as an atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1.0 mg in children),
    rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is
    rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses
    may be required. Artificial respiration with oxygen may be necessary. Ice bags and alcohol sponges
    help to reduce fever, especially in children.
    The fatal adult dose of atropine is not known; 200 mg doses have been used and doses as high
    as 1000 mg have been given.
    In children, 10 mg or less may be fatal. With a dose as low as 0.5 mg, undesirable minimal
    symptoms or responses of overdosage may occur. These increase in severity and extent with larger
    doses of the drug (excitement, hallucinations, delirium and coma with a dose of 10 mg or more).

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  • Dosage and Administration

    Atropine Sulfate Injection, USP may be administered subcutaneously, intramuscularly
    or intravenously. The average adult dose is 0.5 mg (5 mL of a 0.1 mg/mL solution), range 0.4 to
    0.6 mg (4 to 6 mL). As an antisialogogue it is usually injected intramuscularly prior to induction of
    anesthesia. This produces only minimal blocking of vagal activity. In children, the dosage ranges
    from 0.1 mg (2 mL of a 0.05 mg solution) in the newborn to 0.6 mg (6 mL of a 0.1 mg/mL
    solution) in a child age 12 years, injected subcutaneously 30 minutes before surgery. During
    surgery, the drug is given intravenously when reduction in pulse rate and cessation of cardiac action
    are due to increased vagal activity; however, if the anesthetic is cyclopropane, doses less than
    0.4 mg should be used and should be given slowly to avoid the possible production of ventricular
    arrhythmia. Usual doses are used to reduce severe bradycardia and syncope associated with
    hyperactive carotid sinus reflex. For bradyarrhythmias the usual intravenous adult dosage ranges
    from 0.4 to 1 mg (4 to 10 mL of a 0.1 mg/mL solution) every one to two hours as needed; larger
    doses up to a maximum of 2 mg may be required. In children, intravenous dosage ranges from
    0.01 to 0.03 mg (0.2 to 0.6 mL of a 0.05 mg/mL solution) per kg of body weight. Atropine is also a
    specific antidote for cardiovascular collapse resulting from injudicious administration of choline
    ester. When cardiac arrest has occurred, external cardiac massage or other method of resuscitation
    is required to distribute the drug after intravenous injection.
    In anticholinesterase poisoning from exposure to insecticides, large doses of at least 2 to 3 mg
    (20 to 30 mL of a 0.1 mg/mL solution) should be administered parenterally and repeated until signs
    of atropine intoxication appear. In the “rapid” type of mushroom poisoning, atropine should be
    given in doses sufficient to control parasympathomimetic signs before coma and cardiovascular
    collapse supervene.
    Parenteral drug products should be inspected visually for particulate matter and discoloration
    prior to administration, whenever solution and container permit. See PRECAUTIONS.

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  • How Supplied

    Atropine Sulfate Injection, USP is supplied in single-dose containers as follows:

    List No.
    Needle
    Size
    Conc.
    Total Content(Atropine)




















    Lifeshield Abboject Unit of Use Syringe with make luer lock adapter and protected needle




    4910
    20-G
    5mL
    0.1mg/mL (Adult)
    0.5mg
    4911
    20-G
    10mL
    0.1mg/mL (Adult)
    1mg
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  • Storage

    Store at 20 to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

    Revised: February, 2007

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  • Sample Outer Package Label
  • INGREDIENTS AND APPEARANCE
    ATROPINE SULFATE 
    atropine sulfate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-910(NDC:0409-4910)
    Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Atropine Sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I) Atropine Sulfate 0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52584-910-34 1 in 1 BAG 03/01/2010
    1 5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/01/2010
    Labeler - General Injectables & Vaccines, Inc. (108250663)
    Establishment
    Name Address ID/FEI Business Operations
    General Injectables & Vaccines, Inc. 108250663 relabel(52584-910)
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