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«“DRAFT” AtroPen Rx Only Auto-Injector ATROPINE INJECTION FOR USE IN NERVE AGENT AND INSECTICIDE POISONING ONLY CAUTION! PRIMARY PROTECTION ...»

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NDA 17-106/S-032 Package Insert

Page 1

“DRAFT”

AtroPen

Rx Only

Auto-Injector

ATROPINE INJECTION

FOR USE IN NERVE AGENT AND INSECTICIDE POISONING ONLY

CAUTION! PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE

AGENTS AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE

GARMENTS INCLUDING MASKS DESIGNED SPECIFICALLY FOR THIS USE.

INDIVIDUALS SHOULD NOT RELY SOLELY UPON ANTIDOTES SUCH AS ATROPINE AND

PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND

INSECTICIDE POISONING.

SEEK IMMEDIATE MEDICAL ATTENTION AFTER INJECTION WITH ATROPEN.

A STERILE SOLUTION FOR INTRAMUSCULAR USE ONLY

DESCRIPTION

Each prefilled auto-injector provides a dose of the antidote atropine in a self-contained unit, specially designed for self or caregiver administration. Four strengths of AtroPen are available;

they are AtroPen 0.25, AtroPen 0.5 mg, AtroPen 1 mg, and AtroPen 2 mg.

When activated the AtroPen 0.25 mg dispenses 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate). The AtroPen 0.25 mg delivers 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride and Water for Injection. The pH range is 4.0 – 5.0.

When activated the AtroPen 0.5 mg dispenses 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the AtroPen 1 mg dispenses 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the AtroPen 2 mg dispenses 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg AtroPen delivers atropine in 0.7 mL of sterile pyrogen-free solution containing glycerin, phenol, citrate buffer and water for injection. The pH range is 4.0–5.0.

After the AtroPen Auto-Injector has been activated, the empty container should be disposed of properly (see DOSAGE AND ADMINISTRATION). It cannot be refilled, nor can the protruding needle be retracted.

Atropine, an anticholinergic agent (muscarinic antagonist), occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, whose activity is due almost entirely to the levo isomer of the drug.

NDA 17-106/S-032 Package Insert Page 2 Chemically, atropine is designated as 1 H,5 H-Tropan-3 –ol (±) -tropate. Its empirical formula is

C17H23NO3 and its structural formula is:

CLINICAL PHARMACOLOGY

Mechanism of Action:

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 acetylcholine 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 may also be inhibited by atropine, but this occurs less readily than with responses to injected (exogenous) choline esters.

Pharmacodynamics:

Atropine reduces secretions in the mouth and respiratory passages, relieves the constriction and spasm of the respiratory passages, and may reduce the paralysis of respiration, which results from actions of the toxic agent on the central nervous system. 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. Although mild vagal excitation occurs, the increased respiratory rate and occasionally 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 may also lessen the degree of partial heart block when vagal activity is an etiologic factor. In some individuals with complete heart block, the NDA 17-106/S-032 Package Insert Page 3 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 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 especially in infants and small children.

Pharmacokinetics:

Atropine is rapidly and well absorbed after intramuscular administration. Atropine disappears rapidly from the blood and is distributed throughout the various body tissues and fluids. 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.

The approximate Cmax of atropine following 1.67 mg atropine given intramuscularly to adults by the 2 mg AtroPen delivery system was 9.6 ± 1.5 (mean ± SEM) ng/ml. The mean Tmax was 3 minutes. The T½ of intravenous atropine in pediatric subjects under 2 years is 6.9 ± 3.3 (mean ± SD) hours; in children over 2 years, the T½ is 2.5 ± 1.2 (mean ± SD) hours; in adults 16–58 years the T½ is 3.0 ± 0.9 (mean ± SD) hours; in geriatric patients 65–75 years it is 10.0 ± 7.3 (mean ± SD) hours. The protein binding of atropine is 14 to 22% in plasma. There are gender differences in the pharmacokinetics of atropine. The AUC(0-inf) and Cmax were 15% higher in females than males. The half-life of atropine is slightly shorter (approximately 20 minutes) in females than males.

INDICATIONS AND USAGE

The AtroPen Auto-Injector is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides. The AtroPen Auto-Injector should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication. Pralidoxime chloride may serve as an important adjunct to atropine therapy.

The AtroPen is intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings (generally breathing difficulties due to increased secretions);

definitive medical care should be sought immediately. The AtroPen Auto-Injector should be administered as soon as symptoms of organophosphorous or carbamate poisoning appear (usually tearing, excessive oral secretions, wheezing, muscle fasciculations, etc.) In moderate to severe poisoning, the administration of more than one AtroPen may be required until atropinization is achieved (flushing, mydriasis, tachycardia, dryness of the mouth and nose).

(See DOSAGE AND ADMINISTRATION) In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant if seizure is suspected in the unconscious individual NDA 17-106/S-032 Package Insert Page 4 since the classic tonic-clonic jerking may not be apparent due to the effects of the poison. In poisonings due to organophosphorous nerve agents and insecticides it may also be helpful to concurrently administer a cholinesterase reactivator such as pralidoxime chloride.

–  –  –

In the face of life-threatening poisoning by organophosphorous nerve agents and insecticides, there are no absolute contraindications for the use of atropine (see WARNINGS).

–  –  –

CAUTION! PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE

AGENTS AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE

GARMENTS INCLUDING MASKS DESIGNED SPECIFICALLY FOR THIS USE.

INDIVIDUALS SHOULD NOT RELY SOLELY UPON ANTIDOTES SUCH AS ATROPINE AND

PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND

INSECTICIDE POISONING.

Patients who have had previous anaphylactic reactions to atropine who have mild symptoms of organophosphorous or nerve agent poisoning should not be treated without adequate medical supervision.

While AtroPen can be administered to all individuals with a life-threatening exposure to organophosphorous nerve agents and insecticides, it should be administered with extreme caution to individuals with the following disorders when the symptoms of nerve agent poisoning are less severe: individuals who are hypersensitive to any component of the product, disorders of heart rhythm such as atrial flutter, severe narrow angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal insufficiency, or a recent myocardial infarction.

More than one dose of atropine (AtroPen Auto-Injector) may be necessary initially, especially when exposure is massive or symptoms are severe. However, no more than three doses should be administered unless under the supervision of trained medical personnel. High doses of atropine may be required for many hours following high-dose exposure to maintain atropinization. (See DOSAGE AND ADMINISTRATION.) Children and the elderly may be more susceptible to the pharmacologic effects of atropine.

Severe difficulty in breathing requires artificial respiration in addition to the use of atropine since atropine is not dependable in reversing the weakness or paralysis of the respiratory muscles.

–  –  –

General: The desperate condition of the organophosphorous-poisoned individual will generally mask such minor signs and symptoms of atropine treatment as have been noted in normal subjects.

NDA 17-106/S-032 Package Insert Page 5 Atropine should be used with caution in individuals with cardiac disease. Conventional systemic doses may precipitate acute glaucoma in susceptible individuals, convert partial pyloric stenosis into complete pyloric obstruction, precipitate urinary retention in individuals with prostatic hypertrophy, or cause inspissation of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease.

Laboratory Tests: Treatment of organophosphorous nerve agent and insecticide poisoning should be instituted without waiting for the results of laboratory tests. Red blood cell and plasma cholinesterase, and urinary paranitrophenol measurements (in the case of parathion exposure) may be helpful in confirming the diagnosis and following the course of the illness. A reduction in red blood cell cholinesterase concentration to below 50% of normal has been seen only with organophosphorous ester poisoning.

Information for Patients: Appropriate steps must be taken to insure that users understand the indications for and use of the AtroPen, including review of symptoms of poisoning and operation of the AtroPen (see DOSAGE AND ADMINISTRATION ).

Drug Interactions: When atropine and pralidoxime are used together, the signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected than when atropine is used alone because pralidoxime may potentiate the effect of atropine.

The following precautions should be kept in mind in the treatment of anticholinesterase poisoning although they do not bear directly on the use of atropine and pralidoxime. Since barbiturates are potentiated by the anticholinesterases, they should be used cautiously in the treatment of convulsions.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No reports regarding the potential of atropine for carcinogenesis, mutagenesis, or impairment of fertility have been published in the literature. Since atropine is indicated for short-term emergency use only, no investigations of these aspects have been conducted.

Pregnancy: Teratogenic Effects – Pregnancy Category C: Adequate animal reproduction studies have not been conducted with atropine. It is not known whether atropine can cause fetal harm when administered to a pregnant woman or if these agents can affect reproductive capacity.

Atropine should be administered to a pregnant woman only if clearly needed.

Nursing Mothers: Atropine is found in human milk in trace amounts. Caution should be exercised when atropine is administered to a nursing woman.



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