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Atropen

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Atropen

Indications
Dosage
How Supplied

INDICATIONS

The AtroPen® (atropine) 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 (atropine) 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® (atropine) 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® (atropine) 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® (atropine) 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 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.

DOSAGE AND ADMINISTRATION

CAUTION! PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENT AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS, DESIGNED SPECIFICALLY FOR THIS USE.

INDIVIDUALS SHOULD NOT RELY SOLELY UPON THE AVAILABILITY OF ANTIDOTES SUCH AS ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENT AND INSECTICIDE POISONING.

Immediate evacuation from the contaminated environment is essential. Decontamination of the poisoned individual should occur as soon as possible.

The AtroPen® (atropine) 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® (atropine) 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® (atropine) 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® (atropine) 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® (atropine) may be required until atropinization is achieved (flushing, mydriasis, tachycardia, dryness of the mouth and nose). In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant if seizure is suspected in the unconscious individual 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.

It is recommended that three (3) AtroPen® (atropine) auto-injectors be available for use in each person at risk for nerve agent or organophosphate insecticide poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms as described below. No more than three (3) AtroPen® (atropine) injections should be used unless the patient is under the supervision of a trained medical provider. Different dose strengths of the AtroPen® (atropine) are available depending on the recipient's age and weight.

  • Adults and children weighing over 90 lbs (generally over 10 years of age)..............AtroPen® (atropine) 2 mg (green)
  • Children weighing 40 lbs to 90 lbs (generally 4 to 10 years of age)..............AtroPen® (atropine) 1 mg (dark red)
  • Children weighing 15 lbs to 40 lbs (generally 6 months to 4 years of age)..............AtroPen® (atropine) 0.5 mg (blue)

NOTE: Children weighing under 15 lbs (generally younger than 6 months old) should ordinarily not be treated with the AtroPen® auto-injector. Atropine doses for these children should be individualized at doses of 0.05 mg/kg.

Treatment of MILD SYMPTOMS

One (1) AtroPen® (atropine) is recommended if two or more MILD symptoms of nerve agent (nerve gas) or insecticide exposure appear in situations where exposure is known or suspected.

Two (2) additional AtroPen® (atropine) injections given in rapid succession are recommended 10 minutes after receiving the first AtroPen® (atropine) injection if the victim develops any of the SEVERE symptoms listed below. If possible, a person other than the victim should administer the second and third AtroPen® (atropine) injections.

Treatment of SEVERE SYMPTOMS:

If a victim is encountered who is either unconscious or has any of the SEVERE symptoms listed below, immediately administer three (3) AtroPen® (atropine) injections into the victim's mid-lateral thigh in rapid succession using the appropriate weight-based AtroPen® (atropine) dose.

MILD SYMPTOMS of nerve agent or insecticide exposure include the following:

-Blurred vision, miosis
-Excessive unexplained teary eyes
-Excessive unexplained runny nose
-Increased salivation such as sudden unexplained excessive drooling
-Chest tightness or difficulty breathing
-Tremors throughout the body or muscular twitching
-Nausea and/or vomiting
-Unexplained wheezing or coughing
-Acute onset of stomach cramps
-Tachycardia or bradycardia

SEVERE SYMPTOMS of exposure to nerve agent or insecticides include the following:

-Strange or confused behavior
-Severe difficulty breathing or severe secretions from your lungs/airway
-Severe muscular twitching and general weakness
-Involuntary urination and defecation (feces)
-Convulsions
-Unconsciousness

All victims should be evacuated immediately from the contaminated environment. Medical help should be sought immediately. Protective masks and clothing should be used when available. Decontamination procedures should be undertaken as soon as possible. If dermal exposure has occurred, clothing should be removed and the hair and skin washed thoroughly with sodium bicarbonate or alcohol as soon as possible.

Emergency care of the severely poisoned individual should include removal of oral and bronchial secretions, maintenance of a patent airway, supplemental oxygen and, if necessary, artificial ventilation. In general, atropine should not be used until cyanosis has been overcome since atropine may produce ventricular fibrillation and possible seizures in the presence of hypoxia.

Pralidoxime (if used) is most effective if administered immediately or soon after the poisoning. Generally, little is accomplished if pralidoxime is given more than 36 hours after termination of exposure unless the poison is known to age slowly or re-exposure is possible, such as in delayed continuing gastrointestinal absorption of ingested poisons. Fatal relapses, thought to be due to delayed absorption, have been reported after initial improvement. Continued administration for several days may be useful in such patients.

Close supervision of all moderately to severely poisoned patients is indicated for at least 48 to 72 hours.

An anticonvulsant such as diazepam may be administered to treat convulsions if suspected in the unconscious individual. The effects of nerve agents and some insecticides can mask the motor signs of a seizure.

IMPORTANT: PHYSICIANS AND/OR OTHER MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENTS AND INSECTICIDE POISONING SHOULD AVOID EXPOSING THEMSELVES TO CONTAMINATION BY THE VICTIM'S CLOTHING. AGGRESSIVE AND SAFE DECONTAMINATION IS STRONGLY SUGGESTED.

Instructions for administering AtroPen® (atropine) (please refer to the illustrated Self Aid and Caregiver Directions for Use elsewhere):

Warning: Giving additional AtroPen® (atropine) injections by mistake in the absence of actual nerve agent or insecticide poisoning may cause an overdose of atropine which could result in temporary incapacitation (inability to walk properly, see clearly or think clearly for several or more hours). Patients with cardiac disease may be at risk for serious adverse events, including death.

HOW SUPPLIED

The AtroPen® (atropine) is supplied in three strengths. The AtroPen® 0.5 mg provides Atropine Injection (atropine, 0.42 mg/0.7 ml), AtroPen® 1 mg provides Atropine Injection (atropine, 0.84 mg/0.7 ml), and AtroPen® 2 mg provides Atropine Injection (atropine, 1.67 mg/0.7 ml) in sterile solution for intramuscular injection. The AtroPen® (atropine) is a self-contained unit designed for self or caregiver administration.

Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F)

[see USP Controlled Room Temperature]

Keep from freezing. Protect from light.

Manufactured by: MERIDIAN MEDICAL TECHNOLOGIES, INC., 10240 Old Columbia Road, COLUMBIA, MD 21046. FDA Rev date: 9/17/2004

Last reviewed on RxList: 11/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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