Atropen Auto-injector
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 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.
History
There is currently no drug history available for this drug.
Other Information
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 mg, 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. Chemically, atropine is designated as 1 H,5 H-Tropan-3 –ol (±) -tropate. Its empirical formula is C17H23NO3 and its structural formula is:
Sources
Atropen Auto-injector Manufacturers
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Meridian Medical Technologies, Inc.
![Atropen Auto-injector (Atropine Sulfate) Injection [Meridian Medical Technologies, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Atropen Auto-injector | Meridian Medical Technologies, Inc.
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® 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). 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® 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® injections should be used unless the patient is under the supervision of a trained medical provider. Different dose strengths of the AtroPen® are available depending on the recipient's age and weight.
Adults and children weighing over 90 lbs (41 kg)
(generally over 10 years of age) AtroPen® 2 mg (green) Children weighing 40 lbs to 90 lbs (18 to 41 kg)
(generally 4 to 10 years of age) AtroPen® 1 mg (dark red) Children weighing 15 lbs to 40 lbs (7 to 18 kg)
(generally 6 months to 4 years of age) AtroPen® 0.5 mg (blue) Infants weighing less than 15 lbs (7 kg)
(generally less than 6 months of age) AtroPen® 0.25 mg (yellow) Treatment of MILD SYMPTOMS:One (1) AtroPen® 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® injections given in rapid succession are recommended 10 minutes after receiving the first AtroPen® injection if the victim has any of the SEVERE symptoms listed below. If possible, a person other than the victim should administer the second and third AtroPen® 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® injections into the victim's mid-lateral thigh in rapid succession using the appropriate weight-based AtroPen® dose.
Symptoms in infants and young children
* These symptoms are sometimes observed in healthy infants and young children. In this age group, these symptoms are less reliable than other symptoms listed. Symptoms must be considered collectively when nerve agent or pesticide exposure is known or suspected.
** Infants may become drowsy or unconscious, with muscle floppiness rather than muscle twitching, soon after exposure to nerve agents or pesticides.
MILD SYMPTOMS of nerve agent or insecticide exposure include the following: SEVERE SYMPTOMS of exposure to nerve agent or insecticides include the following: - Blurred vision, miosis - Strange or confused behavior - Excessive unexplained teary eyes* - Severe difficulty breathing or severe secretions - Excessive unexplained runny nose* from the lungs/airway - Increased salivation such as sudden unexplained excessive drooling* - Severe muscular twitching and general weakness** - Chest tightness or difficulty breathing - Involuntary urination and defecation (feces)* - Tremors throughout the body or muscular twitching - Convulsions - Nausea and/or vomiting - Unconsciousness - Unexplained wheezing or coughing - Acute onset of stomach cramps - Tachycardia or bradycardiaAll 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® (please refer to the illustrated dose specific Self Aid and Caregiver Directions for Use at the end of this package insert):
Warning: Giving additional AtroPen®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.
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