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Atropen Auto-Injector (Atropine Sulfate) - Indications and Dosage

 
 



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 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® 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 bradycardia

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 ® (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.

HOW SUPPLIED

The AtroPen® is supplied in four strengths. The AtroPen® 0.25 mg (NDC 11704-107-01), provides Atropine Injection (atropine, 0.21 mg/0.3 mL), AtroPen® 0.5 mg (NDC 11704-104-01) provides Atropine Injection (atropine, 0.42 mg/0.7 mL), AtroPen® 1 mg (NDC 11704-105-01) provides Atropine Injection (atropine, 0.84 mg/0.7 mL), and AtroPen® 2 mg (NDC 11704-106-01) provides Atropine Injection (atropine, 1.67 mg/0.7 mL) in sterile solution for intramuscular injection. The AtroPen® 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.
COLUMBIA, MD 21046
A subsidiary of King Pharmaceuticals®, Inc. 1-877-248-7275

0001166
Rev.11/05

Self Aid and Caregiver Aid Directions for Use.

FOLLOW THESE INSTRUCTIONS ONLY WHEN READY TO ADMINISTER ATROPINE

Step 1
USE THE CORRECT DOSE

Adults and children weighing over 90 lbs. (41 kg)
(generally over 10 years of age)
2 mg AtroPen® (GREEN LABEL).
Children weighing 40 lbs. to 90 lbs. (18 to 41 kg)
(generally 4 to 10 years of age)
1 mg AtroPen®(DARK RED LABEL)
Children weighing 15 lbs. to 40 lbs. (7 to 18 kg)
(generally 6 months to 4 years of age)
0.5 mg AtroPen® (BLUE LABEL)
Infants weighing less than 15 lbs. (7 kg)
(generally less than six months of age)
0.25 mg AtroPen® (YELLOW LABEL)

Step 2

KNOW NERVE AGENT AND

INSECTICIDE POISONING SYMPTOMS

In an environment where nerve agent (or nerve gas) or insecticide exposure is known or suspected, the following are mild and severe symptoms of nerve agent intoxication. You may not have all of the symptoms:

MILD SYMPTOMS SEVERE SYMPTOMS
- Blurred vision and sore eyes- Strange or confused behavior
- Teary eyes*- Severe difficulty breathing or severe secretions from lungs/airway
- Runny nose*- Severe muscular twitching and general weakness**
- Increased salivation such as sudden drooling*- Involuntary urination and defecation (feces)*
- Chest tightness or difficulty breathing- Convulsions
- Tremors throughout the body or muscular twitching- Unconsciousness
- Nausea and vomiting
- Involuntary secretions (phlegm from lungs/airway)

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 where 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.

Step 3
TREATMENT OF MILD SYMPTOMS

FIRST DOSE: Give one (1) AtroPen® if you experience two or more MILD symptoms of nerve gas or insecticide exposure. Look for a helper and have them check you for continued or worsening symptoms. Get medical attention immediately.


ADDITIONAL DOSES: Two (2) additional AtroPen® injections given in rapid succession are recommended 10 minutes after receiving the first AtroPen® injection if the victim develops any of the SEVERE symptoms listed above. 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 above, immediately administer three (3) AtroPen® injections into the victim's mid-lateral thigh in rapid succession using the appropriate weight-based AtroPen® dose.


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

Step 4
DIRECTIONS FOR THE USE OF 2 mg, 1 mg, and

0.5 mg ATROPEN ®

(See below for 0.25 mg dose directions)

(A) Snap the grooved end of the plastic sleeve down and over the yellow safety release. Remove the AtroPen® from the plastic sleeve.
Caution: Do not place fingers on green tip.
(B) Firmly grasp the AtroPen® with the green tip pointed down.
(C) Pull off the yellow safety release with your other hand
(D) Aim and firmly jab the green tip straight down (a 90° angle) against the outer thigh. The AtroPen® device will activate and deliver the medicine when you do this. It is okay to inject through clothing, but make sure pockets at the injection site are empty.
Very thin people and small children should also be injected in the thigh, but before giving the AtroPen®, bunch up the thigh to provide a thicker area for injection.
(E) Hold the auto-injector firmly in place for at least 10 seconds to allow the injection to finish.
(F) Remove the AtroPen® and massage the injection site for several seconds. If the needle is not visible, check to be sure the yellow safety release has been removed, and repeat steps D and E, but press harder.
(G) After use, using a hard surface, bend the needle back against the AtroPen® and either pin the used AtroPen® to the victim's clothing or show the used AtroPen® Auto-Injectors to the first medical person you see. This will allow medical personnel to see the number and dose of AtroPen® Auto-Injectors administered. Move yourself and the exposed individual away from the contaminated area right away. Try to find medical help.

DIRECTIONS FOR THE USE OF 0.25 mg ATROPEN®

(A) Remove the plastic cap from the yellow tube and slide the AtroPen® from tube.
Caution: Do not place fingers on black tip
(B) Firmly grasp the AtroPen® with the black tip pointed down.
(C) Pull off the gray safety release with your other hand.
(D) Bunch up the thigh to provide a thicker area for injection. Aim and firmly jab the black tip straight down (a 90° angle) against the outer thigh. The AtroPen® device will activate and deliver the medicine when you do this.
(E) Hold the auto-injector firmly in place for at least 10 seconds to allow the injection to finish.
(F) Remove the AtroPen® and massage the injection site for several seconds. If the needle is not visible, check to be sure the gray safety release has been removed, and repeat steps D and E, but press harder.
(G) After use using a hard surface, bend the needle back against the AtroPen®and either pin the used AtroPen®to the victim's clothing or show the used AtroPen®Auto-Injectors to the next medical person you see. This will allow medical personnel to see the number and dose of AtroPen® Auto-Injectors administered. Move yourself and the exposed individual away from the contaminated area right away. Seek further medical help.

Rev. 11/05
AtroPen® is a registered trademark of
Meridian Medical Technologies™, Inc.,
Columbia, MD 21046
A wholly owned subsidiary of King Pharmaceuticals®, Inc.
1-877-248-7275

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