Meridian Medical Technologies, Inc.

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Meridian Medical Technologies, Inc. Drugs

Atnaa

Atnaa

For optimal reactivation of organophosphorous-inhibited cholinesterase, the ATNAA should be administered as soon as possible after appearance of symptoms of nerve agent poisoning (see below).

The ATNAA should be self- or buddy-administered by military personnel after donning protective mask and hood at the first sign of a chemical attack, and only if some or all of the following mild symptoms of nerve agent exposure are present:
- Unexplained runny nose - Unexplained sudden headache - Sudden drooling - Difficulty in seeing (dimness of vision and miosis) - Tightness of chest or difficulty in breathing - Wheezing and coughing - Localized sweating and muscular twitching in the area of contaminated skin - Stomach cramps - Nausea, with or without vomiting - Tachycardia followed by bradycardia
The following are the instructions that should be given to military personnel.

Self-Aid
Administer one (1) ATNAA into your lateral thigh muscle or buttocks as follows: Remove gray safety cap from back end. Place front end on outer thigh and push hard until injector functions.Hold firmly in place for ten seconds. Using a hard surface, bend needle into hook. Push ejected needle through a pocket flap (or other thick and conspicuous part of outer clothing). Wait 10 to 15 minutes for the antidote to take effect. If you are able to ambulate, know who you are, and where you are, you will NOT need a second injection. Warning: Giving yourself a second set of injections may cause an overdose of the ATNAA which could result in incapacitation. If symptoms of nerve agent poisoning are not relieved after administering one injection, seek someone else to check your symptoms. A buddy must administer the second and third injections, if needed.
Buddy-Aid
Casualties with severe symptoms may experience most or all of the mild symptoms described above, plus most or all of the following: - Strange or confused behavior - Increased wheezing and increased difficulty in breathing - Severely pinpointed pupils - Red eyes with tearing - Vomiting - Severe muscular twitching and general weakness - Involuntary urination and defecation - Convulsions - Unconsciousness - Respiratory failure - Bradycardia If you encounter a service member suffering from severe signs of nerve agent poisoning, render the following aid: Mask the casualty, if necessary. Do not fasten the hood. If self-aid (one ATNAA) has been administered, administer, in rapid succession, two (2) additional ATNAAs into the casualty's lateral thigh muscle or buttocks.
Note: Use the casualty's own ATNAAs when providing aid. Do not use your own injectors on a casualty. If you do, you may not have any antidote available when needed for self-aid.
If self-aid (one ATNAA) has not been administered, administer, in rapid succession, three (3) ATNAAs into the casualty's lateral thigh muscle or buttocks.
IMPORTANT: PHYSICIANS AND/OR MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENTS, SHOULD AVOID EXPOSING THEMSELVES TO CONTAMINATION BY THE VICTIM'S CLOTHING.
Atropen Auto-injector

Atropen Auto-injector

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.
Lidopen

Lidopen

A physician who prescribes this device for the patient, must take appropriate steps to insure that his patient understands the indications and use of this device including review with the patient, in detail, the patient package insert and operation of the Auto-Injector.

Inject the contents of 1 LidoPen® Auto-Injector (300 mg lidocaine hydrochloride, 3 mL, 10% solution) intramuscularly into the anterolateral aspect of the thigh or deltoid region of the arm. See DETAILED INSTRUCTIONS below.

As soon as possible, and when indicated, patients should be changed to an intravenous infusion of lidocaine hydrochloride or to an oral antiarrhythmic preparation for maintenance therapy. However, if necessary, an additional intramuscular injection may be made after an interval of 60-90 minutes. IT SHOULD BE MADE CLEAR TO THE PATIENT THAT THIS SECOND INJECTION SHOULD NOT BE MADE WITHOUT FURTHER INSTRUCTIONS BY QUALIFIED MEDICAL PERSONNEL.

DETAILED INSTRUCTIONS

NOTE: A separate booklet containing information regarding self-administration of the LidoPen®Auto-Injector by patients equipped with a CardioBeeper®will be made available to the patient.

Introduction:

As part of the early management of a heart attack, your physician has prescribed for you a drug — lidocaine hydrochloride contained in an automatic injector — The LidoPen® Auto-Injector.

This drug has been shown to be valuable in the management of certain abnormal heart rhythms which sometimes accompany heart attacks. As with all other drugs, it is not without risk. UNDER NO CIRCUMSTANCES SHOULD IT BE USED WITHOUT SPECIFIC INSTRUCTIONS TO DO SO BY QUALIFIED MEDICAL PERSONNEL.

Therefore, your physician has taken steps to provide you with a CardioBeeper® with which to transmit your heart rate and rhythm by conventional telephone.

Be certain to review the information contained in this booklet and practice with the use of the CardioBeeper®.

The LidoPen® Auto-Injector:

The LidoPen® Auto-Injector is a disposable, prefilled automatic injection device containing 300 mg lidocaine hydrochloride.
Keep the LidoPen® Auto-Injector with you at all times. It should not be kept in excessive heat or cold. You should note the expiration date on the LidoPen® Auto-Injector and make sure yours is replaced prior to that date.
When to use the LidoPen® Auto-Injector:

If you experience the signs and symptoms described to you by your physician as suggesting a possible heart attack, immediately telephone your physician, or center designated by your physician, and transmit your electrocardiogram by CardioBeeper®. You will then be instructed whether or not you are to use the LidoPen® Auto-Injector.

Directions for Use:

When as described above, you have been instructed to use the LidoPen® Auto-Injector, proceed as follows:
Remove gray safety cap. Place black end on thickest part of thigh and press hard until injector functions. Hold firmly in place for ten seconds, then remove. Massage the area of injection for 10 seconds.
UNLESS ABSOLUTELY NECESSARY, DO NOT ATTEMPT TO OPERATE A MOTOR VEHICLE AFTER USE OF THE LidoPen® Auto-Injector.

Proceed as instructed by physician.
Pralidoxime Chloride

Pralidoxime Chloride

Exposure to nerve agents possessing anticholinesterase activity (organophosphate type)

MILD CASE—headache, blurred vision, mild muscarinic signs

MODERATELY SEVERE CASE—excessive sweating, lacrimation, salivation, diarrhea, tightness in the chest

For optimal reactivation of organophosphate-inhibited cholinesterase, atropine and pralidoxime should be administered as soon as possible after exposure. Depending on the severity of symptoms, immediately administer one atropine-containing auto-injector, followed by one pralidoxime-containing auto-injector. Atropine must be given first until its effects become apparent and only then should pralidoxime be administered. If nerve agent symptoms are still present after 15 minutes, repeat injections. If symptoms still exist after an additional 15 minutes, repeat injections for a third time. If after the third set of injections, symptoms remain, do not give any more antidotes but seek medical help.

Directions for Use:

When, as described above, auto-injector use is indicated, proceed as follows:
Remove gray safety cap. Place black end against outer thigh and push hard until the injector functions. Hold firmly in place for ten seconds, then remove. Massage the area of injection. Dispose of properly. Push ejected needle through a pocket flap (or other thick and conspicuous part of outer clothing). Bend needle into a hook.
VERY SEVERE CASE — Cyanosis, Respiratory Embarrassment, Coma

Initial measures should include removal of secretions, maintenance of a patent airway and, if necessary, artificial ventilation. Atropine should not be used until cyanosis has been overcome since atropine produces ventricular fibrillations in the presence of hypoxia. Morphine, theophylline, aminophylline, or succincylcholine are contraindicated. Tranquilizers of the reserpine or phenothiazine type are to be avoided.

"Pralidoxime is most effective if administered immediately after poisoning. Generally, little is accomplished if the drug is given more than 36 hours after termination of exposure. When the poison has been ingested, however, exposure may continue for some time due to slow absorption from the lower bowel, and fatal relapses have been reported after initial improvement. Continued administration for several days may be useful in such patients. Close supervision of the patient is indicated for at least 48 to 72 hours. 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. Diazepam may be given cautiously if convulsions are not controlled by atropine."7

IMPORTANT: PHYSICIANS AND/OR OTHER MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENTS, SHOULD AVOID EXPOSING THEMSELVES TO CONTAMINATION BY THE VICTIMS' CLOTHING.
Duodote

Duodote

THE DUODOTE AUTO-INJECTOR SHOULD BE ADMINISTERED BY EMERGENCY MEDICAL SERVICES PERSONNEL WHO HAVE HAD ADEQUATE TRAINING IN THE RECOGNITION AND TREATMENT OF NERVE AGENT OR INSECTICIDE INTOXICATION.

CAUTION! INDIVIDUALS SHOULD NOT RELY SOLELY UPON ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING.

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

EVACUATION AND DECONTAMINATION PROCEDURES SHOULD BE UNDERTAKEN AS SOON AS POSSIBLE. MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENT POISONING SHOULD AVOID CONTAMINATING THEMSELVES BY EXPOSURE TO THE VICTIM'S CLOTHING.

DuoDote is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides. DuoDote should only be administered to patients experiencing symptoms of organophosphorous poisoning in a situation where exposure is known or suspected. DuoDote should be administered as soon as symptoms of organophosphorous poisoning appear.

The DuoDote Auto-Injector is intended as an initial treatment of the symptoms of organophosphorous insecticide or nerve agent poisonings; definitive medical care should be sought immediately.

NERVE AGENT AND INSECTICIDE POISONING SYMPTOMS

Common symptoms of organophosphorous exposure are listed below. Individuals may not have all symptoms:
MILD SYMPTOMS SEVERE SYMPTOMS - Blurred vision, miosis - Strange or confused behavior - Excessive, unexplained teary eyes - Severe difficulty breathing or copious secretions from lungs/airway - Excessive, unexplained runny nose - Severe muscular twitching and general weakness - Increased salivation such as sudden drooling - Involuntary urination and defecation - Chest tightness or difficulty breathing - Convulsions - Tremors throughout the body or muscular twitching - Unconsciousness - Nausea and/or vomiting - Unexplained wheezing, coughing or increased airway secretions - Acute onset of stomach cramps - Tachycardia or bradycardia
Three (3) DuoDote Auto-Injectors should be available for use in each patient (including emergency medical services personnel) at risk for organophosphorous poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms as described below. Each DuoDote Auto-Injector delivers atropine 2.1 mg plus pralidoxime chloride 600 mg.
Cyanokit

Cyanokit

Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Cyanokit should be administered in conjunction with appropriate airway, ventilatory and circulatory support.

2.1 Recommended Dosing

The starting dose of hydroxocobalamin for adults is 5 g (i.e., both 2.5 g vials) administered as an intravenous infusion over 15 minutes (approximately 15 mL/min), i.e., 7.5 minutes/vial. Depending upon the severity of the poisoning and the clinical response, a second dose of 5 g may be administered by intravenous infusion for a total dose of 10 g. The rate of infusion for the second dose may range from 15 minutes (for patients in extremis) to two hours, as clinically indicated.

2.2 Preparation of Solution for Infusion

Each 2.5 g vial of hydroxocobalamin for injection is to be reconstituted with 100 mL of diluent (not provided with Cyanokit) using the supplied sterile transfer spike. The recommended diluent is 0.9% Sodium Chloride injection (0.9% NaCl). Lactated Ringers injection and 5% Dextrose injection (D5W) have also been found to be compatible with hydroxocobalamin and may be used if 0.9% NaCl is not readily available. The line on each vial label represents 100 mL volume of diluent. Following the addition of diluent to the lyophilized powder, each vial should be repeatedly inverted or rocked, not shaken, for at least 30 seconds prior to infusion.

Hydroxocobalamin solutions should be visually inspected for particulate matter and color prior to administration. If the reconstituted solution is not dark red or if particulate matter is seen after the solution has been appropriately mixed, the solution should be discarded.

2.3 Incompatibility Information

Physical incompatibility (particle formation) and chemical incompatibility were observed with the mixture of hydroxocobalamin in solution with selected drugs that are frequently used in resuscitation efforts. Hydroxocobalamin is also chemically incompatible with sodium thiosulfate and sodium nitrite and has been reported to be incompatible with ascorbic acid. Therefore, these and other drugs should not be administered simultaneously through the same intravenous line as hydroxocobalamin.

Simultaneous administration of hydroxocobalamin and blood products (whole blood, packed red cells, platelet concentrate and/or fresh frozen plasma) through the same intravenous line is not recommended. However, blood products and hydroxocobalamin can be administered simultaneously using separate intravenous lines (preferably on contralateral extremities, if peripheral lines are being used).

2.4 Storage of Reconstituted Drug Product

Once reconstituted, hydroxocobalamin is stable for up to 6 hours at temperatures not exceeding 40°C (104°F). Do not freeze. Any reconstituted product not used by 6 hours should be discarded.
Cyanokit

Cyanokit

Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Cyanokit should be administered in conjunction with appropriate airway, ventilatory and circulatory support.

2.1 Recommended Dosing

The starting dose of hydroxocobalamin for adults is 5 g administered as an intravenous infusion over 15 minutes (approximately 15 mL/min). Administration of the entire vial constitutes a complete starting dose. Depending upon the severity of the poisoning and the clinical response, a second dose of 5 g may be administered by intravenous infusion for a total dose of 10 g. The rate of infusion for the second dose may range from 15 minutes (for patients in extremis) to two hours, as clinically indicated.

2.2 Preparation of Solution for Infusion

The 5 g vial of hydroxocobalamin for injection is to be reconstituted with 200 mL of diluent (not provided with Cyanokit) using the supplied sterile transfer spike. The recommended diluent is 0.9% Sodium Chloride injection (0.9% NaCl). Lactated Ringers injection and 5% Dextrose injection (D5W) have also been found to be compatible with hydroxocobalamin and may be used if 0.9% NaCl is not readily available. The line on the vial label represents 200 mL volume of diluent. Following the addition of diluent to the lyophilized powder, the vial should be repeatedly inverted or rocked, not shaken, for at least 60 seconds prior to infusion.

Hydroxocobalamin solutions should be visually inspected for particulate matter and color prior to administration. If the reconstituted solution is not dark red or if particulate matter is seen after the solution has been appropriately mixed, the solution should be discarded.

2.3 Incompatibility Information

Physical incompatibility (particle formation) and chemical incompatibility were observed with the mixture of hydroxocobalamin in solution with selected drugs that are frequently used in resuscitation efforts. Hydroxocobalamin is also chemically incompatible with sodium thiosulfate and sodium nitrite and has been reported to be incompatible with ascorbic acid. Therefore, these and other drugs should not be administered simultaneously through the same intravenous line as hydroxocobalamin.

Simultaneous administration of hydroxocobalamin and blood products (whole blood, packed red cells, platelet concentrate and/or fresh frozen plasma) through the same intravenous line is not recommended. However, blood products and hydroxocobalamin can be administered simultaneously using separate intravenous lines (preferably on contralateral extremities, if peripheral lines are being used).

2.4 Storage of Reconstituted Drug Product

Once reconstituted, hydroxocobalamin is stable for up to 6 hours at temperatures not exceeding 40°C (104°F). Do not freeze. Any reconstituted product not used by 6 hours should be discarded.

Meridian Medical Technologies, Inc.

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Meridian Medical Technologies, Inc. Drugs