These Highlights Do Not Include All The Information Needed To Use Atropen®

Dosage for Mild Symptoms

Instructions for Use

ATROPEN (at-ROW-pen)

(atropine injection)

for intramuscular use

Self and Caregiver Instructions for Use of ATROPEN

Important: Follow these instructions only when ready to use ATROPEN. If possible, a healthcare provider or someone who has been trained to identify and treat the symptoms of nerve agent and insecticide poisoning should give the ATROPEN injection. If a healthcare provider is not available during an emergency, a patient or caregiver might need to give the ATROPEN injection.

Individuals should not rely only on ATROPEN for protection from nerve agent and insecticide poisoning. Exposed persons and caregivers need to wear clothing to protect their skin and goggles and masks to protect their face and eyes when available, to avoid exposure.

Caution: When the ATROPEN is activated, the needle will quickly extend from the green tip and black tip. Keep your fingers away from the green tip and black tip.

Symptoms in infants and young children:

The mild symptoms excessive, unexplained teary eyes, excessive, unexplained runny nose and increased saliva or sudden drooling, and the severe symptom problems controlling urine or stool (bowel movement) are sometimes seen in healthy infants and young children. In infants and young children, these symptoms are seen less often than the other mild and severe symptoms listed above. Symptoms must be looked at together when nerve agent or insecticide exposure is known or suspected.

The severe symptoms severe muscle twitching and general weakness can happen in infants. Infants may become drowsy or pass out, with muscle floppiness instead of muscle twitching, soon after exposure to nerve agents or insecticides.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

ATROPEN^® is a registered trademark of

Meridian Medical Technologies^®, LLC

St. Louis, MO 63146

1-833-739-0945

Revised: 09/2022

Principal Display Panel - 0.25 mg Carton Label

NDC 11704-107-01

MERIDIAN

MEDICAL TECHNOLOGIES™

ATROPEN ^®

(atropine injection) 0.25 mg

Single-Dose Auto-Injector

for Intramuscular Use Only

Rx Only

For use in Nerve Agent and Insecticide Poisoning

Each auto-injector delivers an injection of 0.21 mg/0.3 mL atropine (equivalent

to 0.25 mg atropine sulfate), 1.5 mg citric acid monohydrate, 2.0 mg sodium

citrate dihydrate and 2.0 mg sodium chloride.

Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration.

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

When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0.

Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly 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, with activity due almost entirely to the levo isomer of the drug.

Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C₁₇H₂₃NO₃ and its structural formula is as follows:

ATROPEN may inhibit sweating which, in a warm environment or with excessive exercise, can lead to hyperthermia and heat injury. To the extent feasible, avoid excessive exercise and heat exposure [see Adverse Reactions (6), Overdosage (10)].

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 when atropine is used alone because pralidoxime may potentiate the effect of atropine. Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases. However, similar behavior has occurred in cases of organophosphate poisoning that were not treated with pralidoxime.

Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to atropine.

ATROPEN is a prefilled single-dose autoinjector that contains a clear solution and is supplied in the following package configurations:

A review of published literature supports the safety and effectiveness of atropine in the setting of organophosphate insecticide poisoning in all pediatric age groups.

Adverse events seen in pediatric patients treated with atropine are similar to those that occur in adult patients, although central nervous system effects are often seen earlier and at lower doses [see Adverse Reactions (6)].

Overheating (atropine fever) caused by suppression of sweat gland activity may be more pronounced in infants and small children. Extreme hyperthermia in a newborn has been reported with as little as 0.065 mg orally.

Geriatric patients may be more susceptible to the effects of atropine. Because of the longer half-life of atropine in geriatric patients, they may require less frequent doses after the initial dose [see Clinical Pharmacology (12.3)].

ATROPEN may cause acute glaucoma and should be administered with caution in patients at risk for acute glaucoma or who have severe narrow angle glaucoma. Monitor for signs and symptoms of intraocular pressure, as appropriate.

None.

The following serious adverse reactions are described elsewhere in the labeling:

• Cardiovascular Risks [see Warnings and Precautions (5.1)]
• Heat Injury [see Warnings and Precautions (5.2)]
• Acute Glaucoma [see Warnings and Precautions (5.3)]
• Urinary Retention [see Warnings and Precautions (5.4)]
• Pyloric Stenosis [see Warnings and Precautions (5.5)]
• Exacerbation of Chronic Lung Disease [see Warnings and Precautions (5.6)]
• Hypersensitivity [see Warnings and Precautions (5.7)]

The following adverse reactions associated with the use of atropine were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Pralidoxime: 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. (7.1)
• Barbiturates: Atropine may potentiate the effect of barbiturates. (7.2)

ATROPEN may cause complete pyloric obstruction in patients with partial pyloric stenosis. These patients should be monitored for gastrointestinal symptoms following administration of ATROPEN.

Atropine can cause hypersensitivity reactions, including anaphylactic reactions [see Adverse Reactions (6)]. Medical supervision is necessary in patients who have had previous anaphylactic reactions to atropine and require treatment for organophosphorus or nerve agent poisoning.

Atropine reduces secretions in the mouth and respiratory passages, relieves airway constriction, and may reduce centrally-mediated respiratory paralysis. In severe organophosphorus poisoning, a fully atropinized patient may develop or continue to have respiratory failure and may require artificial respiration and suctioning of airway secretions. Atropine may cause thickening of secretions.

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. Atropine increases heart rate and reduces atrioventricular conduction time. Adequate atropine doses can prevent or abolish bradycardia or asystole produced by organophosphorus nerve agents.

Atropine may decrease the degree of partial heart block, which can occur after organophosphorus poisoning. In some patients with complete heart block, atropine may accelerate the idioventricular rate; in others, the rate is stabilized. In some patients with conduction defects, atropine may cause paradoxical atrioventricular block and nodal rhythm.

Atropine will not act on the neuromuscular junction and has no effect on muscle paralysis or weakness, fasciculations or tremors.

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

Systemic doses of atropine 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. Atropine can dilate cutaneous blood vessels, particularly the “blush” area (atropine flush), may cause atropine “fever” due to suppression of sweat gland activity especially in infants and small children and may inhibit sweating, thereby causing hyperthermia, particularly in a warm environment or with exercise [see Warnings and Precautions (5.2)].

Atropine is well absorbed after intramuscular administration. Following 1.67 mg atropine given intramuscularly to adults by the 2 mg ATROPEN delivery system, the peak concentration (C_max) is 9.6 ± 1.5 (mean ± SEM) ng/mL reached between 3-60 minutes (T_max). The protein binding of atropine is 14 to 22% in plasma. Atropine is distributed throughout the various body tissues and fluids. Much of the drug is metabolized by enzymatic hydrolysis, particularly in the liver. Atropine has been reported to be excreted in human milk [see Use in Specific Populations (8.2)]. The unchanged drug excreted by urine is approximately 13 to 50%.

ATROPEN may cause urinary retention and should be administered with caution to patients with clinically significant bladder outflow obstruction.

Different dose strengths of ATROPEN are available depending on the patient's age and weight (see Table 1).

ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.

Atropine competitively blocks the effects of acetylcholine, including excess acetylcholine due to organophosphorus poisoning, at muscarinic cholinergic receptors on smooth muscle, cardiac muscle, secretory gland cells, and in peripheral autonomic ganglia and the central nervous system.

Cardiovascular adverse reactions reported in the literature for atropine include, but are not limited to, sinus tachycardia, palpitations, premature ventricular contractions, atrial flutter, atrial fibrillation, ventricular flutter, ventricular fibrillation, cardiac syncope, asystole, and myocardial infarction [see Adverse Reactions (6)]. In patients with a recent myocardial infarction and/or severe coronary artery disease, there is a possibility that atropine-induced tachycardia may cause ischemia, extend or initiate myocardial infarcts, and stimulate ventricular ectopy and fibrillation. ATROPEN should be used with caution in patients with known cardiovascular disease or cardiac conduction problems.

Store between 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF) [See USP Controlled Room Temperature]. Not made with natural rubber latex. Keep from freezing. Protect from light.

After the ATROPEN autoinjector has been activated, the empty container should be disposed of properly. It cannot be refilled, nor can the protruding needle be retracted.

• Cardiovascular (CV) Risks: Tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, etc. Use caution in patients with known CV disease or conduction problems. (5.1)
• Heat Injury: May inhibit sweating and lead to hyperthermia; avoid excessive exercising and heat exposure. (5.2)
• Acute Glaucoma: May precipitate in susceptible individuals. (5.3)
• Urinary Retention: May precipitate in patient with bladder outflow obstruction. (5.4)
• Pyloric Stenosis: May precipitate complete obstruction. (5.5)
• Exacerbation of Chronic Lung Disease: Atropine may cause inspissation of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease; monitor respiratory status. (5.6)
• Hypersensitivity: Atropine may cause hypersensitivity reactions, including anaphylaxis. (5.7)

• ATROPEN is a single-dose autoinjector intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings; definitive medical care should be sought immediately. (2.1)
• Dosage is dependent on weight. (2.2)
• Dosage for Mild Symptoms: If the patient experiences two or more mild symptoms, administer one injection intramuscularly into the mid-lateral thigh. If, at any time after the first dose, the patient develops any of the severe symptoms, administer two additional injections intramuscularly in rapid succession. (2.2)
• Dosage for Severe Symptoms: If the patient is either unconscious or has any of the severe symptoms, immediately administer three injections intramuscularly into the patient's mid-lateral thigh in rapid succession. (2.2)

Injection: Each single-dose ATROPEN autoinjector contains a clear sterile solution of atropine. Four strengths of ATROPEN are available

• 0.25 mg/0.3 mL (yellow label): 0.21 mg atropine (equivalent to 0.25 mg atropine sulfate) in 0.3 mL
• 0.5 mg/0.7 mL (blue label): 0.42 mg atropine (equivalent to 0.5 mg atropine sulfate) in 0.7 mL
• 1 mg/0.7 mL (red label): 0.84 mg atropine (equivalent to 1 mg atropine sulfate) in 0.7 mL
• 2 mg/0.7 mL (green label): 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL

Geriatric patients may be more susceptible to the effects of atropine. (8.5)

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

• It is recommended that three ATROPEN autoinjectors be available for use in each patient at risk for organophosphorus or carbamate poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms [see Dosage and Administration (2.2)]. Different dose strengths of ATROPEN are available depending on the patient's weight.
• ATROPEN should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication, but may be administered by a caregiver or self-administration if a trained provider is not available.
• Only administer ATROPEN to patients experiencing symptoms of organophosphorus or carbamate poisoning in a situation where exposure is known or suspected. ATROPEN is a single-dose autoinjector 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.
• ATROPEN should be administered as soon as symptoms of organophosphorus or carbamate poisoning appear.
• In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant (preferably a benzodiazepine) 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.
• A cholinesterase reactivator such as pralidoxime may serve as an important adjunct to atropine therapy.
• Close supervision of all treated patients is indicated for at least 48 to 72 hours.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see Dosage Forms and Strengths (3)].

Atropine may cause thickening of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease. Respiratory status should be monitored in individuals with chronic lung disease following administration of ATROPEN.

Dosage for Mild Symptoms

Instructions for Use

ATROPEN (at-ROW-pen)

(atropine injection)

for intramuscular use

Self and Caregiver Instructions for Use of ATROPEN

Important: Follow these instructions only when ready to use ATROPEN. If possible, a healthcare provider or someone who has been trained to identify and treat the symptoms of nerve agent and insecticide poisoning should give the ATROPEN injection. If a healthcare provider is not available during an emergency, a patient or caregiver might need to give the ATROPEN injection.

Individuals should not rely only on ATROPEN for protection from nerve agent and insecticide poisoning. Exposed persons and caregivers need to wear clothing to protect their skin and goggles and masks to protect their face and eyes when available, to avoid exposure.

Caution: When the ATROPEN is activated, the needle will quickly extend from the green tip and black tip. Keep your fingers away from the green tip and black tip.

Symptoms in infants and young children:

The mild symptoms excessive, unexplained teary eyes, excessive, unexplained runny nose and increased saliva or sudden drooling, and the severe symptom problems controlling urine or stool (bowel movement) are sometimes seen in healthy infants and young children. In infants and young children, these symptoms are seen less often than the other mild and severe symptoms listed above. Symptoms must be looked at together when nerve agent or insecticide exposure is known or suspected.

The severe symptoms severe muscle twitching and general weakness can happen in infants. Infants may become drowsy or pass out, with muscle floppiness instead of muscle twitching, soon after exposure to nerve agents or insecticides.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

ATROPEN^® is a registered trademark of

Meridian Medical Technologies^®, LLC

St. Louis, MO 63146

1-833-739-0945

Revised: 09/2022

Principal Display Panel - 0.25 mg Carton Label

NDC 11704-107-01

MERIDIAN

MEDICAL TECHNOLOGIES™

ATROPEN ^®

(atropine injection) 0.25 mg

Single-Dose Auto-Injector

for Intramuscular Use Only

Rx Only

For use in Nerve Agent and Insecticide Poisoning

Each auto-injector delivers an injection of 0.21 mg/0.3 mL atropine (equivalent

to 0.25 mg atropine sulfate), 1.5 mg citric acid monohydrate, 2.0 mg sodium

citrate dihydrate and 2.0 mg sodium chloride.

Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration.

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

When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0.

Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly 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, with activity due almost entirely to the levo isomer of the drug.

Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C₁₇H₂₃NO₃ and its structural formula is as follows:

ATROPEN may inhibit sweating which, in a warm environment or with excessive exercise, can lead to hyperthermia and heat injury. To the extent feasible, avoid excessive exercise and heat exposure [see Adverse Reactions (6), Overdosage (10)].

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 when atropine is used alone because pralidoxime may potentiate the effect of atropine. Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases. However, similar behavior has occurred in cases of organophosphate poisoning that were not treated with pralidoxime.

Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to atropine.

ATROPEN is a prefilled single-dose autoinjector that contains a clear solution and is supplied in the following package configurations:

A review of published literature supports the safety and effectiveness of atropine in the setting of organophosphate insecticide poisoning in all pediatric age groups.

Adverse events seen in pediatric patients treated with atropine are similar to those that occur in adult patients, although central nervous system effects are often seen earlier and at lower doses [see Adverse Reactions (6)].

Overheating (atropine fever) caused by suppression of sweat gland activity may be more pronounced in infants and small children. Extreme hyperthermia in a newborn has been reported with as little as 0.065 mg orally.

Geriatric patients may be more susceptible to the effects of atropine. Because of the longer half-life of atropine in geriatric patients, they may require less frequent doses after the initial dose [see Clinical Pharmacology (12.3)].

ATROPEN may cause acute glaucoma and should be administered with caution in patients at risk for acute glaucoma or who have severe narrow angle glaucoma. Monitor for signs and symptoms of intraocular pressure, as appropriate.

None.

The following serious adverse reactions are described elsewhere in the labeling:

• Cardiovascular Risks [see Warnings and Precautions (5.1)]
• Heat Injury [see Warnings and Precautions (5.2)]
• Acute Glaucoma [see Warnings and Precautions (5.3)]
• Urinary Retention [see Warnings and Precautions (5.4)]
• Pyloric Stenosis [see Warnings and Precautions (5.5)]
• Exacerbation of Chronic Lung Disease [see Warnings and Precautions (5.6)]
• Hypersensitivity [see Warnings and Precautions (5.7)]

The following adverse reactions associated with the use of atropine were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Pralidoxime: 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. (7.1)
• Barbiturates: Atropine may potentiate the effect of barbiturates. (7.2)

ATROPEN may cause complete pyloric obstruction in patients with partial pyloric stenosis. These patients should be monitored for gastrointestinal symptoms following administration of ATROPEN.

Atropine can cause hypersensitivity reactions, including anaphylactic reactions [see Adverse Reactions (6)]. Medical supervision is necessary in patients who have had previous anaphylactic reactions to atropine and require treatment for organophosphorus or nerve agent poisoning.

Atropine reduces secretions in the mouth and respiratory passages, relieves airway constriction, and may reduce centrally-mediated respiratory paralysis. In severe organophosphorus poisoning, a fully atropinized patient may develop or continue to have respiratory failure and may require artificial respiration and suctioning of airway secretions. Atropine may cause thickening of secretions.

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. Atropine increases heart rate and reduces atrioventricular conduction time. Adequate atropine doses can prevent or abolish bradycardia or asystole produced by organophosphorus nerve agents.

Atropine may decrease the degree of partial heart block, which can occur after organophosphorus poisoning. In some patients with complete heart block, atropine may accelerate the idioventricular rate; in others, the rate is stabilized. In some patients with conduction defects, atropine may cause paradoxical atrioventricular block and nodal rhythm.

Atropine will not act on the neuromuscular junction and has no effect on muscle paralysis or weakness, fasciculations or tremors.

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

Systemic doses of atropine 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. Atropine can dilate cutaneous blood vessels, particularly the “blush” area (atropine flush), may cause atropine “fever” due to suppression of sweat gland activity especially in infants and small children and may inhibit sweating, thereby causing hyperthermia, particularly in a warm environment or with exercise [see Warnings and Precautions (5.2)].

Atropine is well absorbed after intramuscular administration. Following 1.67 mg atropine given intramuscularly to adults by the 2 mg ATROPEN delivery system, the peak concentration (C_max) is 9.6 ± 1.5 (mean ± SEM) ng/mL reached between 3-60 minutes (T_max). The protein binding of atropine is 14 to 22% in plasma. Atropine is distributed throughout the various body tissues and fluids. Much of the drug is metabolized by enzymatic hydrolysis, particularly in the liver. Atropine has been reported to be excreted in human milk [see Use in Specific Populations (8.2)]. The unchanged drug excreted by urine is approximately 13 to 50%.

ATROPEN may cause urinary retention and should be administered with caution to patients with clinically significant bladder outflow obstruction.

Different dose strengths of ATROPEN are available depending on the patient's age and weight (see Table 1).

ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.

Atropine competitively blocks the effects of acetylcholine, including excess acetylcholine due to organophosphorus poisoning, at muscarinic cholinergic receptors on smooth muscle, cardiac muscle, secretory gland cells, and in peripheral autonomic ganglia and the central nervous system.

Cardiovascular adverse reactions reported in the literature for atropine include, but are not limited to, sinus tachycardia, palpitations, premature ventricular contractions, atrial flutter, atrial fibrillation, ventricular flutter, ventricular fibrillation, cardiac syncope, asystole, and myocardial infarction [see Adverse Reactions (6)]. In patients with a recent myocardial infarction and/or severe coronary artery disease, there is a possibility that atropine-induced tachycardia may cause ischemia, extend or initiate myocardial infarcts, and stimulate ventricular ectopy and fibrillation. ATROPEN should be used with caution in patients with known cardiovascular disease or cardiac conduction problems.

Store between 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF) [See USP Controlled Room Temperature]. Not made with natural rubber latex. Keep from freezing. Protect from light.

After the ATROPEN autoinjector has been activated, the empty container should be disposed of properly. It cannot be refilled, nor can the protruding needle be retracted.

• Cardiovascular (CV) Risks: Tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, etc. Use caution in patients with known CV disease or conduction problems. (5.1)
• Heat Injury: May inhibit sweating and lead to hyperthermia; avoid excessive exercising and heat exposure. (5.2)
• Acute Glaucoma: May precipitate in susceptible individuals. (5.3)
• Urinary Retention: May precipitate in patient with bladder outflow obstruction. (5.4)
• Pyloric Stenosis: May precipitate complete obstruction. (5.5)
• Exacerbation of Chronic Lung Disease: Atropine may cause inspissation of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease; monitor respiratory status. (5.6)
• Hypersensitivity: Atropine may cause hypersensitivity reactions, including anaphylaxis. (5.7)

• ATROPEN is a single-dose autoinjector intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings; definitive medical care should be sought immediately. (2.1)
• Dosage is dependent on weight. (2.2)
• Dosage for Mild Symptoms: If the patient experiences two or more mild symptoms, administer one injection intramuscularly into the mid-lateral thigh. If, at any time after the first dose, the patient develops any of the severe symptoms, administer two additional injections intramuscularly in rapid succession. (2.2)
• Dosage for Severe Symptoms: If the patient is either unconscious or has any of the severe symptoms, immediately administer three injections intramuscularly into the patient's mid-lateral thigh in rapid succession. (2.2)

Injection: Each single-dose ATROPEN autoinjector contains a clear sterile solution of atropine. Four strengths of ATROPEN are available

• 0.25 mg/0.3 mL (yellow label): 0.21 mg atropine (equivalent to 0.25 mg atropine sulfate) in 0.3 mL
• 0.5 mg/0.7 mL (blue label): 0.42 mg atropine (equivalent to 0.5 mg atropine sulfate) in 0.7 mL
• 1 mg/0.7 mL (red label): 0.84 mg atropine (equivalent to 1 mg atropine sulfate) in 0.7 mL
• 2 mg/0.7 mL (green label): 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL

Geriatric patients may be more susceptible to the effects of atropine. (8.5)

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

• It is recommended that three ATROPEN autoinjectors be available for use in each patient at risk for organophosphorus or carbamate poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms [see Dosage and Administration (2.2)]. Different dose strengths of ATROPEN are available depending on the patient's weight.
• ATROPEN should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication, but may be administered by a caregiver or self-administration if a trained provider is not available.
• Only administer ATROPEN to patients experiencing symptoms of organophosphorus or carbamate poisoning in a situation where exposure is known or suspected. ATROPEN is a single-dose autoinjector 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.
• ATROPEN should be administered as soon as symptoms of organophosphorus or carbamate poisoning appear.
• In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant (preferably a benzodiazepine) 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.
• A cholinesterase reactivator such as pralidoxime may serve as an important adjunct to atropine therapy.
• Close supervision of all treated patients is indicated for at least 48 to 72 hours.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see Dosage Forms and Strengths (3)].

Atropine may cause thickening of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease. Respiratory status should be monitored in individuals with chronic lung disease following administration of ATROPEN.