AtroPen

Name: AtroPen

Warnings

Contraindications

No absolute contraindications for ACLS

  • Ineffective in hypothermic bradycardia

Narrow-angle glaucoma, tachycardia, asthma, GI obstruction, severe ulcerative colitis, toxic megacolon, bladder outlet obstruction

Cautions

Caution in hepatic/renal impairment, BPH, CHF

Not for effective treatment of type II second or third-degree AV block with or without a new wide QRS complex

Use caution in autonomic neuropathy, myocardial ischemia, heart failure, paralytic ileus, hepatic impairment, hiatal hernia associated with reflux esophagitis, hyperthyroidism, myasthenia gravis, and renal impairment

Heat prostration can occur in high environmental temperature

Psychosis reported in sensitive individuals and with excessive doses

When recurrent use of atropine is essential in patients with coronary artery disease, total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid detrimental effects of atropine-induced tachycardia on myocardial oxygen demand

May precipitate acute glaucoma

May convert partial organic pyloric stenosis into complete obstruction

May lead to complete urinary retention in patients with prostatic hypertrophy

May cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease

Clinical pharmacology

Mechanism of Action

Atropine is commonly classified as an anticholinergic or antiparasympathetic (parasympatholytic) drug. More precisely, however, it is termed an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters.

Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles, which respond to endogenous acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism, which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents, which inhibit the enzymatic destruction of acetylcholine). The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine, (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation may also be inhibited by atropine, but this occurs less readily than with responses to injected (exogenous) choline esters.

Pharmacodynamics

Atropine reduces secretions in the mouth and respiratory passages, relieves the constriction and spasm of the respiratory passages, and may reduce the paralysis of respiration, which results from actions of the toxic agent on the central nervous system. 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. Although mild vagal excitation occurs, the increased respiratory rate and occasionally increased depth of respiration produced by atropine are more probably the result of bronchiolar dilatation. Accordingly, atropine is an unreliable respiratory stimulant and large or repeated doses may depress respiration.

Adequate doses of atropine abolish various types of reflex vagal cardiac slowing or asystole. The drug also prevents or abolishes bradycardia or asystole produced by injection of choline esters, anticholinesterase agents or other parasympathomimetic drugs, and cardiac arrest produced by stimulation of the vagus. Atropine may also lessen the degree of partial heart block when vagal activity is an etiologic factor. In some individuals with complete heart block, the idioventricular rate may be accelerated by atropine; in others, the rate is stabilized. Occasionally, a large dose may cause atrioventricular (A-V) block and nodal rhythm.

Atropine in clinical doses counteracts the peripheral dilatation and abrupt decrease in blood pressure produced by choline esters. However, when given by itself, atropine does not exert a striking or uniform effect on blood vessels or blood pressure. Systemic doses 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. Occasionally, therapeutic doses dilate cutaneous blood vessels, particularly in the "blush" area (atropine flush), and may cause atropine "fever" due to suppression of sweat gland activity especially in infants and small children.

Pharmacokinetics

Atropine is rapidly and well absorbed after intramuscular administration. Atropine disappears rapidly from the blood and is distributed throughout the various body tissues and fluids. Much of the drug is destroyed by enzymatic hydrolysis, particularly in the liver; from 13 to 50% is excreted unchanged in the urine. Traces are found in various secretions, including milk. Atropine readily crosses the placental barrier and enters the fetal circulation.

The approximate Cmax of atropine following 1.67 mg atropine given intramuscularly to adults by the 2 mg AtroPen® (atropine) delivery system was 9.6 ± 1.5 (mean ± SEM) ng/ml. The mean T max was 3 minutes. The T½ of intravenous atropine in pediatric subjects under 2 years is 6.9 ± 3.3 (mean ± SD) hours; in children over 2 years, the T½ is 2.5 ± 1.2 (mean ± SD) hours; in adults 16–58 years the T½ is 3.0 ± 0.9 (mean ± SD) hours; in geriatric patients 65–75 years it is 10.0 ± 7.3 (mean ± SD) hours. The protein binding of atropine is 14 to 22% in plasma. There are gender differences in the pharmacokinetics of atropine. The AUC(0-inf) and Cmax were 15% higher in females than males. The half-life of atropine is slightly shorter (approximately 20 minutes) in females than males.

Patient information

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
(generally over 10 years of age)
2 mg AtroPen® (atropine)
(GREEN LABEL)
Children weighing 40 lbs to 90 lbs
(generally 4 to 10 years of age)
1 mg AtroPen® (atropine)
(DARK RED LABEL)
Children weighing 15 lbs to 40 lbs
(generally 6 months to 4 years of age) 0.5 mg AtroPen® (atropine)
(BLUE LABEL)
NOTE: Children weighing under 15 lbs (generally younger than 6 months old) should ordinarily not be treated with the AtroPen® auto-injector. Atropine doses in this age group should be individualized at doses of 0.05 mg/kg.
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 these symptoms:
MILD symptoms
  •  Blurred vision and sore eyes
  •  Teary eyes
  •  Runny nose
  •  Increased salivation such as sudden drooling
  •  Chest tightness or difficulty breathing
  •  Tremors throughout the body or muscular twitching
  •  Nausea and vomiting
  •  Involuntary secretions (phlegm from your lungs/airway)

SEVERE symptoms

  •  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
Step 3 TREATMENT OF MILD SYMPTOMS FIRST DOSE: Give one (1) AtroPen® (atropine) 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® (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 above. 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 above, 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.
WARNING: Giving additional AtroPen (atropine) 0 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 THE ATROPEN® (atropine) #00001
(A) Snap the grooved end of the plastic sleeve down and over the yellow safety cap. Remove the AtroPen® (atropine) 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 cap with your other hand.
(D) Aim and firmly jab the green tip straight down (a 90° angle) against the outer thigh. The AtroPen® (atropine) 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® (atropine) , 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 cap has been removed, and repeat steps C and E, but press harder.
(G) After use, using a hard surface, bend the needle back against the AtroPen® (atropine) and either pin the used AtroPen® (atropine) to the victim's clothing or show the used AtroPen® (atropine) auto-injectors to the first medical person you see. This will allow medical personnel to see the number and dose of AtroPen® (atropine) autoinjectors administered. Move yourself and the exposed individual away from the contaminated area right away.
Try to find medical help.

Uses for AtroPen

Surgery

Used as a preoperative medication to inhibit salivation and excessive secretions of the respiratory tract (antisialagogue).196 198 200 However, current surgical practice (e.g., using general anesthetics that do not stimulate salivary and tracheobronchial secretions) has reduced the need to control excessive respiratory secretions during surgery.b

Used to prevent other cholinergic effects during surgery (e.g., cardiac arrhythmias, hypotension, bradycardia) secondary to excessive vagal stimulation, carotid sinus stimulation, or pharmacologic effect of drugs (e.g., succinylcholine).196 200 402

Used to block adverse muscarinic effects of anticholinesterase agents (e.g., neostigmine, pyridostigmine) that are used after surgery to reverse the effects of neuromuscular blocking agents.120 121 196

Used as a premedication for bradycardia during emergency pediatric intubation.402 Not routinely recommended because of lack of supporting evidence, but may be considered in situations where there is an increased risk of bradycardia (e.g., when succinylcholine is used to facilitate intubation).402

Ineffective for preventing acid-aspiration pneumonitis† during surgery.b

ACLS and Bradyarrhythmias

Used in ACLS for management of symptomatic bradycardia.400 401 403 Reverses cholinergically mediated decreases in heart rate, systemic vascular resistance, and BP.106 401

Considered initial drug of choice in adults with unstable bradycardia (e.g., that accompanied by altered mental status, cardiac ischemia, acute heart failure, hypotension, or other signs of shock).400 401

In pediatric advanced life support (PALS), used for treatment of bradycardia secondary to increased vagal activity or primary AV block when bradycardia persists despite adequate oxygenation, ventilation, and CPR (if indicated).403

Previously included in ACLS guidelines for treatment of asystole or pulseless electrical activity (PEA) during CPR;106 however, routine use during cardiac arrest no longer recommended because of lack of evidence demonstrating benefit.400 401 402 403

May be beneficial for treatment of AV nodal block.401 403 However, not likely to be effective in patients with type II second-degree or third-degree AV block, including third-degree AV block accompanied by a new wide QRS complex where location of block is at or below the His-Purkinje level; transcutaneous pacing or rate-accelerating β-adrenergic drugs (e.g., dopamine or epinephrine) preferred in these patients until transvenous pacing can be performed.401

Used in patients with MI who develop symptomatic or hemodynamically unstable sinus bradycardia.201 202 Other uses in MI setting include treatment of sustained bradycardia and hypotension associated with nitroglycerin use, and treatment of nausea and vomiting associated with morphine use.202

Use cautiously in the presence of acute myocardial ischemia or MI because heart rate is a major determinant of myocardial oxygen requirements.b

May be ineffective in patients who have undergone cardiac transplantation due to lack of vagal innervation in transplanted heart.401 Risk of paradoxical slowing of the heart rate and high-degree AV block in patients receiving atropine after cardiac transplantation.401

Pesticide Poisoning

Used concomitantly with a cholinesterase reactivator (pralidoxime chloride) to reverse muscarinic effects associated with toxic exposure to organophosphate anticholinesterase pesticides.103 105 200

Used to reverse muscarinic effects associated with toxic exposure to carbamate anticholinesterase pesticides.105 197 Concomitant cholinesterase reactivator (pralidoxime chloride) therapy may not be necessary.197

A challenge (test) dose of atropine may be useful in diagnosing cholinergic poisoning†.197 Failure of the challenge dose to elicit typical antimuscarinic effects (e.g., mydriasis, tachycardia, dry mucous membranes) strongly suggests the presence of organophosphate or carbamate poisoning.197

Use atropine in conjunction with other protective measures (e.g., decontamination, immediate evacuation, specialized masks and clothing) and treatments (e.g., anticonvulsant for seizures).105

Chemical Warfare Agent Poisoning

Used concomitantly with a cholinesterase reactivator (pralidoxime chloride) to reverse muscarinic effects associated with toxic exposure to organophosphate anticholinesterase nerve agents (e.g., sarin, soman, tabun, VX [methylphosphonothioic acid]) in the context of chemical warfare or terrorism.101 102 103 104 105

Initial management of nerve agent poisoning includes aggressive airway control and ventilation (administration of nebulized β-adrenergic agonist [e.g., albuterol] and antimuscarinics [e.g., ipratropium bromide] may be necessary), and administration of atropine and pralidoxime chloride;101 102 103 diazepam may be needed for seizure control.101

Mushroom Poisoning

Treatment of muscarinic effects associated with toxic ingestion of mushrooms containing muscarine (e.g., certain members of the Clitocybe and Inocybe genera).197 200 However, substantial toxicity is uncommon, and supportive symptomatic care (e.g., atropine) rarely is necessary.197

Radiographic Uses

Has been used to facilitate hypotonic duodenography or contrast examination of the colon; however, glucagon appears to be more effective and generally is preferred in these examinations.b

Has been used to increase visualization of the urinary tract in excretion urography.b

Bronchospasm

Has been used by oral inhalation as a bronchodilator for short-term treatment of bronchospasm associated with bronchial asthma, bronchitis, and COPD; however, a solution for oral inhalation no longer commercially available in the US.b

GI Disorders

Has been used as an adjunct in the treatment of peptic ulcer disease;b c however, no conclusive data that the drug promotes healing, decreases rate of recurrence, or prevents complications of peptic ulcers.b

With the advent of more effective therapies for the treatment of peptic ulcer disease, antimuscarinics have only limited usefulness in this condition.b

Has been used in the treatment of functional disturbances of GI motility such as irritable bowel syndrome;b however, efficacy is limited.b Use only if other measures (e.g., diet, sedation, counseling, amelioration of environmental factors) have been of little or no benefit.b

GU Disorders

Has been used as adjunctive therapy in the management of hypermotility disorders of the lower urinary tract.b May provide symptomatic relief, but the underlying cause should be determined and specifically treated.b

With the exception of uninhibited or reflex neurogenic bladder, there is generally little evidence to support the use of antimuscarinics in the treatment of various GU disorders.c

Biliary Disorders

Has been used in conjunction with morphine or other opiates for symptomatic relief of biliary or renal colic; however, only exerts weak biliary antispasmodic action.b

Pancreatitis

Has been used to reduce pain and hypersecretions in acute pancreatitis, but little evidence of benefit.b

AtroPen Pharmacokinetics

Absorption

Bioavailability

Well absorbed (90%) from the GI tract, principally from upper small intestine.b

Rapidly and well absorbed after IM injection.b Physical exercise, either prior to or immediately following IM injection, increases absorption due to muscle perfusion and decreases clearance.200

Well absorbed following endotracheal administration.b Dilution with sterile water versus 0.9% sodium chloride injection may increase endotracheal absorption.401

Onset

Inhibition of salivation occurs within 30 minutes and peaks within 1–1.6 hours after IM administration.b

Increase in heart rate occurs within 2–4 minutes after IV injection.b

Increase in heart rate occurs within 5–40 minutes and peaks within 20–60 minutes after IM administration.b

Duration

Inhibition of salivation persists for up to 4 hours.b

Plasma Concentrations

Following IM administration, peak plasma concentrations are reached within 30 minutes.b

Distribution

Extent

Rapidly and well distributed throughout the body, including the CNS.105 b

Traces are found in various secretions, including milk.200

Crosses the placental barrier and enters fetal circulation but is not found in amniotic fluid.200

Plasma Protein Binding

Low binding (about 18%) to serum albumin.b

Elimination

Metabolism

Via the liver to several metabolites including tropic acid, atropine (or a chromatographically similar compound), and, possibly, esters of tropic acid and glucuronide conjugates.b

Elimination Route

About 30–50% of a dose is excreted in urine unchanged.b

Excreted mainly through the kidneys;b however, small amounts may be excreted in the feces and expired air.b

Half-life

2–3 hours.b

Biphasic following IM injection; 2–3-hours initially followed by a terminal half-life of 12.5 hours or longer.b

Special Populations

Elimination half-life is more than doubled in children <2 years and the elderly (>65 years of age) compared with other age groups.200

No gender effect on pharmacokinetics and pharmacodynamics.200

Advice to Patients

  • Seek immediate medical attention after injection with an atropine injection auto-injector.105

  • Advise that dry mouth may occur.105 b

  • Advise of risk of hyperthermia and heat prostration; avoid exposure to high environmental temperatures and avoid use when febrile.c

  • Advise patients receiving chronic therapy of possible blurred vision with the drug; activities that require good, clear vision should be avoided.105 b

  • Risk of dizziness or drowsiness; avoid driving or operating machinery until effects on individual are known.c

  • For IM self-administration in nerve gas and pesticide poisoning, proper techniques for storage, attention to expiration dating (replacing before expiration), use, and disposal of the prefilled auto-injector (e.g., AtroPen) and for administration of the drug.105

  • For IM self-administration in nerve gas and pesticide poisoning, importance of understanding the indications for use and the symptoms of poisoning.105

  • For IM self-administration in nerve gas and pesticide poisoning, importance of ensuring adequate understanding of the recognition and treatment of such poisoning and when concomitant cholinesterase reactivator (pralidoxime chloride) therapy may be necessary.105

  • For IM self-administration in nerve gas and pesticide poisoning, importance of not exceeding 3 doses unless under medical supervision.105

  • For IM self-administration in nerve gas and pesticide poisoning, importance of seeking immediate medical attention once the initial dose(s) is administered because respiratory and other supportive care and prolonged atropinization may be needed.105

  • For IM self-administration in nerve gas and pesticide poisoning, importance of recognizing that inadvertent administration when such poisoning is not present could result in atropine toxicity and temporary incapacitation (inability to walk properly, see clearly, or think clearly for several hours or longer).105

  • For self-administration in nerve gas and pesticide poisoning, importance of not contaminating other individuals (e.g., medical and emergency personnel) by clothing exposure; aggressive and safe decontamination by trained personnel is strongly suggested.105

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.105 b

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.105

  • Importance of informing patients of other important precautionary information.105 b (See Cautions.)

What do I need to tell my doctor BEFORE I take AtroPen?

  • If you have an allergy to atropine or any other part of AtroPen (atropine auto-injector).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (AtroPen) best taken?

Use AtroPen as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a muscle.
  • Read how to use before an emergency happens.
  • Someone else may have to give this medicine. Be sure others know where AtroPen is stored and how to give it if needed.
  • Never put your fingers or hand over the tip.
  • Do not take off safety release until ready to use.
  • When you are ready to use, take the pen out of the case.
  • Hold pen with tip down.
  • Make a fist around the pen.
  • Pull off safety release.
  • Jab straight into the outer thigh and hold for as long as you were told.
  • Get medical help right away after using this medicine.
  • Take it with you to the hospital.
  • Do not use AtroPen if the solution changes color, is cloudy, or has particles. Get a new one.

What do I do if I miss a dose?

  • This medicine is used on an as needed basis. Do not use more often than told by the doctor.

Overdosage

Symptoms:

Serious overdosage with atropine is characterized by widespread paralysis of parasympathetically innervated organs. Dry mucous membranes, widely dilated and nonresponsive pupils, tachycardia, fever and cutaneous flush are especially prominent, as are mental and neurological symptoms. Disorientation, mania, hallucinations, gait disturbances and symptoms may last 48 hours or longer. In instances of severe intoxication, respiratory depression, coma, circulatory collapse and death may occur.

The fatal dose of atropine is not known. In the treatment of organophosphorous poisoning, cumulative doses of approximately 2300-3300 mg or more have been administered over several days to 4-5 weeks. In children, medical literature published prior to 1951 reports four deaths, all in patients 10 months to 3 years of age, and all associated with atropine eye drops or ointment. Total estimated ophthalmic doses were 1.6, 2, 4, and 18 mg given as a single dose (2 mg) or over 1-2 days. Review of current published literature since 1950 identified no pediatric deaths associated with atropine. The few deaths in adults were generally seen using typical clinical doses of atropine often in the setting of bradycardia associated with an acute myocardial infarction.

With a dose as low as 0.5 mg, undesirable symptoms or responses of overdosage may occur. These increase in severity and extent with larger doses of the drug (excitement, hallucinations, delirium and coma). Extreme hyperthermia in a newborn has been reported with as little as 0.065 mg orally. However, in the presence of organophosphorous poisoning, much higher doses of atropine appear to be tolerated and required for optimal therapy.

Treatment:

Supportive treatment should be administered as indicated. If respiration is depressed, artificial respiration with oxygen is necessary. Ice bags, alcohol sponges or a hypothermia blanket may be required to reduce fever, especially in children. Catheterization may be necessary if urinary retention occurs. Since atropine elimination takes place through the kidney, output must be maintained and increased if possible, however, dialysis has not been shown to be helpful in overdose situations. Intravenous fluids may be indicated. Because of the affected person's photophobia, the room should be darkened.

In the event of toxic overdosage, a short-acting barbiturate or diazepam may be given as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended. Physostigmine, given as an atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1.0 mg in children), rapidly abolishes delirium and coma caused by large doses of atropine in most situations. Since physostigmine has a short duration of action, the patient may again lapse into coma after one or two hours and repeated doses are likely to be required. Neostigmine, pilocarpine and methacholine are of little real benefit, since they do not penetrate the blood-brain barrier.

Principal Display Panel - 2 mg Carton Label

NDC 11704-106-01

MERIDIAN
MEDICAL TECHNOLOGIES™

AtroPen®
(atropine injection 2 mg)

AUTO-INJECTOR

Rx Only

for use in NERVE AGENT and INSECTICIDE POISONING

AtroPen AUTO-INJECTOR 
atropine sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:11704-107
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atropine sulfate (atropine) Atropine sulfate 0.25 mg  in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
glycerin  
citric acid monohydrate  
phenol  
water  
Packaging
# Item Code Package Description
1 NDC:11704-107-01 0.3 mL in 1 SYRINGE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017106 09/17/2004
AtroPen AUTO-INJECTOR 
atropine sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:11704-104
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atropine sulfate (atropine) Atropine sulfate 0.5 mg  in 0.7 mL
Inactive Ingredients
Ingredient Name Strength
glycerin  
citric acid monohydrate  
phenol  
water  
Packaging
# Item Code Package Description
1 NDC:11704-104-01 0.7 mL in 1 SYRINGE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017106 06/19/2003
AtroPen AUTO-INJECTOR 
atropine sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:11704-105
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atropine sulfate (atropine) Atropine sulfate 1 mg  in 0.7 mL
Inactive Ingredients
Ingredient Name Strength
glycerin  
citric acid monohydrate  
phenol  
water  
Packaging
# Item Code Package Description
1 NDC:11704-105-01 0.7 mL in 1 SYRINGE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017106 06/19/2003
AtroPen AUTO-INJECTOR 
atropine sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:11704-106
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atropine sulfate (atropine) Atropine sulfate 2 mg  in 0.7 mL
Inactive Ingredients
Ingredient Name Strength
glycerin  
citric acid monohydrate  
phenol  
water  
Packaging
# Item Code Package Description
1 NDC:11704-106-01 0.7 mL in 1 SYRINGE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017106 06/19/2003
Labeler - Meridian Medical Technologies, Inc. (167671341)
Establishment
Name Address ID/FEI Operations
Meridian Medical Technologies, Inc. 038889234 MANUFACTURE(11704-107, 11704-104, 11704-105, 11704-106), ANALYSIS(11704-107, 11704-104, 11704-105, 11704-106), STERILIZE(11704-107, 11704-104, 11704-105, 11704-106)
Establishment
Name Address ID/FEI Operations
Meridian Medical Technologies, Inc. 078808315 MANUFACTURE(11704-107, 11704-104, 11704-105, 11704-106), LABEL(11704-107, 11704-104, 11704-105, 11704-106), PACK(11704-107, 11704-104, 11704-105, 11704-106)
Establishment
Name Address ID/FEI Operations
Meridian Medical Technologies, Inc. 167671341 MANUFACTURE(11704-107, 11704-104, 11704-105, 11704-106), LABEL(11704-107, 11704-104, 11704-105, 11704-106), PACK(11704-107, 11704-104, 11704-105, 11704-106), ANALYSIS(11704-107, 11704-104, 11704-105, 11704-106)
Revised: 06/2016   Meridian Medical Technologies, Inc.
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