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Atropine Sulfate Injection Usp, 0.5 Mg/0.7 Ml

FDA Drug Information

Drug Class
Anticholinergic [EPC], Cholinergic Muscarinic Antagonist [EPC]
Route
INTRAMUSCULAR
Dosage Form
INJECTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer). The pH range is 4.1 - 4.5. Atropine, a cholinergic muscarinic antagonist, occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine; its activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-tropan-3–ol (±)-tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is: atropine-01

What Is Atropine Sulfate Injection Usp, 0.5 Mg/0.7 Ml Used For?

Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). Atropine, a cholinergic muscarinic antagonist, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds) (1).

Dosage and Administration

Important Administration Information Three (3) Atropine autoinjectors should be available for use in each patient at risk for nerve agent or organophosphate insecticide poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms [see Dosage and Administration (2.2)]. Only administer Atropine to patients experiencing symptoms of organophosphorus poisoning in a situation where exposure is known or suspected. The Atropine autoinjector is intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings as soon as symptoms appear; definitive medical care should be sought immediately. 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. The Atropine autoinjector 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 by self-administration if a trained provider is not available. Close supervision of all treated patients is indicated for at least 48 to 72 hours. In severe poisonings, concurrent administration of an anticonvulsant (preferably a benzodiazepine) may be warranted if seizure is suspected in the unconscious individual because overt jerking may not be apparent because of the effects of the poison [see Drug Interactions (7.2)]. In poisonings caused by organophosphorous nerve agents and insecticides it may also be helpful to concurrently administer a cholinesterase reactivator such as pralidoxime chloride [see Drug Interactions (7.1)]. The injection site is the mid-lateral thigh area. The Atropine autoinjector can inject through clothing. However, make sure pockets at the injection site are empty. People who may not have a lot of fat at the injection site should also be injected in the mid-lateral thigh, but before giving the injection, bunch up the thigh to provide a thicker area for injection. Dosage Information Dosage for Mild Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds) First Dose: If the patient experiences two or more mild symptoms of nerve agent (nerve gas) or insecticide exposure listed in Table 1, administer one (1) Atropine injection intramuscularly into the mid-lateral outer thigh. Additional Doses: If, at any time after the first dose, the patient develops any of the severe symptoms listed in Table 1, administer two (2) additional Atropine injections intramuscularly in rapid succession. Wait 10 to 15 minutes for Atropine to take effect. If, after 10 to 15 minutes, the patient does not develop any of the severe symptoms listed in Table 1, no additional Atropine injections are recommended. If possible, a person other than the patient should administer the second and third 2 mg Atropine autoinjectors. Dosage for Severe Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds) If a patient is...

Side Effects (Adverse Reactions)

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. Injection Site Reactions Mild to moderate pain may be experienced at the site of injection. Adverse Reactions at Recommended Dosages The major and most common side effects of atropine can be attributed to its antimuscarinic action. These include dryness of the mouth, blurred vision, dry eyes, photophobia, confusion, headache, dizziness, fatigue, tachycardia, palpitations, flushing, urinary hesitance or retention, constipation, abdominal pain, abdominal distention, nausea, vomiting, loss of libido, and impotency. Anhidrosis may produce heat intolerance and impairment of temperature regulation especially in a hot environment. Hypersensitivity Hypersensitivity reactions will occasionally occur with atropine; these are usually seen as skin rashes, on occasion progressing to exfoliation. Anaphylactic reactions have occurred. Additional Adverse Reactions to Atropine by Organ System The following adverse reactions were reported in published literature for atropine in both adults and pediatric patients: Cardiovascular : Sinus tachycardia, supraventricular tachycardia, junctional tachycardia, ventricular tachycardia, bradycardia, palpitations, ventricular arrhythmia, ventricular flutter, ventricular fibrillation, atrial arrhythmia, atrial fibrillation, atrial ectopic beats, ventricular premature contractions, bigeminal beats, trigeminal beats, nodal extrasystole, ventricular extrasystole, supraventricular extrasystole, asystole, cardiac syncope, prolongation of sinus node recovery time, cardiac dilation, left ventricular failure, myocardial infarction, intermittent nodal rhythm (no P wave), prolonged P wave, shortened PR segment, R on T phenomenon, shortened RT duration, widening and flattening of QRS complex, prolonged QT interval, flattening of T wave, repolarization abnormalities, altered ST-T waves, retrograde conduction, transient AV dissociation, increased blood pressure, decreased blood pressure, labile blood pressure, weak or impalpable peripheral pulses. Eye : Mydriasis, pupils poorly reactive to light, decreased contrast sensitivity, decreased visual acuity, decreased accommodation, cycloplegia, strabismus, heterophoria, cyclophoria, acute angle closure glaucoma, conjunctivitis, keratoconjunctivitis sicca, blindness, tearing, dry conjunctiva, irritated eyes, crusting of eyelid, blepharitis. Gastrointestinal : Paralytic ileus, decreased bowel sounds, delayed gastric emptying, decreased food absorption, dysphagia. General : Hyperpyrexia, lethargy, somnolence, chest pain, excessive thirst, weakness, syncope, insomnia, tongue chewing, dehydration, feeling hot. Special Investigations : Leukocytosis, hyponatremia, elevated BUN, elevated hemoglobin, elevated erythrocytes, low hemoglobin, hypoglycemia, hyperglycemia, hypokalemia, increase in photic stimulation on EEG, signs of drowsiness on EEG, runs of alpha waves on EEG, alpha waves (EEG) blocked upon opening eyes. Metabolic : Failure to feed. Central Nervous System : Ataxia, hallucinations (visual or aural), seizures (generally tonic-clonic), abnormal movements, coma, stupor, amnesia, diminished tendon reflexes, hyperreflexia, muscle twitching, opisthotnos, Babinski's reflex/Chaddock's reflex,...

Drug Interactions

Pralidoxime 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 Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to Atropine. Pralidoxime : may potentiate the effect of atropine (7.1). Barbiturates : atropine may potentiate the effect of barbiturates (7.2) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Contraindications

None. None (4)

Overdosage

Symptoms Manifestations of atropine overdose are dose-related and include flushing, dry skin and mucous membranes, tachycardia, widely dilated pupils that are poorly responsive to light, blurred vision, and fever (which can sometimes be dangerously elevated). Locomotor difficulties, disorientation, hallucinations, delirium, confusion, agitation, coma, and central depression can occur and may last 48 hours or longer. In instances of severe atropine intoxication, respiratory depression, coma, circulatory collapse, and death may occur. 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 pediatric patients. Catheterization may be necessary if urinary retention occurs. Since atropine elimination takes place through the kidney, urinary 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 atropine-induced photophobia, the room should be darkened. A benzodiazepine may be needed to control marked excitement and convulsions. However, large doses for sedation should be avoided because the central nervous system depressant effect may coincide with the depressant effect occurring late in severe atropine poisoning. Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions. Central nervous system stimulants are not recommended.

How Supplied

How Supplied The 2 mg Atropine autoinjector provides atropine base 1.67 mg/0.7 mL (equivalent to atropine sulfate 2 mg/0.7 mL) in a sterile solution for intramuscular injection. The 2 mg Atropine autoinjector is supplied as 480 self-contained single-dose autoinjectors per box (NDC 71053-592-01). Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do Not Freeze.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.