Atropine (Injection)

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# Overview
Atropine (Injection) is an anticholinergic that is FDA approved for the treatment of the treatment of poisoning by susceptible organophosphorous nerve agents,  pre-anesthetic medication in surgical patients, pylorospasm, antidote for mushroom poisoning due to muscarine in certain species such as Amanita muscaria.   Common adverse reactions include mild to moderate pain, dryness of the mouth, blurred vision, photophobia, confusion, headache, dizziness, tachycardia, palpitations, flushing, urinary hesitance or retention, constipation, abdominal distention, nausea, vomiting, loss of libido, and impotency.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Atropine Sulfate Injection, USP, may be given parenterally as a pre-anesthetic medication in surgical patients to reduce salivation and bronchial secretions.
- It may also be used to suppress vagal activity associated with the use of halogenated hydrocarbons during inhalation anesthesia and reflex excitation arising from mechanical stimulation during surgery.
- The antispasmodic action of atropine is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine concomitantly with morphine may be indicated.
- Atropine relaxes the upper GI tract and colon during hypotonic radiography.
- In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central nervous system manifestations. It is also used as an antidote for mushroom poisoning due to muscarine in certain species such as Amanita muscaria.
- Antimuscarinic
- Intramuscular, intravenous, or subcutaneous, 400 to 600 g (0.4 to 0.6 mg) every four to six hours.
- Arrhythmias
- Intravenous, 400 g (0.4 mg) to 1 mg every one to two hours as needed, up to a maximum of 2 mg.
- Gastrointestinal radiography
- Intramuscular, 1 mg.
- Preanesthesia (antisialagogue)
- Intramuscular, 200 to 600 g (0.2 to 0.6 mg) one-half to one hour before surgery.
- Cholinergic adjunct (curariform block)
- Intravenous, 600 g (0.6 mg) to 1.2 mg administered a few minutes before or concurrently with 500 g (0.5 mg) to 2 mg of neostigmine methylsulfate, using separate syringes.
- Antidote (to cholinesterase inhibitors)
- Intravenous, 2 to 4 mg initially, then 2 mg repeated every five to ten minutes until muscarinic symptoms disappear or signs of atropine toxicity appear.
- Antidote (to muscarine in mushroom poisoning)
- Intramuscular or intravenous, 1 to 2 mg every hour until respiratory effects subside.
- Antidote (to organophosphate pesticides)
- Intramuscular or intravenous 1 to 2 mg, repeated in twenty to thirty minutes as soon as cyanosis has cleared. Continue dosage until definite improvement occurs and is maintained, sometimes for two days or more.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- Poisoning by parasympathomimetic drug: mild symptoms, in cases where exposure is known or suspected: inject one 2 mg AtroPen(R) (green pen) into the outer thigh as soon as symptoms appear; pralidoxime chloride may also be required.
- Poisoning by parasympathomimetic drug: severe symptoms: inject one 2 mg AtroPen(R) (green pen) into the outer thigh as soon as symptoms appear, administer 2 additional 2 mg AtroPen(R) doses in rapid succession 10 min after receiving the first dose; pralidoxime chloride and/or an anticonvulsant may also be required, patients should be closely monitored for at least 48 to 72 h.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Atropine (Injection) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Antimuscarinic
- Subcutaneous, 10 g (0.01 mg) per kg of body weight, not to exceed 400 g (0.4 mg), or 300 g (0.3 mg) per square meter of body surface, every four to six hours.
- Arrhythmias
- Intravenous, 10 to 30 g (0.01 to 0.03 mg) per kg of body weight.
- Subcutaneous
- Children weighing up to 3 kg: 100 g (0.1 mg).
- Children weighing 7 to 9 kg: 200 g (0.2 mg).
- Children weighing 12 to 16 kg: 300 g (0.3 mg).
- Children weighing 20 to 27 kg: 400 g (0.4 mg).
- Children weighing 32 kg: 500 g (0.5 mg).
- Children weighing 41 kg; 600 g (0.6 mg).
- Intravenous or intramuscular, 1 mg initially, then 0.5 to 1 mg every five to ten minutes until muscarinic symptoms disappear or signs of atropine toxicity appear.
- NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
- Poisoning by parasympathomimetic drug: mild symptoms, in cases where exposure is known or suspected: dose for infants less than 7 kg = 0.25 mg (yellow pen), dose for children 7 to 18 kg = 0.5 mg (blue pen), dose for children 18 to 41 kg = 1 mg (dark red pen), dose for children over 41 kg = 2 mg (green pen): inject one AtroPen(R) into the outer thigh as soon as symptoms appear; pralidoxime chloride may also be required.
- Poisoning by parasympathomimetic drug: severe symptoms: dose for infants less than 7 kg = 0.25 mg (yellow pen), dose for children 7 to 18 kg = 0.5 mg (blue pen), dose for children 18 to 41 kg = 1 mg (dark red pen), dose for children over 41 kg = 2 mg (green pen): inject one AtroPen(R) into the outer thigh as soon as symptoms appear, administer 2 additional AtroPen(R) doses in rapid succession 10 min after receiving the first dose; pralidoxime chloride and/or an anticonvulsant may also be required, patients should be closely monitored for at least 48 to 72 h.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Atropine (Injection) in pediatric patients.

# Contraindications
- Atropine Sulfate is contraindicated in patients with a history of hypersensitivity to this drug.
- Ocular
- Narrow-angle glaucoma; adhesions (synechiae) between the iris and lens of the eye.
- Cardiovascular
- Tachycardia; unstable cardiovascular status in acute hemorrhage.
- GI
- Obstructive disease (e.g., achalasia, pyloroduodenal stenosis, or pyloric obstruction, cardiospasm, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; hepatic disease.
- GU
- Obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); renal disease.
- Musculoskeletal
- Myasthenia gravis.

# Warnings
- Heat prostration can occur with anticholinergic drug use (fever and heat stroke due to decreased sweating) in the presence of a high environmental temperature.
- Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. Treatment of diarrhea with these drugs is inappropriate and possibly harmful.
- Usage in the elderly: Elderly patients may react with excitement, agitation, drowsiness and other untoward manifestations to even small doses of anticholinergic drugs.
- Usage in gastric ulcer may produce a delay in gastric emptying time and may complicate such therapy (antral stasis).

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Atropine (Injection) in the drug label.

## Postmarketing Experience
- GI
- Xerostomia; altered taste perception; nausea; vomiting; dysphagia; heartburn, constipation; bloated feeling; paralytic ileus; gastroesophageal reflux.
- GU
- Urinary hesitancy and retention; impotence.
- Ocular
- Blurred vision; mydriasis; photophobia; cycloplegia; increased intraocular pressure.
- Cardiovascular
- Palpitations; bradycardia (following low doses of atropine); tachycardia (after higher doses).
- CNS
- Headache; flushing; nervousness; drowsiness; weakness; dizziness; insomnia; fever. Elderly patients may exhibit mental confusion or excitement to even small doses. Large doses may produce CNS stimulation (restlessness, tremor).
- Dermatologic
- Hypersensitivity: Severe allergic reactions including anaphylaxis, urticaria and other dermal manifestations.
- Other
- Suppression of lactation; nasal congestion; decreased sweating. Complete anhidrosis cannot occur because large doses would be required, producing severe side effects from parasympathetic paralysis.

# Drug Interactions
There is limited information regarding Drug Interactions of Atropine (Injection) in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
- Reproduction studies performed in mice at doses of 50 mg per kg of body weight have revealed no evidence of impaired fertility or harm to the fetus due to atropine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS): A
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Atropine (Injection) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Atropine (Injection) during labor and delivery.

### Nursing Mothers
- Atropine may be excreted in milk, causing infant toxicity, and may reduce breast milk production. Documentation is lacking or conflicting. Safety for use in nursing mothers has not been established.

### Pediatric Use
There is no FDA guidance on the use of Atropine (Injection) with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Atropine (Injection) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Atropine (Injection) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Atropine (Injection) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Atropine (Injection) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Atropine (Injection) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Atropine (Injection) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Atropine (Injection) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous

### Monitoring
There is limited information regarding Monitoring of Atropine (Injection) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Atropine (Injection) in the drug label.

# Overdosage
- GI
- Dry mouth; dysphagia; vomiting; nausea; abdominal distention.
- CNS
- Theoretically, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and paralysis.
- CNS stimulation; delirium; drowsiness; stupor; fever; dizziness; headache; restlessness; seizures; depression; tremor; hallucinations; ataxia; coma; psychotic behavior; other signs of an acute organic psychosis.
- Cardiovascular
- Circulatory failure; rapid pulse and respiration; tachycardia with weak pulse; hypertension; palpitations.
- GU
- Urinary urgency with difficulty in micturition.
- Ocular
- Blurred vision; photophobia; dilated pupils.
- Miscellaneous
- Leukocytosis, flushed hot dry skin, rash; respiratory failure.
- Administer supportive and symptomatic therapy as indicated Physostigmine 1 to 3 mg I.V. has been utilized to reverse anticholinergic effects. However, profound bradycardia, asystole and seizures may occur.
- The role of physostigmine is not clear; its use should be avoided if other therapeutic agents are successful in reversing cardiac dysrhythmias. Neostigmine methylsulfate 0.5 to 2 mg I.V., repeated as needed, may be given.
- Diazepam or short-acting barbiturates may control excitement. - Hemodialysis is ineffective for atropine poisoning.
- Hyperpyrexia may be treated with physical cooling measures.
- If photophobia occurs, the patient may be kept in a dark room.

# Pharmacology

## Mechanism of Action
- Atropine inhibits the muscarinic actions of acetylcholine at postganglionic parasympathetic neuroeffector sites including smooth muscle, secretory glands and CNS sites. Large doses may block nicotinic receptors at the autonomic ganglia and at the neuromuscular junction.
- Specific anticholinergic responses are dose-related. Small doses of atropine inhibit salivary and bronchial secretions and sweating; moderate doses dilate the pupil, inhibit accommodation and increase the heart rate (vagolytic effect); larger doses will decrease motility of the GI and urinary tracts; very large doses will inhibit gastric acid secretion.

## Structure
- Atropine is chemically 1  H, 5  H - Tropan-3 -ol () -tropate (ester), with the following structural formula:
- Atropine rarely occurs as such in any of the plants and has been prepared by synthesis. It is usually employed in the form of atropine sulfate (the sulfate  monohydrate salt of atropine), which has much greater solubility in water.
- Atropine Sulfate Injection, USP, is a sterile aqueous solution of atropine sulfate. Each mL contains atropine sulfate, 0.1 mg; sodium chloride, 8.8 mg, for isotonicity; citric acid, 0.63 mg, and sodium citrate, 0.29 mg, as buffers. May contain additional citric acid and/or sodium citrate for pH adjustment (3.0-6.5). The air above the liquid in the container has been displaced by nitrogen gas.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Atropine (Injection) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Atropine (Injection) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Atropine (Injection) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Atropine (Injection) in the drug label.

# How Supplied
- In unit-use packages containing the Luer-JetTM Luer-Lock Prefilled Syringe.
- Stock No.                                             Size                       - NDC NO. 3339            1 mg (0.1 mg/mL)            10 mL                  0548-3339-00             FOR I.V. USE
- Ten cartons per package.
- USE ASEPTIC TECHNIQUE
- Do not assemble until ready to use.

## Storage
Store at controlled room temperature 15 to 30C (59 to 86F).

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Atropine (Injection) in the drug label.

# Precautions with Alcohol
- Alcohol-Atropine (Injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- ATROPINE SULFATE 

# Look-Alike Drug Names
There is limited information regarding Atropine (Injection) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price