Atropine Sulfate 1mg/ml Inj, 1ml

Manufacturer AMER REGENT Active Ingredient Atropine Injection(A troe peen) Pronunciation A-troe-peen
It is used to treat some poisonings.In surgery, it is used to lower secretions such as saliva.It is used to treat muscle spasms of the GI (gastrointestinal) tract, gallbladder system, or urinary system.It is used when the heart is not beating.
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Drug Class
Anticholinergic
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Pharmacologic Class
Muscarinic receptor antagonist
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Pregnancy Category
Category C
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FDA Approved
Jan 1940
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Atropine is a medication that helps to speed up your heart rate, dry up secretions (like saliva or mucus), and relax certain muscles in your body. It's often used in emergencies, like when your heart beats too slowly, or as an antidote for certain types of poisoning.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication can be administered in three ways: as an intramuscular injection (into a muscle), subcutaneous injection (under the skin), or intravenous injection (into a vein).

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.

Missing a Dose

If you miss a dose, contact your doctor to find out what steps to take next. They will provide guidance on how to get back on schedule with your medication.
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Lifestyle & Tips

  • Avoid overheating, especially in hot weather or during exercise, as atropine can reduce sweating and increase body temperature.
  • Be aware of potential vision changes (blurred vision, sensitivity to light) and avoid driving or operating machinery if affected.
  • Report any difficulty urinating or severe constipation.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication

Condition-Specific Dosing:

Bradycardia (ACLS): 0.5 mg IV every 3-5 minutes, max 3 mg
Asystole/PEA (ACLS): 1 mg IV every 3-5 minutes, max 3 mg (Note: Atropine is no longer recommended for routine use in asystole/PEA by current ACLS guidelines, but may be considered in specific circumstances like organophosphate poisoning)
Organophosphate Poisoning: Initial 1-2 mg IV/IM, repeat every 5-10 minutes until atropinization (dry mouth, clear lungs, heart rate >80 bpm, pupils dilated)
Pre-anesthesia: 0.4-0.6 mg IM/SC 30-60 minutes prior to surgery or 0.4 mg IV immediately prior to induction
Antidote for Cholinergic Crisis: 0.5-1 mg IV/IM, repeated as needed
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution. For symptomatic bradycardia: 0.02 mg/kg IV/IO (minimum 0.1 mg), repeat once. Max single dose 0.5 mg.
Infant: For symptomatic bradycardia: 0.02 mg/kg IV/IO (minimum 0.1 mg), repeat once. Max single dose 0.5 mg. Max total dose 1 mg.
Child: For symptomatic bradycardia: 0.02 mg/kg IV/IO (minimum 0.1 mg), repeat once. Max single dose 0.5 mg. Max total dose 1 mg (child) or 3 mg (adolescent).
Adolescent: For symptomatic bradycardia: 0.02 mg/kg IV/IO (minimum 0.1 mg), repeat once. Max single dose 0.5 mg. Max total dose 3 mg.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended, monitor for increased anticholinergic effects
Severe: Use with caution, monitor for increased anticholinergic effects and toxicity. Consider dose reduction if prolonged effects observed.
Dialysis: Not significantly dialyzable. No specific adjustment recommended, but monitor closely.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended, monitor for increased anticholinergic effects
Severe: Use with caution, monitor for increased anticholinergic effects and toxicity. Consider dose reduction if prolonged effects observed.

Pharmacology

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Mechanism of Action

Atropine is a competitive antagonist of muscarinic acetylcholine receptors (M1, M2, M3, M4, M5). It blocks the action of acetylcholine at parasympathetic postganglionic effector sites, including smooth muscle, cardiac muscle, and glands. This blockade leads to increased heart rate, decreased salivary and bronchial secretions, decreased gastrointestinal motility, and pupillary dilation.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV), 90% (IM), 25-50% (oral)
Tmax: IV: immediate; IM: 30 minutes; SC: 60 minutes
FoodEffect: Not applicable for injectable forms

Distribution:

Vd: 1.7-4.6 L/kg
ProteinBinding: 14-20%
CnssPenetration: Yes

Elimination:

HalfLife: 2-4 hours (adults), 10 hours (children < 2 years)
Clearance: Not available
ExcretionRoute: Renal (primarily)
Unchanged: 30-50%
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Pharmacodynamics

OnsetOfAction: IV: 1 minute; IM: 10-30 minutes; SC: 30-60 minutes
PeakEffect: IV: 2-4 minutes; IM: 30 minutes
DurationOfAction: 4-6 hours (cardiac effects), longer for ocular effects (up to 72 hours)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Urination difficulties
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Severe dizziness or fainting
Breathing difficulties, slow breathing, or shallow breathing
Confusion
Balance problems
Hallucinations (seeing or hearing things that are not there)
Extreme fatigue or weakness
Restlessness
Shakiness
Abdominal swelling
Severe constipation or stomach pain, which may indicate a serious bowel problem
Erectile dysfunction or decreased libido
Depression
Changes in vision, eye pain, or severe eye irritation
Inability to sweat during physical activity or in warm temperatures

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Blurred vision
Sensitivity to bright lights
Constipation
Stomach pain
Nausea or vomiting
Decreased sweating
Dizziness or headache
Dry mouth
Dry eyes
Dry nose
Dilated pupils
Flushing
Pain at the injection site

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dry mouth or difficulty swallowing
  • Blurred vision or eye pain
  • Difficulty urinating or inability to urinate
  • Severe constipation or abdominal pain
  • Rapid or irregular heartbeat
  • Confusion, agitation, or hallucinations
  • Fever or hot, dry skin
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To minimize the risk of dehydration, be cautious in hot weather or when engaging in physical activity, and drink plenty of fluids to prevent fluid loss.

Accidental Ingestion Warning
If this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center right away, as it may cause harm.

Special Precautions
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population.

Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

Multi-Dose Container Warning
Some products contain benzyl alcohol. To minimize the risk of serious side effects in newborns and infants, it is recommended to avoid products containing benzyl alcohol whenever possible. Benzyl alcohol can cause severe adverse effects in these children, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol and to discuss alternative options.
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Overdose Information

Overdose Symptoms:

  • Severe dry mouth
  • Dilated pupils (mydriasis)
  • Blurred vision
  • Photophobia
  • Flushing of the skin
  • Hot, dry skin
  • Fever
  • Tachycardia
  • Arrhythmias
  • Hypertension (initially, then hypotension)
  • Urinary retention
  • Decreased bowel sounds
  • Restlessness
  • Agitation
  • Confusion
  • Disorientation
  • Hallucinations (visual and auditory)
  • Delirium
  • Ataxia
  • Seizures
  • Coma
  • Respiratory depression

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and may include physostigmine (a cholinesterase inhibitor) as an antidote for severe anticholinergic toxicity.

Drug Interactions

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Major Interactions

  • Other anticholinergic agents (e.g., tricyclic antidepressants, phenothiazines, antihistamines, disopyramide, quinidine): Potentiate anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, CNS effects).
  • Potassium chloride (oral forms): Increased risk of GI lesions due to decreased GI motility.
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Moderate Interactions

  • Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics): Theoretical risk of additive QT prolongation, especially in susceptible patients.
  • Metoclopramide, domperidone: Atropine antagonizes their prokinetic effects.
  • Antacids, antidiarrheals (adsorbent): May reduce atropine absorption if given concurrently.
  • Opioid analgesics: Additive risk of constipation and urinary retention.

Monitoring

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Baseline Monitoring

Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate)

Rationale: To establish baseline and assess response to therapy, especially for bradycardia.

Timing: Prior to administration

Electrocardiogram (ECG)

Rationale: To assess cardiac rhythm and identify underlying causes of bradycardia or asystole.

Timing: Prior to administration, especially in cardiac emergencies

Pupil size and reactivity

Rationale: To assess baseline and monitor for anticholinergic effects, especially in organophosphate poisoning.

Timing: Prior to administration

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Routine Monitoring

Heart Rate and Rhythm

Frequency: Continuously (in acute settings) or frequently (e.g., every 5-15 minutes initially, then as clinically indicated)

Target: Improvement in bradycardia, HR > 60 bpm (or target for specific condition)

Action Threshold: Persistent bradycardia, development of tachycardia, or arrhythmias

Blood Pressure

Frequency: Continuously or frequently (e.g., every 5-15 minutes initially, then as clinically indicated)

Target: Improvement in hypotension associated with bradycardia

Action Threshold: Persistent hypotension or hypertension

Respiratory Rate and Depth

Frequency: Frequently

Target: Normal respiratory effort

Action Threshold: Respiratory depression or distress

Level of Consciousness/Mental Status

Frequency: Frequently

Target: Alert and oriented

Action Threshold: Agitation, delirium, confusion, or somnolence

Pupil size and reactivity

Frequency: Frequently (especially in organophosphate poisoning)

Target: Pupillary dilation (in poisoning), normal reactivity

Action Threshold: Persistent miosis (in poisoning), fixed/dilated pupils (sign of toxicity)

Skin moisture/temperature

Frequency: Periodically

Target: Dry, warm skin (sign of atropinization in poisoning)

Action Threshold: Excessive sweating (in poisoning), flushed/hot skin (sign of toxicity)

Urinary Output

Frequency: Periodically

Target: Adequate

Action Threshold: Urinary retention

Bowel Sounds/Abdominal Distention

Frequency: Periodically

Target: Present bowel sounds, no distention

Action Threshold: Absent bowel sounds, abdominal distention, constipation

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Photophobia
  • Urinary retention
  • Constipation
  • Tachycardia
  • Palpitations
  • Flushing
  • Hot, dry skin
  • Fever
  • Agitation
  • Delirium
  • Hallucinations
  • Confusion
  • Dizziness
  • Headache
  • Nausea
  • Vomiting

Special Patient Groups

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Pregnancy

Category C. Atropine crosses the placenta. While human data are limited, animal studies show some adverse effects at high doses. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of developmental abnormalities.
Second Trimester: Limited data.
Third Trimester: May cause fetal tachycardia, decreased fetal heart rate variability, or uterine contractions. Use with caution near term.
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Lactation

Atropine is excreted into breast milk. While the amount is generally small, it can potentially cause anticholinergic effects in the infant (e.g., drowsiness, constipation, urinary retention) and may decrease milk production. Use with caution, especially with repeated doses or in premature/neonatal infants. Monitor infant for anticholinergic effects.

Infant Risk: Low to Moderate (L3)
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Pediatric Use

Children, especially infants and young children, are more susceptible to the toxic effects of anticholinergic drugs. Fever and CNS effects (agitation, hallucinations) are more common. Dosing must be precise (0.02 mg/kg) and not less than 0.1 mg to avoid paradoxical bradycardia. Close monitoring is essential.

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Geriatric Use

Elderly patients are more susceptible to the anticholinergic effects of atropine, particularly CNS effects (confusion, delirium, hallucinations) and peripheral effects (dry mouth, urinary retention, constipation, blurred vision). Use with caution and consider lower initial doses.

Clinical Information

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Clinical Pearls

  • Atropine is the classic antidote for organophosphate poisoning, reversing muscarinic effects. Titrate to 'atropinization' (drying of secretions, clearing of lungs, heart rate >80 bpm, dilated pupils).
  • In ACLS, atropine is primarily used for symptomatic bradycardia. It is no longer recommended for routine use in asystole or PEA.
  • A minimum dose of 0.1 mg is recommended in children to avoid paradoxical bradycardia, which can occur with very low doses.
  • The mnemonic 'hot as a hare, blind as a bat, dry as a bone, red as a beet, mad as a hatter' describes the classic signs of anticholinergic toxicity.
  • Atropine can cause paradoxical bradycardia if given too slowly or at very low doses, especially in patients with high vagal tone.
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Alternative Therapies

  • For symptomatic bradycardia: Epinephrine, dopamine, transcutaneous pacing.
  • For pre-anesthesia: Glycopyrrolate (less CNS penetration, less tachycardia), scopolamine (more sedative, antiemetic).
  • For organophosphate poisoning: Pralidoxime (2-PAM) is used in conjunction with atropine to reactivate acetylcholinesterase.
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Cost & Coverage

Average Cost: Varies, typically low cost per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.