Atropine Sul 0.1mg/ml Inj, 5ml

Manufacturer HOSPIRA 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 1970
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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 if it's too slow, reduce saliva and other body secretions before surgery, or treat certain types of poisoning. It works by blocking the effects of a natural chemical in your body called acetylcholine.
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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 is administered via injection, which can be given into a muscle, under the skin, or 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 receive guidance on what to do next.
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Lifestyle & Tips

  • Report any vision changes, difficulty urinating, or severe dry mouth.
  • Avoid activities requiring mental alertness (e.g., driving) until you know how atropine affects you, as it can cause blurred vision or dizziness.
  • Stay hydrated to help with dry mouth.

Dosing & Administration

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Adult Dosing

Standard Dose: Bradycardia: 0.5 mg IV every 3-5 minutes as needed, not to exceed a total dose of 3 mg. Organophosphate Poisoning: 1 to 2 mg IV or IM, repeated every 5 to 10 minutes until signs of atropinization appear (e.g., dry mouth, flushing, tachycardia, mydriasis). Pre-anesthetic: 0.4 to 0.6 mg IM or IV 30-60 minutes prior to surgery.
Dose Range: 0.4 - 3 mg

Condition-Specific Dosing:

bradycardia: 0.5 mg IV every 3-5 minutes, max 3 mg total
organophosphate_poisoning: 1-2 mg IV/IM, repeat every 5-10 minutes until atropinization
pre_anesthetic: 0.4-0.6 mg IM/IV 30-60 minutes prior to surgery
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing for bradycardia in neonates is 0.02 mg/kg IV, minimum 0.1 mg, maximum 0.5 mg. Use with extreme caution.
Infant: Bradycardia: 0.02 mg/kg IV, minimum 0.1 mg, maximum 0.5 mg. Organophosphate Poisoning: 0.05 mg/kg IV/IM, repeat every 5-10 minutes until atropinization.
Child: Bradycardia: 0.02 mg/kg IV, minimum 0.1 mg, maximum 0.5 mg. Organophosphate Poisoning: 0.05 mg/kg IV/IM, repeat every 5-10 minutes until atropinization.
Adolescent: Bradycardia: 0.02 mg/kg IV, minimum 0.1 mg, maximum 1 mg. Organophosphate Poisoning: 0.05 mg/kg IV/IM, repeat every 5-10 minutes until atropinization.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, but monitor for increased anticholinergic effects due to reduced excretion.
Severe: No specific dose adjustment recommended, but monitor for increased anticholinergic effects due to reduced excretion. Consider lower end of dosing range.
Dialysis: Atropine is not significantly removed by dialysis. No specific dose adjustment, but monitor closely.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

Pharmacology

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Mechanism of Action

Atropine is a competitive antagonist of acetylcholine at muscarinic receptors. It blocks the effects of acetylcholine at postganglionic parasympathetic neuroeffector sites, including smooth muscle, cardiac muscle, and exocrine glands. This blockade leads to increased heart rate, decreased glandular secretions (salivary, bronchial, sweat), relaxation of smooth muscles (bronchial, gastrointestinal, urinary tract), and mydriasis and cycloplegia.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Rapid (IV), 30 minutes (IM)
FoodEffect: Not applicable for IV/IM administration

Distribution:

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

Elimination:

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

OnsetOfAction: Immediate (IV), 10-30 minutes (IM)
PeakEffect: 2-4 minutes (IV), 30 minutes (IM)
DurationOfAction: 4-6 hours (systemic effects), up to 72 hours (ocular effects)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 problems
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

As with any medication, you may experience side effects. While many people do not have any side effects or only minor ones, it is 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 do not go away, 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 sensitivity to light
  • Difficulty urinating
  • Severe constipation or abdominal pain
  • Confusion, agitation, or hallucinations
  • Rapid or irregular heartbeat
  • 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 dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Precautions

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 during physical activity, and drink plenty of fluids to prevent fluid loss.

Accidental Ingestion Warning
If this medication is swallowed, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or a poison control center.

Special Considerations

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, use caution, as the risk of certain side effects may be higher in this population.
* 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
  • Flushing and hot, dry skin
  • Fever
  • Tachycardia
  • Hypertension followed by hypotension
  • Urinary retention
  • Decreased bowel sounds, paralytic ileus
  • CNS effects: restlessness, confusion, disorientation, delirium, hallucinations, ataxia, seizures, coma
  • Respiratory depression

What to Do:

Seek immediate medical attention or call 911. For accidental overdose, call Poison Control at 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, quinidine, disopyramide): May lead to additive anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, CNS effects).
  • Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine, neostigmine, pyridostigmine): Atropine antagonizes their effects, reducing efficacy.
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Moderate Interactions

  • Potassium chloride (oral forms): Anticholinergic effects can decrease GI motility, increasing risk of GI lesions with oral potassium chloride.
  • Metoclopramide: Atropine antagonizes the prokinetic effects of metoclopramide.
  • Opioid analgesics: May increase risk of severe constipation and paralytic ileus due to additive GI motility reduction.

Monitoring

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Baseline Monitoring

Heart Rate (HR)

Rationale: To assess baseline cardiac status and monitor response to atropine for bradycardia.

Timing: Prior to administration

Blood Pressure (BP)

Rationale: To assess baseline hemodynamic status.

Timing: Prior to administration

Electrocardiogram (ECG)

Rationale: To assess cardiac rhythm, especially in bradycardia.

Timing: Prior to administration and during treatment for bradycardia

Mental Status/Level of Consciousness

Rationale: To assess baseline CNS function, especially in patients susceptible to anticholinergic delirium.

Timing: Prior to administration

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Routine Monitoring

Heart Rate (HR)

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

Target: Individualized based on indication (e.g., increase in bradycardia, signs of atropinization in poisoning)

Action Threshold: Persistent bradycardia, excessive tachycardia (>120 bpm), or signs of atropine toxicity

Blood Pressure (BP)

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

Target: Maintain within normal limits for patient

Action Threshold: Significant hypotension or hypertension

ECG monitoring

Frequency: Continuous (in acute settings)

Target: Resolution of bradycardia, absence of arrhythmias

Action Threshold: Development of new arrhythmias or worsening bradycardia

Urine Output

Frequency: Hourly (in acute settings)

Target: >0.5 mL/kg/hr

Action Threshold: Decreased urine output (suggests urinary retention)

Pupil Size and Reactivity

Frequency: As clinically indicated, especially in organophosphate poisoning

Target: Mydriasis (in poisoning)

Action Threshold: Lack of mydriasis or return of miosis in poisoning

Bowel Sounds/Abdominal Distention

Frequency: Periodically

Target: Presence of bowel sounds, no distention

Action Threshold: Absent bowel sounds, severe abdominal distention (suggests paralytic ileus)

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Flushing
  • Fever
  • CNS effects (agitation, delirium, hallucinations, confusion, somnolence)
  • Nausea/vomiting

Special Patient Groups

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Pregnancy

Atropine is Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Limited data, potential for fetal effects.
Second Trimester: Limited data, potential for fetal effects.
Third Trimester: May inhibit uterine contractions and cause fetal tachycardia. Use with caution near term.
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Lactation

Atropine is excreted into breast milk. It can decrease milk production and may cause anticholinergic effects in the infant (e.g., tachycardia, constipation, urinary retention). Use with caution; monitor infant for adverse effects. Lactation Risk L3 (Moderate Risk).

Infant Risk: Moderate risk of adverse effects (e.g., tachycardia, constipation, urinary retention, decreased milk supply).
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Pediatric Use

Children, especially infants and young children, are more susceptible to the toxic effects of atropine, particularly CNS effects and hyperthermia. Dosing must be precise (0.02 mg/kg). Close monitoring for adverse effects is crucial. Not recommended for routine use in neonates.

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Geriatric Use

Elderly patients are more susceptible to the anticholinergic effects of atropine, including CNS effects (confusion, delirium), urinary retention, and constipation. Use with caution and consider lower initial doses. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Atropine is the first-line agent for symptomatic bradycardia (e.g., hypotension, altered mental status, signs of shock) in the absence of a reversible cause.
  • In organophosphate poisoning, atropine is given until 'atropinization' occurs (e.g., dry mouth, clear lungs, tachycardia, mydriasis). Large doses may be required.
  • Atropine is ineffective for bradycardia due to heart transplant (denervated heart) or hypothermia.
  • Always have physostigmine available when using atropine for diagnostic purposes (e.g., for cycloplegia) or in cases of suspected overdose, as it is an antidote for severe anticholinergic toxicity.
  • Be aware of the 'red as a beet, dry as a bone, blind as a bat, mad as a hatter, hot as a hare' mnemonic for anticholinergic toxicity.
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Alternative Therapies

  • For symptomatic bradycardia: Epinephrine, Dopamine, Transcutaneous Pacing (TCP).
  • For organophosphate poisoning: Pralidoxime (2-PAM) is used in conjunction with atropine to reactivate acetylcholinesterase.
  • For pre-anesthetic use (to reduce secretions): Glycopyrrolate (less CNS penetration).
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Cost & Coverage

Average Cost: Varies widely, typically low cost per 5ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.

Additionally, some medications may have a separate patient information leaflet; your pharmacist can provide this information if available. If you have any questions or concerns about your medication, it is crucial to 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 detailed information about the medication, including the amount taken and the time it was ingested, to ensure prompt and effective treatment.