Atropine Sul 0.4mg/ml Inj, 1ml

Manufacturer AMER REGENT Active Ingredient Atropine Injection(A troe peen) Pronunciation AT-roe-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; Antidote
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Pharmacologic Class
Muscarinic Acetylcholine 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 works by blocking certain signals in your body, primarily those that slow your heart rate, cause sweating, or produce saliva. It's often used in emergencies to speed up a very slow heart rate, or as an antidote for certain types of poisoning. It can also be used before surgery to reduce saliva and other secretions.
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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 unusual symptoms immediately, especially blurred vision, difficulty urinating, or confusion.
  • Avoid overheating, as atropine can reduce sweating and increase body temperature.
  • Stay hydrated to help manage dry mouth.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For symptomatic bradycardia: 0.5 mg IV every 3-5 minutes as needed, not to exceed a total dose of 3 mg. For organophosphate or carbamate poisoning: 1 to 2 mg IV/IM, repeat every 5 to 60 minutes until atropinization (e.g., clear lungs, decreased secretions, heart rate >80 bpm).
Dose Range: 0.5 - 3 mg

Condition-Specific Dosing:

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

Neonatal: Not established for routine use; use with extreme caution. For symptomatic bradycardia (off-label): 0.02 mg/kg IV (minimum 0.1 mg) may be considered in specific situations, but often not recommended as first-line.
Infant: For symptomatic bradycardia: 0.02 mg/kg IV (minimum 0.1 mg), repeat every 3-5 minutes as needed, maximum single dose 0.5 mg. Total maximum dose 1 mg.
Child: For symptomatic bradycardia: 0.02 mg/kg IV (minimum 0.1 mg), repeat every 3-5 minutes as needed, maximum single dose 0.5 mg. Total maximum dose 1 mg.
Adolescent: For symptomatic bradycardia: 0.02 mg/kg IV (minimum 0.1 mg), repeat every 3-5 minutes as needed, maximum single dose 1 mg. Total maximum dose 3 mg.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: No specific adjustment recommended, but use with caution due to renal excretion.
Severe: No specific adjustment recommended, but use with caution due to renal excretion. Monitor for exaggerated effects.
Dialysis: Not significantly dialyzable. No specific adjustment, but monitor closely.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but use with caution due to hepatic metabolism.
Severe: No specific adjustment recommended, but use with caution due to hepatic metabolism. Monitor for exaggerated effects.

Pharmacology

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Mechanism of Action

Atropine is a competitive antagonist of acetylcholine at muscarinic receptors. It blocks the effects of parasympathetic stimulation, leading to increased heart rate, decreased glandular secretions (salivary, bronchial, sweat), relaxation of smooth muscle in the GI tract and urinary bladder, and pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Rapid (IV)
FoodEffect: Not applicable for IV administration

Distribution:

Vd: 2-4 L/kg
ProteinBinding: Approximately 14-20%
CnssPenetration: Yes (crosses blood-brain barrier)

Elimination:

HalfLife: 2-4 hours
Clearance: Not readily available as a single rate, primarily renal excretion
ExcretionRoute: Renal
Unchanged: Approximately 50% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes for IV)
PeakEffect: Within 2-4 minutes (IV)
DurationOfAction: 4-6 hours (systemic effects), longer for ocular effects

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 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

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

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 about side effects, 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
  • Significantly blurred vision or eye pain
  • Difficulty urinating or inability to urinate
  • Severe constipation
  • Confusion, agitation, hallucinations, or unusual behavior
  • Rapid or irregular heartbeat
  • Fever or feeling unusually hot
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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 identify 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 it is safe to take this medication with all your current 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, immediately contact a doctor or poison control center, as it may cause harm.

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.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are 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 and throat
  • Marked pupillary dilation (mydriasis) and loss of accommodation
  • Hot, dry, flushed skin
  • Fever
  • Tachycardia, arrhythmias
  • Hypertension followed by hypotension
  • Urinary retention
  • Decreased bowel sounds, paralytic ileus
  • CNS effects: restlessness, excitement, delirium, hallucinations, 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

  • Cholinesterase inhibitors (e.g., donepezil, rivastigmine, neostigmine, pyridostigmine): Atropine antagonizes their effects.
  • Potassium chloride (oral forms): Atropine can decrease GI motility, increasing risk of GI lesions with oral potassium.
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Moderate Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide): Additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, CNS effects).
  • Drugs that prolong QT interval: Theoretical risk of additive QT prolongation, though atropine's effect on QT is usually minimal at therapeutic doses.
  • Metoclopramide: Atropine antagonizes its prokinetic effects.
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Minor Interactions

  • Antacids: May decrease absorption of oral atropine (not relevant for injectable form).
  • Drugs with narrow therapeutic index whose absorption may be affected by altered GI motility.

Monitoring

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Baseline Monitoring

Heart Rate and Rhythm (ECG)

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

Timing: Prior to administration

Blood Pressure

Rationale: To assess baseline hemodynamic status.

Timing: Prior to administration

Mental Status

Rationale: To assess baseline neurological function, especially in elderly or those with pre-existing cognitive impairment.

Timing: Prior to administration

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Routine Monitoring

Heart Rate and Rhythm (ECG)

Frequency: Continuously during acute use (e.g., bradycardia, poisoning); frequently until stable.

Target: Individualized based on indication (e.g., HR >60 bpm for bradycardia, HR >80 bpm for organophosphate poisoning)

Action Threshold: Persistent bradycardia, development of arrhythmias, or signs of excessive tachycardia.

Blood Pressure

Frequency: Frequently until stable.

Target: Maintain within patient's normal range.

Action Threshold: Significant hypotension or hypertension.

Respiratory Rate and Secretions

Frequency: Frequently, especially in organophosphate poisoning.

Target: Clear lungs, reduced secretions.

Action Threshold: Increased secretions, bronchospasm, respiratory distress.

Pupil Size and Light Reflex

Frequency: Periodically.

Target: Mydriasis and cycloplegia are expected effects.

Action Threshold: Persistent miosis (in poisoning) or signs of excessive anticholinergic effects.

Urine Output

Frequency: Monitor for urinary retention.

Target: Adequate urine output.

Action Threshold: Decreased urine output or bladder distention.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Flushing
  • Fever (especially in children)
  • Urinary retention
  • Constipation
  • CNS effects (agitation, delirium, hallucinations, confusion, especially in elderly or with high doses)
  • Tachycardia
  • Arrhythmias

Special Patient Groups

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Pregnancy

Category C. Atropine crosses the placenta. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fetal tachycardia may occur.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless critically indicated.
Second Trimester: May cause fetal tachycardia.
Third Trimester: May cause fetal tachycardia; potential for decreased fetal heart rate variability.
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Lactation

L3 (Moderately safe). Atropine is excreted into breast milk and may decrease milk production. Use with caution. Monitor breastfed infant for anticholinergic effects (e.g., drowsiness, constipation, urinary retention).

Infant Risk: Low to moderate risk of anticholinergic effects; potential for 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 hyperthermia. Dosing must be precise (0.02 mg/kg). Paradoxical bradycardia may occur with very low doses. Monitor closely for fever, flushing, and CNS effects.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Atropine is the drug of choice for symptomatic bradycardia (e.g., with hypotension, altered mental status, signs of shock) but is generally ineffective for bradycardia associated with high-degree AV blocks (e.g., Mobitz II, 3rd degree AV block) where pacing is often required.
  • It is a critical antidote for organophosphate and carbamate poisoning, where titration to 'atropinization' (drying of secretions, clear lungs, heart rate >80 bpm) is key.
  • Remember the anticholinergic toxidrome: 'Hot as a hare, blind as a bat, dry as a bone, red as a beet, mad as a hatter.'
  • Avoid in patients with narrow-angle glaucoma or prostatic hypertrophy unless the benefits clearly outweigh the risks and close monitoring is possible.
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Alternative Therapies

  • For symptomatic bradycardia: Epinephrine, dopamine, transcutaneous pacing, transvenous pacing.
  • For reduction of secretions: Glycopyrrolate (less CNS penetration).
  • For organophosphate poisoning: Pralidoxime (2-PAM) is often used in conjunction with atropine to reactivate acetylcholinesterase.
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Cost & Coverage

Average Cost: Relatively inexpensive per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (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 safe use, never share your prescription medications with others, and do not take medications prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices. Many communities offer drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is important 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 overdose, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.