Atropine Sulfate 0.1mg/ml Inj, 10ml

Manufacturer INTRNTL MEDICATION SYSTEMS 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, Antidote, Antispasmodic, Bradycardia agent
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Pharmacologic Class
Muscarinic antagonist
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Pregnancy 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 can speed up your heart rate if it's too slow, dry up excess body fluids (like saliva or mucus), or act as an antidote for certain types of poisoning (like nerve gas or some pesticides). It works by blocking the effects of a natural chemical in your body.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered via injection, which can be given into a muscle, under the skin, or into a vein.

For proper storage and disposal of this medication, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store it at home.

If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
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Lifestyle & Tips

  • This medication is typically given in an emergency or hospital setting, so lifestyle modifications are not usually applicable during its acute use.
  • Report any unusual symptoms or discomfort immediately to your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For symptomatic bradycardia: 0.5 mg IV every 3-5 minutes, not to exceed total 3 mg.
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: Initial 1-2 mg IV/IM, repeat every 5-10 minutes until atropinization (e.g., dry secretions, clear lungs, heart rate >80 bpm). Doses may be much higher (tens to hundreds of mg).
Pre-anesthetic Medication: 0.4-0.6 mg IV/IM/SC 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 (rarely used): 0.02 mg/kg IV/IO (minimum 0.1 mg), may repeat once.
Infant: Symptomatic bradycardia: 0.02 mg/kg IV/IO (minimum 0.1 mg), may repeat once. Max single dose 0.5 mg. Max total dose 1 mg.
Child: Symptomatic bradycardia: 0.02 mg/kg IV/IO (minimum 0.1 mg), may repeat once. Max single dose 0.5 mg. Max total dose 1 mg. For organophosphate poisoning: 0.05 mg/kg IV/IM, repeat every 5-10 minutes until atropinization.
Adolescent: Symptomatic bradycardia: 0.02 mg/kg IV/IO (minimum 0.1 mg), may repeat once. Max single dose 1 mg. Max total dose 2 mg. For 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 adjustment recommended.
Moderate: No specific adjustment recommended; monitor for increased anticholinergic effects.
Severe: No specific adjustment recommended; monitor for increased anticholinergic effects due to reduced excretion.
Dialysis: Atropine is dialyzable to some extent, but specific recommendations for dosage adjustment in dialysis patients are not well-established. Monitor clinical response.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended; monitor for increased anticholinergic effects.
Severe: No specific adjustment recommended; monitor for increased anticholinergic effects due to reduced metabolism.

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 (bronchi, GI tract, urinary bladder), and mydriasis.
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Pharmacokinetics

Absorption:

Bioavailability: Rapid and complete after IM/SC/IV administration.
Tmax: IV: 2-4 minutes (onset of action); IM: 30 minutes; SC: 1 hour.
FoodEffect: Not applicable for injectable formulation.

Distribution:

Vd: 1.7-4.6 L/kg
ProteinBinding: Approximately 50%
CnssPenetration: Yes (crosses blood-brain barrier)

Elimination:

HalfLife: 2-4 hours (adults); longer in children and infants.
Clearance: Not readily available as a single rate, but primarily renal.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 30-50% of dose excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: IV: 1-2 minutes; IM: 10-30 minutes; SC: 30-60 minutes.
PeakEffect: IV: 2-4 minutes (cardiac effects); IM: 30 minutes; SC: 1 hour.
DurationOfAction: Cardiac effects: 30-60 minutes; Ocular effects: up to 72 hours; Antisecretory effects: 4 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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 be signs of 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 mild ones, it's essential to contact your doctor if you're bothered by any of the following:

Blurred vision
Sensitivity to bright lights
Constipation
Stomach pain
Nausea or vomiting
Reduced 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
  • Extreme blurred vision or sensitivity to light
  • Difficulty urinating
  • Severe constipation
  • Feeling very hot or flushed
  • Confusion, agitation, or hallucinations
  • Fast or irregular heartbeat
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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, any of 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 or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that it is safe to take this medication in conjunction 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 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 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.

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, 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, avoid using products with benzyl alcohol in newborns and infants 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
  • Dilated, non-reactive pupils (mydriasis)
  • Blurred vision
  • Hot, dry, flushed skin
  • Fever
  • Tachycardia (very fast heart rate)
  • Hypertension (high blood pressure)
  • Urinary retention
  • Abdominal distension
  • Restlessness, excitement, agitation
  • Hallucinations, delirium
  • Ataxia (loss of coordination)
  • Seizures
  • Coma
  • Respiratory depression (in severe cases)

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) to reverse anticholinergic effects, cooling measures for hyperthermia, and benzodiazepines for agitation/seizures.

Drug Interactions

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Major Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, phenothiazines, antihistamines, disopyramide): May lead to additive anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, CNS effects).
  • Cholinesterase inhibitors (e.g., donepezil, rivastigmine, neostigmine, pyridostigmine): Atropine antagonizes their effects, reducing efficacy of cholinesterase inhibitors.
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Moderate Interactions

  • Drugs that slow gastric emptying (e.g., opioids): May further delay absorption of other oral medications.
  • Potassium chloride (oral forms): Increased risk of GI lesions due to delayed gastric emptying.

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

ECG

Rationale: To assess cardiac rhythm and identify underlying cause of bradycardia.

Timing: Prior to administration (if for cardiac indication)

Pupil size and reactivity

Rationale: To assess baseline and monitor for mydriasis/cycloplegia, especially in organophosphate poisoning.

Timing: Prior to administration

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Routine Monitoring

Heart Rate and Rhythm

Frequency: Continuously (IV administration for bradycardia); frequently (every 5-15 minutes) until stable.

Target: Increase in heart rate (for bradycardia); >80 bpm (for organophosphate poisoning).

Action Threshold: Lack of response, or development of tachycardia/arrhythmias.

Blood Pressure

Frequency: Frequently (every 5-15 minutes) until stable.

Target: Maintain adequate perfusion.

Action Threshold: Hypotension or hypertension.

Respiratory Status (Rate, Depth, Secretions)

Frequency: Continuously/frequently, especially in organophosphate poisoning.

Target: Clear lungs, decreased secretions, improved breathing.

Action Threshold: Increased secretions, respiratory distress.

Level of Consciousness/Mental Status

Frequency: Frequently.

Target: Alert and oriented.

Action Threshold: Agitation, delirium, confusion, somnolence.

Urinary Output

Frequency: Monitor for retention.

Target: Adequate output.

Action Threshold: Urinary retention.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Photophobia
  • Urinary retention
  • Constipation
  • Tachycardia
  • Palpitations
  • Flushing
  • Hot, dry skin
  • Fever
  • Agitation
  • Delirium
  • Hallucinations
  • Coma

Special Patient Groups

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Pregnancy

Atropine is classified as Pregnancy Category C. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy 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 in breast milk in small amounts. It may decrease milk production due to its anticholinergic effects. The infant risk is generally low with single or intermittent doses, but monitor for anticholinergic effects in the infant (e.g., dry mouth, constipation, urinary retention, drowsiness). L3 (Moderately safe).

Infant Risk: Low to moderate. Potential for anticholinergic effects (e.g., dry mouth, constipation, urinary retention, drowsiness) and theoretical risk of 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 and CNS effects. Dosing is weight-based and requires careful calculation and monitoring. Paradoxical bradycardia may occur with very low doses.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Atropine is the first-line drug for symptomatic bradycardia in ACLS algorithms.
  • In organophosphate poisoning, atropine is given until 'atropinization' is achieved (e.g., dry secretions, clear lungs, heart rate >80 bpm), which may require very large doses.
  • Paradoxical bradycardia can occur if very low doses (e.g., <0.5 mg in adults) are given, as it may block presynaptic M1 receptors, leading to increased acetylcholine release.
  • Monitor for signs of anticholinergic toxicity: 'Hot as a hare, blind as a bat, dry as a bone, red as a beet, and mad as a hatter.'
  • Atropine does not reverse the neuromuscular blockade of organophosphates; pralidoxime is needed for that.
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Alternative Therapies

  • For symptomatic bradycardia: Transcutaneous pacing, dopamine, epinephrine.
  • For organophosphate poisoning: Pralidoxime (2-PAM) in conjunction with atropine.
  • For pre-anesthetic drying of secretions: Glycopyrrolate (less CNS effects).
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Cost & Coverage

Average Cost: Low (generic) per 10ml 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 and effective treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult 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 was taken to ensure prompt and effective treatment.