Atropine Sul 0.05mg/1ml Inj, 5ml

Manufacturer ACCORD HEALTHCARE Active Ingredient Atropine Injection(A troe peen) Pronunciation AT-roh-peen SUL-fayt
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, Antiarrythmic
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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 given by injection that works by blocking certain signals in your body. It's often used to speed up a slow heart rate, to dry up secretions before surgery, 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 injection 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 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

  • Stay hydrated to help with dry mouth.
  • Avoid activities requiring clear vision if experiencing blurred vision.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For bradycardia: 0.5 mg IV every 3-5 minutes, max 3 mg. For organophosphate poisoning: 1-2 mg IV/IM, repeat every 5-10 minutes until atropinization.
Dose Range: 0.1 - 3 mg

Condition-Specific Dosing:

bradycardia: 0.5 mg IV every 3-5 minutes, maximum total dose of 3 mg (0.04 mg/kg).
preoperative: 0.4-0.6 mg IM/SC/IV 30-60 minutes prior to anesthesia.
organophosphate_poisoning: 1-2 mg IV/IM, repeat every 5-10 minutes until signs of atropinization (e.g., dry mouth, clear lungs, heart rate >80 bpm, pupils dilate). Severe cases may require much higher doses.
cholinergic_crisis: 1-2 mg IV/IM, repeat 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 (minimum 0.1 mg, maximum 0.5 mg).
Infant: For symptomatic bradycardia: 0.02 mg/kg IV (minimum 0.1 mg, maximum 0.5 mg). For organophosphate poisoning: 0.05 mg/kg IV/IM, repeat every 5-10 minutes until atropinization.
Child: For symptomatic bradycardia: 0.02 mg/kg IV (minimum 0.1 mg, maximum 0.5 mg). For organophosphate poisoning: 0.05 mg/kg IV/IM, repeat every 5-10 minutes until atropinization.
Adolescent: For symptomatic bradycardia: 0.02 mg/kg IV (minimum 0.1 mg, maximum 1 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 dose adjustment generally required, but monitor for increased anticholinergic effects.
Moderate: No specific dose adjustment generally required, but monitor for increased anticholinergic effects.
Severe: Use with caution; consider reduced doses and extended dosing intervals due to significant renal excretion of unchanged drug. Monitor closely for anticholinergic toxicity.
Dialysis: Atropine is dialyzable to some extent, but specific recommendations for dose adjustment in dialysis patients are not well-established. Monitor for clinical effect and toxicity.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required, as hepatic metabolism is not the primary elimination route for unchanged drug.

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 and cycloplegia.
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Pharmacokinetics

Absorption:

Bioavailability: High (nearly 100% after IM/SC/IV)
Tmax: IV: minutes; IM: 30 minutes; SC: 1 hour
FoodEffect: Not applicable for parenteral administration.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (variable, can be up to 10 hours in some individuals)
Clearance: Approximately 1.5 L/kg/hr
ExcretionRoute: Renal (urine)
Unchanged: Approximately 30-50% (up to 60% in some studies)
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Pharmacodynamics

OnsetOfAction: IV: 1 minute; IM: 10-15 minutes; SC: 30 minutes
PeakEffect: IV: 2-4 minutes; IM: 30 minutes; SC: 1 hour
DurationOfAction: 4-6 hours (cardiac effects may be shorter, 30-60 minutes)

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. 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 unusual symptoms, contact your doctor for advice:

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
  • Feeling unusually hot or flushed
  • Confusion, agitation, or hallucinations
  • Very 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, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.

To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Be sure to discuss all aspects of your health and medication regimen with your doctor and pharmacist to ensure safe and effective treatment.
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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
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, 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, 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
  • Marked mydriasis (dilated pupils) and cycloplegia (loss of accommodation)
  • Blurred vision
  • Hot, dry, flushed skin
  • Hyperpyrexia (fever)
  • Tachycardia, palpitations, arrhythmias
  • Hypertension (initially), then hypotension
  • Urinary retention
  • Abdominal distention, absent bowel sounds
  • CNS effects: restlessness, tremor, ataxia, confusion, disorientation, hallucinations, delirium, convulsions, coma, respiratory depression

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For suspected poisoning, call a poison control center at 1-800-222-1222. Treatment is supportive, including physostigmine (a cholinesterase inhibitor) for severe anticholinergic toxicity.

Drug Interactions

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Major Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, phenothiazines, antihistamines, quinidine, disopyramide): May lead to additive anticholinergic effects (e.g., severe dry mouth, urinary retention, constipation, blurred vision, CNS effects).
  • Potassium chloride (oral forms): Atropine can decrease GI motility, increasing the risk of GI lesions from potassium chloride tablets.
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Moderate Interactions

  • Drugs that slow gastric emptying (e.g., opioids): May further delay absorption of other orally administered drugs.
  • Antacids/Adsorbent antidiarrheals: May reduce absorption of atropine if given concurrently (separate administration by 1-2 hours).
  • Cholinesterase inhibitors (e.g., donepezil, rivastigmine): Atropine antagonizes their effects, reducing efficacy of cholinesterase inhibitors.

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

Pupil size and reactivity

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

Timing: Prior to administration

Mental Status

Rationale: To assess baseline and monitor for CNS anticholinergic effects.

Timing: Prior to administration

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Routine Monitoring

Heart Rate and Rhythm (ECG)

Frequency: Continuously (IV administration) or frequently (IM/SC)

Target: Individualized based on indication (e.g., increase in bradycardia, resolution of cholinergic crisis)

Action Threshold: Lack of response, excessive tachycardia, or arrhythmias

Blood Pressure

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

Target: Maintain within patient's normal range

Action Threshold: Significant hypotension or hypertension

Respiratory Rate and Effort

Frequency: Frequently

Target: Normal respiratory rate and unlabored breathing

Action Threshold: Respiratory depression or distress (especially in organophosphate poisoning, where atropine improves secretions but not muscle weakness)

Pupil Size and Reactivity

Frequency: Periodically, especially in organophosphate poisoning

Target: Dilated pupils (in poisoning), or normal

Action Threshold: Persistent miosis (in poisoning, indicates insufficient atropinization) or excessive mydriasis with vision changes

Level of Consciousness/Mental Status

Frequency: Periodically

Target: Alert and oriented

Action Threshold: Agitation, delirium, hallucinations, or somnolence

Urine Output

Frequency: Periodically

Target: Adequate urine output

Action Threshold: Urinary retention

Bowel Sounds/Abdominal Distention

Frequency: Periodically

Target: Presence of bowel sounds, no distention

Action Threshold: Absent bowel sounds, severe constipation, or abdominal distention

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Atropine crosses the placental barrier. While human data are limited, animal studies have shown some adverse effects at high doses. Use 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 at high doses.
Second Trimester: Limited data.
Third Trimester: May cause fetal tachycardia and decreased fetal heart rate variability. Can inhibit uterine contractions and cause fetal CNS depression if given close to term.
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Lactation

Atropine is excreted into breast milk. It may cause anticholinergic effects in the infant (e.g., tachycardia, constipation, urinary retention) and may decrease milk production due to its anticholinergic effects on mammary glands. Use with caution; monitor infant for adverse effects.

Infant Risk: Low to moderate risk. Monitor for signs of anticholinergic effects (e.g., irritability, constipation, urinary retention, tachycardia) and for adequate weight gain (due to potential decrease in 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 based on weight. Avoid rapid IV push in infants and children as it may cause a paradoxical bradycardia.

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Geriatric Use

Elderly patients are more susceptible to the anticholinergic side effects of atropine, especially CNS effects (confusion, delirium, hallucinations), urinary retention, and exacerbation of glaucoma. Use with caution and consider lower initial doses.

Clinical Information

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Clinical Pearls

  • Atropine is the primary antidote for organophosphate and carbamate poisoning, but it does not reverse muscle weakness; pralidoxime is needed for that.
  • In bradycardia, ensure adequate ventilation and oxygenation before administering atropine.
  • Atropine can cause a paradoxical bradycardia if given too slowly or at too low a dose (especially in children).
  • Monitor for signs of atropinization (dry mouth, dilated pupils, tachycardia, flushed skin) when treating poisoning to guide dosing.
  • Patients with glaucoma (especially angle-closure) or prostatic hypertrophy are at higher risk for adverse effects (increased intraocular pressure, urinary retention).
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Alternative Therapies

  • For bradycardia: Epinephrine, dopamine, transcutaneous pacing.
  • For preoperative drying of secretions: Glycopyrrolate (does not cross BBB, less CNS effects).
  • For organophosphate poisoning: Pralidoxime (2-PAM) in conjunction with atropine.
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Cost & Coverage

Average Cost: Relatively inexpensive per 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 to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. 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 call 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.