Atropine Sul 0.4mg/ml Inj, 20ml

Manufacturer HIKMA PHARMACEUTICALS USA 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 1939
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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 the body. It's often used in emergencies 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

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

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

If you miss a dose, contact your doctor immediately 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 effects are known, especially if CNS side effects occur.
  • Stay hydrated to help with dry mouth.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly 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 5-60 minutes until atropinization.
Dose Range: 0.5 - 3 mg

Condition-Specific Dosing:

bradycardia: 0.5 mg IV every 3-5 minutes, max 3 mg
organophosphate_poisoning: 1-2 mg IV/IM, repeat every 5-60 minutes until atropinization (dry mouth, clear lungs, heart rate >80 bpm)
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 indications (e.g., bradycardia in resuscitation) may use 0.02 mg/kg IV/IO (min 0.1 mg, max 0.5 mg single dose).
Infant: 0.02 mg/kg IV/IM/SC (min 0.1 mg, max 0.5 mg single dose) for bradycardia or pre-anesthetic. Max total dose 1 mg for child, 2 mg for adolescent.
Child: 0.02 mg/kg IV/IM/SC (min 0.1 mg, max 0.5 mg single dose) for bradycardia or pre-anesthetic. Max total dose 1 mg for child, 2 mg for adolescent.
Adolescent: 0.02 mg/kg IV/IM/SC (min 0.1 mg, max 0.5 mg single dose) for bradycardia or pre-anesthetic. Max total dose 2 mg.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but monitor for increased anticholinergic effects.
Severe: No specific adjustment recommended, but monitor for increased anticholinergic effects due to reduced excretion.
Dialysis: Atropine is not significantly removed by dialysis. No specific adjustment recommended, but monitor for effects.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but monitor for increased anticholinergic effects due to reduced metabolism.
Severe: No specific adjustment recommended, but 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/cycloplegia.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV), ~25% (oral), ~50% (IM)
Tmax: IV: immediate; IM: 30 minutes; SC: 1 hour
FoodEffect: Not applicable for injectable form.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (adults); longer in children and elderly
Clearance: Not readily available as a single rate, primarily renal excretion.
ExcretionRoute: Renal (urine)
Unchanged: 30-50%
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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
  • Confusion, agitation, or hallucinations
  • Rapid or irregular heartbeat
  • Fever without other cause
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.

To ensure your safety, it is vital to review all your medications and health problems with your doctor and pharmacist. Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This precaution will help prevent potential interactions and ensure the safe use of this medication.
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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.

If this medication is accidentally swallowed, it can cause harm. In such cases, immediately contact a doctor or a poison control center for assistance.

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 they may be at a higher risk of experiencing certain side effects.

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.

Special Considerations for Multi-Dose Containers

Some products contain benzyl alcohol. Whenever possible, avoid using products with benzyl alcohol in newborns or infants, as high doses of benzyl alcohol can cause serious side 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
  • Hot, dry, flushed skin
  • Fever
  • Tachycardia
  • Hypertension (early), hypotension (late)
  • Urinary retention
  • Decreased bowel sounds
  • Restlessness, confusion, delirium, hallucinations
  • Ataxia
  • Seizures
  • Coma
  • Respiratory depression

What to Do:

Call 911 or Poison Control immediately (1-800-222-1222). Treatment is supportive, potentially involving 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, disopyramide) - increased anticholinergic effects.
  • Cholinesterase inhibitors (e.g., donepezil, rivastigmine, neostigmine, pyridostigmine) - antagonism of therapeutic effects.
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Moderate Interactions

  • Potassium chloride (oral) - increased risk of GI lesions due to decreased GI motility.
  • Metoclopramide - antagonism of prokinetic effects.
  • Drugs that prolong QT interval (theoretical risk with high doses).
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Minor Interactions

  • Antacids - may decrease absorption of oral atropine (not relevant for injectable).

Monitoring

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Baseline Monitoring

Vital Signs (HR, BP, RR)

Rationale: To establish baseline cardiovascular and respiratory status before administration, especially for bradycardia.

Timing: Prior to administration

ECG

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

Timing: Prior to administration for cardiac indications

Pupil size and reactivity

Rationale: Atropine causes mydriasis and cycloplegia; useful for monitoring effects in poisoning or as a side effect.

Timing: Prior to administration and periodically

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Routine Monitoring

Heart Rate

Frequency: Continuously (IV) or every 5-15 minutes (IM/SC) until desired effect or maximum dose reached, then periodically.

Target: Increase to desired rate (e.g., >60 bpm for symptomatic bradycardia); for poisoning, target >80 bpm.

Action Threshold: If no response to appropriate dosing, consider alternative therapies or higher doses for poisoning.

Blood Pressure

Frequency: Continuously (IV) or every 5-15 minutes (IM/SC) until desired effect or maximum dose reached, then periodically.

Target: Maintain adequate perfusion.

Action Threshold: Hypotension may indicate inadequate response or other issues.

Respiratory Rate and Secretions

Frequency: Continuously (IV) or every 5-15 minutes (IM/SC) until desired effect or maximum dose reached, then periodically.

Target: Clear lungs, decreased secretions (especially in poisoning).

Action Threshold: Persistent bronchorrhea or respiratory distress indicates need for more atropine in poisoning.

Level of Consciousness/Mental Status

Frequency: Periodically, especially with higher doses.

Target: Alert and oriented.

Action Threshold: Agitation, delirium, or coma may indicate atropine toxicity.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Flushing
  • Fever
  • Agitation
  • Delirium
  • Hallucinations
  • Tachycardia
  • Arrhythmias

Special Patient Groups

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Pregnancy

Category C. Animal studies have shown adverse effects, but human data are limited. Use only if potential benefit justifies the potential risk to the fetus. Atropine crosses the placenta.

Trimester-Specific Risks:

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

L3 (Moderately Safe). Atropine is excreted into breast milk. May cause anticholinergic effects in the infant (e.g., constipation, drowsiness) and may decrease milk production due to inhibition of prolactin release and decreased fluid secretion. Use with caution, monitor infant for side effects.

Infant Risk: Low to moderate risk of anticholinergic effects (e.g., drowsiness, constipation, dry mouth) and 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 CNS effects and hyperthermia. Dosing must be carefully calculated based on weight. Avoid rapid IV push in infants and children as it may cause paradoxical bradycardia.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Atropine is the drug of choice for symptomatic bradycardia in ACLS algorithms.
  • For organophosphate poisoning, atropine is given until 'atropinization' (drying of secretions, clear lungs, heart rate >80 bpm) is achieved, which may require very large doses.
  • Paradoxical bradycardia can occur if atropine is given too slowly or at too low a dose (especially in children).
  • Atropine can cause significant dry mouth; advise patients to use lozenges or sips of water.
  • Monitor for urinary retention, especially in elderly males with prostatic hypertrophy.
  • In patients with glaucoma, atropine can increase intraocular pressure; use with extreme caution or avoid.
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Alternative Therapies

  • For bradycardia: Epinephrine, dopamine, transcutaneous pacing, isoproterenol (rarely).
  • For pre-anesthetic drying: Glycopyrrolate (does not cross BBB, less CNS effects).
  • For organophosphate poisoning: Pralidoxime (2-PAM) is used in conjunction with atropine to reactivate cholinesterase.
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Cost & Coverage

Average Cost: Varies widely by supplier and quantity per 20ml vial (0.4mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. 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 correct 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 of ingestion.