atropine/pralidoxime (Rx)

Brand and Other Names:ATNAA, DuoDote
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

IM autoinjector

  • atropine (2.1mg/0.7mL) plus pralidoxime chloride (600mg/2mL) in 2 separate chambers; when activated, sequentially administers both drugs IM through a single needle
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Organophosphate Poisoning

Indicated for treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing >41 kg (90 pounds)

2.1 mg atropine/0.7 mL + 600 mg pralidoxime/2 mL IM

Maximum dose: Not to exceed 3 injections unless medical care support available

3 autoinjectors should be available for use in each patient (including healthcare providers) at risk for organophosphorus poisoning; use 1 for mild symptoms plus 2 more for severe symptoms

See also Administration

Mild symptoms

  • ≥2 mild symptoms: 1 injection IM; if after 10-15 min there are no severe symptoms experienced, no further injections are necessary
  • Additional doses: If, at any time following the first injection, the patient develops any of the severe symptoms, administer 2 additional IM injections in rapid succession
  • Mild symptoms: Bradycardia, chest tightness, breathing difficulties, blurred vision, increased salivation (eg, sudden drooling), miosis, nausea or vomiting, runny nose, stomach cramps (acute onset), salivation, teary eyes, wheezing/coughing, tremors/muscular twitching, airway secretions increased

Severe symptoms

  • Any severe symptom listed below: 3 injections IM in rapid succession
  • Severe symptoms: Confused/strange behavior, involuntary urination/defecation, muscular twitching/generalized weakness (severe), severe breathing difficulties or copious secretion from lung or airway, convulsions, unconsciousness

Dosing Modifications

Renal impairment

  • Pralidoxime can cause decreased renal function
  • Patients with severe renal impairment may require less frequent doses after initial dose

Hepatic impairment

  • Patients with severe hepatic impairment may require less frequent doses after initial dose

Dosing Considerations

Three autoinjectors should be available for use in each patient (including healthcare providers) at risk for organophosphorus poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms; note that individuals may not have all symptoms included under mild or severe symptom category

Only administer drug to patients experiencing symptoms of organophosphorus poisoning in a situation where exposure is known or suspected; autoinjector is intended as an initial treatment of symptoms of organophosphorus nerve agent or insecticide poisonings as soon as symptoms appear; definitive medical care should be sought immediately

The autoinjector should be administered by healthcare providers with adequate training in recognition and treatment of nerve agent or insecticide intoxication

Close supervision of all treated patients is indicated for at least 48 to 72 hours

Dosage Forms & Strengths

IM autoinjector

  • atropine (2.1mg/0.7mL) plus pralidoxime chloride (600mg/2mL) in 2 separate chambers; when activated, sequentially administers both drugs IM through a single needle
more...

Organophosphate Poisoning

Indicated for treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing >41 kg (90 pounds)

≤41 kg: Safety and efficacy not established

>41 kg: 2.1 mg atropine/0.7 mL + 600 mg pralidoxime/2 mL IM

Maximum dose: Not to exceed 3 injections unless medical care support available

3 autoinjectors should be available for use in each patient (including healthcare providers) at risk for organophosphorus poisoning; use 1 for mild symptoms plus 2 more for severe symptoms

Mild symptoms

  • ≥2 mild symptoms: 1 injection IM; if after 10-15 min there are no severe symptoms experienced, no further injections are necessary
  • Additional doses: If, at any time following the first injection, the patient develops any of the severe symptoms, administer 2 additional IM injections in rapid succession
  • Mild symptoms: Bradycardia, chest tightness, breathing difficulties, blurred vision, increased salivation (eg, sudden drooling), miosis, nausea or vomiting, runny nose, stomach cramps (acute onset), salivation, teary eyes, wheezing/coughing, tremors/muscular twitching, airway secretions increased

Severe symptoms

  • Any severe symptom listed below: 3 injections IM in rapid succession
  • Severe symptoms: Confused/strange behavior, involuntary urination/defecation, muscular twitching/generalized weakness (severe), severe breathing difficulties or copious secretion from lung or airway, convulsions, unconsciousness

Dosing Modifications

Renal impairment

  • Pralidoxime can cause decreased renal function
  • Patients with severe renal impairment may require less frequent doses after initial dose

Hepatic impairment

  • Patients with severe hepatic impairment may require less frequent doses after initial dose

Dosing Considerations

Three autoinjectors should be available for use in each patient (including healthcare providers) at risk for organophosphorus poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms; note that individuals may not have all symptoms included under mild or severe symptom category

Only administer drug to patients experiencing symptoms of organophosphorus poisoning in a situation where exposure is known or suspected; autoinjector is intended as an initial treatment of symptoms of organophosphorus nerve agent or insecticide poisonings as soon as symptoms appear; definitive medical care should be sought immediately

The autoinjector should be administered by healthcare providers with adequate training in recognition and treatment of nerve agent or insecticide intoxication

Close supervision of all treated patients is indicated for at least 48 to 72 hours

Older individuals may be more susceptible to atropine effects

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Interactions

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            Adverse Effects

            Frequency Not Defined

            Injection site reaction (muscle tightness, pain)

            Atropine

            • Dry mouth
            • Blurred vision
            • Dry eyes
            • Photophobia
            • Confusion
            • Headache
            • Dizziness

            Pralidoxime

            • Vision changes
            • Dizziness, headache
            • Drowsiness
            • Nausea
            • Tachycardia
            • Increased blood pressure
            • Muscular weakness
            • Dry mouth
            • Emesis
            • Rash
            • Dry skin
            • Hyperventilation
            • Decreased renal function
            • Manic behavior
            • Transient elevation of LFTs
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            Warnings

            Contraindications

            None

            Cautions

            Caution in patients with known cardiovascular disease or cardiac conduction problems

            May inhibit sweating and lead to hyperthermia; avoid excessive exercise and heat exposure

            Caution in susceptible individuals at risk for acute glaucoma

            Caution in patients with bladder outflow obstruction owing to risk of urinary retention

            Caution with partial pyloric stenosis because of risk of complete pyloric obstruction

            May cause inspiration of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease; monitor respiratory status

            Individual should not rely solely upon atropine and pralidoxime to provide complete protection from chemical nerve agents and insecticide poisoning (eg, primary protection is the wearing of protective garments)

            Elderly individuals may be more susceptible to the effects of atropine

            Patients with organophosphorus nerve agent or organophosphorus insecticide poisoning who have received atropine/pralidoxime may exhibit accelerated reversal of the neuromuscular blocking effects of succinylcholine and mivacurium; monitor for neuromuscular effects with concomitant succinylcholine or mivacurium use

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            Pregnancy & Lactation

            Pregnancy

            Atropine readily crosses the placental barrier and enters fetal circulation; there are no adequate data on developmental risk associated with use of atropine, pralidoxime, or combination in pregnant women

            Lactation

            Atropine has been reported to be excreted in human milk; unknown whether pralidoxime is excreted in human milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Atropine: Competitively blocks the effects of acetylcholine, including excess acetylcholine due to organophosphorus poisoning, at muscarinic cholinergic receptors on smooth muscle, cardiac muscle, secretory gland cells, and in peripheral autonomic ganglia and the central nervous system

            Pralidoxime: Reactivates acetylcholinesterase which has been inactivated by phosphorylation due to an organophosphorous nerve agent or insecticide; reactivated acetylcholinesterase hydrolyzes excess acetylcholine, which is clinically important because only a small proportion of active acetylcholinesterase is needed to maintain vital functions

            Absorption

            Atropine

            • Rapidly and well absorbed after IM administration
            • Peak plasma concentration: 13 ng/mL
            • Peak plasma time: 31 minutes

            Pralidoxime

            • Rapidly absorbed after IM injection
            • Peak plasma concentration: 7 mcg/mL
            • Peak plasma time: 28 minutes

            Distribution

            Atropine

            • Rapidly and widely throughout the body
            • Crosses blood brain barrier and enteres fetal circulation
            • Protein bound: 14-22%

            Pralidoxime

            • Distributed throughout the extracellular wate
            • No protein binding
            • Vd: 0.6-2.7 L/kg (may increase in severe organophosphate intoxication)

            Metabolism

            Atropine: Liver via enzymatic hydrolysis

            Pralidoxime: Hepatic

            Elimination

            Atropine

            • Half-life: 2.4 hr
            • Excretion: 50-60% unchanged in urine

            Pralidoxime

            • Half-life: 2 hr
            • Excretion: 72-94% in urine (partly unchanged and partly as a metabolite)
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            Administration

            IM Administration

            ATNAA: Administer IM in the lateral thigh muscle or buttocks; see prescribing information for complete detailed administration instructions

            DuoDote: Administer IM into the mid-lateral thigh; see prescribing information for complete detailed administration instructions

            Storage

            Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

            Keep from freezing

            Protect from light

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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