Atropine Sulfate

ATROPINE SULFATE- atropine sulfate injection
Hikma Pharmaceuticals USA Inc.

1 INDICATIONS AND USAGE

Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.

2 DOSAGE AND ADMINISTRATION

2.1 General Administration

Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact.

After initial use, discard unused portion within 24 hours.

Intravenous administration is usually preferred, but subcutaneous, intramuscular, endotracheal, and intraosseous administration are possible.

2.2 Adult Dosage

Table 1: Recommended Dosage in Adult Patients

Use

Initial Dose

Continued Treatment

Antisialagogue or

0.5 to 1 mg IV/IM/SC

Repeat as needed every 4 to 6 hours.

other antivagal

30 to 60 minutes

(preanesthesia and

preoperatively

Maximum Total Dose

during surgery)

3 mg

Organophosphorus, carbamate, or muscarinic mushroom poisoning

1 to 6 mg IV/IM/ET depending on severity of symptoms

Repeat as needed every 3 to 5 minutes

Dose may be doubled with each administration until response (reduced bronchospasm, improved oxygenation and drying of pulmonary secretions).

Maintenance Dose: Administer 10% to 20% of the loading dose required for response as a continuous infusion per hour and titrate.

Maximum Total Dose: No maximum total dose.

Symptomatic

0.5 mg IV/IM or 1 to 2 mg

As needed every 3 to 5 minutes

bradycardia*

ET by diluting in no more than 10 mL sterile water for injection or 0.9% sodium chloride

Maximum Total Dose 3 mg

IV=intravenous; IM=intramuscular; SC=subcutaneous; ET=endotracheal

*Do not rely on atropine in type II second-degree or third-degree AV block with wide QRS complexes because these bradyarrhythmias are not likely to be responsive to reversal of cholinergic effects by atropine. Atropine has no effect on bradycardia in patients with transplanted hearts.

2.3 Pediatric Dosage

Table 2: Recommended Dosage in Pediatric Patients

Use

Initial Dose

Continued Treatment

Antisialagogue or other antivagal (preanesthesia and during surgery)*

0.02 mg/kg IV/IM/SC 30 to 60 minutes preoperatively

Repeat as needed every 4 to 6 hours.

Maximum Single Dose

Less than 12 years old: 0.5 mg

12 years and older: 1 mg

Maximum Total Dose

Less than 12 years old: 1 mg

12 years and older: 2 mg

Organophosphorus,

0.02 to 0.06 mg/kg

Repeat as needed every 5 minutes

carbamate or

IV/IM/IO/ET

muscarinic

Dose may be doubled with each administration until response

mushroom poisoning

(reduced bronchospasm, improved oxygenation and drying of pulmonary secretions).

Maintenance Dose: Administer 10% to 20% of the loading dose required for response as a continuous infusion per hour and titrate as needed.

Maximum Total Dose: No maximum total dose.

Symptomatic

0.02 mg/kg IV/IO or

Repeat as needed every 5 minutes

bradycardia due to

0.04 to 0.06 mg/kg via

increased vagal tone

endotracheal tube

Maximum Single Dose

or primary AV

followed by 1 to 5 mL

Less than 12 years old: 0.5 mg

conduction block

flush of normal saline

12 years and older: 1 mg

(not secondary to

followed by 5

hypoxia) **

ventilations

IV=intravenous; IM=intramuscular; SC=subcutaneous; IO=intraosseous; ET=endotracheal;

*Available evidence does not support the routine use of atropine in emergency intubation of critically ill infants and children except in specific emergency intubations when there is higher risk of bradycardia

** Atropine has no effect on bradycardia in patients with transplanted hearts.

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