Atropine Injection

Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.

• General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
• Do not administer unless solution is clear and seal is intact
• Each vial is intended for single dose only
• Discard unused portion
• For Intravenous administration
• Titrate based on heart rate, PR interval, blood pressure and symptoms
• Adult Dosage Pediatric Dosage Dosing
• In pediatric populations has not been well studied
• Usual initial dose is 0.01 to 0.03 mg/kg
• Dosing in Patients with Coronary Artery Disease Limit the total dose of atropine sulfate to 0.03 to 0.04 mg/kg [see WARNINGS AND PRECAUTIONS ]
• DOSAGE

3 DOSAGE FORM & STRENGTH Injection: supplied as a clear, colorless solution in a 1 mL glass vial in the following concentrations: 0.4 mg/mL: containing 0.4 mg of atropine sulfate monohydrate equivalent to 0.332 mg of atropine. 1 mg/mL: containing 1 mg atropine sulfate monohydrate equivalent to 0.83 mg of atropine.

None.

7.1 Mexiletine Atropine Sulfate Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.

5.1 Tachycardia When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand. 5.2 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.3 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 5.4 Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy. …

The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. …

IN SPECIFIC POPULATION 8.1 Pregnancy Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations). Available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). …

Excessive dosing may cause palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse occur only with severe intoxication. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma. The fatal adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.