nd due care is essential to avoid overdosage, especially with intravenous administration. Children are more susceptible than adults to the toxic effects of anticholinergic agents.
Precautions
Do not administer unless solution is clear and seal is intact. Discard unused portion.
Atropine Sulfate Injection, USP should be used with caution in all individuals over 40 years of age. Conventional systemic doses may precipitate acute glaucoma in susceptible patients, convert partial organic pyloric stenosis into complete obstruction, lead to complete urinary retention in patients with prostatic hypertrophy or cause inspissation of bronchial secretions and formation of dangerous viscid plugs in patients with chronic lung disease.
Pregnancy Category C. Animal reproduction studies have not been conducted with Atropine. It also is not known whether Atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed.
Adverse Reactions
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 with chronic administration of therapeutic doses. Anhidrosis also may occur and produce heat intolerance or impair temperature regulation in persons living in a hot environment. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation.
Adverse effects following single or repeated injections of Atropine are most often the result of excessive dosage. These include palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to marked palpitation, 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.
Overdosage
In the event of toxic overdosage (see ADVERSE REACTIONS), a short acting barbiturate or diazepam may be given as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in Atropine poisoning. Central stimulants are not recommended. Physostigmine, given as an Atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1.0 mg in children), rapidly abolishes delirium and coma caused by large doses of Atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required. Artificial respiration with oxygen may be necessary. Ice bags and alcohol sponges help to reduce fever, especially in children.
The fatal adult dose of Atropine is not known; 200 mg doses have been used and doses as high as 1000 mg have been given.
In children, 10 mg or less may be fatal. With a dose as low as 0.5 mg, undesirable minimal symptoms or responses of overdosage may occur. These increase in severity and extent with larger doses of the drug (excitement, hallucinations, delirium and coma with a dose of 10 mg or more).
Atropine Dosage and Administration
Atropine Sulfate Injection, USP may be administered subcutaneously, intramuscularly or intrav |
