Composition:

Each mL contains: atropine sulfate USP 1 mg, water for injection USP: q s

Category:

Anticholinergic, emergency medications

Indications and usage:

Pre-operative medication to inhibit secretions and salvation, sinus bradycardia, lessen the degree of atrio-ventricular block, antidote for organophosphorous poisoning or choline esters.

Dosage and administration:

Premedication: IV Dose: 0.3 to 0.6 mg immediately before induction of anesthesia and in incremental doses of 0.1 mg for the treatment of bradycardia. IM Dose: 0.3 to 0.6 mg in 30 to 60 minutes before induction.

Muscarinic side effects of neostigmine: IV Dose: 0.6 to 1.2 mg

Bradycardia: IV Dose: 0.3 to 1.0 mg May be repeated if necessary

Organophophorous Poisoning: 2-3 mg parenterally repeat until signs of atropine toxicity

Children: Premedication:0.02 mg/Kg

Dose for resuscitation of neonates, infants and children:0.03 mg/Kg by IV

Adverse effects:

Dry mouth, decreased sweating, constipation, irritation at injection site, difficulty in swallowing, increased sensitivity to light, confusion, skin rash, orthostatic hypotension, loss of memory, headache, nausea, vomiting, tachyacardia, ventricular fibrillation, palpitation, ataxia.

Special precautions:

Reflux oesophagitis, elderly, infants and children, in pregnancy

TEST

SPECIFICATION AS PER USP

Description

A clear colourless solution

Identification

Complies

pH

3.0 to 6.5

Sterility testing

Complies

Volume Variation

NLT 1.0 ml

Bacterial Endotoxin test

NMT 55.6 USP EU/mg of Atropine Sulphate

Particulate Matter

Sample should be free from particles

Assay: Each ml contains: Atropine Sulphate USP 1mg

90.0% to 110.0%