Atropine disappears rapidly from the blood following injection and is distributed throughout the body. Exercise, both prior to and immediately following intramuscular administration of atropine, significantly increases the absorption of atropine due to increased perfusion in the muscle and significantly decreases the clearance of atropine. The pharmacokinetics of atropine is nonlinear after intravenous administration of 0.5 to 4 mg. Atropine’s plasma protein binding is about 44% and saturable in the 2–20 μg/mL concentration range. Atropine readily crosses the placental barrier and enters the fetal circulation, but is not found in amniotic fluid. Much of the drug is destroyed by enzymatic hydrolysis, particularly in the liver; from 13 to 50% is excreted unchanged in the urine. Traces are found in various secretions, including milk. The major metabolites of atropine are noratropine, atropin-n-oxide, tropine, and tropic acid. The metabolism of atropine is inhibited by organophosphate pesticides.
The elimination half-life of atropine is more than doubled in children under two years and the elderly (>65 years old) compared to other age groups. There is no gender effect on the pharmacokinetics and pharmacodynamics (heart rate changes) of atropine.
Studies have not been performed to evaluate the carcinogenic or mutagenic potential of atropine or its potential to affect fertility adversely.
Atropine Sulfate Injection, USP, 1 mg/10 mL (0.1 mg/mL), is supplied in single-dose syringes as follows:
In unit-use packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe.
|Stock No.||NDC No.||Size|
|3340||76329-3340-1||FOR I.V. USE||10 mL|
Ten cartons per package.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
So. El Monte, CA 91733, U.S.A.
An Amphastar Pharmaceuticals Company Rev. 10-20
© INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2020
Luer-Lock Prefilled Syringe
NDC 76329-3340-1 STOCK NO. 3340
1 mg/10mL (0.1 mg/mL)
FOR INTRAVENOUS USE
10 mL Single-dose syringe. Discard unused portion.
LUER-JET™ LUER-LOCK PREFILLED SYRINGE
| ATROPINE SULFATE |
atropine sulfate injection
|Labeler — International Medication Systems, Limited (055750020)|
|International Medication Systems, Limited||055750020||manufacture (76329-3340), analysis (76329-3340), label (76329-3340)|
Revised: 05/2021 International Medication Systems, Limited
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