Prescription Drug Information: Atropine Sulfate (Page 2 of 2)

12.3 Pharmacokinetics

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.

Specific Populations
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.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed to evaluate the carcinogenic or mutagenic potential of atropine or its potential to affect fertility adversely.

16 HOW SUPPLIED/STORAGE AND HANDLING

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.]

Rx Only

INTERNATIONAL MEDICATION SYSTEMS, LIMITED
So. El Monte, CA 91733, U.S.A.
An Amphastar Pharmaceuticals Company Rev. 10-20

© INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2020

6933390J

Carton Label and Principal Display Panel Text

Luer-Lock Prefilled Syringe

Rx Only

NDC 76329-3340-1 STOCK NO. 3340

ATROPINE SULFATE
INJECTION, USP
1 mg/10mL (0.1 mg/mL)

1 mg
per
10 mL

FOR INTRAVENOUS USE

10 mL Single-dose syringe. Discard unused portion.

LUER-JET™ LUER-LOCK PREFILLED SYRINGE

carton
(click image for full-size original)

ATROPINE SULFATE
atropine sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76329-3340
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM HYDROXIDE
SULFURIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76329-3340-1 10 CARTON in 1 PACKAGE contains a CARTON
1 1 SYRINGE in 1 CARTON This package is contained within the PACKAGE (76329-3340-1) and contains a SYRINGE
1 10 mL in 1 SYRINGE This package is contained within a CARTON and a PACKAGE (76329-3340-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212461 02/17/2021
Labeler — International Medication Systems, Limited (055750020)
Establishment
Name Address ID/FEI Operations
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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