atropine sulfate injection, USP How Supplied/Storage and Handling | Pfizer Medical Information - US

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16 HOW SUPPLIED/STORAGE AND HANDLING

Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows:

Syringes	Concentration (mg/mL)	Fill Volume	Total Atropine Content	NDC# (Unit of Sale)
Ansyr™ Plastic Syringe	0.1 mg/mL	10 mL	1 mg	0409-1630-10 (Bundle of 10)
Ansyr™ Plastic Syringe	0.05 mg/mL	5 mL	0.25 mg	0409-9630-05 (Bundle of 10)
LifeShield™ Abboject™ Glass Syringe	0.1 mg/mL	5 mL	0.5 mg	0409-4910-34 (Bundle of 10)
LifeShield™ Abboject™ Glass Syringe	0.1 mg/mL	10 mL	1 mg	0409-4911-34 (Bundle of 10)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira Logo

Abboject™ is a trademark of the Abbott group of companies.

LifeShield™ is the trademark of ICU Medical, Inc. and is used under license.

LAB-1041-4.0

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

atropine sulfate injection, USP Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

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...

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2 DOSAGE AND ADMINISTRATION

2.1 General Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to...

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3 DOSAGE FORMS AND STRENGTHS

Injection: 0.05 mg/mL and 0.1 mg/mL in Ansyr™ Plastic Syringes.

Injection: 0.1 mg/mL in LifeShield™ Abboject™ Glass Syringes.

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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Tachycardia

When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be...

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6 ADVERSE REACTIONS

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...

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7 DRUG INTERACTIONS

7.1 Mexiletine

Atropine Sulfate Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal...

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10 OVERDOSAGE

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,...

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11 DESCRIPTION

Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Atropine is an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed to evaluate the carcinogenic or mutagenic...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows:

...

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