ATROPINE SULFATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)

Available from:

Medical Purchasing Solutions, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. None. 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. Trace amounts of atropine was found in breast milk. The clinical impact of this is not known. Recommendations for use in pediatric patients are not based on clinical trials. An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disea

Product summary:

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. 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATROPINE SULFATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ATROPINE SULFATE
INJECTION.
ATROPINE SULFATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1960
INDICATIONS AND USAGE
Atropine is a muscarinic antagonist indicated for temporary blockade
of severe or life threatening
muscarinic effects. (1)
DOSAGE AND ADMINISTRATION
• For intravenous administration ( 2.1)
• Titrate according to heart rate, PR interval, blood pressure and
symptoms ( 2.1)
• Adult dosage
- Antisialagogue or for antivagal effects: Initial single dose of 0.5
mg to 1 mg ( 2.2)
- Antidote for organophosphorus or muscarinic mushroom poisoning:
Initial single dose of 2 mg to 3 mg,
repeated every 20–30 minutes ( 2.2)
- Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3–5
minutes if asystole persists ( 2.2)
• Patients with Coronary Artery Disease: Limit the total dose to
0.03 mg/kg to 0.04 mg/kg ( 2.4)
DOSAGE FORMS AND STRENGTHS
0.1 mg/mL injection in Glass Syringe (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Tachycardia ( 5.1)
Glaucoma ( 5.2)
Pyloric obstruction ( 5.3)
Worsening urinary retention ( 5.4)
Viscid bronchial plugs ( 5.5)
ADVERSE REACTIONS
Most adverse reactions are directly related to atropine’s
antimuscarinic action. Dryness of the mouth,
blurred vision, photophobia and tachycardia commonly occur with
chronic administration of therapeutic
doses. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMPHASTAR
PHARMACEUTICALS, INC. AT 1-
800-423-4136, OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. (6)
DRUG INTERACTIONS
_Mexiletine:_ Decreases rate of mexiletine absorption. ( 7.1)
REVISED: 2/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Administration
2.2 Adult Dosage
2.3 Pediatric Dosage
2.4 Dosing in Patients wit