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Atropine Sulfate, 0.1 mg/mL — 10 mL Prefilled Syringe, Pack of 10

NDC/Item Number: 76329334001
Manufacturer:
INTERNATIONAL MED SYS (IMS)
Form
SYRINGE
Unit size
10X10ML
Strength
1MG

Details

Details

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

PRODUCT OVERVIEW

Atropine Sulfate Injection USP is a prescription muscarinic antagonist indicated for temporary blockade of severe or life-threatening muscarinic effects. Labeled clinical uses include antisialagogue or antivagal effects, antidotal therapy for organophosphorus or muscarinic mushroom poisoning, and bradyasystolic cardiac arrest, as directed in the prescribing information.

PRESENTATION

This package contains 10 unit cartons, each with one single-dose 10 mL Luer-Jet Luer-Lock prefilled syringe. Each syringe contains 1 mg atropine sulfate in 10 mL (0.1 mg/mL) for intravenous administration.

ADMINISTRATION

For intravenous use by trained healthcare professionals. Titrate according to heart rate, PR interval, blood pressure, and clinical symptoms. Inspect the solution and container before administration. Consult the full prescribing information for indication-specific dosing, repeat intervals, and monitoring.

IMPORTANT SAFETY INFORMATION

The current labeling lists no contraindications. Warnings and precautions include tachycardia, glaucoma, pyloric obstruction, worsening urinary retention, and viscid bronchial plugs. Common antimuscarinic adverse effects can include dry mouth, blurred vision, photophobia, and tachycardia. Exercise particular care in patients with coronary artery disease and other populations described in the label.

STORAGE

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

PRODUCT DETAILS

• Active ingredient: Atropine sulfate

• Strength: 1 mg/10 mL (0.1 mg/mL)

• Drug class: Muscarinic antagonist / anticholinergic

• Dosage form: Injection in prefilled syringe

• Route: Intravenous

• Package: 10 x 10 mL single-dose Luer-Lock syringes

• Manufacturer: International Medication Systems (IMS), an Amphastar company

• NDC: 76329-3340-01 (76329334001)

• GTIN: 00376329334011

Prescription product. For use by licensed healthcare professionals. See the current FDA-approved labeling for complete indications, dosing, warnings, and precautions.

Source: DailyMed, Atropine Sulfate Injection USP — https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c434062a-cd44-e684-e053-2995a90a91c3