Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows: Unit of Sale and Product Description Strength (Concentration) NDC Bundle of 10 5 mL Single-Dose Ansyr ® Plastic Syringe 0.25 mg/5 mL (0.05 mg/mL) 0409-9630-05 Bundle of 10 10 mL Single-Dose Ansyr ® Plastic Syringe 1 mg/10 mL (0.1 mg/mL) 0409-1630-10 Bundle of 10 5 mL Single-Dose LifeShield ® Abboject ® Glass Syringe 0.5 mg/5 mL (0.1 mg/mL) 0409-4910-34 Bundle of 10 10 mL Single-Dose LifeShield ® Abboject ® Glass Syringe 1 mg/10 mL (0.1 mg/mL) 0409-4911-34 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 Abboject ® is a trademark of Abbott Laboratories. LifeShield ® is the trademark of ICU Medical, Inc. and is used under license. LAB-1041-7.0 Hospira Logo; PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label Atropine Sulfate 1 mg/10 mL (0.1 mg/mL) 10 mL Single-Dose Syringe NDC 0409-1630-15 Rx only Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL) Hospira For Intravenous Use. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA RL-7664 LOT ##-###-AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label; PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton NDC 0409-1630-15 Rx only 10 mL Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL) For Intravenous Use Ansyr ® Single-Dose Syringe Hospira LOT #####AA EXP DMMMYYYY ◀ PRESS AND PULL TO OPEN ▶ PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton; PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label Atropine Sulfate 0.25 mg/5 mL (0.05 mg/mL) 5 mL Single-Dose Syringe Rx only NDC 0409-9630-15 PEDIATRIC 0.25 mg/5 mL (0.05 mg/mL) Atropine Sulfate Injection, USP Hospira For Intravenous Use. Dist. by Hospira, Inc., Lake Forest, IL 60045 USA RL-7665 LOT ##-###-AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label; PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton NDC 0409-9630-15 Rx only 5 mL Pediatric Atropine Sulfate Injection, USP 0.25 mg/5 mL (0.05 mg/mL) For Intravenous Use Ansyr ® Single-Dose Syringe Hospira LOT #####AA EXP DMMMYYYY ◀ PRESS AND PULL TO OPEN ▶ PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton; PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - 0409-4910 5 mL Single-dose syringe NDC 0409-4910-11 Rx only Atropine Sulfate Inj., USP 0.5 mg/5 mL (0.1 mg/mL) For intravenous use. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL-5314 PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - 0409-4910; PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton - 0409-4910 5 mL NDC 0409-4910-11 Rx only Atropine Sulfate Injection, USP 0.5 mg/5 mL (0.1 mg/mL) For intravenous use with male luer lock adapter and 20-Gauge protected needle Glass LIFESHIELD ® ABBOJECT ® Unit of Use Syringe Single-dose syringe Discard unused portion LOT #####AA EXP DMMMYYYY Hospira ◀ PRESS AND PULL TO OPEN PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton - 0409-4910; PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label - 0409-4911 10 mL Single-dose syringe NDC 0409-4911-11 Rx only Atropine Sulfate Inj., USP 1 mg/10 mL (0.1 mg/mL) For intravenous use. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL-5315 PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label - 0409-4911; PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton - 0409-4911 10 mL NDC 0409-4911-11 Rx only Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL) For intravenous use with male luer lock adapter and 20-Gauge protected needle Glass LIFESHIELD ® ABBOJECT ® Unit of Use Syringe Single-dose syringe. Discard unused portion LOT #####AA EXP DMMMYYYY Hospira ◀ PRESS AND PULL TO OPEN PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton - 0409-4911
- 16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows: Unit of Sale and Product Description Strength (Concentration) NDC Bundle of 10 5 mL Single-Dose Ansyr ® Plastic Syringe 0.25 mg/5 mL (0.05 mg/mL) 0409-9630-05 Bundle of 10 10 mL Single-Dose Ansyr ® Plastic Syringe 1 mg/10 mL (0.1 mg/mL) 0409-1630-10 Bundle of 10 5 mL Single-Dose LifeShield ® Abboject ® Glass Syringe 0.5 mg/5 mL (0.1 mg/mL) 0409-4910-34 Bundle of 10 10 mL Single-Dose LifeShield ® Abboject ® Glass Syringe 1 mg/10 mL (0.1 mg/mL) 0409-4911-34 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 Abboject ® is a trademark of Abbott Laboratories. LifeShield ® is the trademark of ICU Medical, Inc. and is used under license. LAB-1041-7.0 Hospira Logo
- PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label Atropine Sulfate 1 mg/10 mL (0.1 mg/mL) 10 mL Single-Dose Syringe NDC 0409-1630-15 Rx only Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL) Hospira For Intravenous Use. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA RL-7664 LOT ##-###-AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label
- PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton NDC 0409-1630-15 Rx only 10 mL Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL) For Intravenous Use Ansyr ® Single-Dose Syringe Hospira LOT #####AA EXP DMMMYYYY ◀ PRESS AND PULL TO OPEN ▶ PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton
- PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label Atropine Sulfate 0.25 mg/5 mL (0.05 mg/mL) 5 mL Single-Dose Syringe Rx only NDC 0409-9630-15 PEDIATRIC 0.25 mg/5 mL (0.05 mg/mL) Atropine Sulfate Injection, USP Hospira For Intravenous Use. Dist. by Hospira, Inc., Lake Forest, IL 60045 USA RL-7665 LOT ##-###-AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label
- PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton NDC 0409-9630-15 Rx only 5 mL Pediatric Atropine Sulfate Injection, USP 0.25 mg/5 mL (0.05 mg/mL) For Intravenous Use Ansyr ® Single-Dose Syringe Hospira LOT #####AA EXP DMMMYYYY ◀ PRESS AND PULL TO OPEN ▶ PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton
- PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - 0409-4910 5 mL Single-dose syringe NDC 0409-4910-11 Rx only Atropine Sulfate Inj., USP 0.5 mg/5 mL (0.1 mg/mL) For intravenous use. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL-5314 PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label - 0409-4910
- PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton - 0409-4910 5 mL NDC 0409-4910-11 Rx only Atropine Sulfate Injection, USP 0.5 mg/5 mL (0.1 mg/mL) For intravenous use with male luer lock adapter and 20-Gauge protected needle Glass LIFESHIELD ® ABBOJECT ® Unit of Use Syringe Single-dose syringe Discard unused portion LOT #####AA EXP DMMMYYYY Hospira ◀ PRESS AND PULL TO OPEN PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton - 0409-4910
- PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label - 0409-4911 10 mL Single-dose syringe NDC 0409-4911-11 Rx only Atropine Sulfate Inj., USP 1 mg/10 mL (0.1 mg/mL) For intravenous use. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL-5315 PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label - 0409-4911
- PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton - 0409-4911 10 mL NDC 0409-4911-11 Rx only Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL) For intravenous use with male luer lock adapter and 20-Gauge protected needle Glass LIFESHIELD ® ABBOJECT ® Unit of Use Syringe Single-dose syringe. Discard unused portion LOT #####AA EXP DMMMYYYY Hospira ◀ PRESS AND PULL TO OPEN PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton - 0409-4911
Overview
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 administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na + ) and chloride (Cl - ) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17 H 23 NO 3 ) 2 H 2 SO 4 H 2 O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula: Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1‑hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. The Ansyr ® syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material. structural formula atropine sulfate
Indications & Usage
Atropine Sulfate Injection 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. Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life‑threatening muscarinic effects. ( 1 )
Dosage & 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 ) 2.1 General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Each syringe is intended for single dose only. Discard unused portion. For intravenous administration. Titrate based on heart rate, PR interval, blood pressure and symptoms. 2.2 Adult Dosage Table 1: Recommended Dosage Use Dose (adults) Repeat Antisialagogue or other antivagal 0.5 to 1 mg 1-2 hours Organophosphorus or muscarinic mushroom poisoning 2 to 3 mg 20-30 minutes Bradyasystolic cardiac arrest 1 mg 3-5 minutes; 3 mg maximum total dose 2.3 Pediatric Dosage Dosing in pediatric populations has not been well studied. Usual initial dose is 0.01 to 0.03 mg/kg. 2.4 Dosing in Patients with Coronary Artery Disease Limit the total dose of atropine sulfate to 0.03 mg/kg to 0.04 mg/kg [see Warnings and Precautions (5.1) ] .
Warnings & Precautions
• Tachycardia ( 5.1 ) • Glaucoma ( 5.2 ) • Pyloric obstruction ( 5.3 ) • Worsening urinary retention ( 5.4 ) • Viscid bronchial plugs ( 5.5 ) 5.1 Tachycardia When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine‑induced tachycardia on myocardial oxygen demand. 5.2 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.3 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 5.4 Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy. 5.5 Viscid Plugs Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.
Contraindications
None. None. ( 4 )
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 possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation. 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 Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
Mexiletine: Decreases rate of mexiletine absorption. ( 7.1 ) 7.1 Mexiletine Atropine Sulfate Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.
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