देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)
Medefil, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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. 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 None. 8.1 Pregnancy 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. 8.3 Nursing Mothers Trace amounts of atropine was found in breast milk. The clinical impact of this is not known. 8.4 Pediatric Use Recommendations for use in pediatric patients are not based on clinical trials. 8.5 Geriatric Use An evaluation of current literature revealed
Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows: 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
ATROPINE SULFATE- ATROPINE SULFATE INJECTION INJECTION, SOLUTION MEDEFIL, INC. ---------- THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEED TO USE ATROPINE SULFATE INJECTION, USP, 1 MG/0 ML (0.1 MG/ML) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATROPINE SULFATE INJECTION, USP. ATROPINE SULFATE INJECTION, USP, 1 MG/10 ML (0.1 MG/ML) FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1960 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 or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. 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 2 DOSAGE AND ADMINISTRATION 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)]. 3 DOSAGE FORMS AND STRENGTHS Injection: 0.1 mg/mL in Plastic Syringe. 4 CONT पूरा दस्तावेज़ पढ़ें