Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)
HF Acquisition Co. LLC, DBA Health First
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. 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 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 disease or other drug therapy.
ATROPINE SULFATE is supplied in the following dosage forms. NDC 51662-1207-1 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) SYR NDC 51662-1207-2 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) SYR, 1 SYR PER POUCH NDC 51662-1207-3 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) SYR, 1 SYR PER POUCH, 10 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Atropine Sulfate Injection, USP, 0.1 mg/mL, is a clear and colorless solution available in 5 mL and 10 mL single-dose glass vials. Each vial is co-packaged with an injector, which together make a LifeShield™ Abboject™ Glass Syringe. 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.]
unapproved drug other
ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION HF ACQUISITION CO. LLC, DBA HEALTH FIRST _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- ATROPINE SULFATE INJECTION, USP 1MG (0.1MG/ML) SYR, 10ML 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. ( 2-2.1, 2-2.3) Titrate according to heart rate, PR interval, blood pressure and symptoms. ( 2-2.1) Adult dosage - Antisialagogue or for antivagal effects: Initial single dose of 0.5 mg to 1 mg. ( 2-2.2) - Antidote for organophosphorus or muscarinic mushroom poisoning: Initial single dose of 2 mg to 3 mg, repeated every 20–30 minutes. ( 2-2.2) - Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3–5 minutes if asystole persists. ( 2-2.2) Patients with Coronary Artery Disease: Total dose should not exceed 0.03 mg/kg to 0.04 mg/kg. ( 5-5.1) DOSAGE FORMS AND STRENGTHS 0.1 mg/mL injection in LifeShield™ Abboject™ Glass Syringe ( 3) CONTRAINDICATIONS None. ( 4) WARNINGS AND PRECAUTIONS Tachycardia ( 5-5.1) Glaucoma ( 5-5.2) Pyloric obstruction ( 5-5.3) Worsening urinary retention ( 5-5.4) Viscid bronchial plugs ( 5-5.5) 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 Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/ Citiți documentul complet