ATROPINE SULFATE injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

HF Acquisition Co LLC, DBA HealthFirst

प्रशासन का मार्ग:

INTRAMUSCULAR

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. 8.5 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.

उत्पाद समीक्षा:

ATROPINE SULFATE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1289-1 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) 10mL ANSYR SYR NDC 51662-1289-2 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) 10mL ANSYR SYR, 1 SYRINGE PER POUCH NDC 51662-1289-3 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) 10mL ANSYR SYR, 1 SYRINGE PER POUCH, 10 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 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.]

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
ATROPINE SULFATE INJECTION, USP 1MG (0.1MG/ML) 10ML ANSYR SYR
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, intramuscular,
subcutaneous or
endotracheal 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, but may also be administered via
subcutaneous,
intramuscular or via an endotracheal tube 2-( 2.1, 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: Limit the total dose to 0.03
mg/kg to 0.04 mg/kg.
2-( 2.4)
DOSAGE FORMS AND STRENGTHS
•
0.05 mg/mL injection in Ansyr™ Plastic Syringe ( 3)
•
0.1 mg/mL injection in Ansyr™ Plastic Syringe ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Tachycardia 5-(5.1)
Glaucoma 5-(5.2)
Pyloric obstruction (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/medwat