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:

General Injectables & Vaccines, Inc

प्रशासन का मार्ग:

INTRAVENOUS

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. 8.4 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 d

उत्पाद समीक्षा:

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. It is supplied in the following presentations: 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:

unapproved drug other

उत्पाद विशेषताएं

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
_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._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ATROPINE SULFATE 0.1 MG/ML INJECTION, USP 10 ML PREFILLED SYRINGE
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
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
0.1 mg/mL injection in LifeShield™ Abboject™ Glass Syringe (3) (3)
CONTRAINDICATIONS
None. (4) (4)
WARNINGS AND PRECAUTIONS
Tachycardia (5.1) (5) (5)
Glaucoma (5.2) (5) (5)
Pyloric obstruction (5.3) (5) (5)
Worsening urinary retention (5.4) (5) (5)
Viscid bronchial plugs (5.5) (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) (6) (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/medwatch. (6) (6)
DRUG INTERACTIONS
Mexiletine: Decreases rate of mexiletine absorption. (7.1) (7) (7)
Revised: 3/2018 (7) (7)
Revised: 12/2019 (7)
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
OVERDOSAGE
DESCRIPTION
CLINICAL PHARMACOLOGY
NONCLINICAL TOXICOLOGY
HOW SUPPLIED
*
FULL PRESCRIBING INFORMATION
INDICATIONS AND USAGE
Atropine Sulfate Injection, USP, is indicated for temporary blockade
of severe or life
threatening muscarinic