ATROPINE SULFATE injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

HF Acquisition Co., LLC, DBA Health First

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Atropine Sulfate Injection, USP, 0.1 mg/mL, is a clear and colorless solution available in 5 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: NDC 51662-1208-1 ATROPINE SULFATE INJECTION, USP 0.5mg/5mL (0.1mg/mL) 5mL SYR NDC 51662-1208-2 ATROPINE SULFATE INJECTION, USP 0.5mg/5mL (0.1mg/mL) 5mL SYR, 1 SYRINGE PER POUCH NDC 51662-1208-3 ATROPINE SULFATE INJECTION, USP 0.5mg/5mL (0.1mg/mL) 5mL SYR, 1 SYRINGE PER POUCH, 10 POUCHES PER CASE 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.]

Berechtigungsstatus:

unapproved drug other

Fachinformation

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._
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ATROPINE SULFATE INJECTION, USP 0.5MG (0.1 MG/ML) SYR, 5ML
FULL PRESCRIBING INFORMATION: CONTENTS*
1 Indications and Usage
2 Dosage and Administration
2.1 General Administration
2.2 Adult Dosage
2.3 Pediatric Dosage
3 Dosage Forms and Strengths
4 Contraindications
5 Warnings and Precautions5 WARNINGS AND PRECAUTIONS
5.1 Tachycardia
5.2 Acute Glaucoma
5.3 Pyloric Obstruction
5.4 Complete Urinary Retention
5.5 Viscid Plugs
6 Adverse Reactions
7 Drug Interactions
7.1 Mexiletine
8 Use in Specific Populations
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 Overdosage
11 Description
12 Clinical Pharmacology
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 Non Clinical Toxicology
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 How Supplied/Storage and Handeling
*
Sections or subsections omitted from the full prescribing information
are not listed.
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