ATROPINE SULFATE- atropine sulfate injection injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Medefil, Inc.

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. 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

Produktbesonderheiten:

Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows: 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

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