ATROPINE SULFATE- atropine sulfate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Atropine Sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I)

Available from:

General Injectables & Vaccines, Inc.

INN (International Name):

Atropine Sulfate

Composition:

Atropine Sulfate .05 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Atropine Sulfate Injection, USP is supplied in single-dose containers as follows: 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.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1041-3.0

Authorization status:

New Drug Application

Summary of Product characteristics

ATROPINE SULFATE - ATROPINE SULFATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
PEDIATRIC ATROPINE SULFATE, INJECTION USP 0.25MG/5ML
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) (2)
DOSAGE AND ADMINISTRATION
For intravenous administration, but may also be administered via
subcutaneous, intramuscular or via
an endotracheal tube (2.1, 2.3).
Titrate according to heart rate, PR interval, blood pressure and
symptoms. (2.1)
Adult dosage
Antisialagogue or for antivagal effects: Initial single dose of 0.5 mg
to 1 mg (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)
Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3-5 minutes
if asystole persists. (2.2)
Patients with Coronary Artery Disease: Limit the total dose to 0.03
mg/kg to 0.04 mg/kg. (2.4)
DOSAGE FORMS AND STRENGTHS
0.05 mg/mL injection in Ansyr
 Plastic Syringe (3)
0.1 mg/mL injection in Ansyr
 Plastic Syring (3)
CONTRAINDICATIONS
None. (5)
WARNINGS AND PRECAUTIONS
Tachycardia (5.1) (6)
Glaucoma (5.2) (6)
Pyloric obstruction (5.3) (6)
Worsening urinary retention (5.4) (6)
Vascid bronchial plugs (5.5) (6)
ADVERSE REACTIONS
Most adverse reactions are directly related to atopine's
antimuscarinic action. Dryness of the mouth,
blurred vision, photophobia and tachycardia commonly occur with
chronic administreation of therepeutic
doses. (6) (7)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HOSPIRA, INC. AT
1-800-441-4100, OR FDA
AT 1-800-FDA-1088 OR
_WWW.FDA.GOV/MEDWA