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:

Hospira, Inc.

INN (International Name):

ATROPINE SULFATE

Composition:

ATROPINE SULFATE 0.1 mg in 1 mL

Administration route:

INTRAVENOUS

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. 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. Trace amounts of atropine was found in breast milk. The clinical impact of this is not known. Recommendations for use in pediatric patients are not based on clinical trials. 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 disea

Product summary:

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.]

Authorization status:

New Drug Application

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
HOSPIRA, INC.
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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. (2.1, 2.3)
Titrate according to heart rate, PR interval, blood pressure and
symptoms. (2.1)
Adult dosage
-
-
-
Patients with Coronary Artery Disease: Total dose should not exceed
0.03 mg/kg to 0.04 mg/kg. (5.1)
DOSAGE FORMS AND STRENGTHS
0.1 mg/mL injection in LifeShield™ Abboject™ Glass Syringe (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Tachycardia (5.1)
Glaucoma (5.2)
Pyloric obstruction (5.3)
Worsening urinary retention (5.4)
Viscid bronchial plugs (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/MEDWATCH_.
DRUG INTERACTIONS
_Mexiletine:_ Decreases rate of mexiletine absorption. (7.1)
REVISED: 3/2018
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
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.