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:

REMEDYREPACK INC.

INN (International Name):

ATROPINE SULFATE

Composition:

ATROPINE SULFATE 0.1 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
REMEDYREPACK 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
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: 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: 11/2017
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