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:

American Regent, Inc.

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. Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations). Available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) .  Animal reproduction studies have not been conducted with atropine. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. Life-sustai

Product summary:

Atropine Sulfate Injection, USP 0.4 and 1 mg/mL are supplied in 1 mL, single-dose glass vials as follows: Table 2: How Supplied Concentration  (mg/mL) NDC # 0.4 mg/mL 25 Vials 0517-1004-25 1 mg/mL 25 Vials 0517-1001-25 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature .]                                                                                        IN1004 Rev. 9/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
AMERICAN REGENT, 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, 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)
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 to
1 mg. (2.2)
Antidote for organophosphorus or muscarinic mushroom poisoning:
Initial single dose of 2 to 3 mg,
repeated every 20 to 30 minutes. (2.2)
Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3 to 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
Injection: 0.4 or 1 mg/mL as a clear, colorless solution in a
single-dose vial. (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 AMERICAN REGENT, INC.
AT 1-800-734-
9236, OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
_Mexiletine:_ Decreases rate of mexiletine absorption. (7.1)
REVISED: 9/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATI