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:

HF Acquisition Co LLC, DBA HealthFirst

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. 8.1 Pregnancy 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-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus. Data Human Data Atropine crosses the placenta [see Clinical Pharmacology (12.3)]. No adequate and well-controlled studies are available regarding use of atropine in pregnant women. In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformation. In a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. No specific pattern of major birth defects was identified. In another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. Methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug associated risk during pregnancy. 8.2 Lactation Risk Summary Trace amounts of atropine have been reported in human milk after oral intake. There are no available data on atropine levels in human milk after intravenous injection, the effects on the breastfed infant, or the effects on milk production. Clinical Considerations Minimizing exposure The elimination half-life of atropine is more than doubled in children less than 2 years of age [SEE CLINICAL PHARMACOLOGY (12.3)]. To minimize potential infant exposure to Atropine Sulfate Injection, a woman may pump and discard her milk for 24 hours after use before resuming to breastfeed her infant. 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 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 0.4 and 1 mg/mL is supplied in 1 mL, single-dose glass vial NDC 51662-1627-1 ATROPINE SULFATE INJECTION USP 0.4mg/mL 1mL VIAL 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.] HF Acquisition Co LLC, DBA HealthFirst 11629 49th PL W. Mukilteo, WA 98275

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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ATROPINE SULFATE INJECTION USP 0.4MG/ML
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.)
Titrate according to heart rate, PR interval, blood pressure and
symptoms. ( 2)
Adult dosage
Antisialagogue or for antivagal effects: Initial single dose of 0.5 to
1 mg. ( 2)
Antidote for organophosphorus or muscarinic mushroom poisoning:
Initial single dose
of 2 to 3 mg, repeated every 20 to 30 minutes. ( 2)
Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3 to 5
minutes if asystole
persists. ( 2)
Patients with Coronary Artery Disease: Limit the total dose to 0.03
mg/kg to 0.04 mg/kg.
( 2)
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)
Glaucoma ( 5)
Pyloric obstruction ( 5)
Worsening urinary retention ( 5)
Viscid bronchial plugs ( 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)
Revised: 9/2021
TABLE OF CONTENTS
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Administration
2.2 Adult