ATROPINE SULFATE injection

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:

ENDOTRACHEAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia. None. 8.1 Pregnancy Risk Summary The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 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 due to potential concerns regarding the effects of atropine on the fetus. Data Human Data 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. The lack of clinical data during lactation precludes a clear determination of the risk of atropine to an infant during lactation. 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. 8.5 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 a non-pyrogenic, isotonic, clear solution and is supplied as follows: NDC 51662-1619-1 ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL NDC 51662-1619-2 ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL in a POUCH NDC 51662-1619-3 ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL in a POUCH, 10 POUCHES in a CASE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. After initial use, store between 20° to 25°C (68° to 77°F) and discard within 24 hours. 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
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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ATROPINE SULFATE INJECTION, USP 8MG/20ML (0.4MG/ML)
HIGHLIGHTS OF PRESCRIBING INFORMATION
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,
intraosseous 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
Dosage is individualized by use, refer to the full prescribing
information for
recommended adult and pediatric dosages ( 2.2, 2.3).
Patients with Ischemic Heart Disease: Do not exceed 0.04 mg/kg. (
2.4,5.2)
DOSAGE FORMS AND STRENGTHS
Injection: 8 mg per 20 mL (0.4 mg per mL) multiple dose glass vial (
3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Hypersensitivity ( 5.1)
Worsening of Ischemic Heart Disease ( 5.2)
Acute Glaucoma ( 5.3)
Pyloric obstruction ( 5.4)
Complete urinary retention ( 5.5)
Viscid plugs ( 5.6)
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 Hikma Pharmaceuticals
USA Inc.
at 1-877-845-0689 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Mexiletine: Decreases rate of mexiletine absorption. ( 7.1)
Revised: 12/2021
TABLE OF CONTENTS
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Administration
2.2 Adult Dosage
2.3 Pediatric Dosage
2.4 Dosing in Patients with Ischemic Heart Disease
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2