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 Health First

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 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. 8.3 Nursing Mothers Trace amounts of atropine was found in breast milk. The clinical impact of this is not known. 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 is supplied in the following dosage forms. NDC 51662-1207-1 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) SYR NDC 51662-1207-2 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) SYR, 1 SYR PER POUCH NDC 51662-1207-3 ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) SYR, 1 SYR PER POUCH, 10 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 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. 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:

unapproved drug other

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE INJECTION, SOLUTION
HF ACQUISITION CO. LLC, DBA HEALTH FIRST
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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ATROPINE SULFATE INJECTION, USP 1MG (0.1MG/ML) SYR, 10ML
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. ( 2-2.1, 2-2.3)
Titrate according to heart rate, PR interval, blood pressure and
symptoms. ( 2-2.1)
Adult dosage
-
Antisialagogue or for antivagal effects: Initial single dose of 0.5 mg
to 1 mg. ( 2-2.2)
-
Antidote for organophosphorus or muscarinic mushroom poisoning:
Initial single dose
of 2 mg to 3 mg, repeated every 20–30 minutes. ( 2-2.2)
-
Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3–5 minutes
if asystole
persists. ( 2-2.2)
Patients with Coronary Artery Disease: Total dose should not exceed
0.03 mg/kg to 0.04
mg/kg. ( 5-5.1)
DOSAGE FORMS AND STRENGTHS
0.1 mg/mL injection in LifeShield™ Abboject™ Glass Syringe ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Tachycardia ( 5-5.1)
Glaucoma ( 5-5.2)
Pyloric obstruction ( 5-5.3)
Worsening urinary retention ( 5-5.4)
Viscid bronchial plugs ( 5-5.5)
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/