FDA
Atropine Sulfate
The FDA lists this product in 32 strengths and forms.
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. 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
Contraindications
None.
Warnings and precautions
5.1Tachycardia When
the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand.
5.2Acute Glaucoma
Atropine may precipitate acute glaucoma.
5.3Pyloric Obstruction
Atropine may convert partial organic pyloric stenosis into complete obstruction.
5.4Complete Urinary Retention
Atropine may lead to complete urinary retention in patients with prostatic hypertrophy.
5.5Viscid Plugs
Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.
Interactions
7.1Mexiletine Atropine Sulfate
Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.
At a glance
- Brand name
- Atropine Sulfate
- Route
- Intravenous
- Dosage form
- Solution
- Applicant
- Medefil Inc
- Status
- Prescription
- FDA approval
- 4 Nov 2022
- Application
- ANDA214970-001



