Atropine Sulfate .4 mg/mL
Atropine Sulfate monohydrate · SOLUTION · Medical Purchasing Solutions, LLC
Atropine Sulfate is a solution containing atropine sulfate monohydrate at .4 mg/mL, taken endotracheal. Manufactured by Medical Purchasing Solutions, LLC.
Key Facts
- Brand Name
- Atropine Sulfate
- Generic Name
- Atropine Sulfate monohydrate
- NDC Code (Product)
71872-7355- Manufacturer
- Medical Purchasing Solutions, LLC
- Strength
- .4 mg/mL
- Dosage Form
- SOLUTION
- Route
- ENDOTRACHEAL, INTRAMEDULLARY, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA215005
- Marketing Start
- 12/09/2024
Recall History
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Physicians Total Care, Inc.
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Martin Avenue Pharmacy, Inc.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Martin Avenue Pharmacy, Inc.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE 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.
Dosage & Administration
2 DOSAGE & ADMINISTRATION 2.1 General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Each vial is intended for single dose only. Discard unused portion. For Intravenous administration. Titrate based on heart rate, PR interval, blood pressure and symptoms. 2.2 Adult Dosage 2.3 Pediatric Dosage Dosing in pediatric populations has not been well studied. Usual initial dose is 0.01 to 0.03 mg/kg. 2.4 Dosing in Patients with Coronary Artery Disease Limit the total dose of atropine sulfate to 0.03 to 0.04 mg/kg [see WARNINGS AND PRECAUTIONS (5.1 )]. DOSAGE
Contraindications
4 CONTRAINDICATIONS None.
Drug Interactions
7 DRUG INTERACTIONS 7.1 Mexiletine 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.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation.
Frequently Asked Questions
What is Atropine Sulfate used for?
Atropine Sulfate contains Atropine Sulfate monohydrate. It is a solution taken endotracheal. Consult your doctor for specific uses.
Is Atropine Sulfate a controlled substance?
Atropine Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Atropine Sulfate?
The generic name for Atropine Sulfate is Atropine Sulfate monohydrate. There are no other listed brand versions of Atropine Sulfate monohydrate.
What is the NDC code for Atropine Sulfate .4 mg/mL?
The NDC (National Drug Code) for Atropine Sulfate .4 mg/mL is 71872-7355, listed by Medical Purchasing Solutions, LLC.
Other Atropine Sulfate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)