"By Megan Brooks
Medscape Medical News
The US Food and Drug Administration (FDA) will require makers of prescription testosterone products to clarify the approved uses of these medications on the product label and add information"...
ATROPINE SULFATE Injection, USP
0.1 mg/mI (Adult)
0.05 mg/mL (Pediatric)
ABBOJECT® Unit of Use Syringe
Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by subcutaneous, intramuscular or intravenous injection.
Each milliliter (mL) contains atropine sulfate, monohydrate 0.1 mg (adult strength) or 0.05 mg (pediatric strength), and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 4.2 (3.0 to 6.5).
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded.
Atropine Sulfate Injection is a parenteral anticholinergic agent and muscarinic antagonist.
Atropine Sulfate, USP is chemically designated 1a H, 5a H-Tropan-3-a ol (±)-tropate(ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 • H2SO4 • H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula:
Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug.
Sodium Chloride, USP is chemically designated NaCI, a white crystalline powder freely soluble in water.
The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.
Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Atropine Information
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