"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
in PL 2040 Plastic Container
For Intravenous Use
GALAXY Container (PL 2040 Plastic)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin Injection, USP and other antibacterial drugs, Nafcillin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Nafcillin Injection, USP is a sterile injectable product containing nafcillin which is added as Nafcillin Sodium, USP, a semisynthetic penicillin derived from the penicillin nucleus, 6aminopenicillanic acid. The chemical name of nafcillin sodium is Monosodium (2S,5R,6R)-6-(2ethoxy-1-naphthamido)-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The molecular formula of Nafcillin Sodium, USP is C21H21N2NaO5S•H2O. The molecular weight is 454.48. The structural formula of nafcillin sodium is as follows:
Nafcillin Injection, USP is a frozen, iso-osmotic, sterile, nonpyrogenic premixed 50 mL or 100 mL solution containing 1 g or 2 g of nafcillin, respectively, added as Nafcillin Sodium, USP. Dextrose, USP has been added to the above dosages to adjust osmolality (approximately 1.8 g and 3.6 g as dextrose hydrous to the 1 g and 2 g dosages, respectively). Sodium Citrate Hydrous, USP has been added as a buffer (approximately 90 mg and 180 mg to the 1 g and 2 g dosages, respectively). The pH has been adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. The pH is 6.5 (6.0 to 8.5). The solution is intended for intravenous use after thawing to room temperature.
This GALAXY container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
What are the possible side effects of nafcillin (Nallpen, Unipen)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives, itching; fever, stomach pain, muscle or joint pain; difficulty breathing; swelling of your face, lips, tongue, or throat. A delayed allergic reaction to nafcillin can occur as few as 2 days to as many as 4 weeks after you use the medication.
Call your doctor at once if you have any of these serious side effects:
- diarrhea that is watery or bloody;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- skin rash, bruising, severe tingling,...
Last reviewed on RxList: 11/18/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Nafcillin Injection Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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