Rx Item-Nafcillin 1Gm/50Ml Frozen Piggy Back24X50Ml By Baxter Pharma Af

NAFCILLIN- nafcillin sodium injection, powder, for solution
Sagent Pharmaceuticals

SAGENT�

Rx only

PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs, Nafcillin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION
Nafcillin for Injection, USP is a semisynthetic antibiotic substance derived from 6-amino-penicillanic acid. It is the sodium salt in a parenteral dosage form. The chemical name of nafcillin sodium is monosodium (2S, 5R, 6R)-6-(2-ethoxy-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). Nafcillin for Injection, USP is a white to yellowish white powder filled in clear glass bottle. Dilute solutions are essentially clear and colorless.

Nafcillin for Injection, USP is supplied in 10 gram Pharmacy Bulk Package bottles. Each Pharmacy Bulk Package contains nafcillin sodium as the monohydrate equivalent to 10 grams of nafcillin. Sodium citrate is added to optimize pH. The sodium content is not more than 66.2 mg [2.9 mEq] per gram of nafcillin.

A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.

CLINICAL PHARMACOLOGY

In a study of five healthy adults administered a single 500 mg dose of nafcillin by intravenous injection over seven minutes, the mean plasma concentration of the drug was approximately 30 mcg/mL at 5 minutes after injection. The mean area under the plasma concentration-versus-time curve (AUC) for nafcillin in this study was 18.06 mcg�h/mL. MICROBIOLOGY

Penicillinase-resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall.

Nafcillin sodium has been shown to be active against most isolates of the following microorganism, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-Positive Bacteria Staphylococcus aureus. INDICATIONS AND USAGE

Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (See CLINICAL PHARMACOLOGY � Susceptibility Test Methods).DOSAGE AND ADMINISTRATION

The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.

Nafcillin for Injection is available for intravenous use.

The usual IV dosage for adults is 500 mg every 4 hours. For severe infections, 1 gram every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation.

Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

Nafcillin-probenecid therapy is generally limited to those infections where very high serum levels of nafcillin are necessary.

Nafcillin 1Gm/50Ml Frozen Piggy Back24X5
BRAND: NAFCIL NDC: 00338-1017-41,338101741 UPC: 3-03381-01741-5,303381017415 NDC 00338-1017-41 UPC/GTIN No.3-03381-01741-5 Mfg.Part No.00338-1017-41

RX ITEM-Nafcillin 1Gm/50Ml Frozen Piggy
Baxter Product Code: 2G3540 UPN/GTIN CS Unit: 50303381017410 UPN/GTIN EA Unit: 00303381017415 National Drug Code: 0338101741 SKU: 2G3540 Nafcillin Injection, USP, 1 gram

NAFCILLIN IN DEXTROSE,ISO
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