Nafcillin

Nafcillin Sodium


Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-328
Nafcillin also known as Nafcillin Sodium is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Nafcillin is 63323-328. This drug is available in dosage form of Injection, Powder, Lyophilized, For Solution. The names of the active, medicinal ingredients in Nafcillin drug includes Nafcillin Sodium - 2 g/8mL . The currest status of Nafcillin drug is Active.

Drug Information:

Drug NDC: 63323-328
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Nafcillin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Nafcillin Sodium
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Fresenius Kabi Usa, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Powder, Lyophilized, For Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:NAFCILLIN SODIUM - 2 g/8mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAMUSCULAR
INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 30 Jun, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA090002
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Fresenius Kabi USA, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1721458
1721460
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:49G3001BCK
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Penicillin-class Antibacterial [EPC]
Penicillins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63323-328-2010 VIAL in 1 CARTON (63323-328-20) / 8 mL in 1 VIAL (63323-328-21)30 Jun, 2011N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Nafcillin nafcillin sodium sodium citrate nafcillin sodium nafcillin nafcillin nafcillin sodium sodium citrate nafcillin sodium nafcillin

Indications and Usage:

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 testing ). nafcillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to a methicillin-resistant staphylococcus sp., therapy with nafcillin for injection should be discontinued and alternative therapy provided. 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 susceptible bacteria. when culture and susceptibility information a
re available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Warnings:

Warnings: serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. these reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. before initiating therapy with nafcillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. if an allergic reaction occurs, nafcillin should be discontinued and appropriate therapy instituted. clostridium difficile associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including nafcillin for injection, and may range in severity from mild diarrhea to fatal colitis. treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of c. difficile . c. difficile produces toxins a and b which contribute to the development of cdad. hypertoxin producing strains
of c. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. cdad must be considered in all patients who present with diarrhea following antibiotic use. careful medical history is necessary since cdad has been reported to occur over two months after the administration of antibacterial agents. if cdad is suspected or confirmed, ongoing antibiotic use not directed against c. difficile may need to be discontinued. appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of c. difficile , and surgical evaluation should be instituted as clinically indicated.

Dosage and Administration:

Dosage and administration: nafcillin for injection is available for intramuscular and 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. recommended dosage for nafcillin for injection, usp drug adults infants and children <40 kg (88 lbs) other recommendations nafcillin 500 mg im every 4 to 6 hours. iv every 4 hours 25 mg/kg im twice daily neonates 10 mg/kg im twice daily nafcillin 1 gram im or iv every 4 hours (severe infections) 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, th
erapy with nafcillin should be continued for at least 14 days. the treatment of endocarditis and osteomyelitis may require a longer duration of therapy. no dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. hemodialysis does not accelerate nafcillin clearance from the blood. with intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. do not add supplementary medication to nafcillin for injection, usp.

Contraindications:

Contraindications: a history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

Adverse Reactions:

Adverse reactions: body as a whole the reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent (see warnings ). sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin when first treated. in such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk or vaccines. two types of allergic reactions to penicillins are noted clinically, immediate and delayed. immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioedema, laryngospasm, bronchospasm, hypotension, vascular collapse, and death. such immediate anaphylactic reactions are very rare (see warnings ) and usually occur after parenteral therapy but have occurred in patients receiving oral therapy. another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and
may include urticaria, pruritus, and fever. although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon. delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as 2 to 4 weeks after initiation of therapy. manifestations of this type of reaction include serum sickness-like symptoms (i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy. local reactions pain, swelling, inflammation, phlebitis, thrombophlebitis, and occasional skin sloughing at the injection site have occurred with intravenous administration of nafcillin (see dosage and administration ). severe tissue necrosis with sloughing secondary to subcutaneous extravasation of nafcillin has been reported. nervous system reactions neurotoxic reactions similar to those observed with penicillin g could occur with large intravenous doses of nafcillin especially in patients with concomitant hepatic insufficiency and renal dysfunction (see precautions ). nephrotoxicity renal tubular damage and interstitial nephritis have been associated with the administration of nafcillin. manifestations of nephrotoxicity are hematuria, proteinuria, and acute kidney injury, and may be associated with rash, fever, and eosinophilia. the majority of cases resolve upon discontinuation of nafcillin. some patients, however, may require dialysis treatment and may develop permanent renal damage. hepatic reactions elevation of liver transaminases and/or cholestasis may occur, especially with administration of high doses of nafcillin. gastrointestinal reactions pseudomembranous colitis has been reported with the use of nafcillin. the onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see warnings ). metabolic reactions agranulocytosis, neutropenia, and bone marrow depression have been associated with the use of nafcillin. to report suspected adverse events, contact fda at 1-800-fda-1088 or www.fda.gov .

Nervous system reactions neurotoxic reactions similar to those observed with penicillin g could occur with large intravenous doses of nafcillin especially in patients with concomitant hepatic insufficiency and renal dysfunction (see precautions ).

Nephrotoxicity renal tubular damage and interstitial nephritis have been associated with the administration of nafcillin. manifestations of nephrotoxicity are hematuria, proteinuria, and acute kidney injury, and may be associated with rash, fever, and eosinophilia. the majority of cases resolve upon discontinuation of nafcillin. some patients, however, may require dialysis treatment and may develop permanent renal damage.

Hepatic reactions elevation of liver transaminases and/or cholestasis may occur, especially with administration of high doses of nafcillin.

Gastrointestinal reactions pseudomembranous colitis has been reported with the use of nafcillin. the onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see warnings ).

Metabolic reactions agranulocytosis, neutropenia, and bone marrow depression have been associated with the use of nafcillin. to report suspected adverse events, contact fda at 1-800-fda-1088 or www.fda.gov .

Overdosage:

Overdosage neurotoxic reactions similar to those observed with penicillin g may arise with intravenous doses of nafcillin especially in patients with concomitant hepatic insufficiency and renal dysfunction (see precautions ). in the case of overdosage, discontinue nafcillin, treat symptomatically and institute supportive measures as required. hemodialysis does not increase the rate of clearance of nafcillin from the blood.

Description:

Description: nafcillin for injection, usp is a semisynthetic antibiotic penicillin derived from the penicillin nucleus, 6-aminopenicillanic acid. it is the sodium salt in a parenteral dosage form. the chemical name is 4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[(2-ethoxy-1-naphthalenyl)carbonyl]amino]-3,3-dimethyl-7-oxo-monosodium salt, monohydrate [2s(2α,5α,6β)]. it is resistant to inactivation by the enzyme penicillinase (beta-lactamase). the structural formula of nafcillin sodium is as follows: c 21 h 21 n 2 nao 5 s•h 2 o m.w. 454.47 nafcillin for injection, usp, for intramuscular or the intravenous route of administration, containing nafcillin sodium as a white crystalline powder for reconstitution. it is soluble in water. the ph of the aqueous solution is 6.0 to 8.5. nafcillin for injection, usp contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial. the sodium content is 65.8 mg [2.9 meq] per gram of nafcillin. the product is buffered with 40 mg sodium citrate per gram. structure

Clinical Pharmacology:

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. the serum half-life of nafcillin administered by the intravenous route ranged from 33 to 61 minutes as measured in three separate studies. in contrast to the other penicillinase-resistant penicillins, only about 30% of nafcillin is excreted as unchanged drug in the urine of normal volunteers, and most within the first six hours. nafcillin is primarily eliminated by nonrenal routes, namely hepatic inactivation and excretion in the bile. nafcillin binds to serum proteins, mainly albumin. the degree of protein binding reported for nafcillin is 89.9 ± 1.5%. reported values vary with the method of study and the investigat
or. the concurrent administration of probenecid with nafcillin increases and prolongs plasma concentrations of nafcillin. probenecid significantly reduces the total body clearance of nafcillin with renal clearance being decreased to a greater extent than nonrenal clearance. the penicillinase-resistant penicillins are widely distributed in various body fluids, including bile, pleural, amniotic and synovial fluids. with normal doses insignificant concentrations are found in the aqueous humor of the eye. high nafcillin csf levels have been obtained in the presence of inflamed meninges. renal failure does not appreciably affect the serum half-life of nafcillin; therefore, no modification of the usual nafcillin dosage is necessary in renal failure with or without hemodialysis. hemodialysis does not accelerate the rate of clearance of nafcillin from the blood. a study which assessed the effects of cirrhosis and extrahepatic biliary obstruction in man demonstrated that the plasma clearance of nafcillin was significantly decreased in patients with hepatic dysfunction. in these patients with cirrhosis and extrahepatic obstruction, nafcillin excretion in the urine was significantly increased from about 30 to 50% of the administered dose, suggesting that renal disease superimposed on hepatic disease could further decrease nafcillin clearance. pharmacokinetics intramuscular injections of nafcillin sodium, usp 1 gram produced peak serum levels in 0.5 to 1 hour of 7.61 mcg/ml. the degree of protein binding reported has been 89.9 +/-1.5%. with normal doses nafcillin is found in therapeutic concentrations in the pleural, bile, and amniotic fluids. insignificant concentrations are found in the cerebrospinal fluid and aqueous humor. blood concentrations may be tripled by the concurrent use of probenecid. clinical studies with nafcillin sodium in infants under three days of age and prematures have revealed higher blood levels and slower rates of urinary excretion than in older children and adults. a high concentration of nafcillin sodium is excreted via the bile. about 30% of an intramuscular dose is excreted in the urine. 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 (methicillin susceptible isolates only) susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.

Pharmacokinetics intramuscular injections of nafcillin sodium, usp 1 gram produced peak serum levels in 0.5 to 1 hour of 7.61 mcg/ml. the degree of protein binding reported has been 89.9 +/-1.5%. with normal doses nafcillin is found in therapeutic concentrations in the pleural, bile, and amniotic fluids. insignificant concentrations are found in the cerebrospinal fluid and aqueous humor. blood concentrations may be tripled by the concurrent use of probenecid. clinical studies with nafcillin sodium in infants under three days of age and prematures have revealed higher blood levels and slower rates of urinary excretion than in older children and adults. a high concentration of nafcillin sodium is excreted via the bile. about 30% of an intramuscular dose is excreted in the urine.

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 (methicillin susceptible isolates only) susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.

How Supplied:

How supplied: nafcillin for injection, usp contains nafcillin sodium equivalent to 1 gram or 2 grams of nafcillin and is supplied as follows: product code unit of sale strength each 302710 ndc 63323-327-10 unit of 10 1 gram per vial ndc 63323-327-21 302820 ndc 63323-328-20 unit of 10 2 grams per vial ndc 63323-328-21 the container closure is not made with natural rubber latex.

Package Label Principal Display Panel:

[package label.principal display panel] package label - principal display - nafcillin 1 gram vial label ndc 63323-327-21 nafcillin for injection, usp 1 gram per vial buffered - for iv or im use. each vial contains nafcillin sodium, as the monohydrate equivalent to 1 gram of nafcillin. rx only package label - principal display - nafcillin 1 gram vial carton panel ndc 63323-327-10 nafcillin for injection, usp 1 gram per vial buffered - for intravenous or intramuscular use. 10 x 1 gram vials package label - principal display - nafcillin 2 grams vial label ndc 63323-328-21 nafcillin for injection, usp 2 grams per vial buffered - for iv or im use. each vial contains nafcillin sodium, as the monohydrate equivalent to 2 grams of nafcillin. rx only package label - principal display - nafcillin 2 grams carton label panel ndc 63323-328-20 nafcillin for injection, usp 2 grams per vial buffered - for intravenous or intramuscular use. 10 x 2 grams vials vial carton vial carton


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