Dicloxacillin Sodium


Redpharm Drug, Inc.
Human Prescription Drug
NDC 67296-1205
Dicloxacillin Sodium is a human prescription drug labeled by 'Redpharm Drug, Inc.'. National Drug Code (NDC) number for Dicloxacillin Sodium is 67296-1205. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Dicloxacillin Sodium drug includes Dicloxacillin Sodium - 500 mg/1 . The currest status of Dicloxacillin Sodium drug is Active.

Drug Information:

Drug NDC: 67296-1205
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: Dicloxacillin Sodium
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: Dicloxacillin Sodium
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Redpharm Drug, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Capsule
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:DICLOXACILLIN SODIUM - 500 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 01 Apr, 1971
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 26 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: ANDA061454
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:RedPharm Drug, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:197596
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.
UPC:0367296120547
UPC stands for Universal Product Code.
UNII:4HZT2V9KX0
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
67296-1205-440 CAPSULE in 1 BOTTLE (67296-1205-4)01 Apr, 1971N/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:

Dicloxacillin sodium dicloxacillin sodium dicloxacillin sodium dicloxacillin ammonia ferrosoferric oxide gelatin magnesium stearate potassium hydroxide titanium dioxide fd&c blue no. 1 propylene glycol shellac light blue gg855

Indications and Usage:

Indications and usage the penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see clinical pharmacology – susceptibility testing). the penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. the penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin
sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules 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 are 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 shock with collapse) reactions have occurred in patients receiving penicillin. the incidence of anaphylactic shock in all penicillin-treated patients is between 0.015 and 0.04 percent. anaphylactic shock resulting in death has occurred in approximately 0.002 percent of the patients treated. although anaphylaxis is more frequent following a parenteral administration, it has occurred in patients receiving oral penicillins. when penicillin therapy is indicated, it should be initiated only after a comprehensive patient drug and allergy history has been obtained. if an allergic reaction occurs, dicloxacillin should be discontinued and appropriate therapy instituted. individuals with a history of penicillin hypersensitivity may also experience allergic reactions when treated with a cephalosporin. clostridium difficile associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including diclo
xacillin sodium, 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 concurrent administration of the penicillinase-resistant penicillins and probenecid increases and prolongs serum penicillin levels. probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary. oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see precautions – general). oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a pa recommended dosages for dicloxacillin sodium, usp in mild to moderate and severe infections drug adults children mild to moderate severe mild to moderate severe * patients weighing less than 40 kg (88 lbs.) dicloxacillin 125 mg every 6 hours 250 mg every 6 hours 12.5 mg/kg/ d
ay* in equally divided doses every 6 hours 25 mg/kg/ day* in equally divided doses every 6 hours dicloxacillin is best absorbed when taken on an empty stomach, and should be administered at least 1 hour before or 2 hours after meals. dicloxacillin should be taken with at least 4 fluid ounces (120 ml) of water and should not be taken in the supine position or immediately before going to bed (see precautions). renteral agent as soon as the clinical condition warrants.

Contraindications:

Contraindications dicloxacillin sodium is contraindicated in persons who have shown hypersensitivity to any of the penicillins or any component of the formulations.

Adverse Reactions:

Adverse reactions hypersensitive reactions 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 and vaccines. two types of allergic reactions to penicillin are noted clinically, immediate and delayed. immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioneurotic edema, 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 admin
istration 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 (ie, fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. gastrointestinal reactions nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy. pseudomembranous colitis has been reported with the use of dicloxacillin. therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with dicloxacillin use. reports have been received during postmarketing surveillance of esophageal burning, esophagitis, and esophageal ulceration, particularly after ingestion of dicloxacillin capsules with an insufficient quantity of water and/or before going to bed (see precautions and dosage and administration). nervous system reactions neurotoxic reactions similar to those observed with penicillin g (e.g., lethargy, confusion, twitching, multifocal myoclonus, localized or generalized epileptiform seizures) may occur with large intravenous doses of the penicillinase-resistant penicillins especially in patients with renal insufficiency. renal reactions renal tubular damage and interstitial nephritis have been associated with the administration of methicillin sodium and infrequently with the administration of nafcillin and oxacillin. manifestations of this reaction may include rash, fever, eosinophilia, hematuria, proteinuria, and renal insufficiency. methicillin-induced nephropathy does not appear to be dose-related and is generally reversible upon prompt discontinuation of therapy. hematologic reactions eosinophilia, hemolytic anemia, agranulocytosis, neutropenia, leukopenia, granulocytopenia, thrombocytopenia, and bone marrow depression have been associated with the use of penicillinase-resistant penicillins. hepatic reactions hepatotoxicity, characterized by fever, nausea, and vomiting associated with abnormal liver function tests, mainly elevated ast (sgot) levels, has been associated with the use of oxacillin and cloxacillin. cholestatic hepatitis has been reported rarely. asymptomatic, transient increases in serum concentrations of alkaline phosphatase, ast (sgot), and alt (sgpt) have been reported.

Description:

Description dicloxacillin sodium, usp is an antibacterial agent of the isoxazolyl penicillin series. it is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration. dicloxacillin sodium, usp is chemically designated as 4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-, monosodium salt, monohydrate, [2s-(2α5α,6β)] and has the following structural formula: [dicloxacillin sodium chemical structure] each capsule for oral administration contains dicloxacillin sodium, usp equivalent to 250 or 500 mg of dicloxacillin. the inactive ingredient is magnesium stearate. the capsule shells contain fd&c blue 1, titanium dioxide, and gelatin. the capsule ink contains shellac, propylene glycol, black iron oxide, ammonium hydroxide and potassium hydroxide

Clinical Pharmacology:

Clinical pharmacology 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. dicloxacillin sodium has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the indications and usage section. aerobic gram-positive microorganisms: staphylococcus spp. susceptibility testing: susceptibility of staphylococcal isolates to dicloxacillin may be inferred by testing penicillin and either oxacillin or cefoxitin1. for staphylococcal isolates, penicillin susceptibility implies susceptibility to other β-lactam agents, and penicillin resistance implies resistance to penicillinase-labile penicillins. resistance to oxacillin (or cefoxitin) implies resistance to all other β-lactam agents, except newer agents with activity against methicilli
n-resistant staphylococcus aureus. routine testing of dicloxacillin is not advised. pharmacokinetics dicloxacillin sodium, usp is resistant to destruction by acid. absorption of dicloxacillin sodium after oral administration is rapid but incomplete. food in the gastrointestinal tract decreases the absorption of dicloxacillin. studies with an oral dose of 125 mg gave average serum levels at 60 minutes of 4.74 mcg/ml. at four hours, average levels were 0.62 mcg/ml. in one study, single oral doses of dicloxacillin sodium 500 mg produced peak serum concentrations of 10 to 17 mcg/ml at 1 to 1.5 hours. once absorbed, dicloxacillin sodium is 95% to 99% bound to serum proteins, mainly albumin. dicloxacillin sodium, with normal doses, has insignificant concentrations in the cerebrospinal and ascitic fluids. it is found in therapeutic concentrations in the pleural, bile, and amniotic fluids. dicloxacillin sodium is rapidly excreted as unchanged drug in the urine by glomerular filtration and active tubular secretion. the elimination half-life for dicloxacillin sodium is about 0.7 hours. dicloxacillin is not dialyzable. only minimal amounts are removed by hemodialysis or peritoneal dialysis.

How Supplied:

How supplied dicloxacillin sodium capsules, usp 250 mg light blue opaque cap/body capsule printed with gg854 containing dicloxacillin sodium, usp equivalent to 250 mg dicloxacillin. bottle of 100 capsules ndc 0781-2248-01 500 mg light blue opaque cap/body capsule printed with gg855 containing dicloxacillin sodium, usp equivalent to 500 mg dicloxacillin. bottle of 100 capsules ndc 0781-2258-01 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature].

Package Label Principal Display Panel:

500 mg label dicloxacillin 500mg


Comments/ Reviews:

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