NDC 23594-125 Cefaclor

Cefaclor

NDC Product Code 23594-125

NDC CODE: 23594-125

Proprietary Name: Cefaclor What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cefaclor What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine and respiratory tract infections). It works by stopping the growth of bacteria. This antibiotic only treats bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Product Characteristics

Color(s):
WHITE (C48325)
Flavor(s):
STRAWBERRY (C73417)

NDC Code Structure

  • 23594 - Aytu Therapeutics, Llc

NDC 23594-125-01

Package Description: 150 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Cefaclor with NDC 23594-125 is a a human prescription drug product labeled by Aytu Therapeutics, Llc. The generic name of Cefaclor is cefaclor. The product's dosage form is for suspension and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 309042, 309044 and 313888.

Dosage Form: For Suspension - A product, usually a solid, intended for suspension prior to administration.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cefaclor Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SUCROSE (UNII: C151H8M554)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cephalosporin Antibacterial - [EPC] (Established Pharmacologic Class)
  • Cephalosporins - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Aytu Therapeutics, Llc
Labeler Code: 23594
FDA Application Number: ANDA065412 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-26-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Cefaclor Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor for Oral Suspension, USP, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Otitis media caused by


Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and


Streptococcus pyogenesNote:


β-lactamase-negative, ampicillin-resistant (BLNAR) strains of


Haemophilus influenzae should be considered resistant to cefaclor despite apparent


in vitro susceptibility of some BLNAR strains.

Lower respiratory tract infections, including pneumonia, caused by


Streptococcus pneumoniae, Haemophilus influenzae, and


Streptococcus pyogenes Note:


β-lactamase-negative, ampicillin-resistant (BLNAR) strains of


Haemophilus influenzae should be considered resistant to cefaclor despite apparent


in vitro susceptibility of some BLNAR strains.

Pharyngitis and Tonsillitis, caused by


Streptococcus pyogenesNote: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.

Urinary tract infections, including pyelonephritis and cystitis, caused by


Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci

Skin and skin structure infections caused by


Staphylococcus aureus and


Streptococcus pyogenesAppropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor for Oral Suspension 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.

TABLE 1:Cefaclor for Oral Suspension, USP20 mg/kg/dayWeight125 mg/5 mL250 mg/5 mL9 kg1/2 tsp t.i.d.18 kg1 tsp t.i.d.1/2 tsp t.i.d.40 mg/kg/day9 kg1 tsp t.i.d.1/2 tsp t.i.d.18 kg1 tsp t.i.d.

Manufactured by:Yung Shin Pharmaceutical Ind. Co., Ltd.


Tachia, Taichung 43769, TAIWAN


Distributed by:Cerecor, Inc.


Research Triangle Park, NC 27713


www.cerecor.com


Revised: 02/18

Description

Cefaclor, USP, is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C


15H


14ClN


3O


4S∙H


2O and the molecular weight is 385.82.


After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain methylcellulose, sodium lauryl sulfate, sucrose, and xanthan gum, FD&C Red No. 40, strawberry flavor. The color of drug powder in the dry powder state is white to off-white. After reconstitution, it turns to a red suspension.

Clinical Pharmacology

Cefaclor is well-absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food; however, when it is taken with food, the peak concentration achieved is 50% to 75% of that observed when the drug is administered to fasting subjects and generally appears from three-fourths to 1 hour later. Following administration of 250 mg, 500 mg, and 1 g doses to fasting subjects, average peak serum levels of approximately 7, 13, and 23 mcg/mL, respectively, were obtained within 30 to 60 minutes. Approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours, the greater portion being excreted within the first 2 hours. During this 8-hour period, peak urine concentrations following the 250 mg, 500 mg and 1 g doses were approximately 600, 900 and 1,900 mcg/mL, respectively. The serum half-life in normal subjects is 0.6 to 0.9 hour. In patients with reduced renal function, the serum half-life of cefaclor is slightly prolonged. In those with complete absence of renal function, the plasma half-life of the intact molecule is 2.3 to 2.8 hours. Excretion pathways in patients with markedly impaired renal function have not been determined. Hemodialysis shortens the half-life by 25% to 30%.

Mechanism Of Action

As with other cephalosporins, the bactericidal action of cefaclor results from inhibition of cell-wall synthesis.

Mechanism Of Resistance

Resistance to cefaclor is primarily through hydrolysis of beta-lactamases, alteration of penicillin-binding proteins (PBPs) and decreased permeability.


Pseudomonas spp.,


Acinetobacter calcoaceticus and most strains of


Enterococci (Enterococcus faecalis, group D streptococci),


Enterobacter spp., indole-positive


Proteus, Morganella morganii (formerly


Proteus morganii),


Providencia rettgeri (formerly


Proteus rettgeri), and


Serratia spp. are resistant to cefaclor. Cefaclor is inactive against methicillin-resistant staphylococci.


β-lactamase-negative, ampicillin-resistant strains of


H. influenzae should be considered resistant to cefaclor despite apparent


in vitro susceptibility to this agent.

Antibacterial Activity

Cefaclor has been shown to be active against most strains of the following microorganisms both


in vitro and in clinical infections as described in the


INDICATIONS AND USAGE section.


Gram-positive BacteriaStaphylococcus aureus (methicillin susceptible only)Coagulase negative staphylococci (methicillin susceptible only)Streptococcus pneumoniaeStreptococcus pyogenes (group A β-hemolytic streptococci)


Gram-negative BacteriaEscherichia coliHaemophilus influenzae (excluding β-lactamase-negative, ampicillin-resistant strains)


Klebsiella spp.Proteus mirabilisThe following in vitro data are available,


but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentrations (MICs) less than or equal to the susceptible breakpoint of cefaclor. However, the safety and effectiveness of cefaclor in treating clinical infections due to these bacteria has not been established in adequate and well-controlled trials.


Gram-negative BacteriaCitrobacter diversusMoraxella catarrhalisNeisseria gonorrhoeaeAnaerobic BacteriaBacteroides spp.Peptococcus spp.Peptostreptococcus spp.Propionibacterium acnes

Susceptibility Test Methods

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.

Indications And Usage

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

Contraindications

Cefaclor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Warnings

BEFORE THERAPY WITH CEFACLOR IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFACLOR, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN- SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFACLOR OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.Antibiotics, including cefaclor, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefaclor for Oral Suspension, USP, 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.

General

Prescribing cefaclor in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increase the risk of the development of drug-resistant bacteria.Prolonged use of cefaclor may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. It should be recognized that a positive Coombs' test may be due to the drug, e.g., in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition.Cefaclor should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuria is 2.3 to 2.8 hours, dosage adjustments for patients with moderate or severe renal impairment are usually not required. Clinical experience with cefaclor under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made.As with other β-lactam antibiotics, the renal excretion of cefaclor is inhibited by probenecid.Antibiotics, including cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Information For Patients

Patients should be counseled that antibacterial drugs including Cefaclor for Oral Suspension should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefaclor for Oral Suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping dose or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefaclor for Oral Suspension or other antibacterial drugs in the future.Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug/Laboratory Test Interactions

Patients receiving cefaclor may show a false-positive reaction for glucose in the urine with tests that use Benedict's and Fehling's solutions and also with Clinitest


® tablets.


There have been reports of increased anticoagulant effect when cefaclor and oral anticoagulants were administered concomitantly.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies have not been performed to determine potential for carcinogenicity, mutagenicity, or impairment of fertility.

Labor And Delivery

The effect of cefaclor on labor and delivery is unknown.

Nursing Mothers

Small amounts of cefaclor have been detected in mother's milk following administration of single 500 mg doses. Average levels were 0.18, 0.20, 0.21, and 0.16 mcg/mL at 2, 3, 4, and 5 hours, respectively. Trace amounts were detected at 1 hour. The effect on nursing infants is not known. Caution should be exercised when cefaclor is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of this product for use in infants less than 1 month of age have not been established.

Geriatric Use

Of the 3,703 patients in clinical studies of cefaclor, 594 (16.0%) were 65 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.This drug is known to be substantially excreted by the kidney (see


CLINICAL PHARMACOLOGY), and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see


DOSAGE AND ADMINISTRATION).

Adverse Reactions

Adverse effects considered to be related to therapy with cefaclor are listed below:Hypersensitivity reactions have been reported in about 1.5% of patients and include morbilliform eruptions (1 in 100). Pruritus, urticaria, and positive Coombs' tests each occur in less than 1 in 200 patients.


Cases of


serum-sickness-like reactions have been reported with the use of cefaclor. These are characterized by findings of erythema multiforme, rashes, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes, and no evidence to date of sequelae of the reaction. Occasionally, solitary symptoms may occur, but do not represent a


serum-sickness-like reaction. While further investigation is ongoing,


serum-sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in pediatric patients than in adults with an overall occurrence ranging from 1 in 200 (0.5%) in one focused trial to 2 in 8,346 (0.024%) in overall clinical trials (with an incidence in pediatric patients in clinical trials of 0.055%) to 1 in 38,000 (0.003%) in spontaneous event reports. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy; occasionally these reactions have resulted in hospitalization, usually of short duration (median hospitalization = 2 to 3 days, based on postmarketing surveillance studies). In those requiring hospitalization, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in pediatric patients. Antihistamines and glucocorticoids appear to enhance resolution of the signs and symptoms. No serious sequelae have been reported.


More severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis have been reported rarely. Anaphylactoid events may be manifested by solitary symptoms, including angioedema, asthenia, edema (including face and limbs), dyspnea, paresthesias, syncope, hypotension, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy.Rarely, hypersensitivity symptoms may persist for several months.Gastrointestinal symptoms occur in about 2.5% of patients and include diarrhea (1 in 70).


Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see


WARNINGS ). Nausea and vomiting have been reported rarely. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.


Other effects considered related to therapy included eosinophilia (1 in 50 patients), genital pruritus, moniliasis or vaginitis (about 1 in 50 patients), and, rarely, thrombocytopenia or reversible interstitial nephritis.

Cephalosporin-Class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with cefaclor, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, false-positive test for urinary glucose, elevated bilirubin, elevated LDH, and pancytopenia.Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated (see


DOSAGE AND ADMINISTRATION and


OVERDOSAGE sections).


To report SUSPECTED ADVERSE REACTIONS, contact Cerecor, Inc. at 866-416-9637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration

Cefaclor is administered orally.

Directions For Mixing:

Add appropriate water volume as indicated in the following table in two portions to dry mixture in the bottle. Shake well after each addition.Each 5 mL (approximately one teaspoonful) will then contain Cefaclor, USP, monohydrate equivalent to 125 mg, 250 mg or 375 mg anhydrous cefaclor, respectively, as shown in the following table.Oversize bottle provides extra space for shaking.TABLE 3:Cefaclor For Oral Suspension, USPStrengthPackage Size


(when mixed)


Water


Volume


to Add


Anhydrous


Cefaclor/5 mL


(approx. one


teaspoonful)


125 mg/5 mL150 mL


106 mL125 mg250 mg/5 mL150 mL


106 mL250 mg375 mg/5 mL100 mL


68 mL375 mg

How Supplied

Cefaclor Oral Suspension, USP, is supplied in bottles with child-resistant caps as:125 mg/5 mL strawberry flavor:


    NDC 23594-125-01 (150 mL size)


250 mg/5 mL strawberry flavor


    NDC 23594-250-01 (150 mL size)


375 mg/5 mL strawberry flavor


    NDC 23594-375-01 (100 mL size)


After mixing, store in a refrigerator. Shake well before using. Keep tightly closed. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days.

Storage And Handling

Store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

* Please review the disclaimer below.