NDC 0093-1087 Cefaclor

Cefaclor

NDC Product Code 0093-1087

NDC CODE: 0093-1087

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):
BLUE (C48333 - DARK BLUE)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
93;1087
Score: 1

NDC Code Structure

  • 0093 - Teva Pharmaceuticals Usa, Inc.

NDC 0093-1087-01

Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC Product Information

Cefaclor with NDC 0093-1087 is a a human prescription drug product labeled by Teva Pharmaceuticals Usa, Inc.. The generic name of Cefaclor is cefaclor. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: Teva Pharmaceuticals Usa, Inc.

Dosage Form: Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.

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.

  • CEFACLOR 500 mg/1

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.

  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K29/32 (UNII: 390RMW2PEQ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: Teva Pharmaceuticals Usa, Inc.
Labeler Code: 0093
FDA Application Number: ANDA065058 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: 09-26-2002 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Cefaclor

Cefaclor is pronounced as (sef' a klor)

Why is cefaclor medication prescribed?
Cefaclor is used to treat certain infections caused by bacteria, such as pneumonia and other lower respiratory tract (lung) infections; and infections of the skin, ears, ...
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* 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

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

Description

Cefaclor, USP, the active ingredient in cefaclor extended-release tablets USP, is a semisynthetic cephalosporin antibiotic for oral administration. Cefaclor, USP, is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The cefaclor extended-release tablets formulation of cefaclor differs pharmacokinetically from the immediate-release formulation of cefaclor.C15H14ClN3O4S • H2O M.W. 385.82Each cefaclor extended-release tablet contains cefaclor monohydrate equivalent to 500 mg (1.36 mmol) anhydrous cefaclor. In addition, each extended-release tablet contains the following inactive ingredients: FD&C Blue #2 - indigo carmine lake, hypromellose, magnesium stearate, mannitol, polyethylene glycol, povidone and titanium dioxide.

Pharmacokinetics

The cefaclor extended-release tablet formulation of cefaclor is pharmacokinetically different from the cefaclor immediate-release capsule formulation of cefaclor. (See TABLE 1.) No direct comparisons with the suspension formulation of cefaclor have been conducted; therefore, there are no data with which to compare the pharmacokinetic properties of the extended-release tablet formulation and the suspension formulation. Until further data are available, the pharmacokinetic equivalence of the extended-release tablet and the suspension formulations should NOT be assumed.

Absorption And Metabolism

The extent of absorption (AUC) and the maximum plasma concentration (Cmax) of cefaclor from cefaclor extended-release tablets are greater when the extended-release tablet is taken with food.[NOTE: The extent of absorption (AUC) of cefaclor from cefaclor immediate-release capsules is unaffected by food intake; however, when cefaclor immediate-release capsules are taken with food, the Cmax is decreased.]There is no evidence of metabolism of cefaclor in humans.

Comparative Serum Pharmacokinetics

Serum pharmacokinetic parameters for cefaclor extended-release tablets and cefaclor immediate-release capsules are shown in the table below.Table 1: COMPARATIVE PHARMACOKINETICS OF CEFACLOR IMMEDIATE-RELEASE CAPSULES VS. CEFACLOR EXTENDED-RELEASE TABLETS IN FASTING AND FED STATESParameterCefaclor Extended-Release TabletsCefaclor Extended-Release TabletsCefaclor Immediate-Release Capsules375 mg500 mg2 x 250 mgfedfastfedfastfedfastn = 10n = 16n = 16n = 15n = 16Cmax3.7 (1.1)NA8.2 (4.2)5.4 (1.6)9.3 (2.7)16.8 (4.7)Tmax2.7 (1.0)NA2.5 (0.8)1.5 (0.7)1.5 (0.6)0.9 (0.4)AUC9.9 (2.2)NA18.1 (4.2)14.8 (4.0)20.5 (2.8)19.2 (5.0)(± 1 standard deviation)NA = data not availableNo drug accumulation was noted when cefaclor extended-release tablets were given twice daily.The plasma half-life in healthy subjects is independent of dosage form and averages approximately 1 hour.

Food Effect On Pharmacokinetics

When cefaclor extended-release tablets are taken with food, the AUC is 10% lower while the Cmax is 12% lower and occurs 1 hour later compared to cefaclor immediate-release capsules. In contrast, when cefaclor extended-release tablets are taken without food, the AUC is 23% lower while the Cmax is 67% lower and occurs 0.6 hours later, using an equivalent milligram dose of cefaclor immediate-release capsules as a reference. Therefore, cefaclor extended-release tablets should be taken with food.

Renal Insufficiency

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%.

Geriatric Patients

In elderly subjects (over age 65) with normal serum creatinine values, higher peak plasma concentrations and AUCs have been observed. This is considered to be primarily a result of an age-related decrement in renal function, and has no apparent clinical significance. Therefore, dosage adjustment is not necessary in elderly subjects with normal serum creatinine values.

Microbiology

Mechanism of ActionAs with other cephalosporins, the bactericidal action of cefaclor results from inhibition of cell-wall synthesis. Mechanism of ResistanceResistance to cefaclor is primarily through hydrolysis of ß-lactamases alteration of penicillin-binding proteins (PBPs) and decreased permeability. Pseudomonas spp., Acinetobacter calcoaceticus and most strains of Enterococi (Enterococcus faecalis, group D streptococci), Enterobacter spp., indole-positive Proteus, Morganella morganii (formerly Proteus morganii), Providencia rettgeri (formerly Proteusrettgeri) 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. List of MicroorganismsCefaclor extended-release tablets have 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)Streptococcus pneumoniae Streptococcus pyogenes Gram-negative BacteriaHaemophilus influenzae (excluding β-lactamase-negative, ampicillin-resistant strains) Moraxella catarrhalisThe 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 for cefalor. However, the safety and effectiveness of cefaclor extended-release tablets in treating clinical infections due to these bacteria has not been established in adequate and well-controlled trials.Gram-positive BacteriaStaphylococcus epidermidis (methicillin susceptible only)Gram-negative BacteriaHaemophilus parainfluenzae Klebsiella pneumoniae Anaerobic BacteriaPeptococcus niger Peptostreptococci Propionibacterium acnes

Susceptibility Testing

When available, the clinical microbiology laboratory should provide the result of in vitro susceptibility test results for antimicrobial drugs used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug for treatment.Dilution TechniquesQuantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized method (broth, agar, or microdilution) 1,3. The MIC values should be interpreted according to criteria provided in Table 2.Diffusion Techniques Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method2,3. This procedure uses paper disks impregnated with 30 mcg cefaclor to test the susceptibility of microorganisms to cefaclor. The disc diffusion interpretive criteria are provided in Table 2.Table 2: SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR CEFACLORMicroorganismsSusceptibility of staphylococci to cefaclor may be deduced from testing only penicillin and either cefoxitin or oxacillinSusceptibility of Streptococcus pyogenes to cefaclor may also be deduced from testing penicillinMinimal InhibitoryConcentration(mcg/mL)ZoneDiameter(mm)SIRSIRStreptococcus pneumoniae< 12> 4------A report of Susceptible indicates that antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations at the site of infection necessary to inhibit growth of the pathogen. A report of Intermediate indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.Quality ControlStandardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test. 1, 2, 3, 4 Standard cefaclor powder should provide the following range of MIC values noted in Table 3. For the diffusion technique using the 30 mcg disk the criteria in Table 3 should be achieved.Table 3: ACCEPTABLE QUALITY CONTROL RANGES FOR CEFACLORQC StrainMinimal Inhibitory Concentration (mcg/mL)Zone Diameter (mm)Escherichia coli ATCC 259221 to 423 to 27Haemophilus influenzae ATCC 497661 to 425 to 31Staphylococcus aureus ATCC 25923--27 to 31Staphylococcus aureus ATCC 292131 to 4--Streptococcus pneumoniae ATCC 496191 to 424 to 32

Indications And Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP 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.The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.)Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae.NOTE: In view of the insufficient numbers of isolates of ß-lactamase-producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by ß-lactamase-producing H. influenzae.Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. (See above NOTE.)Pharyngitis and tonsillitis due to Streptococcus pyogenes.NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available.Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible only).NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.

Contraindications

Cefaclor extended-release tablets are contraindicated in patients with known hypersensitivity to cefaclor and other cephalosporins.

Warnings

BEFORE THERAPY WITH CEFACLOR EXTENDED-RELEASE TABLETS 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-SENSITIVITY AMONG BETA-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 EXTENDED-RELEASE TABLETS 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. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefaclor 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 increase 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 extended-release tablets USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.Superinfection (overgrowth by non-susceptible organisms) should always be considered a possibility in a patient being treated with a broad spectrum antimicrobial. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Information For Patients

Patients should be counseled that antibacterial drugs including cefaclor extended-release tablets USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefaclor extended-release tablets USP are 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 doses 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 extended-release tablets USP 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.

Antacids

The extent of absorption of cefaclor extended-release tablets is diminished if magnesium or aluminum hydroxide-containing antacids are taken within 1 hour of administration; H2 blockers do not alter either the rate or the extent of absorption of cefaclor extended-release tablets.

Probenecid

The renal excretion of cefaclor is inhibited by probenecid.

Warfarin

There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving cefaclor and warfarin concomitantly. No specific studies have been performed to rule in or rule out this potential drug/drug interaction.

Laboratory Test Interactions

Administration of cefaclor extended-release tablets may result in a false-positive reaction for glucose in the urine. This phenomenon has been seen in patients taking cephalosporin antibiotics when the test is performed using Benedict's and Fehling's solutions and also with Clinitest® tablets.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential for cefaclor. Reproduction studies have revealed no evidence of impaired fertility.

Pregnancy Category B

Reproduction studies using cefaclor have been performed in mice, rats and ferrets at doses up to 3 to 5 times the maximum human dose (1500 mg/day) based on mg/m2. These studies have revealed no harm to the fetus due to cefaclor. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, cefaclor extended-release tablets should be used during pregnancy only if clearly needed.

Labor And Delivery

Cefaclor extended-release tablets have not been studied for use during labor and delivery. Treatment should be given only if clearly needed.

Nursing Mothers

No studies in lactating women have been performed with cefaclor extended-release tablets. Small amounts of cefaclor (≤ 0.21 mcg/mL) have been detected in human milk following administration of single 500 mg doses of cefaclor extended-release tablets. The effect on nursing infants is not known. Caution should be exercised when cefaclor extended-release tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of cefaclor extended-release tablets in pediatric patients less than 16 years of age have not been established.

Geriatric Use

Healthy geriatric volunteers (≥ 65 years old) who received a single 750 mg dose of cefaclor extended-release tablets had 40% to 50% higher AUC and 20% lower renal clearance values when compared to healthy adult volunteers less than 45 years of age. These differences are considered to be primarily a result of age-related decreases in renal function. In clinical studies when geriatric patients received the usual recommended adult doses, clinical efficacy and safety were comparable to results in non-geriatric adult patients. No dosage changes are recommended for healthy geriatric patients.

Clinical Trials

There were 3272 patients treated with multiple doses of cefaclor extended-release tablets in controlled clinical trials and an additional 211 subjects in pharmacology studies. There were no deaths in these trials thought to be related to toxicity from cefaclor extended-release tablets. Treatment was discontinued in 1.7% of patients due to adverse events thought to be possibly or probably drug-related.The following adverse clinical and laboratory events were reported during the cefaclor extended-release tablets clinical trials conducted in North America at doses of 375 mg or 500 mg BID; however, relatedness of the adverse events to the drug was not assigned by clinical investigators during the trials (see TABLES 4 and 5).Table 4: ADVERSE CLINICAL EVENTS - CEFACLOR EXTENDED-RELEASE TABLETS MULTIPLE DOSE DOSING REGIMENS CLINICAL TRIALS - NORTH AMERICA (n = 1400)Incidence Equal to or Greater Than 1%EventIncidenceHeadache4.9%Rhinitis3.9%Diarrhea3.8%Nausea3.4%Vaginitisn = 934 for these events (subset of female participants).2.4%Vaginal Moniliasis2.2%Abdominal Pain1.6%Cough Increased1.5%Pharyngitis1.4%Pruritus1.4%Back Pain1.0%Adverse reactions occurring during the clinical trials with cefaclor extended-release tablets with an incidence of less than 1% but greater than 0.1% included the following (listed alphabetically):Accidental injury, anorexia, anxiety, arthralgia, asthma, bronchitis, chest pain, chills, congestive heart failure, conjunctivitis, constipation, dizziness, dysmenorrhea, dyspepsia, dysuria, ear pain, edema, fever, flatulence, flu syndrome, gastritis, infection, insomnia, leukorrhea, lung disorder, maculopapular rash, malaise, menstrual disorder, myalgia, nausea and vomiting, neck pain, nervousness, nocturia, otitis media, pain, palpitation, peripheral edema, rash, respiratory disorder, sinusitis, somnolence, surgical procedure, sweating, tremor, urticaria, vomiting.NOTE: One case of serum-sickness-like reaction was reported among the 3272 adult patients treated with cefaclor extended-release tablets during the controlled clinical trials. These reactions have also been reported with the use of cefaclor in other oral formulations and are seen more frequently in pediatric patients than in adults. These reactions are characterized by findings of erythema multiforme, rash, 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. 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 with overall occurrence ranging from 1 in 200 (0.5%) in one focused trial; to 2 in 8346 (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 patients 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.Table 5: ADVERSE CLINICAL LABORATORY EVENTS CEFACLOR EXTENDED-RELEASE TABLETS MULTIPLE DOSE DOSING REGIMENS CLINICAL TRIALS – NORTH AMERICAEventIncidenceIncidence Less Than 1%, but Greater Than 0.1%Albumin decreased0.3%Alkaline phosphatase increased0.3%ALT/SGPT increased0.3%Bilirubin total increased0.3%Blood urea nitrogen (BUN) increased0.2%Calcium decreased0.7%Creatine phosphokinase increased0.7%Creatinine increased0.5%Eosinophils increased0.3%Erythrocyte count decreased0.3%GGT increased0.2%Hemoglobin decreased0.2%Lymphocytes decreased0.3%Mean Cell Volume (MCV) increased0.7%Neutrophils segmented decreased0.3%Phosphorous increased0.7%Platelet count decreased0.3%Potassium increased0.4%Sodium decreased0.3%Sodium increased0.4%

In Postmarketing Experience

In addition to the events reported during clinical trials with cefaclor extended-release tablets, the following adverse experiences are among those that have been reported during worldwide postmarketing surveillance: allergic reaction, anaphylactoid reaction, angioedema, face edema, hypotension, Stevens-Johnson syndrome, syncope, paresthesia, vasodilatation and vertigo.

Other Adverse Reactions Associated With Other Formulations Of Cefaclor

In addition to the above, the following other adverse reactions and altered laboratory tests have been associated with cefaclor in other oral formulations:

Clinical

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, edema (including face and limbs), paresthesias, syncope, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy. Rarely, hypersensitivity symptoms may persist for several months.Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. (See WARNINGS.)

Confusion, erythema multiforme, genital pruritus, hepatic dysfunction including cholestasis, hemolytic anemia, reversible hyperactivity, hypertonia, and reversible interstitial nephritis.

Laboratory

Abnormal urinalysis, eosinophilia, leukopenia, neutropenia, transient elevations in AST, and transient thrombocytopenia have been reported.

Positive direct Coombs’ test.

Cephalosporin-Class Reactions

In addition to the adverse reactions listed above, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Overdosage

The toxic symptoms following an overdose of cefaclor may include nausea, vomiting, epigastric distress, and diarrhea. The severity of the epigastric distress and the diarrhea are dose-related.Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage. Consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed.Although cefaclor is considered dialyzable, neither forced diuresis, peritoneal dialysis, hemodialysis, nor charcoal hemoperfusion have been demonstrated to be beneficial in an overdose of cefaclor.

Dosage And Administration

The absorption of cefaclor extended-release tablets is enhanced when it is administered with food. (See CLINICAL PHARMACOLOGY.) Therefore, cefaclor extended-release tablets should be administered with meals (i.e., at least within one hour of eating). The extended-release tablets should not be cut, crushed, or chewed.See INDICATIONS AND USAGE for information about patients for whom cefaclor extended-release tablets are indicated.NOTE: 500 mg BID of cefaclor extended-release tablets is clinically equivalent to 250 mg TID of cefaclor immediate-release as a capsule in those indications listed in the INDICATIONS AND USAGE section of this label. 500 mg BID of cefaclor extended-release tablets is NOT equivalent to 500 mg TID of other cefaclor formulations. Adults (age 16 years and older):Type of Infection (as qualified in the INDICATIONS AND USAGE section of this labeling)Total Daily DoseDose and FrequencyDurationAcute Bacterial Exacerbations of Chronic Bronchitis due to H. influenzae (non-ß-lactamase-producing strains only). Moraxella catarrhalis (including ß-lactamase-producing strains), or Streptococcus pneumoniae (See INDICATIONS AND USAGE.)1000 mg500 mg q 12 hours7 daysSecondary Bacterial Infection of Acute Bronchitis due to H. influenzae (non-ß-lactamase-producing strains only). M. catarrhalis (including ß-lactamase-producing strains), or S. pneumoniae (See INDICATIONS AND USAGE.)1000 mg500 mg q 12 hours7 daysPharyngitis and/or tonsillitis due to S. pyogenes750 mg375 mg q 12 hours10 daysUncomplicated Skin and Skin Structure Infections due to S. aureus (methicillin-susceptible strains) (See INDICATIONS AND USAGE.)750 mg375 mg q 12 hours7 to 10 daysElderly patients with normal renal function do not require dosage adjustments.

How Supplied

Cefaclor extended-release tablets USP, 500 mg (based on the anhydrous), are available as film-coated, oval-shaped, unscored, dark blue tablets, debossed with “93” on one side and “1087” on the other side. They are available in bottles of 100. (NDC 0093-1087-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Acute Bacterial Exacerbations Of Chronic Bronchitis And Secondary Bacterial Infections Of Acute Bronchitis

In adequate and well-controlled clinical trials of cefaclor extended-release tablets in the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB) and secondary bacterial infections of acute bronchitis (SBIAB), only 4 evaluable patients with ABECB and no evaluable patients with SBIAB had infections caused by ß-lactamase-producing H. influenzae. Four patients do not provide adequate data upon which to judge clinical efficacy of cefaclor extended-release tablets against ß-lactamase-producing H. influenzae.

Uncomplicated Skin And Skin Structure Infections

  • Cefaclor extended-release tablets (375 mg Q12H) (n = 115) were compared to cefaclor immediate-release capsules (250 mg TID) (n = 106) for the treatment of patients with uncomplicated skin and skin structure infections, including cellulitis, pyoderma, abscess and impetigo. Patients were treated for 7 to 10 days and were evaluated for clinical resolution and bacterial eradication approximately one week after completing therapy. To be evaluable, all patients had to have a recognized pathogen isolated from the skin infection just prior to the initiation of therapy. The results of this randomized, double-blinded, U.S. trial demonstrated:1.overall clinical cure rates were 72% (83 of 115 patients) and 75% (80 of 106 patients), respectively, for cefaclor extended-release tablets and cefaclor immediate-release capsules [95% CI around the 3% difference = -16% to +9%],2.overall bacteriologic eradication rates against Staphylococcus aureus were comparable (see TABLE 6).Table 6: CLINICAL RESPONSECure plus improvement IN PATIENTS WITH SKIN AND SKIN STRUCTURE INFECTIONSOutcome by PathogenCEFACLOR EXTENDED-RELEASE TABLETSCEFACLOR IMMEDIATE-RELEASE CAPSULESStaphylococcus aureus67/95(71%)58/81(71%)Streptococcus pyogenes10/16(63%)8/9(89%)Other streptococci7/11(64%)5/6(83%)Total84/122(69%)71/96(74%)

References

  • 1.Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.2.Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012. 3.Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement, CLSI document M100-S24, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2014.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. L 12/2014

Cefaclor Extended-Release Tablets Usp 500 Mg, 100S Label Text

NDC 0093-1087-01CefaclorExtended-ReleaseTablets USP500 mgRx only100 TABLETSTEVA

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