DICEF

Semisynthetic, broad-spectrum antibiotic derivative of cephalexin.

For the treatment of certain infections caused by bacteria such as pneumonia and ear, lung, skin, throat, and urinary tract infections.

Cefaclor is a second generation cephalosporin antibiotic with a spectrum resembling first-generation cephalosporins.

In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell-wall synthesis.

As indicated by in vitro and in vivo clinical studies, cefaclor was shown to be effective against most strains of Gram positive aerobes.

• Staphylococci (including coagulase-positive, coagulase-negative, and penicillinase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes (group A ß-hemolytic streptococci), as well as Gram-negative aerobes.

• Escherichia coli, Haemophilus influenzae (including ß-lactamase-producing ampicillin-resistant strains), Klebsiella sp, and Proteus mirabilis.

serine-type D-Ala-D-Ala carboxypeptidase (Streptococcus pneumoniae) Inhibitor Penicillin-binding protein 1A (Clostridium perfringens (strain 13 / Type A)) Inhibitor.

Well absorbed after oral administration, independent of food intake.

No appreciable biotransformation in liver (approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours).

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.

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Symptoms of overdose include diarrhea, nausea, stomach upset, and vomiting.

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 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.

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

The absorption of cefaclor extended-release tablets is enhanced when it is administered with food.

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.

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 Dose Dose and Frequency Duration Acute 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 1000 mg 500 mg q 12 hours 7 days Pharyngitis and/or tonsillitis due to S. pyogenes 750 mg 375 mg q 12 hours 10 days Uncomplicated Skin and Skin Structure.

Infections due to S. aureus (methicillin-susceptible strains) 750 mg 375 mg q 12 hours to 10 days Elderly patients with normal renal function do not require dosage adjustments.

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) .

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Reproduction studies using cefaclor have been performed in mice, rats and ferrets at doses up to to 5 times the maximum human dose (1500 mg/day) based on mg/m 2.

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.

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.

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

Of the 3272 patients in clinical studies of cefaclor extended-release tablets, 608 (18.2%) were and older.

No overall differences in safety or effectiveness were observed between these and younger patients.

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, 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.