Cefaclor

What is Cefaclor?

• Cefaclor (Ceclor; Ceclor CD; Raniclor) is a semisynthetic cephalosporin antibiotic used to treat certain bacterial infections such as pneumonia and infections of the ear, lung, skin, throat, and urinary tract.

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Cefaclor

Cefaclor V1

What are the uses of this medicine?

Cefaclor (Ceclor; Ceclor CD; Raniclor) is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

• Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes
• Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes
• Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
• 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 pyogenes

How does this medicine work?

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

Cefaclor has been shown to be active against most strains of the following microorganisms: Gram-positive Bacteria:

• Staphylococcus aureus (methicillin susceptible only)
• Coagulase negative staphylococci (methicillin susceptible only)
• Streptococcus pneumoniae
• Streptococcus pyogenes (group A -hemolytic streptococci)

Gram-negative Bacteria:

• Escherichia coli
• Haemophilus influenzae (excluding -lactamase-negative, ampicillin-resistant strains)
• Klebsiella spp.
• Proteus mirabilis

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known allergy to the cephalosporin group of antibiotics.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), and probenecid (Probalan)

• If you are taking antacids that contain magnesium or aluminum, take them 1 hour before or 1 hour after cefaclor extended release tablets.

Is this medicine FDA approved?

• It was patented in 1973 and approved for medical use in 1979.

How should this medicine be used?

Recommended dosage: In Adults:

• The usual adult dosage is 250 mg every 8 hours.
• For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.

In Pediatric Patients:

• The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours.
• In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.

• Cefaclor may be administered in the presence of impaired renal function.
• In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.

• 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.

Administration:

• Cefaclor comes as a capsule, an extended-release (long-acting) tablet, and a suspension (liquid) to take by mouth.
• The capsule and liquid are usually taken with or without food every 8 or 12 hours .
• The long-acting tablet is usually taken within 1 hour of eating a meal every 12 hours (twice a day) for 7 to 10 days .
• Take cefaclor at around the same times every day.
• Shake the suspension well before each use to mix the medication evenly.
• Swallow the long-acting tablets whole; do not split, chew, or crush them.
• You should begin to feel better during the first few days of treatment with cefaclor.
• If your symptoms do not improve or get worse, call your doctor.
• Take cefaclor until you finish the prescription, even if you feel better.
• If you stop taking cefaclor too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a capsule, an extended-release (long-acting) tablet, and a suspension (liquid)

This medicine is available in fallowing brand namesː

• Ceclor
• Ceclor CD
• Raniclor

What side effects can this medication cause?

The most common side effects of this medicine include:

• Hypersensitivity reactions
• Pruritus
• urticaria
• positive Coombs' tests
• serum-sickness
• diarrhea
• Nausea and vomiting

Less common side effects, may include:

• 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.
• CNS ─ Rarely, reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, and somnolence have been reported.
• Hepatic ─ Slight elevations of AST, ALT, or alkaline phosphatase values
• Hematopoietic ─ As has also been reported with other β-lactam antibiotics, transient lymphocytosis, leukopenia, and, rarely, hemolytic anemia, aplastic anemia, agranulocytosis, and reversible neutropenia
• Renal ─ Slight elevations in BUN or serum creatinine or abnormal urinalysis

What special precautions should I follow?

• 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 increases 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.
• Cefaclor should be administered with caution in the presence of markedly impaired renal function.
• 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.
• Patients should be counseled that antibacterial drugs including cefaclor should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• When cefaclor 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 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 or other antibacterial drugs in the future.

• The effect of cefaclor on labor and delivery is unknown.
• Small amounts of cefaclor have been detected in mother's milk following administration of single 500-mg doses. Caution should be exercised when cefaclor is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, vomiting, epigastric distress, and diarrhea.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Protect the patient's airway and support ventilation and perfusion.
• Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc.
• 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.
• Safeguard the patient's airway when employing gastric emptying or charcoal.
• Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cefaclor.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredients:

• CEFACLOR

Inactive ingredients:

• magnesium stearate
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• LACTOSE MONOHYDRATE
• TALC
• GELATIN
• TITANIUM DIOXIDE
• FD&C BLUE NO. 1
• FD&C Red No. 3
• SHELLAC
• AMMONIA
• POTASSIUM HYDROXIDE
• FERROSOFERRIC OXIDE
• ALCOHOL
• ISOPROPYL ALCOHOL
• TERT-BUTYL ALCOHOL
• propylene glycol

Who manufactures and distributes this medicine?

Manufactured by: Yung Shin Pharmaceutical Ind. Co., Ltd.Tachia, Taichung, TAIWAN

Distributed by:

• Carlsbad Technology, Balfour Ct.
• Carlsbad, CA USA

What should I know about storage and disposal of this medication?

• Store at 20℃ - 25℃ (68℃ to 77℉).

• Dailymed label info on Cefaclor
• FDA Cefaclor

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