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IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
Cefaclor for Oral Suspension, USP, is a beta-lactam cephalosporin antibiotic indicated in the treatment of the noted infections when caused by susceptible strains of the designated microorganisms listed to the right.

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

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions can occur in patients who have demonstrated some form of allergy, particularly to cefaclor, cephalosporins, penicillins, or other drugs. If given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among β-lactam antibiotics 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.
  • Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibiotics, including Cefaclor for Oral Suspension, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients presenting with diarrhea after taking antibiotics, and can occur over 2 months after administration of antibiotics. Ongoing antibiotic use not directed against C. difficile may need to be discontinued.
  • Use only in proven or strongly suspected bacterial infections of susceptible organisms. Do not use for prophylactic use.
  • Prolonged use may result in overgrowth of nonsusceptible organisms. If superinfection occurs appropriate measures should be taken.
  • Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.
  • Use with caution in patients with impaired renal function. Careful clinical and laboratory observation are warranted.
  • As with other beta-lactam antibiotics, renal excretion of cefaclor is inhibited by probenecid.
  • Exercise caution in patients with history of gastrointestinal disease, particularly colitis.
  • Cases of serum-sickness-like reactions have been reported with the use of cefaclor, characterized by findings of erythema multiforme, rashes, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever.

ADVERSE REACTIONS
Most common adverse reactions to cefaclor: hypersensitivity, gastrointestinal symptoms including diarrhea, eosinophilia, genital pruritus, and moniliasis or vaginitis.

To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

1117 CEF HCP ISI

Make CEFACLOR Your FIRST CHOICE CEPHALOSPORIN

Proven Efficacy Toward Infectious Diseases1

* Excluding β-lactamase-negative, ampicillin-resistant strains
** Group A β-hemolytic streptococci
† 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.
‡ Methicillin susceptible only

Otitis Media

Otitis Media due to Streptococcus pneumoniae, Haemophilus influenzae*, staphylococci, and Streptococcus pyogenes**

Pharyngitis and Tonsillitis

Pharyngitis and Tonsillitis due to Streptococcus pyogenes

Lower Respiratory Tract Infections

Lower respiratory tract infections, including pneumonia, due to Streptococcus pneumoniae, Haemophilus influenzae*, and Streptococcus pyogenes**

Urinary Tract Infections

Urinary tract infections including pyelonephritis and cystitis, due to Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci

Skin and Skin Structure Infections

Skin and skin structure infections due to Staphylococcus aureus and Streptococcus pyogenes**

Safe and effective for children as young as one month of age1

Consistent and pleasant strawberry flavor1

2.5% incidence rate of GI symptoms, including diarrhea1

Covered by many insurance and Medicaid Plans

RESOURCES

Dosage and Administration

According to the Full Prescribing Information for Cefaclor for Oral Suspension, USP, the duration of therapy is not specifically defined for the treatment of the approved indications except when treating β-hemolytic streptococcal infections. In the case of such infection, a therapeutic dosage of cefaclor should be administered for at least 10 days.

Adult Patient Dosing Option: The usual adult dosage is 250 mg every 8 hours. Doses may be doubled for more severe infections or those caused by less susceptible organisms.

Our Pediatric Portfolio

Avadel is a specialty pharmaceutical company that seeks to develop products that are proven to be safe, effective, and pediatric-friendly. We focus on providing primary care therapies designed to increase patient compliance and improve patient care. Visit the product websites below to learn more:

1. Cefaclor for Oral Suspension Prescribing Information, January 2017

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
Cefaclor for Oral Suspension, USP, is a beta-lactam cephalosporin antibiotic indicated in the treatment of the noted infections when caused by susceptible strains of the designated microorganisms listed to the right.

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

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions can occur in patients who have demonstrated some form of allergy, particularly to cefaclor, cephalosporins, penicillins, or other drugs. If given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among β-lactam antibiotics 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.
  • Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibiotics, including Cefaclor for Oral Suspension, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients presenting with diarrhea after taking antibiotics, and can occur over 2 months after administration of antibiotics. Ongoing antibiotic use not directed against C. difficile may need to be discontinued.
  • Use only in proven or strongly suspected bacterial infections of susceptible organisms. Do not use for prophylactic use.
  • Prolonged use may result in overgrowth of nonsusceptible organisms. If superinfection occurs appropriate measures should be taken.
  • Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.
  • Use with caution in patients with impaired renal function. Careful clinical and laboratory observation are warranted.
  • As with other beta-lactam antibiotics, renal excretion of cefaclor is inhibited by probenecid.
  • Exercise caution in patients with history of gastrointestinal disease, particularly colitis.
  • Cases of serum-sickness-like reactions have been reported with the use of cefaclor, characterized by findings of erythema multiforme, rashes, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever.

ADVERSE REACTIONS
Most common adverse reactions to cefaclor: hypersensitivity, gastrointestinal symptoms including diarrhea, eosinophilia, genital pruritus, and moniliasis or vaginitis.

To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

1117 CEF HCP ISI

IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
Cefaclor for Oral Suspension, USP, is a beta-lactam cephalosporin antibiotic indicated in the treatment of the noted infections when caused by susceptible strains of the designated microorganisms listed to the right.
CONTRAINDICATIONS
Cefaclor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Avadel provides pediatric-friendly medications and medical devices designed to increase compliance and improve patient care.

AVADEL PHARMACEUTICALS (USA), INC.
Chesterfield, MO 63005
Phone: 636-449-1830 | info@avadel.com
www.avadel.com

© Avadel. All rights reserved.

1117 CEF PRM WBST_CB2