Indicated for:

Pharyngitis/Tonsillitis:

• CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients aged (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes.

• CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged (3 months to 12 years) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes.

The efficacy of CEFTIN in the prevention of rheumatic fever was not established in clinical trials.

The efficacy of CEFTIN in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials.

Acute Bacterial Otitis Media:

• CEFTIN tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β lactamase–producing strains), Moraxella catarrhalis (including β-lactamase producing strains), or Streptococcus pyogenes.

• CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged (3 months to 12 years) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes.

Acute Bacterial Maxillary Sinusitis: 

• CEFTIN tablets are indicated for the treatment of adult and pediatric patients aged (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase–producing strains only).

• CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged (3 months to 12 years) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase–producing strains only).

The effectiveness of CEFTIN for sinus infections caused by β-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials.

Acute Bacterial Exacerbations of Chronic Bronchitis: 

• CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients aged (13 years and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (β-lactamase–negative strains), or Haemophilus parainfluenzae (β-lactamase–negative strains).

The safety and effectiveness of CEFTIN administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

Uncomplicated Skin and Skin-Structure Infections:

• CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients aged (13 years and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including β-lactamase–producing strains) or Streptococcus pyogenes.

Uncomplicated Urinary Tract Infections: 

• CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients aged (13 years and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae.

Uncomplicated Gonorrhea:

• CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients aged (13 years and older) with uncomplicated gonorrhea, urethral and endocervical, caused by penicillinase­ producing and non-penicillinase–producing susceptible strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing susceptible strains of Neisseria gonorrhoeae.

Early Lyme Disease (erythema migrans):

• CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients aged (13 years and older) with early Lyme disease (erythema migrans) caused by susceptible strains of Borrelia burgdorferi.

Impetigo: 

• CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged (3 months to 12 years) with impetigo caused by susceptible strains of Staphylococcus aureus (including β-lactamase–producing strains) or Streptococcus pyogenes.

CEFTIN tablets and CEFTIN for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis

CEFTIN is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to CEFTIN or to other β–lactam antibacterial drugs (e.g., penicillins and cephalosporins).

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CEFTIN, and may range in severity from mild diarrhea to fatal colitis.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on β-lactam antibacterials, including CEFTIN.

Cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. Counsel patients to consider alternate supplementary (non hormonal) contraceptive measures during treatment.

The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.

Cefuroxime is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.

Administer CEFTIN at least 1 hour before or 2 hours after administration of short acting antacids. Histamine-2 (H2) antagonists and proton pump inhibitors should be avoided.

Co-administration of probenecid with cefuroxime axetil is not recommended.

A false-positive result for glucose in the urine may occur with copper reduction tests, and a false negative result for blood/plasma glucose may occur with ferricyanide tests in subjects receiving CEFTIN.

There are no adequate and well-controlled studies in pregnant women. Animal studies: no evidence of impaired fertility or harm to the fetus.

Based on several published case reports describing multiple lactating women who received cefuroxime via intravenous, intramuscular, and oral routes, cefuroxime is present in human milk.

GoToSource

• Use of intracameral cefuroxime as an antibiotic prophylaxis agent for intraocular use. GoToSource

• Psoriasis. GoToSource

• Use at tooth extraction sites. GoToSource

• Use in patients under the age of 3 months of age. GoToSource

Toxic epidermal necrolysis (severe skin reaction). GoToSource

Anaphylactic shock (potentially life-threatening allergic reaction). GoToSource

Linear IgA bullous dermatosis (autoimmune skin disorder with blisters on the skin and mucous membranes). GoToSource

Kounis syndrome (hypersensitivity reaction). GoToSource

Bilateral renal cortical necrosis (death of tissue in the outer part of kidney from blockage of the small arteries that supply blood to the cortex). GoToSource

Secondary thrombotic thrombocytopenic purpura (blood disorder causing blood clots to form in small blood vessels). GoToSource

Clostridium difficile-associated diarrhea. GoToSource

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