CEFTIN- cefuroxime axetil powder, for suspension
CEFTIN- cefuroxime axetil tablet, film coated
GlaxoSmithKline LLC
INDICATIONS AND USAGE
1.1 Pharyngitis/Tonsillitis
CEFTIN � tablets are indicated for the treatment of adult patients and pediatric patients (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.
Limitations of Use
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The efficacy of CEFTIN in the prevention of rheumatic fever was not established in clinical trials.
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The efficacy of CEFTIN in the treatment of penicillin?resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials.
1.2 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 ?- lactamase�producing strains), Moraxella catarrhalis (including ?- 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 ?- lactamase�producing strains), Moraxella catarrhalis (including ?- lactamase�producing strains), or Streptococcus pyogenes.
1.3 Acute Bacterial Maxillary Sinusitis
CEFTIN tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non- ??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- ??lactamase�producing strains only).
Limitations of Use
The effectiveness of CEFTIN for sinus infections caused by ?-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
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
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CEFTIN tablets and CEFTIN for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see Clinical Pharmacology (12.3)].
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Administer CEFTIN tablets or oral suspension as described in the appropriate dosage guidelines [see Dosage and Administration (2.2, 2.3, 2.4)].
Administer CEFTIN tablets with or without food.
Administer CEFTIN for oral suspension with food.
Pediatric patients (aged 13 years and older) who cannot swallow the CEFTIN tablets whole should receive CEFTIN for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration (2.2)].
DESCRIPTION
CEFTIN tablets and CEFTIN for oral suspension contain cefuroxime as cefuroxime axetil. CEFTIN is a semisynthetic, cephalosporin antibacterial drug for oral administration.
The chemical name of cefuroxime axetil (1?(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72 -(Z)-(O -methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20 H22 N4 O10 S, and it has a molecular weight of 510.48.
Microbiology
Mechanism of Action
Cefuroxime axetil is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefuroxime axetil has activity in the presence of some ?-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria.
Mechanism of Resistance
Resistance to cefuroxime axetil is primarily through hydrolysis by ?-lactamase, alteration of penicillin-binding proteins (PBPs), decreased permeability, and the presence of bacterial efflux pumps.
Susceptibility to cefuroxime axetil will vary with geography and time; local susceptibility data should be consulted, if available. Beta-lactamase?negative, ampicillin-resistant (BLNAR) isolates of H. influenzaeshould be considered resistant to cefuroxime axetil.
HOW SUPPLIED/STORAGE AND HANDLING
CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule?shaped, film?coated tablets engraved with �GX ES7? on one side and blank on the other side as follows:
20 Tablets/Bottle NDC 0173-0387-00
CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule?shaped, film?coated tablets engraved with �GX EG2? on one side and blank on the other side as follows:
20 Tablets/Bottle NDC 0173-0394-00
Store the tablets between 15� and 30�C (59� and 86�F). Replace cap securely after each opening.
CEFTIN for oral suspension is provided as dry, white to off?white, tutti?frutti�flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:
125 mg/5 mL:
100?mL Suspension NDC 0173-0740-00
250 mg/5 mL:
50?mL Suspension NDC 0173-0741-10
100?mL Suspension NDC 0173-0741-00
Before reconstitution, store dry powder between 2� and 30�C (36� and 86�F).
After reconstitution, immediately store suspension refrigerated between 2� and 8�C (36� and 46�F). DISCARD AFTER 10 DAYS.