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Ceftin (Cefuroxime Axetil) - Indications and Dosage

 
 



INDICATIONS AND USAGE

NOTE: CEFTIN TABLETS AND CEFTIN FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

CEFTIN Tablets

CEFTIN Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

  1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.

  2. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. CEFTIN Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well­controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.

  3. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae , Haemophilus influenzae (including beta-lactamase–producing strains), Moraxella catarrhalis (including beta-lactamase–producing strains), or Streptococcus pyogenes.

  4. Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase–producing strains only). (See CLINICAL STUDIES section.)

  5. NOTE: In view of the insufficient numbers of isolates of beta-lactamase–producing strains of Haemophilus influenzae and Moraxella catarrhalis that were obtained from clinical trials with CEFTIN Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of CEFTIN Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis.

  6. Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae , Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta­lactamase negative strains). (See DOSAGE AND ADMINISTRATION section and CLINICAL STUDIES section.)

  7. Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase–producing strains) or Streptococcus pyogenes.

  8. Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae .

  9. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non­penicillinase–producing strains of Neisseria gonorrhoeae anduncomplicated gonorrhea, rectal, in females, caused by non­penicillinase–producing strains of Neisseria gonorrhoeae .

  10. Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

CEFTIN for Oral Suspension

CEFTIN for Oral Suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. The safety and effectiveness of CEFTIN for Oral Suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well­controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen.

  1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.

  2. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. CEFTIN for Oral Suspension is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.

  3. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae , Haemophilus influenzae (including beta-lactamase–producing strains), Moraxella catarrhalis (including beta-lactamase–producing strains), or Streptococcus pyogenes.

  4. Impetigo caused by S taphylococcus aureus (including beta-lactamase–producing strains) or Streptococcus pyogenes .

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFTIN and other antibacterial drugs, CEFTIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

NOTE: CEFTIN TABLETS AND CEFTIN FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

Table 7 CEFTIN Tablets (May be administered without regard to meals.)

Population/Infection

Dosage

Duration (days)

Adolescents and Adults (13 years and older)

Pharyngitis/tonsillitis

250 mg b.i.d.

10

Acute bacterial maxillary sinusitis

250 mg b.i.d.

10

Acute bacterial exacerbations of chronic bronchitis

250 or 500 mg b.i.d.

10 *

Secondary bacterial infections of acute bronchitis

250 or 500 mg b.i.d.

5-10

Uncomplicated skin and skin-structure infections

250 or 500 mg b.i.d.

10

Uncomplicated urinary tract infections

250 mg b.i.d.

7-10

Uncomplicated gonorrhea

1,000 mg once

single dose

Early Lyme disease

500 mg b.i.d.

20

Pediatric Patients (who can swallow tablets whole)

Acute otitis media

250 mg b.i.d.

10

Acute bacterial maxillary sinusitis

250 mg b.i.d.

10

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

CEFTIN for Oral Suspension

CEFTIN for Oral Suspension may be administered to pediatric patients ranging in age from 3 months to 12 years, according to dosages in Table 8:

Table 8: CEFTIN for Oral Suspension (Must be administered with food. Shake well each time before using.)

Population/Infection

Dosage

Daily Maximum Dose

Duration (days)

Pediatric Patients (3 months to 12 years)

Pharyngitis/tonsillitis

20 mg/kg/day divided b.i.d.

500 mg

10

Acute otitis media

30 mg/kg/day divided b.i.d.

1,000 mg

10

Acute bacterial maxillary sinusitis

30 mg/kg/day divided b.i.d.

1,000 mg

10

Impetigo

30 mg/kg/day divided b.i.d.

1,000 mg

10

Patients With Renal Failure

The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.

Directions for Mixing CEFTIN for Oral Suspension

Prepare a suspension at the time of dispensing as follows:

  1. Shake the bottle to loosen the powder.

  2. Remove the cap.

  3. Add the total amount of water for reconstitution (see Table 9) and replace the cap.

  4. Invert the bottle and vigorously rock the bottle from side to side so that water rises through the powder.

  5. Once the sound of the powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction.

Table 9. Amount of Water Required for Reconstitution of Labeled Volumes of CEFTIN for Oral Suspension

CEFTIN for Oral Suspension

Labeled Volume After Reconstitution

Amount of Water Required

for Reconstitution

125 mg/5 mL

100 mL

37 mL

250 mg/5 mL

50 mL

19 mL

100 mL

35 mL

NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE EACH USE. Replace cap securely after each opening. Store the reconstituted suspension between 2° and 8°C (36° and 46°F) (in a refrigerator). DISCARD AFTER 10 DAYS.

HOW SUPPLIED

CEFTIN Tablets

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

60 Tablets/Bottle NDC 0173-0394-42

Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.

CEFTIN for Oral Suspension

CEFTIN for Oral Suspension is provided as dry, white to off-white, tutti-frutti–flavored powder. When reconstituted as directed, CEFTIN for Oral Suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. It is supplied in amber glass bottles as follows:

125 mg/5 mL:

100­mL 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 between 2° and 8°C (36° and 46°F), in a refrigerator. DISCARD AFTER 10 DAYS.

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