Cefuroxime Axetil

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Side Effects & Adverse Reactions

CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

BEFORE THERAPY WITH CEFUROXIME AXETIL PRODUCTS IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFUROXIME AXETIL PRODUCTS, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF A CLINICALLY SIGNIFICANT ALLERGIC REACTION TO CEFUROXIME AXETIL PRODUCTS OCCURS, DISCONTINUE THE DRUG AND INSTITUTE APPROPRIATE THERAPY. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefuroxime axetil, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

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Manufacturer Warnings

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Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets USP and other antibacterial drugs, cefuroxime axetil tablets USP 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.

NOTE: CEFUROXIME AXETIL TABLETS USP AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIO‑EQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

Cefuroxime Axetil Tablets USP:Cefuroxime axetil tablets USP 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.

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. Cefuroxime axetil tablets USP 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 well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.

2. 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.

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

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 cefuroxime axetil tablets USP for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of cefuroxime axetil tablets USP for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis.

4. 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 (beta-lactamase negative strains) (see DOSAGE AND ADMINISTRATIONand CLINICAL STUDIES).

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

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

7. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase–producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing strains of Neisseria gonorrhoeae.

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

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History

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Other Information

Cefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.

Chemically, cefuroxime axetil, the 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 C20H22N4O10S, and it has a molecular weight of 510.48.

Cefuroxime axetil is in the amorphous form and has the following structural formula:

Cefuroxime axetil tablets USP are film-coated and contain the equivalent of 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Cefuroxime axetil tablets USP contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide.

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Cefuroxime Axetil Manufacturers

Preferred Pharmaceuticali Inc.

Cefuroxime Axetil | Preferred Pharmaceuticali Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 9. Cefuroxime Axetil Tablets (May be administered without regard to meals.) aThe safety and effectiveness of cefuroxime axetil tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

Population/Infection

Dosage

Duration
(days)

   Adolescents and Adults (13 years and older)

      Pharyngitis/tonsillitis

250 mg twice daily

10

      Acute bacterial maxillary sinusitis

250 mg twice daily

10

      Acute bacterial exacerbations of chronic bronchitis

250 or 500 mg twice daily

10a

      Secondary bacterial infections of acute bronchitis

250 or 500 mg twice daily

5 to 10

      Uncomplicated skin and skin‑-structure infections

250 or 500 mg twice daily

10

      Uncomplicated urinary tract infections

250 mg twice daily

7 to 10

      Uncomplicated gonorrhea

1,000 mg once daily

single dose

      Early Lyme disease

500 mg twice daily

20

   Pediatric Patients (who can swallow tablets whole)

      Acute otitis media

250 mg twice daily

10

      Acute bacterial maxillary sinusitis

250 mg twice daily

10
Patients With Renal Impairment
Because cefuroxime is eliminated primarily by the kidney, a dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 11.
Table 11. Dosing in Patients with Renal Impairment
Creatinine Clearance (mL/min)

Recommended Dosage

≥30

No dosage adjustment

10 to <30

Standard individual dose given every 24 hours

<10 (without hemodialysis)

Standard individual dose given every 48 hours

Hemodialysis

A single additional standard dose should be given at the end of each dialysis

No Recall
Direct Rx

Cefuroxime Axetil | Direct Rx

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 9. Cefuroxime Axetil Tablets (May be administered without regard to meals.) aThe safety and effectiveness of cefuroxime axetil tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection Dosage Duration
(days) Adolescents and Adults (13 years and older) Pharyngitis/tonsillitis 250 mg twice daily 10 Acute bacterial maxillary sinusitis 250 mg twice daily 10 Acute bacterial exacerbations of chronic bronchitis 250 or 500 mg twice daily 10a Secondary bacterial infections of acute bronchitis 250 or 500 mg twice daily 5-10 Uncomplicated skin and skin-structure infections 250 or 500 mg twice daily 10 Uncomplicated urinary tract infections 250 mg twice daily 7-10 Uncomplicated gonorrhea 1,000 mg once daily single dose Early Lyme disease 500 mg twice daily 20 Pediatric Patients (who can swallow tablets whole) Acute otitis media 250 mg twice daily 10 Acute bacterial maxillary sinusitis 250 mg twice daily 10
Patients With Renal Impairment

Because cefuroxime is eliminated primarily by the kidney, a dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 11.

Table 11. Dosing in Patients with Renal Impairment Creatinine Clearance (mL/min) Recommended Dosage ≥30 No dosage adjustment 10 to <30 Standard individual dose given every 24 hours <10 (without hemodialysis) Standard individual dose given every 48 hours Hemodialysis A single additional standard dose should be given at the end of each dialysis

No Recall
Ranbaxy Pharmaceuticals Inc.

Cefuroxime Axetil | Ranbaxy Pharmaceuticals Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4: Cefuroxime Axetil 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 to 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 to 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 cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

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.

No Recall
Rebel Distributors Corp

Cefuroxime Axetil | Rebel Distributors Corp

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

Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) * The safety and effectiveness of cefuroxime axetil administered
for less than 10 days in patients with acute exacerbations of
chronic bronchitis have not been established.

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

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.

No Recall
Ascend Laboratories, Llc

Cefuroxime Axetil | Ascend Laboratories, Llc

2.1 Important Administration Instructions Cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see Clinical Pharmacology (12.3)]. Administer cefuroxime axetil tablets as described in the appropriate dosage guidelines [see Dosage and Administration (2.2)]. Administer cefuroxime axetil tablets with or without food. Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration (2.2)]. 2.2 Dosage for Cefuroxime axetil Tablets
Administer cefuroxime axetil tablets as described in the dosage guidelines table below with or without food.

Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets

Infection
Dosage
Duration (Days)
Adults and Adolescents (13 years and older)
Pharyngitis/tonsillitis (mild to moderate)
250 mg every 12 hours
10
Acute bacterial maxillary sinusitis (mild to moderate)
250 mg every 12 hours
10
Acute bacterial exacerbations of chronic bronchitis (mild to moderate)
250 or 500 mg every 12 hours
10 a
Secondary bacterial infections of acute bronchitis
250 or 500 mg every 12 hours
5 to 10
Uncomplicated skin and skin-structure infections
250 or 500 mg every 12 hours
10
Uncomplicated urinary tract infections
250 mg every 12 hours
7 to 10
Uncomplicated gonorrhea
1,000 mg
Single dose
Early Lyme disease
500 mg every 12 hours
20
Pediatric Patients younger than 13 years (who can swallow tablets whole)b
Acute bacterial otitis media
250 mg every 12 hours
10
Acute bacterial maxillary sinusitis
250 mg every 12 hours
10

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

b When crushed, the tablet has a strong, persistent bitter taste. Therefore, patients who cannot swallow the tablet whole should receive the oral suspension.
2.5 Dosage in Patients with Impaired Renal Function
A dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology (12.3)].

Table 4. Dosing in Adults with Renal Impairment

Creatinine Clearance (mL/min)
Recommended Dosage
≥30
No dosage adjustment
10 to ˂30
Standard individual dose given every 24 hours
˂10 (without hemodialysis)
Standard individual dose given every 48 hours
Hemodialysis
A single additional standard dose should be given at the end of each dialysis

No Recall
Physicians Total Care, Inc.

Cefuroxime Axetil | Physicians Total Care, Inc.

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

Table 4. Cefuroxime Axetil 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 cefuroxime axetil administered
for less than 10 days in patients with acute exacerbations of
chronic bronchitis have not been established.

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.

No Recall
H.j. Harkins Company, Inc.

Cefuroxime Axetil | H.j. Harkins Company, Inc.

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

Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) Population/Infection Dosage Duration (days)
*The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
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

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.

No Recall
H.j. Harkins Company, Inc.

Cefuroxime Axetil | H.j. Harkins Company, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) *The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

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
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.

No Recall
Wockhardt Limited

Cefuroxime Axetil | Wockhardt Limited

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)
*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease
250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.
10
10
10*
5-10
10
7-10
single dose
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
Acute bacterial maxillary sinusitis
250 mg b.i.d.
250 mg b.i.d.
10
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.

No Recall
Wockhardt Usa Llc.

Cefuroxime Axetil | Wockhardt Usa Llc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)
*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease
250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.
10
10
10*
5-10
10
7-10
single dose
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
Acute bacterial maxillary sinusitis
250 mg b.i.d.
250 mg b.i.d.
10
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.

No Recall
Pd-rx Pharmaceuticals, Inc.

Cefuroxime Axetil | Pd-rx Pharmaceuticals, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)
*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease
250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.
10
10
10*
5-10
10
7-10
single dose
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
Acute bacterial maxillary sinusitis
250 mg b.i.d.
250 mg b.i.d.
10
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.

No Recall
Pd-rx Pharmaceuticals, Inc.

Cefuroxime Axetil | Pd-rx Pharmaceuticals, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)
*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease
250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.
10
10
10*
5-10
10
7-10
single dose
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
Acute bacterial maxillary sinusitis
250 mg b.i.d.
250 mg b.i.d.
10
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.

No Recall
Pd-rx Pharmaceuticals, Inc.

Cefuroxime Axetil | Pd-rx Pharmaceuticals, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)
*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease
250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.
10
10
10*
5-10
10
7-10
single dose
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
Acute bacterial maxillary sinusitis
250 mg b.i.d.
250 mg b.i.d.
10
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.

No Recall
Medvantx, Inc.

Cefuroxime Axetil | Medvantx, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY)
Table 4. Cefuroxime axetil Tablets (May be administered without regard to meals.) Population/Infection Dosage Duration (days) * The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established. 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 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.

No Recall
Stat Rx Usa Llc

Cefuroxime Axetil | Stat Rx Usa Llc

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)
*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease
250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.
10
10
10*
5-10
10
7-10
single dose
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
Acute bacterial maxillary sinusitis
250 mg b.i.d.
250 mg b.i.d.
10
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.

No Recall
Apotex Corp.

Cefuroxime Axetil | Cardinal Health

2.1     Adult Hypertension
The recommended starting dose of valsartan is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once a day.

The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.

No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of valsartan in patients with hepatic or severe renal impairment.

Valsartan may be administered with other antihypertensive agents.

Valsartan may be administered with or without food.
2.2     Pediatric Hypertension 6 to 16 Years of Age
For children who can swallow tablets, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total). The dosage should be adjusted according to blood pressure response. Doses higher than 2.7 mg/kg (up to 160 mg) once daily have not been studied in pediatric patients 6 to 16 years old.

For children who cannot swallow tablets, or children for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths of valsartan, the use of a suspension is recommended. Follow the suspension preparation instructions below (see Preparation of Suspension) to administer valsartan as a suspension. When the suspension is replaced by a tablet, the dose of valsartan may have to be increased. The exposure to valsartan with the suspension is 1.6 times greater than with the tablet.
No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m 2 [see Pediatric Use (8.4)] . Valsartan is not recommended for patients <6 years old [see Adverse Reactions (6.1), Clinical Studies (14.1)].
Preparation of Suspension (for 160 mL of a 4 mg/mL suspension)

Add 80 mL of Ora-Plus®* oral suspending vehicle to an amber glass bottle containing 8 valsartan 80 mg tablets, and shake for a minimum of 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 80 mL of Ora-Sweet SF®* oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients. The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30°C/86°F) or up to 75 days at refrigerated conditions (2-8°C/35-46°F) in the glass bottle with a child-resistant screw-cap closure. Shake the bottle well (at least 10 seconds) prior to dispensing the suspension.

*Ora-Sweet SF® and Ora-Plus® are registered trademarks of Paddock Laboratories, Inc.
2.3     Heart Failure
The recommended starting dose of valsartan is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.
2.4     Post-Myocardial Infarction
Valsartan may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of valsartan is 20 mg twice daily. Patients may be uptitrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction. Valsartan may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, and statins.

No Recall
A-s Medication Solutions Llc

Cefuroxime Axetil | A-s Medication Solutions Llc

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)
*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease
250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.
10
10
10*
5-10
10
7-10
single dose
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
Acute bacterial maxillary sinusitis
250 mg b.i.d.
250 mg b.i.d.
10
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.

No Recall
A-s Medication Solutions Llc

Cefuroxime Axetil | A-s Medication Solutions Llc

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) Population/Infection Dosage Duration (days)
*The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
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

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.

No Recall
Lupin Pharmaceuticals, Inc.

Cefuroxime Axetil | Gensavis Pharmaceuticals, Llc

DOSAGE AND ADMINISTRATION:

Adults and children over 12 years of age: 1 tsp. (5ml) daily. Total 24 servings (120 ml) in a bottle. Children under 12 years of age: take as directed by physician.

No Recall
Citron Pharma Llc

Cefuroxime Axetil | Burberry Limited

Apply liberally 15 mins before sun exposure. Reapply at least every 2 hrs. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.

No Recall
Pd-rx Pharmaceuticals, Inc.

Cefuroxime Axetil | Pd-rx Pharmaceuticals, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) *The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

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
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.

No Recall
Northstar Rx Llc

Cefuroxime Axetil | Jubilant Cadista Pharmaceuticals Inc.

Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Indomethacin extended-release capsules 75 mg are available for oral use. Indomethacin extended-release capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, indomethacin extended-release capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin extended-release capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.

Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.

Always give indomethacin extended-release capsules 75 mg with food, immediately after meals or with antacids to reduce gastric irritation.

Pediatric Use
Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:

1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.

The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):

Suggested Dosage:

The following recommendations on dosing pertain to immediate-release indomethacin capsules, USP and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.

Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.

In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.

The following information refers to extended-release Indomethacin Capsules (75 mg):

If indomethacin extended-release capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin extended-release capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, indomethacin extended-release capsules 75 mg may be prescribed as one capsule twice daily.

If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.

If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.

Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.

As advancing years appear to increase the possibility of adverse reactions, indomethacin extended-release capsules should be used with greater care in the aged.

2. Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.

The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.

No Recall
Clinical Solutions Wholesale

Cefuroxime Axetil | Clinical Solutions Wholesale

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.) *The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

Population/Infection

Dosage

Duration (days)

Adolescents and Adults (13 years and older)

Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease

250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.

10
10
10*
5-10
10
7-10
single dose
20

Pediatric Patients (who can swallow tablets whole)

Acute otitis media
Acute bacterial maxillary sinusitis

250 mg b.i.d.
250 mg b.i.d.

10
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.

No Recall
Aurobindo Pharma Limited

Cefuroxime Axetil | Aurobindo Pharma Limited

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

Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) *The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

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
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.

No Recall
Aurobindo Pharma Limited

Cefuroxime Axetil | Paramesh Banerji Life Sciences Llc

Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician.

No Recall
Gen-source Rx

Cefuroxime Axetil | Gen-source Rx

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

Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) *The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

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
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.

No Recall
Unit Dose Services

Cefuroxime Axetil | Unit Dose Services

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE ). CLINICAL PHARMACOLOGY
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.)
*The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis Acute bacterial maxillary sinusitis Acute bacterial exacerbations of chronic bronchitis Secondary bacterial infections of acute bronchitis Uncomplicated skin and skin-structure infections Uncomplicated urinary tract infections Uncomplicated gonorrhea Early Lyme disease

250 mg b.i.d. 250 mg b.i.d. 250 or 500 mg b.i.d. 250 or 500 mg b.i.d. 250 or 500 mg b.i.d. 125 or 250 mg b.i.d. 1,000 mg once 500 mg b.i.d.

10 10 10* 5-10 10 7-10 single dose 20

Pediatric Patients (who can swallow tablets whole)
Acute otitis media Acute bacterial maxillary sinusitis

250 mg b.i.d. 250 mg b.i.d.

10 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.

No Recall
Gen-source Rx

Cefuroxime Axetil | Cvs Pharmacy

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

No Recall
Direct Rx

Cefuroxime Axetil | Direct Rx

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Preferred Pharmaceuticals, Inc.

Cefuroxime Axetil | Preferred Pharmaceuticals, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM PER MILLIGRAM BASIS (see CLINICAL PHARMACOLOGY ).
Table 4: Cefuroxime Axetil Tablets(May be administered without regard to meals.) Population/Infection
Dosage
Duration (days)
* The safety and effectiveness of cefuroxime axetil tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
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

1000 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
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.

No Recall
Preferred Pharmaceuticals, Inc.

Cefuroxime Axetil | Preferred Pharmaceuticals, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) *The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

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
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.

No Recall
Preferred Pharmaceuticals, Inc.

Cefuroxime Axetil | Preferred Pharmaceuticals, Inc.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.) *The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

Population/Infection

Dosage

Duration (days)

Adolescents and Adults (13 years and older)

Pharyngitis/tonsillitis
Acute bacterial maxillary sinusitis
Acute bacterial exacerbations of chronic bronchitis
Secondary bacterial infections of acute bronchitis
Uncomplicated skin and skin-structure infections
Uncomplicated urinary tract infections
Uncomplicated gonorrhea
Early Lyme disease

250 mg b.i.d.
250 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
250 or 500 mg b.i.d.
125 or 250 mg b.i.d.
1,000 mg once
500 mg b.i.d.

10
10
10*
5-10
10
7-10
single dose
20

Pediatric Patients (who can swallow tablets whole)

Acute otitis media
Acute bacterial maxillary sinusitis

250 mg b.i.d.
250 mg b.i.d.

10
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.

No Recall