CEFUROXIME AXETIL- cefuroxime axetil tablet
Lupin Pharmaceuticals, Inc.
Cefuroxime axetil 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.
Limitations of Use
- The efficacy of cefuroxime axetil in the prevention of rheumatic fever was not established in clinical trials.
- The efficacy of cefuroxime axetil in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials.
Cefuroxime axetil 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.
Cefuroxime axetil 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-β-lactamase–producing strains only).
Limitations of Use
The effectiveness of cefuroxime axetil 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 [see CLINICAL STUDIES (14.1)].
Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 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).
Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including β– lactamase–producing strains) or Streptococcus pyogenes.
Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae.
Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 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.
Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with early Lyme disease (erythema migrans) caused by susceptible strains of Borrelia burgdorferi.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil 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.
- 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)].
|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*|
|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 ) †|
|Acute bacterial otitis media||250 mg every 12 hours||10|
|Acute bacterial maxillary sinusitis||250 mg every 12 hours||10|
A dosage interval adjustment is required for patients whose creatinine clearance is less than 30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see CLINICAL PHARMACOLOGY (12.3)].
|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|
- 250 mg of cefuroxime (as cefuroxime axetil) are white to off-white, capsule-shaped, film-coated tablets with “LUPIN” debossed on one side and “302” on the other side.
- 500 mg of cefuroxime (as cefuroxime axetil) are white to off-white, capsule-shaped, film-coated tablets with “LUPIN” debossed on one side and “303” on the other side.
Cefuroxime axetil is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on β-lactam antibacterials, including cefuroxime axetil [see ADVERSE REACTIONS (6.2)]. These reactions are more likely to occur in individuals with a history of β-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Cefuroxime axetil is contraindicated in patients with a known hypersensitivity to cefuroxime axetil or other β-lactam antibacterial drugs [see CONTRAINDICATIONS (4)]. Before initiating therapy with cefuroxime axetil, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue cefuroxime axetil and institute appropriate therapy.
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.
Prescribing cefuroxime axetil either in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
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 cefuroxime axetil [see DRUG INTERACTIONS (7.3)].
Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS (5.1)].
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Multiple-Dose Dosing Regimens with 7 to 10 Days’ Duration: In multiple-dose clinical trials, 912 subjects were treated with cefuroxime axetil (125 to 500 mg twice daily). It is noted that 125 mg twice daily is not an approved dosage. Twenty (2.2%) subjects discontinued medication due to adverse reactions. Seventeen (85%) of the 20 subjects who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of subjects treated with cefuroxime axetil who discontinued study drug because of adverse reactions was similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse reactions increased with the higher recommended doses.
The adverse reactions in Table 5 are for subjects (n = 912) treated with cefuroxime axetil in multiple-dose clinical trials.
|Adverse Reaction||Cefuroxime Axetil Tablets ( n = 912 )|
|Blood and lymphatic system disorders|
|Transient elevation in AST||2%|
|Transient elevation in ALT||2%|
|Transient elevation in LDH||1%|
Immune System Disorders: Hives, swollen tongue.
Metabolism and Nutrition Disorders: Anorexia.
Nervous System Disorders: Headache.
Cardiac Disorders: Chest pain.
Respiratory Disorders: Shortness of breath.
Gastrointestinal Disorders: Abdominal pain, abdominal cramps, flatulence, indigestion, mouth ulcers.
Skin and Subcutaneous Tissue Disorders: Rash, itch
Renal and Urinary Disorders: Dysuria.
Reproductive System and Breast Disorders: Vaginitis, vulvar itch.
General Disorders and Administration Site Conditions: Chills, sleepiness, thirst.
Investigations: Positive Coombs’ test.
Early Lyme Disease with 20-Day Regimen: Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice daily for 20 days. The most common drug-related adverse experiences were diarrhea (10.6%), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days’ dosing.
Single-Dose Regimen for Uncomplicated Gonorrhea: In clinical trials using a single 1,000-mg dose of cefuroxime axetil tablets, 1,061 subjects were treated for uncomplicated gonorrhea.
The adverse reactions in Table 6 were for subjects treated with a single dose of 1,000 mg cefuroxime axetil tablets in U.S. clinical trials.
|Adverse Reaction||Cefuroxime Axetil Tablets ( n = 1 , 061 )|
The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 1,061) treated with a single dose of cefuroxime axetil tablets 1,000 mg for uncomplicated gonorrhea in U.S. clinical trials.
Infections and Infestations: Vaginal candidiasis.
Nervous System Disorders: Headache, dizziness, somnolence.
Cardiac Disorders: Tightness/pain in chest, tachycardia.
Gastrointestinal Disorders: Abdominal pain, dyspepsia.
Skin and Subcutaneous Tissue Disorders: Erythema, rash, pruritus.
Musculoskeletal and Connective Tissue Disorders: Muscle cramps, muscle stiffness, muscle spasm of neck, lockjaw-type reaction.
Renal and Urinary Disorders: Bleeding/pain in urethra, kidney pain.
Reproductive System and Breast Disorders: Vaginal itch, vaginal discharge.
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