Cefuroxime Axetil (Page 2 of 6)

3 DOSAGE FORMS & STRENGTHS

Cefuroxime axetil tablets,USP 250 mg of cefuroxime (as cefuroxime axetil), are blue, capsule-shaped, biconvex, film-coated tablets with “204” debossed on one side and plain on the other side

Cefuroxime Axetil Tablets,USP 500 mg of cefuroxime (as cefuroxime axetil), are blue, capsule-shaped, biconvex, film-coated tablets with 203” debossed on one side and plain on the other side.

4 CONTRAINDICATIONS

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).

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylactic Reactions

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.

5.2 Clostridium difficile-associated Diarrhea

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.

5.3 Potential for Microbial Overgrowth

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

5.4 Development of Drug-resistant Bacteria

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.

5.6 Interference with Glucose Tests

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)].

6ADVERSE REACTIONS

The following serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label:

Anaphylactic Reactions [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

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.

Tablets

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.

Table 5. Adverse Reactions (≥1%) after Multiple-Dose Regimens with Cefuroxime Axetil Tablets

Adverse Reaction Cefuroxime Axetil (n = 912)
Blood and lymphatic system disorders
Eosinophilia 1%
Gastrointestinal disorders
Diarrhea 4%
Nausea/Vomiting 3%
Investigations
Transient elevation in AST 2%
Transient elevation in ALT 2%
Transient elevation in LDH 1%

The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 912) treated with cefuroxime axetil in multiple-dose clinical trials.

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, 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 in U.S. clinical trials.

Table 6. Adverse Reactions (≥1%) after Single-Dose Regimen with 1,000-mg Cefuroxime Axetil Tablets for Uncomplicated Gonorrhea

Adverse Reaction Cefuroxime axetil (n = 1,061)
Gastrointestinal disorders
Nausea/Vomiting 7%
Diarrhea 4%

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 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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