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Cefuroxime Axetil Tablets, USP | Cefuroxime Axetil

05:39 EDT 27th August 2014 | BioPortfolio

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Cefuroxime axetil tablets are uncoated and contain the equivalent of 125, 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, microcrystalline cellulose and sodium lauryl sulfate.

IMAGE cefuroxime-str.jpg
Table 1. Postprandial Pharmacokinetics of Cefuroxime Administered as Cefuroxime Axetil Tablets to Adults*
*Mean values of 12 healthy adult volunteers.
Drug administered immediately after a meal.
Dose
(Cefuroxime
Equivalent)
Peak Plasma
Concentration
(mcg/mL)
Time of Peak
Plasma
Concentration (hr)
Mean
Elimination
Half-Life (hr)
AUC
(mcg-hr mL)
   125 mg
2.1
2.2
1.2
6.7
   250 mg
4.1
2.5
1.2
12.9
   500 mg
7
3
1.2
27.4
   1,000 mg
13.6
2.5
1.3
50
MIC (mcg/mL)
Interpretation
≤4
(S) Susceptible
8-16
(I) Intermediate
≥32
(R) Resistant
Microorganism
MIC (mcg/mL)
Escherichia coli ATCC 25922
2-8
Staphylococcus aureus ATCC 29213
0.5-2
Zone Diameter (mm)
Interpretation
≥23
(S) Susceptible
15-22
(I) Intermediate
≤14
(R) Resistant
Microorganism
Zone Diameter (mm)
Escherichia coli ATCC 25922
20-26
Staphylococcus aureus ATCC 25923
27-35

 

Table 2. Adverse Reactions— Cefuroxime Axetil Tablets Multiple-Dose Dosing Regimens—Clinical Trials
   Incidence ≥1%
   Diarrhea/loose stools                                        3.7%
   Nausea/vomiting                                               3%
   Transient elevation in AST                                2%
   Transient elevation in ALT                               1.6%
   Eosinophilia                                                     1.1%
   Transient elevation in LDH                                1%
   Incidence
      <1% but >0.1%
   Abdominal pain
   Abdominal cramps
   Flatulence
   Indigestion
   Headache
   Vaginitis
   Vulvar itch
   Rash
   Hives
   Itch
   Dysuria
   Chills
   Chest pain
   Shortness of breath
   Mouth ulcers
   Swollen tongue
   Sleepiness
   Thirst
   Anorexia
   Positive Coombs test
Table 3. Adverse Reactions— Cefuroxime Axetil Tablets 1-g Single-Dose Regimen for Uncomplicated Gonorrhea—Clinical Trials
   Incidence ≥1%
   Nausea/vomiting                            6.8%
   Diarrhea                                        4.2%
   Incidence
      <1% but >0.1%
   Abdominal pain
   Dyspepsia
   Erythema
   Rash
   Pruritus
   Vaginal candidiasis
   Vaginal itch
   Vaginal discharge
   Headache
   Dizziness
   Somnolence
   Muscle cramps
   Muscle stiffness
   Muscle spasm of neck
   Tightness/pain in chest
   Bleeding/pain in urethra
   Kidney pain
   Tachycardia
   Lockjaw-type reaction
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
Table 5. Clinical Effectiveness of Cefuroxime Axetil Tablets Compared to Beta-Lactamase Inhibitor-Containing Control Drug in the Treatment of Acute Bacterial Maxillary Sinusitis
*95% Confidence interval around the success difference [-0.08, +0.32].
95% Confidence interval around the success difference [-0.1, +0.16].
 
U.S. Patients*
South American Patients
Cefuroxime Axetil
(n = 49)
Control
(n = 43)
Cefuroxime Axetil
(n = 87)
Control
(n = 89)
   Clinical success
   (cure + improvement)
65%
53%
77%
74%
   Clinical cure
53%
44%
72%
64%
   Clinical improvement
12%
9%
5%
10%
Table 6. Clinical Effectiveness of Cefuroxime Axetil Tablets Compared to Doxycycline in the Treatment of Early Lyme Disease
* 95% confidence interval around the satisfactory difference for Part I (-0.08, +0.05).
95% confidence interval around the satisfactory difference for Part II (-0.13, +0.07).
n’s include patients assessed as unsatisfactory clinical outcomes (failure + recurrence) in Part I (cefuroxime axetil tablets - 11 [5 failure, 6 recurrence]; doxycycline - 8 [6 failure, 2 recurrence]).
§ Satisfactory clinical outcome includes cure + improvement (Part I) and success + improvement (Part II).
Part I
(1 Month Posttreatment)*
Part II
(1 Year Posttreatment)
Cefuroxime Axetil
(n = 125)
Doxycycline
(n = 108)
Cefuroxime Axetil
(n = 105)
Doxycycline
(n = 83)
   Satisfactory
   clinical outcome§
91%
93%
84%
87%
   Clinical cure/success
72%
73%
73%
73%
   Clinical improvement
19%
19%
10%
13%
Table 7. Clinical Effectiveness of Cefuroxime Axetil Tablets 250 mg Twice Daily in Secondary Bacterial Infections of Acute Bronchitis: Comparison of 5 Versus 10 Days’ Treatment Duration
*95% Confidence interval around the success difference [-0.164, +0.029].
95% Confidence interval around the success difference [-0.061, +0.103].
CAE-516 and CAE-517*
CAEA4001 and CAEA4002
5 day
(n = 127)
10 day
(n = 139)
5 day
(n = 173)
10 day
(n = 192)
   Clinical success
   (cure + improvement)
80%
87%
84%
82%
   Clinical cure
61%
70%
73%
72%
   Clinical improvement
19%
17%
11%
10%
IMAGE cefuroxime-fig3.jpg

Manufacturer

H.J. Harkins Company, Inc.

Active Ingredients

Source

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