SUPRAX (Page 6 of 7)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Cefixime did not cause point mutations in bacteria or mammalian cells, DNA damage, or chromosome damage in vitro and did not exhibit clastogenic potential in vivo in the mouse micronucleus test. In rats, fertility and reproductive performance were not affected by cefixime at doses up to 25 times the adult therapeutic dose.

14 CLINICAL STUDIES

Comparative clinical trials of otitis media were conducted in nearly 400 children between the ages of 6 months to 10 years. Streptococcus pneumoniae was isolated from 47% of the patients, Haemophilus influenzae from 34%, Moraxella catarrhalis from 15% and S. pyogenes from 4%.

The overall response rate of Streptococcus pneumoniae to cefixime was approximately 10% lower and that of Haemophilus influenzae or Moraxella catarrhalis approximately 7% higher (12% when beta-lactamase positive isolates of H. influenzae are included) than the response rates of these organisms to the active control drugs.

In these studies, patients were randomized and treated with either cefixime at dose regimens of 4 mg/kg twice a day or 8 mg/kg once a day, or with a comparator. Sixty-nine to 70% of the patients in each group had resolution of signs and symptoms of otitis media when evaluated 2 to 4 weeks post-treatment, but persistent effusion was found in 15% of the patients. When evaluated at the completion of therapy, 17% of patients receiving cefixime and 14% of patients receiving effective comparative drugs (18% including those patients who had Haemophilus influenzae resistant to the control drug and who received the control antibiotic) were considered to be treatment failures. By the 2 to 4 week follow-up, a total of 30%-31% of patients had evidence of either treatment failure or recurrent disease.

(a)Number eradicated/number isolated.

(b)An additional 20 beta-lactamase positive isolates of Haemophilus influenzae were isolated, but were excluded from this analysis because they were resistant to the control antibiotic. In nineteen of these, the clinical course could be assessed and a favorable outcome occurred in 10. When these cases are included in the overall bacteriological evaluation of therapy with the control drugs, 140/185 (76%) of pathogens were considered to be eradicated.

Bacteriological Outcome of Otitis Media at Two to Four Weeks Post - Therapy Based on Repeat Middle Ear Fluid Culture or Extrapolation from Clinical Outcome
Organism Cefixime ( a ) 4 mg / kg BID Cefixime ( a ) 8 mg / kg QD Control ( a ) drugs
Streptococcus pneumoniae 48/70 (69%) 18/22 (82%) 82/100 (82%)
Haemophilus influenzae beta-lactamase negative 24/34 (71%) 13/17 (76%) 23/34 (68%)
Haemophilus influenzae beta-lactamase positive 17/22 (77%) 9/12 (75%) 1/1 (b)
Moraxella catarrhalis 26/31 (84%) 5/5 18/24 (75%)
S . pyogenes 5/5 3/3 6/7
All Isolates 120/162 (74%) 48/59 (81%) 130/166 (78%)

15 REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement, CLSI document M100-S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard — Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

16 HOW SUPPLIED/STORAGE AND HANDLING

Suprax® is available for oral administration in following dosage forms, strengths and packages listed in the table below:

Dosage Form Strength Description Package Size NDC Code Storage
White to off-white, film-coated, capsule shaped tablets with beveled edges and Bottles of 10 tablets 27437-201-10
Suprax ® ( cefixime ) Tablets USP 400 mg a divided score line on each side, debossed with “SUPRAX” across one side Bottle of 50 tablets 27437-201-08 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].
and “LUPIN” across other side, containing 400 mg of cefixime as the trihydrate. Bottle of 100 tablets 27437-201-01
Suprax ® ( cefixime ) Capsules 400 mg Size “00EL” capsules with pink opaque cap and pink opaque body, imprinted with “LU” on cap and “U43” on body in black Bottle of 50 capsules 27437-208-08 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].
ink, containing white to yellowish white granular powder containing 400 mg of cefixime as the trihydrate. Unit Dose Package of 10(1 blister of 10 capsules) 27437-208-11
Bottles of 10 tablets 27437-203-10
100 mg Pink, round tablet, debossed with “SUPRAX 100” on one side and “LUPIN” on other side. Bottle of 50 tablets 27437-203-08
Unit Dose Package of 10(1 blister of 10 tablets) 27437-203-11
Bottles of 10 tablets 27437-204-10
Suprax ® ( cefixime ) Chewable Tablets 150 mg Pink, round tablet, debossed with “SUPRAX 150” on one side and “LUPIN” on other side. Bottle of 50 tablets 27437-204-08 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].
Unit Dose Package of 10(1 blister of 10 tablets) 27437-204-11
Bottles of 10 tablets 27437-205-10
200 mg Pink, round tablet, debossed with “SUPRAX 200” on one side and “LUPIN” on other side. Bottle of 50 tablets 27437-205-08
Unit Dose Package of 10(1 blister of 10 tablets) 27437-205-11
Off-white to pale yellow colored powder. After reconstituted as Bottle of 50 mL 68180-202-03
100 mg/5 mL directed, each 5 mL of reconstituted suspension contains 100 mg of Bottle of 75 mL 68180-202-02
cefixime as the trihydrate. Bottle of 100 mL 68180-202-01
Bottle of 25 mL 27437-206-05
Bottle of 37.5 mL 27437-206-06 Prior to reconstitution: Store drug powder at
Suprax ® ( cefixime ) for Oral Suspension USP 200 mg/5 mL Off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of Bottle of 50 mL 27437-206-03 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].
reconstituted suspension contains 200 mg of cefixime as the trihydrate. Bottle of 75 mL 27437-206-02 After reconstitution: Store at room temperature or under refrigeration.Keep tightly closed.
Bottle of 100 mL 27437-206-01
500 mg/5 mL Off white to cream colored powder forming off-white to pale yellow suspension with characteristic fruity odor Bottle of 10 mL 27437-207-02
on constitution. After reconstituted as directed,each mL of reconstituted suspension contains 100 mg of cefixime as the trihydrate. Bottle of 20 mL 27437-207-03

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.