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Uses
To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime for oral suspension USP and other antibacterial drugs, cefixime for oral suspension USP should be used only to treat 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefixime is a cephalosporin antibacterial indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria:
Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)
Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for cefixime than for the comparator. [See CLINICAL STUDIES (14).]
Pharyngitis and Tonsillitis caused by Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime for oral suspension USP is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime for oral suspension USP in the subsequent prevention of rheumatic fever is not available.)
Acute Exacerbations of Chronic Bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
History
There is currently no drug history available for this drug.
Other Information
Cefixime is a semisynthetic, cephalosporin antibacterial for oral administration. Chemically, it is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, 72-(Z)-[O-(carboxy methyl) oxime] trihydrate.
Molecular weight = 507.50 as the trihydrate. Chemical Formula is C16H15N5O7S2.3H2O.
The structural formula for cefixime is:
- Inactive ingredients contained in the powder for oral suspension are: colloidal silicon dioxide, strawberry Guarana flavor, sucrose, and xanthan gum.
Sources
Cefixime Manufacturers
-
Aurobindo Pharma Limited
Cefixime | Aurobindo Pharma Limited
2.1 Adults
The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule and tablet may be administered without regard to food.
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.
The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because cefixime for oral suspension is available in three different concentrations (100 mg/5 mL, 200 mg/5 mL, and 500 mg/5 mL).
Table 1. Suggested doses for pediatric patients
* The preferred concentrations of oral suspension to use are 100 mg/5 mL or 200 mg/5 mL for pediatric patients in these weight ranges. PEDIATRIC DOSAGE CHART
Doses are suggested for each weight range and rounded for ease of administration
Cefixime for Oral Suspension
Cefixime Chewable Tablet
100 mg/5 mL
200 mg/5 mL
500 mg/5 mL
Patient Weight
(kg)
Dose/Day
(mg)
Dose/Day
(mL)
Dose/Day
(mL)
Dose/Day (mL)
Dose
5 to 7.5*
50
2.5
--
--
--
7.6 to 10*
80
4
2
--
--
10.1 to 12.5
100
5
2.5
1
1 tablet of 100 mg
12.6 to 20.5
150
7.5
4
1.5
1 tablet of 150 mg
20.6 to 28
200
10
5
2
1 tablet of 200 mg
28.1 to 33
250
12.5
6
2.5
1 tablet of 100 mg and 1 tablet of 150 mg
33.1 to 40
300
15
7.5
3
2 tablets of 150 mg
40.1 to 45
350
17.5
9
3.5
1 tablet of 150 mg and 1 tablet of 200 mg
45.1 or greater
400
20
10
4
2 tablets of 200 mg
Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Cefixime chewable tablets must be chewed or crushed before swallowing.
Otitis media should be treated with the chewable tablets or suspension. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose.
Therefore, the tablet or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media. [See CLINICAL PHARMACOLOGY (12.3).]
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.
2.3 Renal ImpairmentCefixime for oral suspension may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.
Table 2. Doses for Adults with Renal Impairment * The preferred concentrations of oral suspension to use are 200 mg/5 mL or 500 mg/5 mL for patients with this renal dysfunction Renal Dysfunction
Cefixime for Oral Suspension
Tablet
Chewable Tablet
Creatinine Clearance (mL/min)
100 mg/5 mL
200 mg/5 mL
500 mg/5 mL
400 mg
200 mg
Dose/Day (mL)
Dose/Day (mL)
Dose/Day (mL)
Dose/Day
Dose/Day
60 or greater
Normal dose
Normal dose
Normal dose
Normal dose
Normal dose
21 to 59 *
OR renal hemodialysis*
13
6.5
2.6
Not Appropriate
Not Appropriate
20 or less OR continuous peritoneal dialysis
8.6
4.4
1.8
0.5 tablet
1 tablet
2.4 Reconstitution Directions for Oral Suspension
Strength
Bottle Size
Reconstitution Directions
100 mg/5 mL
100 mL
To reconstitute, suspend with 70 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
200 mg/5 mL
75 mL
To reconstitute, suspend with 52.5 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
100 mg/5 mL and
200 mg/5 mL
50 mL
To reconstitute, suspend with 35 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.
-
Lupin Pharmaceuticals, Inc.
Cefixime | Lupin Pharmaceuticals, Inc.
2.1 AdultsThe recommended dose of cefixime is 400 mg daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.
2.2 Pediatric Patients (6 months or older)The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because cefixime for oral suspension is available in two different concentrations (100 mg/5 mL and 200 mg/5 mL).
Table 1. Suggested doses for pediatric patients PEDIATRIC DOSAGE CHART
Doses are suggested for each weight range and rounded for ease of administration
Cefixime for Oral Suspension
100 mg/5 mL
200 mg/5 mL
Patient Weight
(kg)
Dose/Day
(mg)
Dose/Day
(mL)
Dose/Day
(mL)
5 to 7.5
50
2.5
--
7.6 to 10
80
4
2
10.1 to 12.5
100
5
2.5
12.6 to 20.5
150
7.5
4
20.6 to 28
200
10
5
28.1 to 33
250
12.5
6
33.1 to 40
300
15
7.5
40.1 to 45
350
17.5
9
45.1 or greater
400
20
10
Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose.
Otitis media should be treated with the suspension. Clinical trials of otitis media were conducted with the suspension, and the suspension results in higher peak blood levels than the tablet when administered at the same dose.
Therefore, the tablet should not be substituted for the suspension in the treatment of otitis media. [See CLINICAL PHARMACOLOGY (12.3)]
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.
2.3 Renal ImpairmentCefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.
Table 2. Doses for Adults with Renal Impairment * The preferred concentrations of oral suspension to use is 200 mg/5 mL for patients with this renal dysfunction Renal Dysfunction
Cefixime for Oral Suspension
Creatinine Clearance (mL/min)
100 mg/5 mL
200 mg/5 mL
Dose/Day (mL)
Dose/Day (mL)
60 or greater
Normal dose
Normal dose
21 to 59*OR renal hemodialysis* 13
6.5
20 or less
OR continuous peritoneal dialysis
8.6
4.4
2.4 Reconstitution Directions for Oral Suspension Strength
Bottle Size
Reconstitution Directions
200 mg/5 mL
75 mL
To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen
powder contents prior to reconstitution. Add approximately half the total amount of
water for reconstitution and shake well. Add the remainder of water and shake well.
100 mg/5 mL and
200 mg/5 mL
50 mL
To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen
powder contents prior to reconstitution. Add approximately half the total amount of
water for reconstitution and shake well. Add the remainder of water and shake well.
After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.
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