Suprax
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Questions & Answers
Side Effects & Adverse Reactions
BEFORE THERAPY WITH SUPRAX IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO SUPRAX OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime.
Antibiotics, including Suprax, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.
Treatment with broad spectrum antibiotics, including Suprax, alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of severe antibiotic-associated diarrhea including pseudomembranous colitis.
Pseudomembranous colitis has been reported with the use of Suprax and other broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, and cephalosporins); therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment and may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, management should include fluids, electrolytes, and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
To reduce the development of drug resistant bacteria and maintain the effectiveness of Suprax (cefixime) and other antibacterial drugs, Suprax 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Suprax is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis, (most of which are beta-lactamase positive) and S. pyogenes*.
Note: For information on otitis media caused by Streptococcus pneumoniae, see CLINICAL STUDIES section.
Pharyngitis and Tonsillitis, caused by S. pyogenes.
Note: Penicillin is the usual drug of choice in the treatment of S. pyogenes infections, including the prophylaxis of rheumatic fever. Suprax is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of Suprax in the subsequent prevention of rheumatic fever are not available.
Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains).
Uncomplicated gonorrhea (cervical/urethral), caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase- producing strains).
Appropriate cultures and susceptibility studies should be performed to determine the causative organism and its susceptibility to cefixime; however, therapy may be started while awaiting the results of these studies. Therapy should be adjusted, if necessary, once these results are known.
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.
History
There is currently no drug history available for this drug.
Other Information
Suprax (cefixime) is a semisynthetic, cephalosporin antibiotic 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-(carboxymethyl) oxime] trihydrate.
Molecular weight = 507.50 as the trihydrate. Chemical Formula is C16H15N5O7S2.3H2O
The structural formula for cefixime is:
Suprax is available for oral administration as 400 mg film coated tablets and as powder for oral suspension which when reconstituted provides either 100 mg/5 mL or 200 mg/5 mL of cefixime as trihydrate.
Inactive ingredients contained in the 400 mg tablets are: dibasic calcium phosphate, hypromellose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
The powder for oral suspension contains the following inactive ingredients: strawberry flavor, sodium benzoate, sucrose, colloidal silicon dioxide and xanthan gum.
Sources
Suprax Manufacturers
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Pd-rx Pharmaceuticals, Inc.
![Suprax (Cefixime) Tablet [Pd-rx Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Suprax | Pd-rx Pharmaceuticals, Inc.
Adults: The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet daily or as 200 mg tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.
Children: 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.
PEDIATRIC DOSAGE CHART
100 mg/5 mL
200 mg/5 mL
Patient Weight
(kg)
Dose/Day mg
Dose/Day mL
Dose/Day
tsp of Suspension
Dose/Day mL
Dose/Day
tsp of Suspension
6.25
50
2.5
½
1.25
¼
12.5
100
5
1
2.5
½
18.75
150
7.5
1½
3.75
¾
25
200
10
2
5
1
31.25
250
12.5
2½
6.25
1¼
37.5
300
15
3
7.5
1½
Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.
Otitis media should be treated with the suspension. Clinical studies 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.)
Efficacy and safety in infants aged less than six months have not been established.
In the treatment of infections due to S. pyogenes, a therapeutic dosage of Suprax should be administered for at least 10 days.
Renal ImpairmentSuprax 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. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval (i.e., 300 mg daily). Patients whose clearance is < 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (i.e., 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.
Reconstitution Directions For Oral Suspension Strength
Bottle Size
Reconstitution Directions
100 mg/5 mL and
200 mg/5 mL
100 mL
To reconstitute, suspend with 68 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
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.
200 mg/5 mL
37.5 mL
To reconstitute, suspend with 26 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
25 mL
To reconstitute, suspend with 17 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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Lupin Pharma
Suprax | Lupin Pharma
ALL RECOMMENDED DOSAGE FOR CEFIXIME SUSPENSION ARE INCLUDED IN THIS SECTION FOR INFORMATIONAL PURPOSE ONLY. SUPRAX (CEFIXIME) CHEWABLE TABLETS 100 MG ARE APPROPRIATE FOR A 100 MG DOSE, SUPRAX (CEFIXIME) CHEWABLE TABLETS 150 MG ARE APPROPRIATE FOR A 150 MG DOSE AND SUPRAX (CEFIXIME) CHEWABLE TABLETS 200 MG ARE APPROPRIATE FOR A 200 MG DOSE.
SUPRAX (CEFIXIME) CHEWABLE TABLETS MUST BE CHEWED OR CRUSHED BEFORE SWALLOWING.
Adults: The recommended dose is 400 mg daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.
Children: The recommended dose is 8 mg/kg/day of the cefixime. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
PEDIATRIC DOSAGE CHART
100 mg/5 mL
200 mg/5 mL
Suprax (cefixime) Chewable Tablet
Patient Weight
(kg)
Dose/Day
mg
Dose/Day
mL
Dose/Day
tsp of Suspension
Dose/Day
mL
Dose/Day
tsp of Suspension
Dose
6.25
50
2.5
½
1.25
¼
---
12.5
100
5
1
2.5
½
1 tablet of 100 mg
18.75
150
7.5
1½
3.75
¾
1 tablet of 150 mg
25
200
10
2
5
1
1 tablet of 200 mg
31.25
250
12.5
2½
6.25
1¼
1 tablet of 100 mg and 1 tablet of 150 mg
37.5
300
15
3
7.5
1½
2 tablets of 150 mg
Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.
Otitis media should be treated with Suprax (cefixime) chewable tablets or suspension. Clinical studies of otitis media were conducted with Suprax (cefixime) chewable tablets or suspension, and the Suprax (cefixime) chewable tablets or suspension results in higher peak blood levels than the immediate-release tablets when administered at the same dose. Therefore, the immediate-release tablets should not be substituted for Suprax (cefixime) chewable tablets or suspension in the treatment of otitis media. (See CLINICAL PHARMACOLOGY.)
Efficacy and safety in infants aged less than six months have not been established.
In the treatment of infections due to S. pyogenes, a therapeutic dosage of Suprax (cefixime) chewable tablets should be administered for at least 10 days.
Renal ImpairmentSuprax (cefixime) chewable tablets 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. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval (i.e., 300 mg daily). Patients whose clearance is < 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (i.e., 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.
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Bryant Ranch Prepack
Suprax | Bryant Ranch Prepack
Adults: The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet daily or as 200 mg tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.
Children: 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.
PEDIATRIC DOSAGE CHART
100 mg/5 mL
200 mg/5 mL
Patient Weight
(kg)
Dose/Day mg
Dose/Day mL
Dose/Day
tsp of Suspension
Dose/Day mL
Dose/Day
tsp of Suspension
6.25
50
2.5
½
1.25
¼
12.5
100
5
1
2.5
½
18.75
150
7.5
1½
3.75
¾
25
200
10
2
5
1
31.25
250
12.5
2½
6.25
1¼
37.5
300
15
3
7.5
1½
Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.
Otitis media should be treated with the suspension. Clinical studies 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.)
Efficacy and safety in infants aged less than six months have not been established.
In the treatment of infections due to S. pyogenes, a therapeutic dosage of Suprax should be administered for at least 10 days.
Renal ImpairmentSuprax 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. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval (i.e., 300 mg daily). Patients whose clearance is < 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (i.e., 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.
Reconstitution Directions For Oral Suspension Strength
Bottle Size
Reconstitution Directions
100 mg/5 mL and
200 mg/5 mL
100 mL
To reconstitute, suspend with 68 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
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.
200 mg/5 mL
37.5 mL
To reconstitute, suspend with 26 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
25 mL
To reconstitute, suspend with 17 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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A-s Medication Solutions Llc
Suprax | A-s Medication Solutions Llc
2.1 AdultsThe 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.
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 Suprax 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
Suprax (cefixime) for Oral Suspension
Suprax (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
40.1to 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. Suprax (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 ImpairmentSuprax 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
Suprax (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 and
200 mg/5 mL
100 mL
To reconstitute, suspend with 68 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
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.
200 mg/5 mL
37.5 mL
To reconstitute, suspend with 26 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
25 mL
To reconstitute, suspend with 17 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.
500 mg/5 mL
20 mL
To reconstitute, suspend with 14 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.
500 mg/5 mL
10 mL
To reconstitute, suspend with 8 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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Pd-rx Pharmaceuticals, Inc.
Suprax | Pd-rx Pharmaceuticals, Inc.
2.1 AdultsThe 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.
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 Suprax 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
Suprax (cefixime) for Oral Suspension
Suprax (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
40.1to 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. Suprax (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 ImpairmentSuprax 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
Suprax (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 and
200 mg/5 mL
100 mL
To reconstitute, suspend with 68 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
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.
200 mg/5 mL
37.5 mL
To reconstitute, suspend with 26 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
25 mL
To reconstitute, suspend with 17 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.
500 mg/5 mL
20 mL
To reconstitute, suspend with 14 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.
500 mg/5 mL
10 mL
To reconstitute, suspend with 8 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 Pharma
Suprax | Lupin Pharma
2.1 AdultsThe 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.
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 Suprax 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
Suprax (cefixime) for Oral Suspension
Suprax (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
40.1to 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. Suprax (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 ImpairmentSuprax 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
Suprax (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 and
200 mg/5 mL
100 mL
To reconstitute, suspend with 68 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
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.
200 mg/5 mL
37.5 mL
To reconstitute, suspend with 26 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
25 mL
To reconstitute, suspend with 17 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.
500 mg/5 mL
20 mL
To reconstitute, suspend with 14 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.
500 mg/5 mL
10 mL
To reconstitute, suspend with 8 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.
Suprax | Lupin Pharmaceuticals, Inc.
2.1 AdultsThe 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.
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 Suprax 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
Suprax (cefixime) for Oral Suspension
Suprax (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
40.1to 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. Suprax (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 ImpairmentSuprax 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
Suprax (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 and
200 mg/5 mL
100 mL
To reconstitute, suspend with 68 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
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.
200 mg/5 mL
37.5 mL
To reconstitute, suspend with 26 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
25 mL
To reconstitute, suspend with 17 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.
500 mg/5 mL
20 mL
To reconstitute, suspend with 14 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.
500 mg/5 mL
10 mL
To reconstitute, suspend with 8 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 Limited
Suprax | Lupin Limited
2.1 AdultsThe 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.
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 Suprax 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
Suprax (cefixime) for Oral Suspension
Suprax (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
40.1to 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. Suprax (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 ImpairmentSuprax 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
Suprax (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 and
200 mg/5 mL
100 mL
To reconstitute, suspend with 68 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
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.
200 mg/5 mL
37.5 mL
To reconstitute, suspend with 26 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
25 mL
To reconstitute, suspend with 17 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.
500 mg/5 mL
20 mL
To reconstitute, suspend with 14 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.
500 mg/5 mL
10 mL
To reconstitute, suspend with 8 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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