Recommended Topic Related To:

Suprax

"The Centers for Disease Control and Prevention (CDC) and the Department of Homeland Security's Customs & Border Protection (CBP) this week will begin new layers of entry screening at five U.S. airports that receive over 94 percent of traveler"...

Suprax

Indications
Dosage
How Supplied

INDICATIONS

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 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 (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

Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.

Otitis Media

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].

Pharyngitis and Tonsillitis

Pharyngitis and Tonsillitis caused by Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Suprax is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Suprax in the subsequent prevention of rheumatic fever is not available.)

Acute Exacerbations of Chronic Bronchitis

Acute Exacerbations of Chronic Bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.

Uncomplicated Gonorrhea (cervical/urethral)

Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).

DOSAGE AND ADMINISTRATION

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.

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

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
40.1 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
*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.

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]

In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

Renal Impairment

Suprax 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

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
* The preferred concentrations of oral suspension to use are 200 mg/5 mL or 500 mg/5 mL for patients with this renal dysfunction

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.

HOW SUPPLIED

Dosage Forms And Strengths

Suprax is available for oral administration in the following dosage forms and strengths:

  • Film-coated tablets provide 400 mg of cefixime as trihydrate. These are white to off-white, film-coated, capsule shaped tablets with beveled edges and a divided score line on each side. The tablet is debossed with “SUPRAX” across one side and “LUPIN” across the other side.
  • Capsules provide 400 mg of cefixime as trihydrate. These are size “00EL” capsules with pink opaque cap and pink opaque body with “LU” on the cap and “U43” on the body in black ink. Capsules contain white to yellowish white granular powder.
  • Chewable tablets provide either 100 mg or 150 mg or 200 mg of cefixime as trihydrate. The 100 mg tablet is pink, round tablet, debossed with “SUPRAX 100” on one side and “LUPIN” on other side. The 150 mg tablet is pink, round tablet, debossed with “SUPRAX 150” on one side and “LUPIN” on other side. The 200 mg tablet is pink, round tablet, debossed with “SUPRAX 200” on one side and “LUPIN” on other side.
  • Powder for oral suspension, when reconstituted, provides either 100 mg/5 mL or 200 mg/5 mL or 500 mg/5 mL of cefixime as trihydrate. For 100 mg/5 mL and 200 mg/5 mL, the powder has an off white to pale yellow color and is strawberry flavored. For 500 mg/5 mL, the powder has an off white to cream color and is strawberry flavored.

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

Manufactured for: Lupin Pharma Baltimore, Maryland 21202 United States. & Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Mandideep 462 046 India. Revised: March 2013

Last reviewed on RxList: 3/6/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Suprax - User Reviews

Suprax User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Suprax sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.