Suprax

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to cefixime.

If you are diabetic and test your urine for sugar, use Clinistix or TesTape (not Clinitest) to test your urine while taking this medication.

Do not let anyone else take your medication. Your prescription is probably not refillable..

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Cefixime is a semi-synthetic (partially man-made), oral antibiotic in the cephalosporin family of antibiotics. The cephalosporin family includes cephalexin (Keflex), cefaclor (Ceclor), cefuroxime (Zinacef), cefpodoxime (Vantin), cefprozil (Cefzil), and many injectable forms. Like other cephalosporins, cefixime stops bacteria from multiplying by preventing bacteria from forming the walls that surround them. The walls are necessary to protect bacteria from their environment and to keep the contents of the bacterial cell together; most bacteria cannot survive without a cell wall. Cefixime is active against a very wide spectrum of bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes (the cause of strep throat), Hemophilus influenzae, Moraxella catarrhalis, E. coli, Klebsiella, Proteus mirabilis, Salmonella, Shigella, and Neisseria gonorrhoeae. The FDA approved cefixime in April 1989.

Common side effects of cefixime include:

• diarrhea,
• nausea,
• abdominal pain,
• vomiting and,
• skin rash.

Other side effects include:

• fever,
• joint pain,
• arthritis,
• abnormal liver tests,
• vaginitis,
• itching,
• headaches, and
• dizziness.

The recommended adult dose for otitis media, tonsillitis, pharyngitis, and urinary tract infections is 400 mg once daily or divided and given as 200 mg every 12 hours. Pediatric patients (6 months and older) have a recommended dose of 8 mg/kg/day once daily or in two doses of 4/mg/kg every 12 hours.

Patients should be counseled that antibacterial drugs, including cefixime, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefixime is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefixime for oral suspension or cefixime chewable tablets or other antibacterial drugs in the future.

Phenylketonurics: Suprax (cefixime) Chewable Tablets contains 3.3 mg, 5 mg and 6.7 mg of phenylalanine per 100 mg, 150 mg and 200 mg strength, respectively.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

• Based on spectrum of activity, classified as a third generation cephalosporin.3 13 15 50 69 75 Expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins;2 3 5 14 23 59 60 75 less active against Enterobacteriaceae than some other third-generation cephalosporins.15 75 101

• Usually bactericidal.1 2 14 34 65 69 78

• Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.1 2 75

• Spectrum of activity includes many gram-positive and gram-negative aerobic bacteria;1 inactive against most anaerobic bacteria.2 14 23 59 60 75 Inactive against chlamydia, fungi, and viruses.1 2 b

• Gram-positive aerobes: Active in vitro against Streptococcus pneumoniae1 and Streptococcus pyogenes (group A β-hemolytic streptococci).1 2 3 13 14 20 23 50 59 60 66 77 78 79 Also active in vitro against S. agalactiae (group B streptococci)1 2 13 15 18 23 50 59 60 66 75 and groups C, F, and G streptococci.13 23 59 60 66 Most staphylococci, enterococci, and Listeria monocytogenes are resistant.1 2 3 13 14 18 20 23 59 60 66 69 75 78 101

• Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to cefixime, although results of in vitro susceptibility tests may indicate susceptibility.132

• Gram-negative aerobes: Active in vitro against Neisseria gonorrhoeae,1 2 3 5 11 14 23 59 60 75 Haemophilus influenzae (including β-lactamase-producing strains),1 2 3 5 8 10 13 14 18 20 23 50 59 65 66 68 75 76 77 78 Moraxella catarrhalis (including β-lactamase-producing strains),1 2 3 5 13 20 23 58 59 66 75 77 78 Escherichia coli,1 and Proteus mirabilis.1 15 21 23 59 60 75 Also active in vitro against H. parainfluenzae,1 2 8 13 Klebsiella,1 Pasteurella multocida,1 P. vulgaris,1 Providencia,1 Salmonella,1 Shigella,1 and Serratia.1 Most Enterobacter5 60 75 and Pseudomonas are resistant.2 5 13 14 15 20 23 59 60 66 75 101

Suprax (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins.

Information for Patients

Counsel patients that antibacterial drugs, including cefixime, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefixime is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefixime for oral suspension or cefixime chewable tablets or other antibacterial drugs in the future.

Counsel patients with phenylketonuria that Suprax chewable tablets contain aspartame, a source of phenylalanine as follows: Each Suprax chewable tablet contains 3.3 mg, 5 mg and 6.7 mg of phenylalanine per 100 mg, 150 mg and 200 mg strength, respectively.

Advise patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

ID#: 250330

Suprax® CEFIXIME FOR ORAL SUSPENSION USP

100 mg/5 mL

Rx only

NDC 68180-202-03: Bottle of 50 mL

Suprax® CEFIXIME FOR ORAL SUSPENSION USP

100 mg/5 mL

Rx only

NDC 68180-202-04: Bottle of 10 mL (Physician Sample Pack)

NDC 68180-202-05: Carton for 10 mL x 6 Bottles (Physician Sample Pack)