Cedax

Pregnancy Category: B

Lactation: excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the capsules at room temperature and away from excess heat and moisture (not in the bathroom). Keep liquid medicine in the refrigerator, closed tightly, and dispose of any unused medication after 14 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see DOSAGE AND ADMINISTRATION and Clinical Studies sections).

Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).

NOTE: In acute bacterial exacerbations of chronic bronchitis clinical trials where Moraxella catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control.

Acute Bacterial Otitis Media due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pyogenes.

NOTE: Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against Streptococcus pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered.

Pharyngitis and Tonsillitis due to Streptococcus pyogenes.

NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Ceftibuten is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the CEDAX (ceftibuten) product for the prophylaxis of subsequent rheumatic fever are not available.

Common side effects of Cedax include:

• nausea
• headache
• diarrhea
• upset stomach
• dizziness
• stomach pain
• vomiting

This is not a complete list of Cedax side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cedax. See the “Drug Precautions” section.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Ceftibuten is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Ceftibuten is used to treat many different types of infections caused by bacteria.

Ceftibuten may also be used for other purposes not listed in this medication guide.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;

• fever, chills, body aches, flu symptoms;

• unusual bleeding;

• blood in your urine;

• seizure (convulsions);

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• jaundice (yellowing of the skin or eyes);

• fever, swollen glands, rash or itching, joint pain, or general ill feeling;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

Less serious side effects may include:

• nausea, vomiting, stomach pain, upset stomach, belching, constipation, mild diarrhea;

• stiff or tight muscles;

• numbness or tingly feeling;

• headache, dizziness, drowsiness, tired feeling;

• feeling agitated, irritable, restless, or hyperactive;

• dry mouth;

• white patches or sores inside your mouth or on your lips;

• unusual or unpleasant taste in your mouth;

• stuffy nose, noisy breathing;

• sleep problems (insomnia);

• mild itching or skin rash;

• vaginal itching or discharge;

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration.1 5 28 29 31 Oral bioavailability is 75–90%.5

In adults, a 400-mg ceftibuten dose given as the oral suspension is bioequivalent to a 400-mg dose given as 400-mg capsules.40

Food

Food decreases rate and extent of absorption of ceftibuten; this effect is more pronounced with the oral suspension than with capsules.1 31

Distribution

Extent

Distributed into blister fluid,31 bronchial secretions,1 31 33 nasal secretions,31 sputum,1 middle ear fluid,1 31 32 tracheal secretions,31 and tonsillar tissue.41

Not known whether the drug crosses the placenta or is distributed into milk.1 66

Plasma Protein Binding

Approximately 65%.1

Elimination

Metabolism

Ceftibuten is present in plasma and urine principally as cis-ceftibuten; about 10% of a dose is converted in vivo to trans-ceftibuten.1 29 The trans-isomer has only about 12% of the antibacterial activity of the cis-isomer.1 30

Elimination Route

The cis- and trans-isomers of ceftibuten eliminated principally in urine.1 29 30 Approximately 56% of a dose eliminated in urine and 39% excreted in feces within 24 hours.1

Half-life

Adults with normal renal function: 2–2.6 hours.1 29 30 31

Children 6 months to 16 years of age: 1.9–2.5 hours.31 35

Special Populations

In renal impairment, plasma half-life averages 7.1–22.3 hours depending on creatinine clearance.1

Cedax (ceftibuten) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA. December, 1993.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests – Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA. December, 1993.

For inquires call 1-800-793-2145

Manufactured by:

Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC.

Whitehouse Station, NJ 08889, USA

Distributed by Pernix Therapeutics, LLC

Morristown, NJ 07960, USA

Rev. 03/15

34459029

Summary of Use during Lactation

Ceftibuten is acceptable to use during breastfeeding. Limited information indicates that single maternal doses of ceftibuten up to 200 mg produce low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, has been reported with cephalosporins, but these effects have not been adequately evaluated.

Drug Levels

Maternal Levels. After a single 200 mg oral dose of ceftibuten in 6 women, the drug was undetectable (<1 mg/L) at any time up to 24 hours after the dose.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Barr WH, Lin CC, Radwanski E et al. The pharmacokinetics of ceftibuten in humans. Diagn Microbiol Infect Dis. 1991;14:93-100. PMID: 2013216