Pronunciation:

sef-ti-BUE-ten

Brand Names:

• Cedax

Classifications:

Pharmacologic—

3rd Generation Cephalosporin

Uses of This Medicine:

Ceftibuten is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ceftibuten in children. However, safety and efficacy have not been established in infants younger than 6 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ceftibuten in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving ceftibuten.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live
• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Levonorgestrel
• Mestranol
• Methotrexate
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis (inflammation in gut), history of or
• Diarrhea, severe, history of—Use with caution. May make these conditions worse.

• Diabetes—The oral liquid form of this medicine contains sucrose (table sugar), which can make this condition worse.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take the oral liquid at least 2 hours before or 1 hour after a meal.

Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or suspension):
  • For infections:
    • Adults and teenagers—400 milligrams (mg) once a day for 10 days.
    • Infants and children 6 months up to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 9 milligrams (mg) per kilogram (kg) of body weight per day taken for 10 days.
    • Infants up to 6 months of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days.

Precautions While Using This Medicine:

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Ceftibuten may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you or your child have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Burning while urinating

confusion

decreased urination

difficult or labored breathing

difficult or painful urination

dizziness

dry mouth

fainting

fever

increase in heart rate

lightheadedness

rapid breathing

shortness of breath

sunken eyes

thirst

tightness in the chest

unusual tiredness or weakness

wheezing

wrinkled skin

Incidence not known

Abdominal or stomach cramps or tenderness

back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bloating

bloody or cloudy urine

bloody, black, or tarry stools

chest pain

chills

clay-colored stools

cloudy urine

cough or hoarseness

coughing up blood

dark urine

decrease in urine output or decrease in urine-concentrating ability

diarrhea

diarrhea, watery and severe, which may also be bloody

difficulty with breathing or swallowing

fast heartbeat

feeling of discomfort

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

fever with or without chills

general body swelling

general feeling of tiredness or weakness

high fever

hives

increased menstrual flow or vaginal bleeding

increased thirst

inflammation of the joints

itching

joint or muscle pain

loss of appetite

lower back or side pain

muscle aches

nausea or vomiting

noisy breathing

nosebleeds

pain

pale skin

paralysis

problems with speech or speaking

prolonged bleeding from cuts

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red or black, tarry stools

red or dark brown urine

red skin lesions, often with a purple center

red, irritated eyes

seizures

severe mood or mental changes

skin rash

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sudden decrease in the amount of urine

swollen lymph glands

swollen or painful glands

unpleasant breath odor

unusual behavior

unusual bleeding or bruising

unusual weight loss

vomiting of blood

wheezing

yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

belching

heartburn

indigestion

loose stools

stomach discomfort, upset, or pain

Rare

Agitation

bad, unusual, or unpleasant (after) taste

bloated, full feeling

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

constipation

cracks in the skin at the corners of the mouth

dry mouth

excess air or gas in the stomach or intestines

feeling unusually cold

full feeling

headache

hives or welts

increase in the body movements

irritability

itching of the vagina or genital area

pain during sexual intercourse

passing gas

redness of the skin

shivering

sleepiness or unusual drowsiness

sleeplessness

soreness or redness around the fingernails and toenails

stuffy nose

thick, white vaginal discharge with no odor or with a mild odor

trouble with sleeping

unable to sleep

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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