Cedax

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.

This product is available in the following dosage forms:

• Capsule
• Powder for Suspension

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:

1. 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.

2. Pediatric Population:
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.

3. Geriatric population:
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.

4. Pregnancy:
All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

5. Breastfeeding:
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.

6. Drug Interactions:
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.
• Warfarin

7. 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.

8. 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.

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.

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.

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.