Cedax (Oral)

Ceftibuten is used to treat bacterial infections in various parts of the body. It is part of a group of medicines called cephalosporin antibiotics. It works by killing bacteria or stopping them from growing. However, this medicine will not work for colds, flu, or other virus infections.

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

If your symptoms do not get better in a few days, or if they get worse, contact your doctor.

Ceftibuten may cause diarrhea, which can sometimes be severe. Do not take any medication or give any medication to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may worsen the diarrhea or make it last longer. If you have any questions about this, or if mild diarrhea continues or worsens, consult your doctor.

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

In deciding to use a medicine, you need to think about the risks versus the benefits. This is a choice you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Studies so far have not shown any specific problems in children that would limit the usefulness of ceftibuten. However, safety and effectiveness have not been established for infants younger than 6 months.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of ceftibuten. However, older adults may have age-related kidney issues, which could require caution and a dose adjustment when using ceftibuten.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a potential interaction. In these cases, your doctor may change the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below while using this medicine. The following interactions are significant but may not include all possibilities.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both are prescribed, your doctor may change the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food, especially certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

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

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

• Kidney disease—Use with caution. Effects may be increased because the medicine is removed from the body more slowly.

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

In the U.S.

• Cedax

Pharmacologic Class: 3rd Generation Cephalosporin

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.