Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Cedax

Descriptions


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

Before Using

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.

Pediatric

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.

Geriatric

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.

Pregnancy

Information about this ceftibuten-oral-route
Pregnancy Category Explanation
All Trimesters 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.

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.

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

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

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

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

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

  1. Burning while urinating
  2. confusion
  3. decreased urination
  4. difficult or labored breathing
  5. difficult or painful urination
  6. dizziness
  7. dry mouth
  8. fainting
  9. fever
  10. increase in heart rate
  11. lightheadedness
  12. rapid breathing
  13. shortness of breath
  14. sunken eyes
  15. thirst
  16. tightness in the chest
  17. unusual tiredness or weakness
  18. wheezing
  19. wrinkled skin

Incidence not known

  1. Abdominal or stomach cramps or tenderness
  2. back, leg, or stomach pains
  3. bleeding gums
  4. blistering, peeling, or loosening of the skin
  5. bloating
  6. bloody or cloudy urine
  7. bloody, black, or tarry stools
  8. chest pain
  9. chills
  10. clay-colored stools
  11. cloudy urine
  12. cough or hoarseness
  13. coughing up blood
  14. dark urine
  15. decrease in urine output or decrease in urine-concentrating ability
  16. diarrhea
  17. diarrhea, watery and severe, which may also be bloody
  18. difficulty with breathing or swallowing
  19. fast heartbeat
  20. feeling of discomfort
  21. feeling that others are watching you or controlling your behavior
  22. feeling that others can hear your thoughts
  23. feeling, seeing, or hearing things that are not there
  24. fever with or without chills
  25. general body swelling
  26. general feeling of tiredness or weakness
  27. high fever
  28. hives
  29. increased menstrual flow or vaginal bleeding
  30. increased thirst
  31. inflammation of the joints
  32. itching
  33. joint or muscle pain
  34. loss of appetite
  35. lower back or side pain
  36. muscle aches
  37. nausea or vomiting
  38. noisy breathing
  39. nosebleeds
  40. pain
  41. pale skin
  42. paralysis
  43. problems with speech or speaking
  44. prolonged bleeding from cuts
  45. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  46. red or black, tarry stools
  47. red or dark brown urine
  48. red skin lesions, often with a purple center
  49. red, irritated eyes
  50. seizures
  51. severe mood or mental changes
  52. skin rash
  53. sore throat
  54. sores, ulcers, or white spots on the lips or in the mouth
  55. sudden decrease in the amount of urine
  56. swollen lymph glands
  57. swollen or painful glands
  58. unpleasant breath odor
  59. unusual behavior
  60. unusual bleeding or bruising
  61. unusual weight loss
  62. vomiting of blood
  63. wheezing
  64. 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

  1. Acid or sour stomach
  2. belching
  3. heartburn
  4. indigestion
  5. loose stools
  6. stomach discomfort, upset, or pain

Rare

  1. Agitation
  2. bad, unusual, or unpleasant (after) taste
  3. bloated, full feeling
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. change in taste
  6. constipation
  7. cracks in the skin at the corners of the mouth
  8. dry mouth
  9. excess air or gas in the stomach or intestines
  10. feeling unusually cold
  11. full feeling
  12. headache
  13. hives or welts
  14. increase in the body movements
  15. irritability
  16. itching of the vagina or genital area
  17. pain during sexual intercourse
  18. passing gas
  19. redness of the skin
  20. shivering
  21. sleepiness or unusual drowsiness
  22. sleeplessness
  23. soreness or redness around the fingernails and toenails
  24. stuffy nose
  25. thick, white vaginal discharge with no odor or with a mild odor
  26. trouble with sleeping
  27. unable to sleep
  28. 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.