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In the U.S.—

Lorabid

• Antibacterial, systemic

Loracarbef (loe-ra-KAR-bef) is used to treat bacterial infections in many different parts of the body. It works by killing bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections.

Loracarbef is available only with your doctor's prescription, in the following dosage forms:

Oral
• Capsules (U.S.)
• Oral suspension (U.S.)

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 loracarbef, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to loracarbef or to any related medicines such as penicillins or cephalosporins. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Loracarbef has not been studied in pregnant women. However, loracarbef has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether loracarbef passes into breast milk.

Children—This medicine has been tested in a limited number of children 6 months of age and older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Older adults—This medicine has been tested in a limited number of elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 loracarbef, it is especially important that your health care professional know if you are taking any of the following:

• Probenicid (e.g., Benemid)—Probenecid increases the blood level of loracarbef, increasing the chance of side effects

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

• Kidney disease—Kidney disease may increase the blood level of loracarbef, increasing the chance of side effects

Loracarbef should be taken at least 1 hour before or at least 2 hours after meals.

To help clear up your infection completely, keep taking loracarbef for the full time of treatment, even if you begin to feel better after a few days. If you have a ``strep'' infection, you should keep taking this medicine for at least 10 days. This is especially important in ``strep'' infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing—

The dose of loracarbef 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 loracarbef. Your dose may be different if you have kidney disease. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or teaspoonfuls of suspension 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 taking loracarbef.

• For oral dosage forms (capsules or oral suspension):
  • For bronchitis:
    • Adults and children 13 years of age and older—200 to 400 milligrams (mg) every twelve hours for seven days.
    • Children 6 months to 12 years of age—Use and dose to be determined by your doctor.
  • For otitis media (ear infection):
    • Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor.
  • For pneumonia:
    • Adults and children 13 years of age and older—400 mg every twelve hours for fourteen days.
    • Children 6 months to 12 years of age—Use and dose to be determined by your doctor.
  • For sinusitis:
    • Adults and children 13 years of age and older—400 mg every twelve hours for ten days.
    • Children 6 months to 12 years of age—Use and dose to be determined by your doctor.
  • For skin and soft tissue infections:
    • Adults and children 13 years of age and older—200 mg every twelve hours for seven days.
    • Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor.
  • For streptococcal pharyngitis (``strep throat''):
    • Adults and children 13 years of age and older—200 mg every twelve hours for ten days.
    • Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor.
  • For urinary tract infections:
    • Adults and children 13 years of age and older—200 to 400 mg every twelve to twenty-four hours for seven to fourteen days.
    • Children 6 months to 12 years of age—Use and dose to be determined by your doctor.

Missed dose—

If you do miss a dose of this medicine, take it as soon as possible. This will help to keep a constant amount of medicine in the blood or urine. 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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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

In some patients, loracarbef may cause diarrhea.

• Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor . Diarrhea medicines may make your diarrhea worse or last longer.
• For mild diarrhea, diarrhea medicine containing kaolin or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or last longer.
• If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

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 as soon as possible if any of the following side effects occur:

• More common
  • Itching;  skin rash 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Diarrhea;  loss of appetite;  nausea and vomiting;  stomach pain 
  
  

• Rare
  • Dizziness;  drowsiness;  headache;  itching or discharge from the vagina;  nervousness;  trouble in sleeping 
  
  

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

Revised: 06/20/1995