Lorabid Pulvules (Oral)

Loracarbef is used to treat bacterial infections in various parts of the body. It works by killing bacteria or stopping them from growing. This medicine will not work for colds, flu, or other viral infections.

Loracarbef is available only with your doctor's prescription.

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

In some patients, loracarbef may cause diarrhea.

• Severe diarrhea may indicate a serious side effect. Do not take any diarrhea medicine without first consulting your doctor. Diarrhea medicines may worsen your diarrhea or prolong it.
• For mild diarrhea, you may take diarrhea medicine containing kaolin or attapulgite (e.g., Kaopectate tablets, Diasorb). However, do not take other types of diarrhea medicine, as they may worsen your diarrhea or prolong it.
• If you have any questions about this or if mild diarrhea continues or worsens, contact your health care professional.

In deciding to use a medicine, the risks of taking it must be balanced with the benefits it will provide. 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 reactions to this medicine or any other medicines. Also let your healthcare professional know 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

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

Geriatric

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 compared to younger adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or specific types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been highlighted based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Kidney disease—Kidney disease may increase the blood level of loracarbef, raising the chance of 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 as soon as possible if any of the following side effects occur:

More common

• Itching
• skin rash

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:

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 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.

• Lorabid
• Lorabid Pulvules

Pharmacologic Class: Second generation cephalosporins

Chemical Class: loracarbef

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 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 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 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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.