Lorabid Pulvules

In the U.S.

• Lorabid
• Lorabid Pulvules

Available Dosage Forms:

• Powder for Suspension
• Capsule

Therapeutic Class: Antibiotic

Pharmacologic Class: 2nd Generation Cephalosporin

Chemical Class: Carbacephem

Loracarbef 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 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

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.

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 than it does in younger adults.

Pregnancy

Breast Feeding

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.

Interactions with 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. Tell 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 eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Kidney disease—Kidney disease may increase the blood level of loracarbef, increasing 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:

• 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:

• Diarrhea
• loss of appetite
• nausea and vomiting
• stomach pain

• 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.

Applies to loracarbef: oral capsule, oral powder for reconstitution

General

Loracarbef (the active ingredient contained in Lorabid Pulvules) is generally well tolerated.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea (4.1%), nausea (1.9%), vomiting (1.4%), abdominal pain (1.4%), and anorexia. The incidence of side effects increases with higher doses. Pseudomembranous colitis has been reported in patients treated with beta-lactam antibiotics.[Ref]

Nervous system

Nervous system side effects have included headache (2.9%), somnolence, insomnia, and dizziness. Some beta-lactam antibiotics have been associated with seizures in renally impaired patients.[Ref]

Hypersensitivity

Hypersensitivity reactions have included rash (1.2%), urticaria, pruritus, and erythema multiforme. Anaphylaxis, serum-sickness-like reactions, and Stevens-Johnson syndrome have been reported rarely. Beta-lactam antibiotics have been associated with toxic epidermal necrolysis,[Ref]

Respiratory

Respiratory side effects have included rhinitis (1.6%).[Ref]

Hematologic

Hematologic side effects have included transient thrombocytopenia, leukopenia, and eosinophilia. Beta-lactam antibiotics as a class have been associated with agranulocytosis, aplastic anemia, hemolytic anemia, hemorrhage, positive direct Coombs' test, pancytopenia, neutropenia, and prolonged prothrombin time.[Ref]

Renal

Renal side effects have included transient elevations in serum creatinine and BUN. Some beta-lactam antibiotics have been associated with toxic nephropathy.[Ref]

Hepatic

Hepatic side effects have included transient elevations in AST (SGOT), ALT (SGPT), and alkaline phosphatase. Hepatic dysfunction including cholestasis with or without jaundice has been rarely reported. Some beta-lactam antibiotics have been associated with LDH elevations.[Ref]

A 73-year-old man developed itching and jaundice, pale stools, and right upper quadrant pain two weeks after completion of a four week course of loracarbef for pneumonia. Bilirubin, AST, ALT, alkaline phosphatase levels were elevated. Liver biopsy showed widening of portal areas, pericellular fibrosis, and irregular fibrous bands in the parenchyma. Swollen hepatocytes and cholestasis in the cytoplasma and canaliculi were observed. Lab values returned to normal after 10 weeks.[Ref]

Cardiovascular

Cardiovascular side effects have included vasodilatation.[Ref]

Genitourinary

Genitourinary side effects have included vaginitis (1.3%) and vaginal moniliasis (1.1%).[Ref]

Some side effects of Lorabid Pulvules may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.