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warnings
WARNINGS BEFORE THERAPY WITH LORABID IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO LORACARBEF, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO LORABID OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE THE USE OF EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with broad-spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.” After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug effective against C. difficile -associated colitis.
ADVERSE REACTIONS The nature of adverse reactions to loracarbef are similar to those observed with orally administered β-lactam antimicrobials. The majority of adverse reactions observed in clinical trials were of a mild and transient nature; 1.5% of patients discontinued therapy because of drug-related adverse reactions. No one reaction requiring discontinuation accounted for >0.03% of the total patient population; however, of those reactions resulting in discontinuation, gastrointestinal events (diarrhea and abdominal pain) and skin rashes predominated. All Patients The following adverse events, irrespective of relationship to drug, have been reported following the use of Lorabid in clinical trials. Incidence rates (combined for all dosing regimens and dosage forms) were less than 1% for the total patient population, except as otherwise noted: Gastrointestinal: The most commonly observed adverse reactions were related to the gastrointestinal system. The incidence of gastrointestinal adverse reactions increased in patients treated with higher doses. Individual event rates included diarrhea, 4.1%; nausea, 1.9%; vomiting, 1.4%; abdominal pain, 1.4%; and anorexia. Hypersensitivity: Hypersensitivity reactions including, skin rashes (1.2%), urticaria, pruritus, and erythema multiforme. Central Nervous System: Headache (2.9%), somnolence, nervousness, insomnia, and dizziness. Hemic and Lymphatic Systems: Transient thrombocytopenia, leukopenia, and eosinophilia. Hepatic: Transient elevations in AST (SGOT), ALT (SGPT), and alkaline phosphatase. Renal: Transient elevations in BUN and creatinine. Cardiovascular System: Vasodilatation. Genitourinary: Vaginitis (1.3%), vaginal moniliasis (1.1%). As with other β-lactam antibiotics, the following potentially severe adverse experiences have been reported rarely with loracarbef in worldwide post-marketing surveillance: anaphylaxis, hepatic dysfunction including cholestasis (with or without jaundice), prolongation of the prothrombin time with clinical bleeding in patients taking anticoagulants, and Stevens-Johnson syndrome. Pediatric Patients The incidences of several adverse events, irrespective of relationship to drug, following treatment with Lorabid were significantly different in the pediatric population and the adult population as follows: Event Pediatric Adult Diarrhea 5.8% 3.6% Headache 0.9% 3.2% Rhinitis 6.3% 1.6% Nausea 0.0% 2.5% Rash 2.9% 0.7% Vomiting 3.3% 0.5% Somnolence 2.1% 0.4% Anorexia 2.3% 0.3% β-Lactam Antimicrobial Class Labeling: The following adverse reactions and altered laboratory test results have been reported in patients treated with β-lactam antibiotics: Adverse Reactions —Allergic reactions, aplastic anemia, hemolytic anemia, hemorrhage, agranulocytosis, toxic epidermal necrolysis, renal dysfunction, and toxic nephropathy. As with other β-lactam antibiotics, serum sickness-like reactions have been reported rarely with loracarbef. Several β-lactam antibiotics have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Altered Laboratory Tests —Increased prothrombin time, positive direct Coombs' test, elevated LDH, pancytopenia, and neutropenia.