Lorabid Side Effects

Please note - some side effects for Lorabid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lorabid - for the Consumer

Lorabid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lorabid:

Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain; stuffy nose; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; decreased urination; fever; hoarseness; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; yellowing of the eyes or skin.

Lorabid Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lorabid Suspension:

Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain; stuffy nose; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; decreased urination; fever; hoarseness; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; yellowing of the eyes or skin.

Lorabid Side Effects - for the Professional

Lorabid

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:

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.

Side Effects by Body System

General

Loracarbef is generally well tolerated.

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.

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.

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,

Respiratory

Respiratory side effects have included rhinitis (1.6%).

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.

Renal

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

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.

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.

Cardiovascular

Cardiovascular side effects have included vasodilatation.

Genitourinary

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

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