"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
Lorabid Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lorabid (loracarbef) is an antibiotic used to treat many different types of infections caused by bacteria. The brand name Lorabid is discontinued, but generic versions may be available. Common side effects of Lorabid (loracarbef) include itching or skin rash, nausea, vomiting, stomach pain or cramps, loss of appetite, diarrhea, flushing (warmth, redness, or tingling under your skin), headache, dizziness, drowsiness, vaginal itching or discharge, runny or stuffy nose, rash, or drowsiness.
Dosage of Lorabid depends on the disease being treated. Lorabid may interact with probenecid, or diuretics. Tell your doctor all medications and supplements you use. Lorabid is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Lorabid (loracarbef) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lorabid Overview - Patient Information: Side Effects
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lorabid (Loracarbef)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lorabid FDA Prescribing Information: Side Effects
The nature of adverse reactions to loracarbef are similar to those observed with orally administered b-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.
The following adverse events, irrespective of relationship to drug, have been reported following the use of loracarbef 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.
Central Nervous System: Headache (2.9%), somnolence, nervousness, insomnia, and dizziness.
Renal: Transient elevations in BUN and creatinine.
Cardiovascular System: Vasodilatation.
Genitourinary: Vaginitis (1.3%), vaginal moniliasis (1.1%).
As with other b-lactam antibiotics, the following potentially severe adverse experiences have been reported rarely with loracarbef in worldwide post-marketing surveillance: anaphylaxis, hepatic dysfunction including cholestasis, prolongation of the prothrombin time with clinical bleeding in patients taking anticoagulants, and Stevens-Johnson syndrome.
The incidences of several adverse events, irrespective of relationship to drug, following treatment with loracarbef were significantly different in the pediatric population and the adult population as follows (TABLE 12):
b-Lactam Antimicrobial Class Labeling
The following adverse reactions and altered laboratory test results have been reported in patients treated with b-lactam antibiotics:
Adverse Reactions: Allergic reactions, aplastic anemia, hemolytic anemia, hemorrhage, agranulocytosis, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy. As with other b-lactam antibiotics, serum sickness-like reactions have been reported rarely with loracarbef.
Several b-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.
Read the entire FDA prescribing information for Lorabid (Loracarbef)
Additional Lorabid Information
Lorabid - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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