A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lorabid Side Effects, and Drug Interactions - Loracarbef
Lorabid Side Effects, and Drug Interactions - Loracarbef
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.
All Patients
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.
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 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.
Pediatric Patients
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):
| TABLE 12 |
| 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% |
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.
Altered Laboratory Tests: Increased prothrombin
time, positive direct Coombs' test, elevated LDH, pancytopenia,
and neutropenia.
DRUG INTERACTIONS
Probenecid: As
with other b-lactam antibiotics, renal
excretion of loracarbef
is inhibited by probenecid
and resulted in an approximate
80% increase in the AUC
for loracarbef (see CLINICAL PHARMACOLOGY).
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