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
Vantin Side Effects, and Drug Interactions - Cefpodoxime Proxetil
Vantin Side Effects, and Drug Interactions - Cefpodoxime Proxetil
SIDE EFFECTS
CLINICAL TRIALS
Film-coated Tablets (Multiple dose)
In clinical trials
using multiple doses
of cefpodoxime proxetil film-coated tablets, 3338 patients were
treated with the recommended dosages of cefpodoxime (100 to 400
mg Q 12 hours). There were
no deaths or permanent
disabilities thought related to drug
toxicity. Eighty-one (2.4%) patients discontinued medication due
to adverse events thought possibly- or probably-related to drug
toxicity. Sixty-six (66%) of the 100 patients who discontinued therapy
(whether thought related to drug
therapy or not) did
so because of gastrointestinal
disturbances, usually diarrhea. The percentage of cefpodoxime proxetil-treated
patients who discontinued study drug
because of adverse events was significantly greater at a dose
of 800 mg daily than at a
dose of 400 mg daily or at
a dose of 200 mg
daily. Adverse events thought possibly- or probably-related to cefpodoxime
in multiple dose
clinical trials (N=3338
cefpodoxime-treated patients) were:
Incidence Greater Than 1%:
Diarrhea or loose stool
were dose related: decreasing
from 10.6% of patients receiving 800 mg
per day to 5.9% for those
receiving 200 mg per day.
Of patients with diarrhea,
10% had C. difficile organism
or toxin in the stool. (See WARNINGS.)
|
Nausea
|
3. 8%
|
|
Vaginal Fungal Infections
|
3.1%
|
|
Abdominal Pain
|
1.6%
|
|
Rash
|
1.4%
|
|
Headache
|
1.1%
|
|
Vomiting
|
1.1%
|
Incidence Less Than 1%:
- Cardiovascular: Chest pain,
hypotension.
- Dermatologic: Fungal skin
infection, skin
scaling/peeling.
- Endocrine: Menstrual irregularity.
- Genital: Pruritus.
- Gastrointestinal: Flatulence, decreased salivation,
candidiasis. Pseudomembranous colitis.
- Hypersensitivity: Anaphylactic shock.
- Metabolic: Decreased appetite.
- Miscellaneous: malaise,
fever.
- Central Nervous System: Dizziness, fatigue,
anxiety, insomnia,
flushing nightmares, weakness.
- Respiratory: Cough, epistaxis.
- Special Senses: Taste alteration, eye
itching, tinnitus.
Granules for Oral Suspension (Multiple dose)
In clinical trials
using multiple doses of cefpodoxime proxetil granules for
oral suspension,
1586 pediatric patients
(90% of whom were less than 12 years of age) were treated with the
recommended dosages of cefpodoxime (10 mg/kg/day Q24 hours or divided
Q12 hours to a maximum
equivalent adult dose). There were no
deaths or permanent
disabilities in any of the patients in these studies. Twenty-three
patients (1.5%) discontinued medication due to adverse events thought
Possibly- or Probably-related to study drug. Primarily, these discontinuations
were for gastrointestinal
disturbances, usually diarrhea,
vomiting or diaper
area rashes.
Adverse events thought possibly- or probably-related to cefpodoxime
proxetil for oral suspension
in multiple dose
clinical trials (N=1586
cefpodoxime treated patients) were:
Incidence Greater Than 1%:
|
Diarrhea
|
5.7%
|
|
The incidence
of diarrhea
in infants and toddlers (age 6 months to
2 years) was 15.4%.
|
|
Diaper Rash/Fungal Skin Rash
|
2.3%
|
|
The incidence
of diaper rash
in infants and toddlers was 12.1%.
|
|
Other skin
rashes
|
1.8%
|
|
Vomiting
|
2.1%
|
Incidence Less Than 1%:
- Central Nervous System: Headache, irritability.
- Dermatologic: Exacerbation of acne,
exfoliative dermatitis.
- Genital: Pruritus or vaginitis.
- Gastrointestinal: Nausea, abdominal
pain, candidiasis,
decreased salivation, Pseudomembranous colitis.
- Metabolic: Decreased appetite.
- Miscellaneous: Fever.
- Psychiatric: Hyperactivity/nervousness.
- Respiratory: Epistaxis, rhintis.
Film-coated Tablets (Single dose)
In clinical trials
using a single dose of
cefpodoxime proxetil film-coated tablets, 509 patients were treated
with the recommended dosage
of cefpodoxime (200 mg). There were no
deaths or permanent
disabilities thought related to drug
toxicity in these studies.
Adverse events thought possibly- or probably-related to cefpodoxime
in single dose clinical
trials conducted in the United States were:
Incidence Greater Than 1%:
|
Nausea
|
1.4%
|
|
Diarrhea
|
1.2%
|
Incidence Less Than 1%:
- Central Nervous System: Dizziness, headache,
syncope.
- Dermatologic: Rash.
- Genital: Vaginitis.
- Gastrointestinal: Abdominal pain.
- Psychiatric: Anxiety.
Laboratory Changes (Adult patients)
Significant laboratory
changes that have been reported in adult
patients in clinical
trials of cefpodoxime proxetil, without regard to drug
relationship, were:
- Hepatic: Transient increases in AST
(SGOT), ALT (SGPT), GGT,
alkaline phosphates, bilirubin,
and LDH. Hematologic: Eosinophilia, leukocytosis, lymphocytosis,
granulocytosis, basophilia, monocytosis, thrombocytosis, decreased
hemoglobin, leukopenia,
neutropenia, lymphocytopenia,
thrombocytopenia, positive Coombs' test, and prolonged PT, and
PTT.
- Serum Chemistry: Increases in glucose,
decreases in glucose, decreases in serum
albumin, decreases
in serum total protein.
- Renal: Increases in BUN
and creatinine.
Most of these abnormalities were transient
and not clinically significant.
Laboratory Changes (Pediatric patients)
Significant laboratory
changes that have been reported in pediatric patients in clinical
trials of cefpodoxime proxetil, without regard to drug relationship,
were:
- Hematologic: Eosinophilia, decreased hemoglobin,
decreased hematocrit.
- Hepatic: Transiently increased ALT
(SGPT)
Most of these abnormalities were transient
and not clinically significant.
Post-marketing Experience
The following serious adverse experiences have been reported: allergic
reactions including Stevens-Johnson syndrome,
toxic epidermal necrolysis,
erythema multiforme and serum
sickness-like reactions, pseudomembranous colitis, bloody diarrhea
with abdominal pain,
ulcerative colitis,
rectorrhagia with hypotension,
anaphylactic shock, acute
liver injury,
in utero exposure with miscarriage, purpuric
nephritis, pulmonary
infiltrate with eosinophilia,
and eyelid dermatitis.
One death was attributed
to pseudomembranous colitis
and disseminated intravascular coagulation.
Cephalosporin Class Labeling
In addition to the
adverse reactions listed above which have been observed in patients
treated with cefpodoxime proxetil, the following adverse reactions
and altered laboratory
tests have been reported for cephalosporin
class antibiotics.
Adverse Reactions and Abnormal Laboratory Tests:
Renal dysfunction, toxic
nephropathy, hepatic
dysfunction including
cholestasis, spastic anemia,
hemolytic anemia,
serum sickness-like reaction,
hemorrhage, agranulocytosis, and pancytopenia. Several cephalosporins
have been implicated in triggering seizures, particularly in patients
with renal impairment
when the dosage was not
reduced. (See DOSAGE AND ADMINISTRATION
and OVERDOSAGE.) If seizures
associated with drug therapy
occur, the drug should
be discontinued. Anticonvulsant therapy
can be given if clinically indicated.
DRUG INTERACTIONS
Antacids: Concomitant administration
of high doses of antacids (sodium bicarbonate
and aluminum hydroxide)
or H2 backers reduces peak plasma
levels by 24% to 42% and the extent of absorption
by 27% to 32%, respectively. The rate
of absorption is
not altered by these concomitant medications. Oral anti-cholinergics
(e.g., propantheline) delay peak plasma levels (47% increase in
Tmax), but do not affect
the extent of absorption (AUC).
Probenecid: As
with other beta-lactam antibiotics, renal excretion of cefpodoxime
was inhibited by probenecid
and resulted in an approximately 31% increase in AUC
and 20% increase in peak cefpodoxime plasma levels.
Nephrotoxic drugs: Although nephrotoxicity has not
been noted when cefpodoxime proxetil was given alone, close monitoring
of renal function is advised when cefpodoxime proxetil is administered
concomitantly with compounds of known nephrotoxic potential.
Drug/Laboratory Test Interactions
Cephalosporins, including cefpodoxime proxetil, are known to occasionally
induce a positive direct
Coombs' test.
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