Cefpodoxime Proxetil Side Effects
Brand Names: Vantin
Please note - some side effects for Cefpodoxime Proxetil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Cefpodoxime Proxetil Side Effects - for the Professional
In clinical trials using multiple doses of Cefpodoxime Proxetil film-coated tablets, 4696 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. One-hundred twenty-nine (2.7%) patients discontinued medication due to adverse events thought possibly or probably related to drug toxicity. Ninety-three (52%) of the 178 patients who discontinued therapy (whether thought related to drug therapy or not) did so because of gastrointestinal disturbances, nausea, vomiting, or 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=4696 cefpodoxime-treated patients) were:
Incidence Greater Than 1%:
Diarrhea or loose stools were dose related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Of patients with diarrhea, 10% had C. difficile organism or toxin in the stool.
Vaginal Fungal Infections 1%
Vulvovaginal Infections 1.3%
Abdominal Pain 1.2%
Incidence Less Than 1%: By body system in decreasing order:
Adverse events thought possibly or probably related to Cefpodoxime Proxetil that occurred in less than 1% of patients (N=4696)
Body - fungal infections, abdominal distention, malaise, fatigue, asthenia, fever, chest pain, back pain, chills, generalized pain, abnormal microbiological tests, moniliasis, abscess, allergic reaction, facial edema, bacterial infections, parasitic infections, localized edema, localized pain.
Cardiovascular - congestive heart failure, migraine, palpitations, vasodilation, hematoma, hypertension, hypotension.
Digestive - vomiting, dyspepsia, dry mouth, flatulence, decreased appetite, constipation, oral moniliasis, anorexia, eructation, gastritis, mouth ulcers, gastrointestinal disorders, rectal disorders, tongue disorders, tooth disorders, increased thirst, oral lesions, tenesmus, dry throat, toothache.
Hemic and Lymphatic - anemia.
Metabolic and Nutritional - dehydration, gout, peripheral edema, weight increase.
Musculo-skeletal - myalgia.
Nervous - dizziness, insomnia, somnolence, anxiety, shakiness, nervousness, cerebral infarction, change in dreams, impaired concentration, confusion, nightmares, paresthesia, vertigo.
Respiratory - asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, sinusitis.
Skin - urticaria, rash, pruritus non-application site, diaphoresis, maculopapular rash, fungal dermatitis, desquamation, dry skin non-application site, hair loss, vesiculobullous rash, sunburn.
Special Senses - taste alterations, eye irritation, taste loss, tinnitus.
Urogenital - hematuria, urinary tract infections, metrorrhagia, dysuria, urinary frequency, nocturia, penile infection, proteinuria, vaginal pain.
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%:
Incidence Less Than 1%:
Central Nervous System: Dizziness, headache, syncope.
Gastrointestinal: Abdominal pain.
Significant laboratory changes that have been reported in adult and pediatric patients in clinical trials of Cefpodoxime Proxetil, without regard to drug relationship, were:
Hepatic: Transient increases in AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin, and LDH.
Hematologic: Eosinophilia, leukocytosis, lymphocytosis, granulocytosis, basophilia, monocytosis, thrombocytosis, decreased hemoglobin, decreased hematocrit, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, thrombocythemia, positive Coombs’ test, and prolonged PT, and PTT.
Serum Chemistry: Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia.
Renal: Increases in BUN and creatinine.
Most of these abnormalities were transient and not clinically significant.
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.
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, aplastic 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. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
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