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Does cefpodoxime proxetil (Vantin) cause side effects?
Cefpodoxime proxetil (Vantin, Bantan) is a cephalosporin antibiotic used to treat middle ear infections (otitis media), tonsillitis, throat (pharyngitis), laryngitis, sinusitis, pneumonia, urinary tract infections (UTIs), skin structure or skin infections caused by susceptible bacteria, gonorrhea, and acute and chronic bronchitis (bacterial) in patients with chronic obstructive pulmonary disease (COPD).
Common side effects of cefpodoxime proxetil include diarrhea, nausea, abdominal pain, vomiting, skin rash, diaper rash, fever, muscle pain, allergic reactions, vaginitis, vaginal infections, itching, headaches, dizziness, and insomnia.
Serious side effects of cefpodoxime proxetil include pseudomembranous colitis, a potentially serious bacterial infection of the colon caused by a bacterium called Clostridium difficile (C. difficile colitis). Symptoms of pseudomembranous colitis include diarrhea, abdominal pain, fever, and shock.pregnancy because there are no adequate studies in pregnant women. Cefpodoxime proxetil is excreted in human milk. Women should decide whether to discontinue breastfeeding or to discontinue the drug.
What are the important side effects for cefpodoxime proxetil (Vantin)?
Side effects include:
- Abdominal pain
- Skin rash
- Diaper rash
- Muscle pain
- Allergic reactions
- Vaginal infections
Cefpodoxime should be avoided by patients who are allergic to cephalosporin type antibiotics. Since this drug is chemically related to penicillin, some patients allergic to penicillin also may have an allergic reaction (sometimes even life-threatening anaphylaxis) to cefpodoxime.
Possible serious side effects.
Like other antibiotics, cefpodoxime may cause a condition called pseudomembranous colitis, a potentially serious bacterial infection of the colon caused by a bacterium called Clostridium difficile (C. difficile colitis). Patients who develop this type of colitis as a result of antibiotic treatment can have signs and symptoms of:
- Abdominal pain
Cefpodoxime proxetil (Vantin) side effects list for healthcare professionals
Film-coated Tablets (Multiple dose)
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.
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.
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.
Musculo-skeletal - myalgia.
Special Senses - taste alterations, eye irritation, taste loss, tinnitus.
Granules For Oral Suspension (Multiple dose)
In clinical trials using multiple doses of cefpodoxime proxetil granules for oral suspension, 2128 pediatric patients (93% of whom were less than 12 years of age) were treated with the recommended dosages of cefpodoxime (10 mg/kg/day Q 24 hours or divided Q 12 hours to a maximum equivalent adult dose). There were no deaths or permanent disabilities in any of the patients in these studies. Twenty-four patients (1.1%) 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 rashes.
Adverse events thought possibly or probably related, or of unknown relationship to cefpodoxime proxetil for oral suspension in multiple-dose clinical trials (N=2128 patients treated with cefpodoxime) were:
Incidence Greater Than 1%
The incidence of diarrhea in infants and toddlers (age 1 month to 2 years) was 12.8%.
Diaper rash/Fungal skin rash 2.0% (includes moniliasis)
The incidence of diaper rash in infants and toddlers was 8.5%.
Other skin rashes 1.8%
Incidence Less Than 1%
Body: Localized abdominal pain, abdominal cramp, headache, monilia, generalized abdominal pain, asthenia, fever, fungal infection.
Hemic & Lymphatic: Thrombocythemia, positive direct Coombs' test, eosinophilia, leukocytosis, leukopenia, prolonged partial thromboplastin time, thrombocytopenic purpura.
Metabolic & Nutritional: Increased SGPT.
Nervous: Hallucination, hyperkinesia, nervousness, somnolence.
Respiratory: Epistaxis, rhinitis.
Special Senses: Taste perversion.
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%
Incidence Less Than 1%
Significant laboratory changes that have been reported in adult and pediatric patients in clinical trials of cefpodoxime proxetil, without regard to drug relationship, were:
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.
Renal: Increases in BUN and creatinine.
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, 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.
What drugs interact with cefpodoxime proxetil (Vantin)?
Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers 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).
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.
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.
Cefpodoxime proxetil (Vantin, Bantan) is a cephalosporin antibiotic used to treat middle ear infections (otitis media), tonsillitis, throat (pharyngitis), laryngitis, sinusitis, pneumonia, urinary tract infections (UTIs), and others. Common side effects of cefpodoxime proxetil include diarrhea, nausea, abdominal pain, vomiting, skin rash, diaper rash, fever, muscle pain, allergic reactions, vaginitis, vaginal infections, itching, headaches, dizziness, and insomnia.
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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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.