Vantin

What Is Vantin?

Vantin (cefpodoxime proxetil) is a cephalosporin antibiotic used to treat many different types of infections caused by bacteria. Vantin is available in generic form.

What Are Side Effects of Vantin?

Common side effects of Vantin include:

• diarrhea,
• nausea,
• vomiting,
• stomach pain,
• bloating,
• gas,
• constipation,
• headache,
• tired feeling,
• stiff or tight muscles,
• back pain,
• muscle pain,
• anxiety,
• nervousness,
• feeling restless or hyperactive,
• numbness or tingly feeling,
• flushing (warmth or redness under your skin),
• dizziness,
• spinning sensation,
• strange dreams,
• nightmares,
• stuffy nose,
• dry mouth,
• unusual or unpleasant taste in your mouth,
• white patches or sores inside your mouth or on your lips,
• diaper rash in an infant taking liquid cefpodoxime,
• itching or skin rash, or
• vaginal itching or discharge.

Tell your doctor if you have unlikely but serious side effects of Vantin including:

• swelling of the ankles or feet,
• tiredness,
• fast or pounding heartbeat,
• trouble breathing,
• new signs of infection (e.g., fever, persistent sore throat),
• dark urine,
• persistent nausea or vomiting,
• yellowing eyes or skin,
• easy bruising or bleeding, or
• changes in the amount of urine.

Dosage for Vantin

The recommended dosages of Vantin and durations of treatment for adults and adolescents 12 and older depend on the condition being treated. Dose varies from 100-400 mg twice daily, from 7 to 14 days.

What Drugs, Substances, or Supplements Interact with Vantin?

Vantin may interact with lithium, probenecid, methotrexate, antiviral medicines, cancer medicines, diuretics (water pills), medications that reduce stomach acid, IV antibiotics, medicines used to prevent organ transplant rejection, medicines used to treat ulcerative colitis, or pain or arthritis medicines. Tell your doctor all medications you are taking.

Vantin During Pregnancy or Breastfeeding

During pregnancy, Vantin should be used only when prescribed. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Vantin (cefpodoxime proxetil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Vantin Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• fever, chills, sore throat, mouth sores, swollen glands, joint pain, or not feeling well;
• a seizure; or
• liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• diarrhea;
• nausea, stomach pain;
• headache;
• vaginal itching or discharge; or
• diaper rash in an infant using this medicine.

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.

Read the entire detailed patient monograph for Vantin (Cefpodoxmine Proxetil)

 

Vantin Professional Information

SIDE EFFECTS

Clinical Trials

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 7.0%

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. (See WARNINGS.)

Nausea 3.3%
Vaginal Fungal Infections 1.0%
Vulvovaginal Infections 1.3%
Abdominal Pain 1.2%
Headache 1.0%

Incidence Less Than 1%

By body system in decreasing order

Clinical Studies

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.

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%

Diarrhea 6.0%
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%
Vomiting 2.3%

Incidence Less Than 1%

Body: Localized abdominal pain, abdominal cramp, headache, monilia, generalized abdominal pain, asthenia, fever, fungal infection.

Digestive: Nausea, monilia, anorexia, dry mouth, stomatitis, pseudomembranous colitis.

Hemic & Lymphatic: Thrombocythemia, positive direct Coombs' test, eosinophilia, leukocytosis, leukopenia, prolonged partial thromboplastin time, thrombocytopenic purpura.

Metabolic & Nutritional: Increased SGPT.

Musculo-Skeletal: Myalgia.

Nervous: Hallucination, hyperkinesia, nervousness, somnolence.

Respiratory: Epistaxis, rhinitis.

Skin: Skin moniliasis, urticaria, fungal dermatitis, acne, exfoliative dermatitis, maculopapular rash.

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%

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

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.

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. (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.

Read the entire FDA prescribing information for Vantin (Cefpodoxmine Proxetil)