Cefpodoxime

Cefpodoxime is part of the drug class:

• Third generation cephalosporins

Serious side effects have been reported with cefpodoxime. See the "Drug Precautions" section.

Common side effects of cefpodoxime include the following:

• diarrhea
• nausea
• stomach pain
• vaginal fungal infections
• headache
• rash
• vomiting

This is not a complete list of cefpodoxime side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Usual Adult Dose for Bronchitis:

Acute bacterial exacerbation of chronic bronchitis: 200 mg orally every 12 hours for 10 days

Usual Adult Dose for Cystitis:

100 mg orally every 12 hours for 7 days

Usual Adult Dose for Gonococcal Infection -- Uncomplicated:

Uncomplicated urethral, cervical, or female anorectal infections: 200 mg orally one time

Alternatively, the Centers for Disease Control and Prevention suggest 400 mg orally one time may be effective for both male and female patients as an oral alternative for the treatment of uncomplicated gonorrhea of the cervix, urethra, or rectum.

Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.

The patient's sexual partner(s) should also be evaluated/treated.

Cefpodoxime is not indicated for pharyngeal N gonorrhoeae infections.

Usual Adult Dose for Gonococcal Infection -- Disseminated:

400 mg orally twice a day

Initial therapy for disseminated gonococcal infections requires parenteral therapy which should be continued for 24 to 48 hours after clinical improvement is observed. Oral therapy may then be administered to complete a total course of at least 1 week.

Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.

The patient's sexual partner(s) should also be evaluated/treated.

Usual Adult Dose for Pneumonia:

Community-acquired pneumonia: 200 mg orally every 12 hours for 14 days

Usual Adult Dose for Pyelonephritis:

100 mg orally every 12 hours
Therapy should be continued for about 14 days, depending on the nature and severity of the infection.

Usual Adult Dose for Sinusitis:

200 mg orally every 12 hours for 10 days

Usual Adult Dose for Skin or Soft Tissue Infection:

Uncomplicated infection: 400 mg orally every 12 hours for 7 to 14 days

Usual Adult Dose for Tonsillitis/Pharyngitis:

100 mg orally every 12 hours for 5 to 10 days
There are insufficient data to establish efficacy in the subsequent prophylaxis of rheumatic fever.

Usual Adult Dose for Upper Respiratory Tract Infection:

100 mg orally every 12 hours
Therapy should be continued for approximately 10 to 14 days, depending on the nature and severity of the infection.

Usual Pediatric Dose for Bronchitis:

Acute bacterial exacerbation of chronic bronchitis:
12 years or older: 200 mg orally every 12 hours for 10 days

Usual Pediatric Dose for Cystitis:

12 years or older: 100 mg orally every 12 hours for 7 days

Usual Pediatric Dose for Gonococcal Infection -- Uncomplicated:

Uncomplicated urethral, cervical, or female anorectal infections:
12 years or older: 200 mg orally one time

Alternatively, the Centers for Disease Control and Prevention suggest 400 mg orally one time may be effective for both male and female patients as an oral alternative for the treatment of uncomplicated gonorrhea of the cervix, urethra, or rectum.

Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.

The patient's sexual partner(s) should also be evaluated.

Cefpodoxime is not indicated for pharyngeal N gonorrhoeae infections.

Usual Pediatric Dose for Gonococcal Infection -- Disseminated:

12 years or older: 400 mg orally twice a day

Initial therapy for disseminated gonococcal infections requires parenteral therapy which should be continued for 24 to 48 hours after clinical improvement is observed. Oral therapy may then be administered to complete a total course of at least 1 week.

Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.

The patient's sexual partner(s) should also be evaluated/treated.

Usual Pediatric Dose for Otitis Media:

2 months through 12 years: 5 mg/kg/dose (maximum 200 mg) orally every 12 hours for 5 days
Maximum dose: 400 mg/day

Usual Pediatric Dose for Pneumonia:

Community-acquired pneumonia:
12 years or older: 200 mg orally every 12 hours for 14 days

Usual Pediatric Dose for Sinusitis:

2 months through 12 years: 5 mg/kg/dose (maximum 200 mg) orally every 12 hours for 10 days
Maximum dose: 400 mg/day

12 years or older: 200 mg orally every 12 hours for 10 days

Usual Pediatric Dose for Skin or Soft Tissue Infection:

Uncomplicated infection:
12 years or older: 400 mg orally every 12 hours for 7 to 14 days

Usual Pediatric Dose for Tonsillitis/Pharyngitis:

2 months through 12 years: 5 mg/kg/dose (maximum 100 mg) orally every 12 hours for 5 to 10 days
Maximum dose: 200 mg/day

12 years or older: 100 mg orally every 12 hours for 5 to 10 days

There are insufficient data to establish efficacy in the subsequent prophylaxis of rheumatic fever.

Refer to adult dosing.

Oral: Administer around-the-clock to promote less variation in peak and trough serum levels. Administer tablets with food; suspension may be administered without regard to food. Shake suspension well before using.

Concerns related to adverse effects:

• Beta-lactam allergy: Use with caution in patients with a history of beta-lactam allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

Applies to cefpodoxime: oral powder for suspension, oral tablet

Along with its needed effects, cefpodoxime may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cefpodoxime:

• Diarrhea
• loose stools

• Change in the color, amount, or odor of vaginal discharge

• Abdominal or stomach cramps or tenderness
• black, tarry stools
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody nose
• bloody or cloudy urine
• blurred vision
• burning while urinating
• chest pain
• collection of blood under the skin
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough or hoarseness
• cough producing mucus
• dark urine
• decreased urination
• decreased urine output
• deep, dark purple bruise
• diarrhea, watery and severe, which may also be bloody
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty with breathing or troubled breathing
• dilated neck veins
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• extreme fatigue
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth or heat
• fever or chills
• flushing or redness of the skin, especially on the face and neck
• frequent urge to urinate
• general body swelling
• headache
• hearing loss
• heavier menstrual periods
• increase in heart rate
• increased thirst
• increased urge to urinate during the night
• increased weight
• irregular breathing
• irregular heartbeat
• itching of the vagina or genital area
• itching, pain, redness, or swelling
• loss of appetite
• lower back or side pain
• nausea or vomiting
• nervousness
• noisy breathing
• nosebleeds
• pain
• pain during sexual intercourse
• pain or swelling of the treated skin
• pain or tenderness around the eyes and cheekbones
• pain, warmth, or burning in the fingers, toes, and legs
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• problems with vision or hearing
• rapid breathing
• rapid weight gain
• runny nose
• shortness of breath or troubled breathing
• skin rash
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• sunken eyes
• sweating
• swelling of the face, fingers, feet, or lower legs
• swelling or puffiness of the face
• swollen glands
• thick, white vaginal discharge with no odor or with a mild odor
• thirst
• tightness of the chest or wheezing
• tingling of the hands or feet
• troubled breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• waking to urinate at night
• weight gain
• wheezing
• wrinkled skin
• yellowing of the eyes or skin

• Abdominal or stomach pain
• blistering, peeling, or loosening of the skin
• bloody, black, or tarry stools
• clay-colored stools
• feeling of discomfort
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• inflammation of the joints
• irritation or inflammation of the eyelid
• itching
• joint or muscle pain
• muscle aches
• rectal bleeding
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sudden decrease in the amount of urine
• swollen lymph glands
• swollen or painful glands
• unpleasant breath odor
• vomiting of blood

Some side effects of cefpodoxime may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Accumulation of pus
• acid or sour stomach
• ankle, knee, or great toe joint pain
• bad, unusual, or unpleasant (after) taste
• belching
• blemishes on the skin
• bloated or full feeling
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• constipation
• cracks in the skin
• decreased appetite
• difficulty with moving
• dry skin
• excess air or gas in the stomach or intestines
• fear or nervousness
• feeling of constant movement of self or surroundings
• frequent urge to defecate
• general feeling of discomfort or illness
• hair loss
• headache, severe and throbbing
• heartburn
• hives or welts
• increase in body movements
• increased sweating
• increased thirst
• indigestion
• irritation or soreness of the mouth
• joint stiffness or swelling
• lack or loss of strength
• loss of heat from the body
• lower back or side pain
• muscle aching or cramping
• muscle pains or stiffness
• passing of gas
• peeling of the skin
• pimples
• poor concentration
• pressure in the stomach
• red, sore eyes
• red, swollen skin
• redness of the skin
• scaly skin
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• sleepiness or unusual drowsiness
• sleeplessness
• sore mouth or tongue
• soreness or redness around the fingernails and toenails
• stomach discomfort, upset, or pain
• stomach upset
• straining while passing stool
• swelling of the abdominal or stomach area
• swelling or inflammation of the mouth
• swollen, red, or tender area of infection
• trouble with sleeping
• unable to sleep
• white patches in the mouth, tongue, or throat

Applies to cefpodoxime: oral powder for reconstitution, oral tablet

Hypersensitivity

Hypersensitivity side effects have included rash and urticaria. Cross-reactivity in penicillin-allergic patients may occur. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, serum sickness-like reactions, and anaphylactic shock have been reported during postmarketing experience.[Ref]

Gastrointestinal

Diarrhea and loose stools may be dose-related and has been reported in 10.4% of patients taking 800 mg cefpodoxime per day, compared to 5.7% of patients taking 200 mg per day. Ten percent of these patients tested positive Clostridium difficile organisms or toxins.

C difficile was isolated in six of six volunteers given cefpodoxime for 10 days compared with one of six volunteers given placebo. The symptoms associated with C difficile were mild and did not result in withdrawal from the study. The excretion of C difficile in the stool was not statistically associated with the passage of loose stools and none of the subjects went on to develop pseudomembranous colitis.

In postmarketing experience reports, one death was attributed to pseudomembranous colitis and disseminated intravascular coagulation.[Ref]

Gastrointestinal side effects have included diarrhea (7%), nausea (3.3%), and abdominal pain (1.2%). Pseudomembranous colitis, 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, stomatitis, tenesmus, dry throat, toothache, taste alteration, and taste loss have been reported in less than 1% of patients. Pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, and rectorrhagia with hypotension have been reported during postmarketing experience.[Ref]

Hematologic

Hematologic side effects have included anemia (less than 1%), leukocytosis, lymphocytosis, granulocytosis, basophilia, monocytosis, thrombocytosis, decreased hemoglobin, decreased hematocrit, leukopenia, lymphocytopenia, thrombocythemia, neutropenia, thrombocytopenia and eosinophilia, positive Coombs' test, and prolonged PT and PTT. Most of these effects were transient and clinically insignificant. Easy bleeding or bruising has been reported. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, neutropenia, pancytopenia, and agranulocytosis.[Ref]

Hepatic

Hepatic side effects have included increased AST, ALT, GGT, alkaline phosphatase, bilirubin, and LDH. These changes have generally been transient and clinically insignificant. Acute liver injury has been reported during postmarketing experience. Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.[Ref]

Respiratory

Respiratory side effects have included asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, and sinusitis in less than 1% of patients. Pulmonary infiltrate with eosinophilia has been reported during postmarketing experience.[Ref]

Renal

Renal side effects have included increased BUN and creatinine. These changes have generally been transient and clinically insignificant. Purpuric nephritis has been reported during postmarketing experience. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.[Ref]

Dermatologic

Dermatologic side effects have included urticaria, rash, pruritus, diaphoresis, maculopapular rash, diaper rash, fungal dermatitis, acne, exfoliative dermatitis, desquamation, dry skin, hair loss, vesiculobullous rash, and sunburn in less than 1% of patients. Eyelid dermatitis has been reported during postmarketing experience.[Ref]

Nervous system

Nervous system side effects have included headache (1%). Dizziness, insomnia, somnolence, anxiety, shakiness, nervousness, cerebral infarction, change in dreams, impaired concentration, confusion, nightmares, paresthesia, vertigo, tinnitus, hallucination, hyperkinesia, syncope, and somnolence have been reported in less than 1% of patients. Some cephalosporins have been associated with seizures in renally impaired patients.[Ref]

Genitourinary

Genitourinary side effects have included vaginal fungal infections (1%) and vulvovaginal infections (1.3%). Hematuria, urinary tract infections, metrorrhagia, dysuria, urinary frequency, nocturia, penile infection, proteinuria, vaginitis, and vaginal pain have been reported in less than 1% of patients. Change in quantity of urine has been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects have included myalgia (less than 1%).[Ref]

Cardiovascular

Cardiovascular side effects have included congestive heart failure, palpitations, vasodilation, hematoma, migraine, hypertension, and hypotension in less than 1% of patients.[Ref]

Metabolic

Metabolic side effects have included dehydration, gout, peripheral edema, and weight increase in less than 1% of patients. Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia have been reported. These changes have generally been transient and clinically insignificant.[Ref]

Ocular

Ocular side effects have included eye irritation in less than 1% of patients.[Ref]

Other

Other side effects have included fungal infections, abdominal distention, malaise, fatigue, asthenia, fever, chest pain, back pain, chills, generalized pain, abnormal microbiological test, moniliasis, abscess, allergic reaction, facial edema, bacterial infections, parasitic infections, localized edema, and localized pain in less than 1% of patients.[Ref]

Endocrine

Endocrine side effects have included galactorrhea with cefpodoxime-associated hyperprolactinemia.[Ref]

Some side effects of cefpodoxime may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

100 mg orally every 12 hours for 7 days

100 mg orally every 12 hours for 5 to 10 days
There are insufficient data to establish efficacy in the subsequent prophylaxis of rheumatic fever.

Acute bacterial exacerbation of chronic bronchitis:
12 years or older: 200 mg orally every 12 hours for 10 days

Uncomplicated infection:
12 years or older: 400 mg orally every 12 hours for 7 to 14 days

Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following cephalosporin therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.

Cephalosporins may be associated with a fall in prothrombin activity. Risk factors include renal or hepatic impairment, poor nutritional state, a protracted course of antimicrobial therapy, and chronic anticoagulation therapy. Prothrombin times should be monitored and vitamin K therapy initiated if indicated.

Serious and occasionally fatal hypersensitivity reactions have been reported with antibiotics. The drug should be discontinued immediately at the first appearance of a skin rash or other signs of hypersensitivity. Severe, acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, cardiovascular support and airway management as clinically indicated.

Dosage adjustments are recommended in patients with renal insufficiency. Some cephalosporins have been associated with seizures in renally impaired patients with elevated serum concentrations. The drug should be discontinued if seizures occur. Nephrotoxicity has occurred with concomitant cephalosporins and aminoglycosides or potent diuretics. Renal function should be monitored, especially in elderly patients.