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Spectracef

Last reviewed on RxList: 2/23/2017
Spectracef Side Effects Center

Last reviewed on RxList 1/22/2016

Spectracef (cefditoren pivoxil) is a cephalosporin antibiotic used to treat many different types of bacterial infections that can cause bronchitis, tonsillitis, pneumonia, or skin infection. Common side effects of Spectracef include diarrhea, headache, nausea, vomiting, stomach pain or upset, constipation, belching, dry mouth, appetite changes, dizziness, restlessness, hyperactivity, muscle stiffness or tightness, muscle pain, white patches or sores inside your mouth or on your lips, unusual or unpleasant taste in your mouth, trouble sleeping (insomnia), strange dreams, runny or stuffy nose, itching or skin rash, or vaginal itching or discharge.

The dose of Spectracef depends on the infection being treated. Doses range from 200-400 mg taken twice daily, for a duration of 10 to 14 days. Spectracef may interact with probenecid, blood thinners, or medications to reduce stomach acid such as antacids, cimetidine, famotidine, omeprazole, ranitidine, and others. Tell your doctor all medications you use. During pregnancy, Spectracef should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

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

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.

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Spectracef Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • a seizure (convulsions);
  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • swelling in your feet or ankles, feeling tired or short or breath;
  • easy bruising or bleeding (nosebleeds, bleeding gums); or
  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • indigestion, stomach pain;
  • headache; or
  • vaginal itching or discharge.

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 Spectracef (Cefditoren Pivoxil)

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Spectracef Professional Information

SIDE EFFECTS

Clinical Trials – SPECTRACEF® (cefditoren pivoxil) Tablets (Adults and Adolescent Patients ≥ 12 Years of Age)

In clinical trials, 4834 adult and adolescent patients have been treated with the recommended doses of cefditoren pivoxil tablets (200 mg or 400 mg BID). Most adverse events were mild and self-limiting. No deaths or permanent disabilities have been attributed to cefditoren. The following adverse events were thought by the investigators to be possibly, probably, or definitely related to cefditoren tablets in multiple-dose clinical trials:

Treatment-Related Adverse Events in Trials in Adults and Adolescent Patients ≥ 12 Years of Age

    SPECTRACEF Comparatorsa
N=2648
200 mg BID
N=2675
400 mg BID
N=2159
Incidence > 1% Diarrhea 11% 15% 8%
Nausea 4% 6% 5%
Headache 3% 2% 2%
Abdominal Pain 2% 2% 1%
Vaginal Moniliasis 3%b 6%c 6%d
Dyspepsia 1% 2% 2%
Vomiting 1% 1% 2%
aincludes amoxicillin/clavulanate, cefadroxil monohydrate, cefuroxime axetil, cefpodoxime proxetil, clarithromycin, and penicillin
b1428 females
c1135 females
d1461 females

The overall incidence of adverse events, and in particular diarrhea, increased with the higher recommended dose of SPECTRACEF®. Treatment related adverse events experienced by < 1% but >0.1% of patients who received 200 mg or 400 mg BID of cefditoren pivoxil were abnormal dreams, allergic reaction, anorexia, asthenia, asthma, coagulation time increased, constipation, dizziness, dry mouth, eructation, face edema, fever, flatulence, fungal infection, gastrointestinal disorder, hyperglycemia, increased appetite, insomnia, leukopenia, leukorrhea, liver function test abnormal, myalgia, nervousness, oral moniliasis, pain, peripheral edema, pharyngitis, pseudomembranous colitis, pruritus, rash, rhinitis, sinusitis, somnolence, stomatitis, sweating, taste perversion, thirst, thrombocythemia, urticaria, and vaginitis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment. (See WARNINGS.) Sixty-one of 2675 (2%) patients who received 200 mg BID and 69 of 2159 (3%) patients who received 400 mg BID of cefditoren pivoxil discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with cefditoren therapy. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea. Diarrhea was the reason for discontinuation in 19 of 2675 (0.7%) patients who received 200 mg BID and in 31 of 2159 (1.4%) patients who received 400 mg BID of cefditoren pivoxil.

Changes in laboratory parameters of possible clinical significance, without regard to drug relationship and which occurred in ≥ 1% of patients who received cefditoren pivoxil 200 mg or 400 mg BID, were hematuria (3.0% and 3.1%), increased urine white blood cells (2.3% and 2.3%), decreased hematocrit (2.1% and 2.2%), and increased glucose (1.8% and 1.1%). Those events which occurred in < 1% but > 0.1% of patients included the following: increased/decreased white blood cells, increased eosinophils, decreased neutrophils, increased lymphocytes, increased platelet count, decreased hemoglobin, decreased sodium, increased potassium, decreased chloride, decreased inorganic phosphorus, decreased calcium, increased SGPT/ALT, increased SGOT/AST, increased cholesterol, decreased albumin, proteinuria, and increased BUN. It is not known if these abnormalities were caused by the drug or the underlying condition being treated.

Cephalosporin Class Adverse Reactions

In addition to the adverse reactions listed above which have been observed in patients treated with cefditoren pivoxil, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics: Adverse Reactions: Allergic reactions, anaphylaxis, drug fever, Stevens-Johnson syndrome, serum sickness-like reaction, erythema multiforme, toxic epidermal necrolysis, colitis, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and superinfection. Altered Laboratory Tests: Prolonged prothrombin time, positive direct Coombs' test, false-positive test for urinary glucose, elevated alkaline phosphatase, elevated bilirubin, elevated LDH, increased creatinine, pancytopenia, neutropenia, and agranulocytosis. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION.) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Postmarketing Experience

The following adverse experiences, regardless of their relationship to cefditoren pivoxil, have been reported during extensive postmarketing experience, beginning with approval in Japan in 1994: pneumonia interstitial, eosinophilic pneumonia acute, acute renal failure, arthralgia, thrombocytopenia, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, anaphylaxis and anaphylactic shock.

Read the entire FDA prescribing information for Spectracef (Cefditoren Pivoxil)

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© Spectracef Patient Information is supplied by Cerner Multum, Inc. and Spectracef Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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