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Spectracef

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Spectracef

Spectracef

Spectracef Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Spectracef (cefditoren pivoxil) is used to treat many different types of bacterial infections that can cause bronchitis, tonsillitis, pneumonia, or skin infection. It is a cephalosporin antibiotic. Common side effects include diarrhea, headache, nausea/vomiting, or stomach upset.

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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Spectracef in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, mild diarrhea;
  • constipation, belching, upset stomach;
  • dry mouth, appetite changes;
  • headache, dizziness, feeling restless or hyperactive;
  • stiff or tight muscles;
  • 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;
  • mild itching or skin rash; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Spectracef (Cefditoren Pivoxil) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Spectracef Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, headache, nausea/vomiting, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: shortness of breath, swelling of the ankles/feet, muscle weakness, increased hunger, increased thirst/urination, dark urine, persistent nausea/vomiting, yellowing eyes/skin, change in the amount of urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: new signs of infection (e.g., fever, persistent sore throat), easy bleeding/bruising, tiredness, fast/pounding heartbeat, seizures, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Spectracef (Cefditoren Pivoxil)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Spectracef FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 - User Reviews

Spectracef User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Spectracef sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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.


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