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Spectracef

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Overview

What is Spectracef?

SPECTRACEF® tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren.

cefditoren pivoxil

cefditoren pivoxil



What does Spectracef look like?



What are the available doses of Spectracef?

Sorry No records found.

What should I talk to my health care provider before I take Spectracef?

Sorry No records found

How should I use Spectracef?

SPECTRACEF® (cefditoren pivoxil) is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below.

Acute Bacterial Exacerbation of Chronic Bronchitis

Haemophilus influenzae

Haemophilus parainfluenzae

Streptococcus pneumoniae

Moraxella catarrhalis

Community-Acquired Pneumonia

Haemophilus influenzae

Haemophilus parainfluenzae

Streptococcus pneumoniae

Moraxella catarrhalis

Pharyngitis/Tonsillitis

Streptococcus pyogenes

Streptococcus pyogenes

Streptococcus pyogenes

Uncomplicated Skin and Skin-Structure Infections

Staphylococcus aureus

Streptococcus pyogenes.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF® and other antibacterial drugs, SPECTRACEF® should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

(See for Indicated Pathogens.)

SPECTRACEF® (cefditoren pivoxil) Dosage and Administration* Adults and Adolescents (≥12 Years)

*Should be taken with meals


What interacts with Spectracef?

Sorry No Records found


What are the warnings of Spectracef?

Sorry No Records found


What are the precautions of Spectracef?

Sorry No Records found


What are the side effects of Spectracef?

Sorry No records found


What should I look out for while using Spectracef?

SPECTRACEF® is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components.

SPECTRACEF® is contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency, because use of SPECTRACEF® causes renal excretion of carnitine. (See .)

SPECTRACEF® tablets contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered SPECTRACEF®.

BEFORE THERAPY WITH SPECTRACEF® (CEFDITOREN PIVOXIL) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDITOREN PIVOXIL, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFDITOREN PIVOXIL IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG ß-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFDITOREN PIVOXIL OCCURS, THE DRUG SHOULD BE DISCONTINUED. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefditoren pivoxil, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by is a primary cause of antibiotic-associated colitis.

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against colitis.


What might happen if I take too much Spectracef?

Information on cefditoren pivoxil overdosage in humans is not available. However, with other ß-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of cefditoren from the body, particularly if renal function is compromised (30% reduction of plasma concentrations following 4 hours of hemodialysis). Treat overdosage symptomatically and institute supportive measures as required.

In acute animal toxicity studies, cefditoren pivoxil when tested at the limit oral doses of 5100 mg/kg in rats and up to 2000 mg/kg in dogs did not exhibit any health effects of concern. Certain effects, such as diarrhea and soft stool lasting for a few days were observed in some animals as expected with most oral antibiotics due to inhibition of intestinal microflora.


How should I store and handle Spectracef?

SPECTRACEF® (cefditoren pivoxil) tablets containing cefditoren pivoxil equivalent to 200 mg or 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 200” or “CBP 400” in blue. These tablets are available in blister packages, as follow: