cefditoren (Rx)

Brand and Other Names:Spectracef
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg
  • 400mg

Chronic Bronchitis

Acute Bacterial Exacerbation of Chronic Bronchitis

400 mg PO q-12hr for 10 days

Pneumonia

Community-acquired

400 mg PO q12hr for 14 days

Other Infections

Pharyngitis, Tonsilitis, Uncomplicated Skin and Skin Structure Infections

200 mg PO q12hr for 10 days

Renal Impairment

CrCl 30-49 mL/minute/1.73 sq.meter: No more than 200 mg PO q12hr

CrCl <30 mL/minute/1.73/sq.meter: 200 mg PO qDay

End-stage: Dosing not established

Other Information

Take with meal to enhance absorption

Other Indications & Uses

(H. influenzae, H. parainfluenzae, S. pneumoniae, M. catarrhalis); pharyngitis/tonsillitis (S. pyogenes); skin infections (S. aureus, S. pyogenes)

<12 years old: Safety & efficacy not established

>12 years old: As in adults

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Interactions

Interaction Checker

and cefditoren

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (9)

              • argatroban

                cefditoren will increase the level or effect of argatroban by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity

              • BCG vaccine live

                cefditoren decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.

              • bivalirudin

                cefditoren will increase the level or effect of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity

              • cholera vaccine

                cefditoren, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

              • dalteparin

                cefditoren will increase the level or effect of dalteparin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity

              • enoxaparin

                cefditoren will increase the level or effect of enoxaparin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity

              • fondaparinux

                cefditoren will increase the level or effect of fondaparinux by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity

              • heparin

                cefditoren will increase the level or effect of heparin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity

              • warfarin

                cefditoren increases effects of warfarin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.

              Monitor Closely (25)

              • aluminum hydroxide

                aluminum hydroxide will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • azithromycin

                azithromycin decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • bazedoxifene/conjugated estrogens

                cefditoren will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • calcium carbonate

                calcium carbonate will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • cimetidine

                cimetidine will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • clarithromycin

                clarithromycin decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • demeclocycline

                demeclocycline decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • dexlansoprazole

                dexlansoprazole will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • dienogest/estradiol valerate

                cefditoren will decrease the level or effect of dienogest/estradiol valerate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. An alternate or additional form of birth control may be advisable during concomitant use.

              • doxycycline

                doxycycline decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • erythromycin base

                erythromycin base decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • erythromycin lactobionate

                erythromycin lactobionate decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • erythromycin stearate

                erythromycin stearate decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • estrogens conjugated synthetic

                cefditoren will decrease the level or effect of estrogens conjugated synthetic by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • famotidine

                famotidine will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • ibuprofen/famotidine

                ibuprofen/famotidine will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • minocycline

                minocycline decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • nizatidine

                nizatidine will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • probenecid

                probenecid will increase the level or effect of cefditoren by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • sodium bicarbonate

                sodium bicarbonate will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • sodium picosulfate/magnesium oxide/anhydrous citric acid

                cefditoren decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.

              • sodium zirconium cyclosilicate

                sodium zirconium cyclosilicate will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

              • tetracycline

                tetracycline decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.

              • voclosporin

                voclosporin, cefditoren. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (5)

              • chloramphenicol

                chloramphenicol decreases effects of cefditoren by pharmacodynamic antagonism. Minor/Significance Unknown.

              • choline magnesium trisalicylate

                cefditoren will increase the level or effect of choline magnesium trisalicylate by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • furosemide

                cefditoren increases toxicity of furosemide by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of nephrotoxicity.

              • rose hips

                rose hips will increase the level or effect of cefditoren by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • willow bark

                cefditoren will increase the level or effect of willow bark by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Diarrhea (11-15%)

              1-10%

              Nausea (4-6%)

              Headache (2-3%)

              Abdominal pain (2%)

              Dyspepsia (1-2%)

              Vomiting (1%)

              <1%

              Bacterial/fungal superinfection

              C. difficile colitis

              Hypersensitivity

              Increased bleeding time

              Stevens-Johnson syndrome

              Vaginal moniliasis

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              Warnings

              Contraindications

              Documented hypersensitivity to drug, penicillin, related compounds, or milk protein sodium caseinate; carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency

              Cautions

              May cause diarrhea, nausea, and vaginal moniliasis (yeast infection); pseudomembranous colitis may occur; clinical manifestations of carnitine deficiency may occur with prolonged use; prolonged use may result in emergence and overgrowth of resistant organisms; caution in breastfeeding

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              Pregnancy & Lactation

              Pregnancy Category: B

              Lactation: excretion in milk unknown; use with caution

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Half-Life: 1.2-2 hr

              Peak Plasma Time: 1.5-3 hr

              Excretion: urine

              Mechanism of Action

              Semi-synthetic cephalosporin administered as prodrug. Hydrolyzed by esterases during absorption and distributed in circulating blood as active cefditoren. Bactericidal activity results from inhibition of cell wall synthesis via affinity for penicillin-binding proteins. No dose adjustment necessary for mild renal impairment (CrCl 50-80 mgL/min/1.73 m2) or mild to moderate hepatic impairment.

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              cefditoren pivoxil oral
              -
              400 mg tablet
              cefditoren pivoxil oral
              -
              200 mg tablet
              Spectracef oral
              -
              400 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              cefditoren pivoxil oral

              CEFDITOREN - ORAL

              (SEF-di-TOR-en)

              COMMON BRAND NAME(S): Spectracef

              USES: Cefditoren is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics. It works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

              HOW TO USE: Take this medication by mouth as directed by your doctor, usually twice daily (every 12 hours) with a meal. The dosage is based on your medical condition and response to treatment.For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.This medication is not recommended for longer use (over several months) because of the increased risk of side effects.Tell your doctor if your condition lasts or gets worse.

              SIDE EFFECTS: Diarrhea, nausea, vomiting, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: easy bleeding/bruising, unusual tiredness, mental/mood changes (such as confusion), seizures, signs of kidney problems (such as change in the amount of urine), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), new signs of infection (such as sore throat that doesn't go away, fever, chills), swelling ankles/feet, sudden unexplained weight gain, muscle weakness, increased thirst/urination, signs of low blood sugar (such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, tingling hands/feet).This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new 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, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking cefditoren, tell your doctor or pharmacist if you are allergic to it; or to other antibiotics (such as penicillins, other cephalosporins); or if you have any other allergies. This product may contain inactive ingredients (such as milk protein), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, a certain metabolic disorder (carnitine deficiency), decreased muscle mass, stomach/intestinal disease (such as colitis).Cefditoren may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: drugs that decrease stomach acid (such as antacids, H2 blockers such as ranitidine).This medication may interfere with certain lab tests (such as Coombs' test, certain urine glucose tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures.

              NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.