ceftibuten (Rx)

Brand and Other Names:Cedax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 400mg

oral suspension

  • 90mg/5mL
  • 180mg/5mL

Infections

400 mg PO qDay for 10 days

Renal Impairment

CrCl 30-49 mL/min: 200 mg PO qDay or 4.5 mg/kg qDay

CrCl 5-29 mL/min: 100 mg PO qDay or 2.25 mg/kg qDay

Supplement following hemodialysis

Other Indications & Uses

Mild to moderate respiratory tract infections (ie, acute exacerbation of chronic bronchitis) caused by susceptible bacteria

AOM caused by susceptible bacteria & pharyngitis/tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci)

Off-label: UTI caused by susceptible bacteria

Dosage Forms & Strengths

capsule

  • 400mg

oral suspension

  • 90mg/5mL
  • 180mg/5mL

Infections

<6 months: Safety and efficacy not established

6-12 years old or <45 kg: 9 mg/kg PO qDay; 400 mg/day PO for 10 days maximum  

>12 years old or >45 kg: As in adults

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Interactions

Interaction Checker

and ceftibuten

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • BCG vaccine live

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

              • cholera vaccine

                ceftibuten, 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.

              • typhoid vaccine live

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

              Monitor Closely (16)

              • bazedoxifene/conjugated estrogens

                ceftibuten 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.

              • dienogest/estradiol valerate

                ceftibuten 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.

              • estradiol

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

              • estropipate

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

              • ethinylestradiol

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

              • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate

                ceftibuten will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.

              • mestranol

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

              • mycophenolate

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

              • pivmecillinam

                pivmecillinam, ceftibuten. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • probenecid

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

              • sodium picosulfate/magnesium oxide/anhydrous citric acid

                ceftibuten 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.

              • temocillin

                temocillin, ceftibuten. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • ticarcillin

                ticarcillin, ceftibuten. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • voclosporin

                voclosporin, ceftibuten. 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.

              • warfarin

                ceftibuten increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.

              • zinc

                zinc will decrease the level or effect of ceftibuten by cation binding in GI tract. Modify Therapy/Monitor Closely. Consider adminstering oral zinc salts at least 3 hr after ceftibuten.

              Minor (49)

              • aminohippurate sodium

                ceftibuten will increase the level or effect of aminohippurate sodium by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin

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

              • aspirin rectal

                ceftibuten will increase the level or effect of aspirin rectal by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin/citric acid/sodium bicarbonate

                ceftibuten will increase the level or effect of aspirin/citric acid/sodium bicarbonate by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • bendroflumethiazide

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

              • cefpodoxime

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

              • chloramphenicol

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

              • choline magnesium trisalicylate

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

              • etodolac

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

              • famotidine

                famotidine will decrease the level or effect of ceftibuten by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.

              • fenbufen

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

              • fenoprofen

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

              • flurbiprofen

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

              • furosemide

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

              • ganciclovir

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

              • hydrochlorothiazide

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

              • ibuprofen

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

              • ibuprofen/famotidine

                ibuprofen/famotidine will decrease the level or effect of ceftibuten by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.

              • indapamide

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

              • indomethacin

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

              • ketoprofen

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

              • ketorolac

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

              • ketorolac intranasal

                ceftibuten will increase the level or effect of ketorolac intranasal by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • lornoxicam

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

              • meclofenamate

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

              • mefenamic acid

                ceftibuten will increase the level or effect of mefenamic acid by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meloxicam

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

              • mesalamine

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

              • methyclothiazide

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

              • metolazone

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

              • nabumetone

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

              • naproxen

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

              • nizatidine

                nizatidine will increase the level or effect of ceftibuten by unspecified interaction mechanism. Minor/Significance Unknown.

              • oxaprozin

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

              • pantothenic acid

                ceftibuten will decrease the level or effect of pantothenic acid by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • parecoxib

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

              • piroxicam

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

              • pyridoxine

                ceftibuten will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • pyridoxine (Antidote)

                ceftibuten will decrease the level or effect of pyridoxine (Antidote) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • rose hips

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

              • salicylates (non-asa)

                ceftibuten will increase the level or effect of salicylates (non-asa) by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • salsalate

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

              • sulfasalazine

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

              • sulindac

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

              • thiamine

                ceftibuten will decrease the level or effect of thiamine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • tolfenamic acid

                ceftibuten will increase the level or effect of tolfenamic acid by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • tolmetin

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

              • valganciclovir

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

              • willow bark

                ceftibuten 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

              1-10%

              Increased BUN (4%)

              Nausea (4%)

              Diarrhea (3%)

              Headache (3%)

              Increased eosinophils (3%)

              Decreased hemoglobin (2%)

              Dyspepsia (2%)

              Thrombocytosis (2%)

              Abdominal pain (1%)

              Dizziness (1%)

              Increased ALT (1%)

              Increased bilirubin (1%)

              Vomiting (1%)

              <1%

              Anorexia

              Candidiasis

              Constipation

              Dysuria

              Agitation

              Fatigue

              Insomnia

              Irritability

              Paresthesia

              Rigors

              Diaper rash

              Urticaria

              Dry mouth

              Dyspnea

              Nasal congestion

              Increased transaminases

              Increased creatinine

              Leukopenia

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              Warnings

              Contraindications

              Documented hypersensitivity

              Cautions

              Diabetics: oral suspension contains 1 g sucrose/tsp

              Modify dosage in severe renal impairment; prolonged use may result in superinfection; caution in seizure disorder; may cause antibiotic associated colitis

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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: 2.4 hr

              Peak Plasma Time: 2-3 hr

              Absorption: rapid; food decreases peak concentrations, delays Tmax, & lowers AUC

              Vd: children: 0.5 L/kg; adults: 0.21 L/kg

              Excretion: urine (56%); feces (39%)

              Mechanism of Action

              Third-generation cephalosporin that is bactericidal. Inhibits cell wall mucopeptide synthesis.

              Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs)

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              Formulary

              FormularyPatient Discounts

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
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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.