sef-poe-DOX-eem

Therapeutic Classification: anti-infectives

Pharmacologic Classification: third generation cephalosporins

• Treatment of the following infections caused by susceptible organisms:
  • Skin and skin structure infections,
  • Uncomplicated urinary tract infections,
  • Uncomplicated gynecological infections including gonorrhea,
  • Respiratory tract infections,
  • Otitis media.

• Binds to the bacterial cell wall membrane, causing cell death.

• Bactericidal action against susceptible bacteria.

Spectrum:

• Similar to that of second-generation cephalosporins, but activity against staphylococci is less, whereas activity against gram-negative pathogens is greater, even for organisms resistant to first- and second-generation agents.
• Notable is increased action against:
  • Haemophilus influenzae (including -lactamase-producing strains),
  • Escherichia coli,
  • Klebsiella pneumoniae,
  • Neisseria gonorrhoeae,
  • Proteus.
• Not active against methicillin-resistant staphylococci or enterococci.

Absorption: Cefpodoxime proxetil is a prodrug that is converted to cefpodoxim (the active component) in GI tract during absorption; 50% absorbed after oral administration; absorption of tablets ↑ with food.

Distribution: Widely distributed. Crosses the placenta; enters breast milk.

Metabolism/Excretion: 29–33% excreted unchanged in urine.

Half-life: 2–3 hr (↑ in renal impairment).

(blood levels)

Contraindicated in:

• Hypersensitivity to cephalosporins
• Serious hypersensitivity to penicillins
• Lactation: Lactation.

Use Cautiously in:

• Renal impairment (↑ dosing interval recommended if CCr <30 mL/min)
• History of GI disease, especially colitis
• Geri: Dose adjustment due to age-related ↓ in renal function may be necessary
• OB: Pedi: Pregnancy and infants <2 mo (safety not established).

CNS: SEIZURES (VERY HIGH DOSES), headache.

GI: CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, abdominal pain, nausea, vomiting.

Derm: rash, urticaria.

GU: vaginal moniliasis.

Hemat: bleeding, blood dyscrasias, hemolytic anemia.

Misc: ALLERGIC REACTIONS INCLUDING ANAPHYLAXIS , superinfection.

Drug-Drug:

• Probenecid↓ excretion and ↑ blood levels.
• Concurrent use of loop diuretics or nephrotoxic agents including aminoglycosides may ↑ risk of nephrotoxicity.
• Antacids or histamine H2 receptor antagonists↓ absorption of cefpodoxime (take 2 hr before or after).

• PO (Adults and Children 12 yr): Most infections — 200 mg every 12 hr; Skin and skin structure infections — 400 mg every 12 hr; Urinary tract infections/pharyngitis — 100 mg every 12 hr; Gonorrhea — 200 mg single dose.
• PO (Children 2 mo–12 yr): Pharyngitis/tonsillitis/otitis media/acute maxillary sinusitis — 5 mg/kg every 12 hr (not to exceed 200 mg/dose).

(Generic available)

• Tablets: 100 mg; 200 mg;
• Oral suspension (lemon creme flavor): 50 mg/5 mL; 100 mg/5 mL;

• Assess patient for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
• Before initiating therapy, obtain a history to determine previous use of and reactions to penicillins or cephalosporins. Persons with a negative history of penicillin sensitivity may still have an allergic response.
• Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
• Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue the drug and notify the physician or other health care professional immediately if these symptoms occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
• Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of Clostridium difficile-associated diarrhea (CDAD). May begin up to several wk following cessation of therapy.

• May cause positive results for Coombs' test.
  • May cause ↑ serum AST, ALT, alkaline phosphatase, bilirubin, LDH, BUN, and creatinine.
  • May rarely cause leukopenia, neutropenia, agranulocytosis, thrombocytopenia, eosinophilia, lymphocytosis, and thrombocytosis.

• PO: Administer around the clock. Administer tablets with meals to enhance absorption. Suspension may be administered without regard to meals. Shake oral suspension well before administering. Suspension is stable for 14 days after reconstitution in refrigerator.
  • Do not administer concurrently with antacids or other drugs taken to reduce stomach acid.

• Instruct patient to take medication at evenly spaced times and to finish the medication completely, even if feeling better. Take missed doses as soon as possible unless almost time for next dose; do not double doses. Instruct patient to use calibrated measuring device with suspension. Advise patient that sharing of this medication may be dangerous.
• Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
• Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.

• Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.

Vantin

Simplicef

• Risk for infection (Indications, Side Effects).
• Diarrhea (Adverse Reactions).
• Deficient knowledge, Relate med (Patient/Family Teaching).

NDC Code^*

• 0781- Sandoz Inc
  • 0781-5438- Cefpodoxime Proxetil
    • 0781-5438-01- 100 TABLET, FILM COATED in 1 BOTTLE (0781-5438-01)

• 0781- Sandoz Inc
  • 0781-5438- Cefpodoxime Proxetil
    • 0781-5438-20- 20 TABLET, FILM COATED in 1 BOTTLE (0781-5438-20)

• 0781- Sandoz Inc
  • 0781-5439- Cefpodoxime Proxetil
    • 0781-5439-01- 100 TABLET, FILM COATED in 1 BOTTLE (0781-5439-01)

• 0781- Sandoz Inc
  • 0781-5439- Cefpodoxime Proxetil
    • 0781-5439-20- 20 TABLET, FILM COATED in 1 BOTTLE (0781-5439-20)

• 16714- NorthStar Rx LLC
  • 16714-394- CEFPODOXIME PROXETIL
    • 16714-394-01- 20 TABLET, FILM COATED in 1 BOTTLE (16714-394-01)

• 16714- NorthStar Rx LLC
  • 16714-395- CEFPODOXIME PROXETIL
    • 16714-395-01- 20 TABLET, FILM COATED in 1 BOTTLE (16714-395-01)

• 16714- NorthStar Rx LLC
  • 16714-402- Cefpodoxime Proxetil
    • 16714-402-01- 1 BOTTLE in 1 CARTON (16714-402-01) > 50 mL in 1 BOTTLE

• 16714- NorthStar Rx LLC
  • 16714-402- Cefpodoxime Proxetil
    • 16714-402-02- 1 BOTTLE in 1 CARTON (16714-402-02) > 100 mL in 1 BOTTLE

• 16714- NorthStar Rx LLC
  • 16714-403- Cefpodoxime Proxetil
    • 16714-403-01- 1 BOTTLE in 1 CARTON (16714-403-01) > 50 mL in 1 BOTTLE

• 16714- NorthStar Rx LLC
  • 16714-403- Cefpodoxime Proxetil
    • 16714-403-02- 1 BOTTLE in 1 CARTON (16714-403-02) > 100 mL in 1 BOTTLE

• 26637- Putney Inc
  • 26637-711- Cefpodoxime Proxetil
    • 26637-711-10- 100 TABLET, FILM COATED in 1 BOTTLE (26637-711-10)

• 26637- Putney Inc
  • 26637-712- Cefpodoxime Proxetil
    • 26637-712-10- 100 TABLET, FILM COATED in 1 BOTTLE (26637-712-10)

• 42043- OrchidPharma Inc
  • 42043-121- Cefpodoxime Proxetil
    • 42043-121-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42043-121-01)

• 55289- PD-Rx Pharmaceuticals, Inc.
  • 55289-393- CEFPODOXIME PROXETIL
    • 55289-393-02- 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-393-02)

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-402- Cefpodoxime Proxetil
    • 64980-402-10- 1 BOTTLE in 1 CARTON (64980-402-10) > 100 mL in 1 BOTTLE

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-402- Cefpodoxime Proxetil
    • 64980-402-50- 1 BOTTLE in 1 CARTON (64980-402-50) > 50 mL in 1 BOTTLE

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-403- Cefpodoxime Proxetil
    • 64980-403-10- 1 BOTTLE in 1 CARTON (64980-403-10) > 100 mL in 1 BOTTLE

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-403- Cefpodoxime Proxetil
    • 64980-403-50- 1 BOTTLE in 1 CARTON (64980-403-50) > 50 mL in 1 BOTTLE

• 65862- Aurobindo Pharma Limited
  • 65862-095- CEFPODOXIME PROXETIL
    • 65862-095-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-095-01)

• 65862- Aurobindo Pharma Limited
  • 65862-095- CEFPODOXIME PROXETIL
    • 65862-095-20- 20 TABLET, FILM COATED in 1 BOTTLE (65862-095-20)

• 65862- Aurobindo Pharma Limited
  • 65862-095- CEFPODOXIME PROXETIL
    • 65862-095-99- 1000 TABLET, FILM COATED in 1 BOTTLE (65862-095-99)

• 65862- Aurobindo Pharma Limited
  • 65862-096- CEFPODOXIME PROXETIL
    • 65862-096-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-096-01)

• 65862- Aurobindo Pharma Limited
  • 65862-096- CEFPODOXIME PROXETIL
    • 65862-096-20- 20 TABLET, FILM COATED in 1 BOTTLE (65862-096-20)

• 65862- Aurobindo Pharma Limited
  • 65862-096- CEFPODOXIME PROXETIL
    • 65862-096-99- 1000 TABLET, FILM COATED in 1 BOTTLE (65862-096-99)

• 65862- Aurobindo Pharma Limited
  • 65862-140- Cefpodoxime Proxetil
    • 65862-140-01- 1 BOTTLE in 1 CARTON (65862-140-01) > 100 mL in 1 BOTTLE

• 65862- Aurobindo Pharma Limited
  • 65862-140- Cefpodoxime Proxetil
    • 65862-140-50- 1 BOTTLE in 1 CARTON (65862-140-50) > 50 mL in 1 BOTTLE

• 65862- Aurobindo Pharma Limited
  • 65862-140- Cefpodoxime Proxetil
    • 65862-140-75- 1 BOTTLE in 1 CARTON (65862-140-75) > 75 mL in 1 BOTTLE

• 65862- Aurobindo Pharma Limited
  • 65862-141- Cefpodoxime Proxetil
    • 65862-141-01- 1 BOTTLE in 1 CARTON (65862-141-01) > 100 mL in 1 BOTTLE

• 65862- Aurobindo Pharma Limited
  • 65862-141- Cefpodoxime Proxetil
    • 65862-141-50- 1 BOTTLE in 1 CARTON (65862-141-50) > 50 mL in 1 BOTTLE

• 65862- Aurobindo Pharma Limited
  • 65862-141- Cefpodoxime Proxetil
    • 65862-141-75- 1 BOTTLE in 1 CARTON (65862-141-75) > 75 mL in 1 BOTTLE

• 69043- Cronus Pharma LLC
  • 69043-006- CEFPODOXIME PROXETIL
    • 69043-006-01- 100 TABLET, FILM COATED in 1 BOTTLE (69043-006-01)

• 69043- Cronus Pharma LLC
  • 69043-007- CEFPODOXIME PROXETIL
    • 69043-007-01- 100 TABLET, FILM COATED in 1 BOTTLE (69043-007-01)