cefprozil

REMS

Treatment of the following infections caused by susceptible organisms:
- Respiratory tract infections,
- Uncomplicated skin and skin structure infections,
- Otitis media.

Contraindicated in:

Hypersensitivity to cephalosporins;
Serious hypersensitivity to penicillins.

Use Cautiously in:

Renal impairment (dosage ↓ recommended if CCr <30 mL/min);
History of GI disease, especially colitis;
Suspension contains aspartame and should be avoided in patients with phenylketonuria;
Geri: Dosage adjustment due to age-related ↓ in renal function may be necessary;
OB: Has been used safely.

Derm: rash, urticaria

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

GU: vaginitis

Hemat: eosinophilia, hemolytic anemia, leukopenia

Neuro: dizziness, SEIZURES (VERY HIGH DOSES)

Misc: ANAPHYLAXISALLERGIC REACTIONS INCLUDING , superinfection

Drug-drug:

Probenecid ↓excretion and increases blood levels.
Concurrent use of aminoglycosides may ↑ risk of nephrotoxicity.

(Generic available)

Tablets: 250 mg; 500 mg
Oral suspensionbubblegum flavor: 125 mg/5 mL; 250 mg/5 mL

PO (Adults and Children ≥13 yr): Most infections: 250–500 mg every 12 hr or 500 mg every 24 hr.
PO (Children 6 mo–12 yr): Otitis media: 15 mg/kg every 12 hr; Acute sinusitis: 7.5–15 mg/kg every 12 hr (higher dose to be used for moderate-to-severe infections).
PO (Children 2–12 yr): Pharyngitis/tonsillitis: 7.5 mg/kg every 12 hr; Skin and skin structure infections: 20 mg/kg every 24 hr.

Renal Impairment

(Adults and Children ≥6 mo): CCr <30 mL/min: ½of usual dose at normal dosing interval.

Binds to bacterial cell wall membrane, causing cell death.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Similar to that of first-generation cephalosporins but has increased activity against several other gram-negative pathogens including:
- Haemophilus influenzae (including β-lactamase-producing strains),
- Proteus,
- Moraxella catarrhalis (including β-lactamase-producing strains).
Not active against methicillin-resistant staphylococci or enterococci.

Therapeutic Classification: anti-infectives

Pharmacologic Classification: second generation cephalosporins

Absorption: Well absorbed following oral administration.

Distribution: Widely distributed. Enters breast milk in low concentrations.

Metabolism/Excretion: Excreted primarily unchanged by the kidneys.

Half-Life: 90 min (↑ in renal impairment).

Cefzil

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1–2 hr	12–24 hr

Instruct patient to take medication around the clock 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.

sef-PROE-zil

NDC Code

0093- Teva Pharmaceuticals USA, Inc.
- 0093-1077- Cefprozil
  - 0093-1077-01- 100 TABLET, FILM COATED in 1 BOTTLE (0093-1077-01)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-1078- Cefprozil
  - 0093-1078-53- 50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53)

16714- NorthStar Rx LLC
- 16714-396- Cefprozil
  - 16714-396-01- 50 mL in 1 BOTTLE (16714-396-01)

16714- NorthStar Rx LLC
- 16714-396- Cefprozil
  - 16714-396-02- 75 mL in 1 BOTTLE (16714-396-02)

16714- NorthStar Rx LLC
- 16714-396- Cefprozil
  - 16714-396-03- 100 mL in 1 BOTTLE (16714-396-03)

16714- NorthStar Rx LLC
- 16714-397- Cefprozil
  - 16714-397-01- 50 mL in 1 BOTTLE (16714-397-01)

16714- NorthStar Rx LLC
- 16714-397- Cefprozil
  - 16714-397-02- 75 mL in 1 BOTTLE (16714-397-02)

16714- NorthStar Rx LLC
- 16714-397- Cefprozil
  - 16714-397-03- 100 mL in 1 BOTTLE (16714-397-03)

16714- NorthStar Rx LLC
- 16714-398- Cefprozil
  - 16714-398-01- 100 TABLET, FILM COATED in 1 BOTTLE (16714-398-01)

16714- NorthStar Rx LLC
- 16714-399- Cefprozil
  - 16714-399-01- 50 TABLET, FILM COATED in 1 BOTTLE (16714-399-01)

50090- A-S Medication Solutions
- 50090-1188- Cefprozil
  - 50090-1188-0- 20 TABLET, FILM COATED in 1 BOTTLE (50090-1188-0)

50090- A-S Medication Solutions
- 50090-1739- Cefprozil
  - 50090-1739-0- 20 TABLET, FILM COATED in 1 BOTTLE (50090-1739-0)

50090- A-S Medication Solutions
- 50090-3226- Cefprozil
  - 50090-3226-0- 50 mL in 1 BOTTLE (50090-3226-0)

53217- Aidarex Pharmaceuticals LLC
- 53217-031- CEFPROZIL
  - 53217-031-20- 20 TABLET in 1 BOTTLE (53217-031-20)

55700- Lake Erie Medical DBA Quality Care Products LLC
- 55700-294- Cefprozil
  - 55700-294-20- 20 TABLET, FILM COATED in 1 BOTTLE (55700-294-20)

55700- Lake Erie Medical DBA Quality Care Products LLC
- 55700-455- Cefprozil
  - 55700-455-20- 20 TABLET, FILM COATED in 1 BOTTLE (55700-455-20)

55700- Quality Care Products, LLC
- 55700-708- Cefprozil
  - 55700-708-20- 20 TABLET, FILM COATED in 1 BOTTLE (55700-708-20)

57237- Rising Health, LLC
- 57237-034- Cefprozil
  - 57237-034-01- 100 mL in 1 BOTTLE (57237-034-01)

57237- Rising Health, LLC
- 57237-034- Cefprozil
  - 57237-034-50- 50 mL in 1 BOTTLE (57237-034-50)

57237- Rising Health, LLC
- 57237-034- Cefprozil
  - 57237-034-75- 75 mL in 1 BOTTLE (57237-034-75)

57237- Rising Health, LLC
- 57237-035- Cefprozil
  - 57237-035-01- 100 mL in 1 BOTTLE (57237-035-01)

57237- Rising Health, LLC
- 57237-035- Cefprozil
  - 57237-035-50- 50 mL in 1 BOTTLE (57237-035-50)

57237- Rising Health, LLC
- 57237-035- Cefprozil
  - 57237-035-75- 75 mL in 1 BOTTLE (57237-035-75)

57237- Rising Health, LLC
- 57237-036- Cefprozil
  - 57237-036-01- 100 TABLET, FILM COATED in 1 BOTTLE (57237-036-01)

57237- Rising Health, LLC
- 57237-037- Cefprozil
  - 57237-037-01- 100 TABLET, FILM COATED in 1 BOTTLE (57237-037-01)

57237- Rising Health, LLC
- 57237-037- Cefprozil
  - 57237-037-50- 50 TABLET, FILM COATED in 1 BOTTLE (57237-037-50)

64679- Wockhardt USA LLC.
- 64679-712- CEFPROZIL
  - 64679-712-01- 50 TABLET, FILM COATED in 1 BOTTLE (64679-712-01)

64679- Wockhardt USA LLC.
- 64679-712- CEFPROZIL
  - 64679-712-02- 1000 TABLET, FILM COATED in 1 BOTTLE (64679-712-02)

64679- Wockhardt USA LLC.
- 64679-712- CEFPROZIL
  - 64679-712-03- 100 TABLET, FILM COATED in 1 BOTTLE (64679-712-03)

64679- Wockhardt USA LLC.
- 64679-712- CEFPROZIL
  - 64679-712-04- 500 TABLET, FILM COATED in 1 BOTTLE (64679-712-04)

64679- Wockhardt USA LLC.
- 64679-713- CEFPROZIL
  - 64679-713-01- 50 TABLET, FILM COATED in 1 BOTTLE (64679-713-01)

64679- Wockhardt USA LLC.
- 64679-713- CEFPROZIL
  - 64679-713-02- 500 TABLET, FILM COATED in 1 BOTTLE (64679-713-02)

64679- Wockhardt USA LLC.
- 64679-713- CEFPROZIL
  - 64679-713-03- 100 TABLET, FILM COATED in 1 BOTTLE (64679-713-03)

65862- Aurobindo Pharma Limited
- 65862-068- Cefprozil
  - 65862-068-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-068-01)

65862- Aurobindo Pharma Limited
- 65862-068- Cefprozil
  - 65862-068-05- 500 TABLET, FILM COATED in 1 BOTTLE (65862-068-05)

65862- Aurobindo Pharma Limited
- 65862-068- Cefprozil
  - 65862-068-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-068-30)

65862- Aurobindo Pharma Limited
- 65862-068- Cefprozil
  - 65862-068-50- 50 TABLET, FILM COATED in 1 BOTTLE (65862-068-50)

65862- Aurobindo Pharma Limited
- 65862-069- Cefprozil
  - 65862-069-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-069-01)

65862- Aurobindo Pharma Limited
- 65862-069- Cefprozil
  - 65862-069-05- 500 TABLET, FILM COATED in 1 BOTTLE (65862-069-05)

65862- Aurobindo Pharma Limited
- 65862-069- Cefprozil
  - 65862-069-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-069-30)

65862- Aurobindo Pharma Limited
- 65862-069- Cefprozil
  - 65862-069-50- 50 TABLET, FILM COATED in 1 BOTTLE (65862-069-50)

65862- Aurobindo Pharma Limited
- 65862-099- Cefprozil
  - 65862-099-01- 100 mL in 1 BOTTLE (65862-099-01)

65862- Aurobindo Pharma Limited
- 65862-099- Cefprozil
  - 65862-099-50- 50 mL in 1 BOTTLE (65862-099-50)

65862- Aurobindo Pharma Limited
- 65862-099- Cefprozil
  - 65862-099-75- 75 mL in 1 BOTTLE (65862-099-75)

65862- Aurobindo Pharma Limited
- 65862-100- Cefprozil
  - 65862-100-01- 100 mL in 1 BOTTLE (65862-100-01)

65862- Aurobindo Pharma Limited
- 65862-100- Cefprozil
  - 65862-100-50- 50 mL in 1 BOTTLE (65862-100-50)

65862- Aurobindo Pharma Limited
- 65862-100- Cefprozil
  - 65862-100-75- 75 mL in 1 BOTTLE (65862-100-75)

68180- Lupin Pharmaceuticals, Inc.
- 68180-401- CEFPROZIL
  - 68180-401-01- 50 mL in 1 BOTTLE (68180-401-01)

68180- Lupin Pharmaceuticals, Inc.
- 68180-401- CEFPROZIL
  - 68180-401-02- 75 mL in 1 BOTTLE (68180-401-02)

68180- Lupin Pharmaceuticals, Inc.
- 68180-401- CEFPROZIL
  - 68180-401-03- 100 mL in 1 BOTTLE (68180-401-03)

68180- Lupin Pharmaceuticals, Inc.
- 68180-402- CEFPROZIL
  - 68180-402-01- 50 mL in 1 BOTTLE (68180-402-01)

68180- Lupin Pharmaceuticals, Inc.
- 68180-402- CEFPROZIL
  - 68180-402-02- 75 mL in 1 BOTTLE (68180-402-02)

68180- Lupin Pharmaceuticals, Inc.
- 68180-402- CEFPROZIL
  - 68180-402-03- 100 mL in 1 BOTTLE (68180-402-03)

68180- Lupin Pharmaceuticals, Inc.
- 68180-403- CEFPROZIL
  - 68180-403-01- 100 TABLET in 1 BOTTLE (68180-403-01)

68180- Lupin Pharmaceuticals, Inc.
- 68180-404- CEFPROZIL
  - 68180-404-01- 50 TABLET in 1 BOTTLE (68180-404-01)

68180- Lupin Pharmaceuticals, Inc.
- 68180-404- CEFPROZIL
  - 68180-404-02- 100 TABLET in 1 BOTTLE (68180-404-02)

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Canadian Brand Names ⬆ ⬇

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Patient/Family Teaching ⬆ ⬇

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