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: Lactation: Has been used safely.

CNS: SEIZURES (VERY HIGH DOSES), dizziness.

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

Derm: rash, urticaria.

GU: vaginitis.

Hemat: eosinophilia, hemolytic anemia, leukopenia.

Misc: ALLERGIC REACTIONS INCLUDING ANAPHYLAXIS, 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 suspension (bubblegum 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 — ½ of 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 -lactamase-producing strains),
- Proteus,
- Moraxella catarrhalis (including -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 ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆