cefprozil

sef-PROE-zil

Therapeutic Classification: anti-infectives

Pharmacologic Classification: second generation cephalosporins

REMS

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

Inhibits bacterial cell wall synthesis.

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.

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).

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

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.

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.

(Generic available)

Tablets: 250 mg; 500 mg
Oral suspensionbubblegum flavor: 125 mg/5 mL; 250 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 Clostridioides difficile-associated diarrhea (CDAD). May begin up to several wk following cessation of therapy.

Lab Test Considerations:

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

PO: Administer around the clock. May be administered on full or empty stomach. Administration with food may minimize GI irritation. Shake oral suspension well before administering. Suspension is stable for 14 days after reconstitution if refrigerated.

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.

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

Cefzil

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
  - 16714-396-02- 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
- 50090-1710- Cefprozil
  - 50090-1710-0- 20 TABLET, FILM COATED in 1 BOTTLE (50090-1710-0)

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

57237- Rising Pharma Holdings, Inc.
- 57237-034- Cefprozil
  - 57237-034-01- 100 mL in 1 BOTTLE (57237-034-01)

57237- Rising Pharma Holdings, Inc.
- 57237-034- Cefprozil
  - 57237-034-50- 50 mL in 1 BOTTLE (57237-034-50)

57237- Rising Pharma Holdings, Inc.
- 57237-034- Cefprozil
  - 57237-034-75- 75 mL in 1 BOTTLE (57237-034-75)

57237- Rising Pharma Holdings, Inc.
- 57237-035- Cefprozil
  - 57237-035-01- 100 mL in 1 BOTTLE (57237-035-01)

57237- Rising Pharma Holdings, Inc.
- 57237-035- Cefprozil
  - 57237-035-50- 50 mL in 1 BOTTLE (57237-035-50)

57237- Rising Pharma Holdings, Inc.
- 57237-035- Cefprozil
  - 57237-035-75- 75 mL in 1 BOTTLE (57237-035-75)

57237- Rising Pharma Holdings, Inc.
- 57237-036- Cefprozil
  - 57237-036-01- 100 TABLET, FILM COATED in 1 BOTTLE (57237-036-01)

57237- Rising Pharma Holdings, Inc.
- 57237-037- Cefprozil
  - 57237-037-01- 100 TABLET, FILM COATED in 1 BOTTLE (57237-037-01)

57237- Rising Pharma Holdings, Inc.
- 57237-037- Cefprozil
  - 57237-037-50- 50 TABLET, FILM COATED in 1 BOTTLE (57237-037-50)

57297- LUPIN LIMITED
- 57297-400-
  - 57297-400-01- 1 BAG in 1 DRUM (57297-400-01) / 1 kg in 1 BAG

57297- LUPIN LIMITED
- 57297-400-
  - 57297-400-02- 1 BAG in 1 DRUM (57297-400-02) / 5 kg in 1 BAG

57297- LUPIN LIMITED
- 57297-400-
  - 57297-400-03- 1 BAG in 1 DRUM (57297-400-03) / 10 kg in 1 BAG

57297- LUPIN LIMITED
- 57297-400-
  57297-400-04- 1 BAG in 1 DRUM (57297-400-04) / 25 kg in 1 BAG

57297- LUPIN LIMITED
- 57297-400-
  57297-400-05- 1 BAG in 1 DRUM (57297-400-05) / 30 kg in 1 BAG

57297- LUPIN LIMITED
- 57297-400-
  57297-400-06- 1 BAG in 1 DRUM (57297-400-06) / 50 kg in 1 BAG

61788- Covalent Laboratories Private Limited
- 61788-4000-
  61788-4000-1- 5 kg in 1 DRUM (61788-4000-1)

61788- Covalent Laboratories Private Limited
- 61788-4000-
  61788-4000-2- 10 kg in 1 DRUM (61788-4000-2)

61788- Covalent Laboratories Private Limited
- 61788-4000-
  61788-4000-3- 25 kg in 1 DRUM (61788-4000-3)

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-
  - 65862-068-39- 3000 TABLET, FILM COATED in 1 BAG (65862-068-39)

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-
  - 65862-069-15- 1500 TABLET, FILM COATED in 1 BAG (65862-069-15)

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)

65862- Aurobindo Pharma Limited
- 65862-378-
  - 65862-378-37- 50 kg in 1 DRUM (65862-378-37)

67296- RedPharm Drug, Inc.
- 67296-1180- Cefprozil
  67296-1180-2- 20 TABLET, FILM COATED in 1 BOTTLE (67296-1180-2)

67877- Ascend Laboratories, LLC
- 67877-243- Cefprozil
  - 67877-243-50- 50 TABLET, FILM COATED in 1 BOTTLE (67877-243-50)

67877- Ascend Laboratories, LLC
- 67877-244- Cefprozil
  - 67877-244-01- 100 TABLET, FILM COATED in 1 BOTTLE (67877-244-01)

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)

82608- PURE AND CURE HEALTHCARE PRIVATE LIMITED
- 82608-009-
  - 82608-009-01- 1 BAG in 1 DRUM (82608-009-01) / 20 kg in 1 BAG

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