cefotaxime

REMS

Treatment of the following infections caused by susceptible organisms:
- Skin and skin structure infections,
- Bone and joint infections,
- Urinary tract infections,
- Gynecological infections including gonorrhea,
- Lower respiratory tract infections,
- Intra-abdominal infections,
- Septicemia,
- Meningitis,
- Lyme disease.
Perioperative prophylaxis.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to cephalosporins;
Serious hypersensitivity to penicillins.

Use Cautiously in:

Renal impairment (↓ dose recommended if CCr <20 mL/min);
History of GI disease, especially colitis;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Geri: Dosage adjustment may be necessary due to age-related ↓ in renal function.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: pruritus, rash, urticaria

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

Hemat: agranulocytosis, bleeding, eosinophilia, hemolytic anemia, neutropenia, thrombocytopenia

Local: pain at IM site, phlebitis at IV site

Neuro: SEIZURES (HIGH DOSES)

Misc: ANAPHYLAXISALLERGIC REACTIONS INCLUDING , superinfection

Interactions ⬆ ⬇

Drug-drug:

Probenecid↓ excretion and increases serum levels.
Concurrent use of aminoglycosides, NSAIDs, or loop diuretics may ↑ risk of nephrotoxicity.

Availability ⬆ ⬇

(Generic available)

Lyophilized powder for injection: 500 mg; 1 g; 2 g; 10 g

Route/Dosage ⬆ ⬇

IM IV (Adults and Children >12 yr): Most uncomplicated infections: 1 g every 12 hr; Moderate or severe infections: 1–2 g every 6–8 hr; Life-threatening infections: 2 g every 4 hr (maximum dose: 12 g/day); Gonococcal urethritis/cervicitis or rectal gonorrhea in females: 500 mg IM (single dose); Rectal gonorrhea in males: 1 g IM (single dose); Perioperative prophylaxis: 1 g 30–90 min before initial incision (one-time dose).
IM IV (Children 1 mo-12 yr): <50 kg : 100–200 mg/kg/day divided every 6–8 hr; Meningitis: 200 mg/kg/day divided every 6 hr;Invasive pneumococcal meningitis–225–300 mg/kg/day divided every 6–8 hr;≥ 50 kg: see adult dosing.
IV (Neonates 1–4 wk): 50 mg/kg every 6–8 hr.
IV (Neonates ≤1 wk): 50 mg/kg every 8–12 hr.

Renal Impairment

IM IV (Adults ): CCr <20 mL/min: ↓dose by 50%.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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

Therapeutic effects:

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:
- Acinetobacter,
- Citrobacter,
- Enterobacter,
- Haemophilus influenzae(including β-lactamase-producing strains),
- Haemophilus parainfluenzae,
- Escherichia coli,
- Klebsiella pneumoniae,
- Morganella morganii,
- Neisseria gonorrhoeae and meningitidis,
- Proteus,
- Providencia,
- Serratia,
- Moraxella catarrhalis,
- Borrelia burgdorferi.
Has some activity against anaerobes, includingBacteroides fragilis.
Not active against methicillin-resistant staphylococci.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: third generation cephalosporins

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following IM administration; IV administration results in complete bioavailability.

Distribution: Widely distributed. Crosses the placenta; enters breast milk in low concentrations. CSF penetration better than with first- and second-generation agents.

Metabolism/Excretion: Partly metabolized to active metabolite; 20–36% excreted unchanged in the urine.

Half-Life: Premature neonates: 5–6 hr; Full–term neonates: 2–3.4 hr; Children: 1.5 hr; Adults: 1–1.5 hr (↑ in renal impairment).

Time/Action Profile ⬆ ⬇

(blood levels)

ROUTE	ONSET	PEAK	DURATION
IM	rapid	0.5 hr	4–12 hr
IV	rapid	end of infusion	4–12 hr

Patient/Family Teaching ⬆ ⬇

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.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9930- Cefotaxime
  - 0143-9930-10- 10 VIAL in 1 PACKAGE (0143-9930-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9930-01)

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9931- Cefotaxime
  - 0143-9931-25- 25 VIAL in 1 PACKAGE (0143-9931-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9931-01)

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9933- Cefotaxime
  - 0143-9933-25- 25 VIAL in 1 PACKAGE (0143-9933-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9933-01)

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9935- Cefotaxime
  - 0143-9935-01- 1 INJECTION in 1 PACKAGE (0143-9935-01)

52946- ACS Dobfar S.p.A
- 52946-0826-
  - 52946-0826-0- 20 kg in 1 BOX (52946-0826-0)

section name header

Indications ⬇