ertapenem (er-ta-pen-em) INVanz

 Indications

Moderate to severe: complicated intra-abdominal infections,

complicated skin and skin structure infections,

community acquired pneumonia, complicated urinary

tract infections (including pyelonephritis), acute pelvic

infections including postpartum endomyometritis, septic

abortion, and postsurgical gynecologic infections.

Prophylaxis of surgical site infection following elective

colorectal surgery.

Action

Binds to bacterial cell wall, resulting in cell death. Ertapenem

resists the actions of many enzymes that degrade

most other penicillins and penicillin-like anti-infectives.

Therapeutic Effects: Bactericidal action against

susceptible bacteria. Spectrum: Active against the following

aerobic gram-positive organisms: Staphylococcus

aureus (methicillin-susceptible strains only),

Staphylococcus epidermidis, Streptococcus agalactiae,

S. pneumoniae (penicillin-susceptible strains

only), and S. pyogenes. Also active against the following

gram-negative aerobic organisms: Escherichia coli,

Haemophilus influenzae (beta-lactamase negative

strains), Klebsiella pneumonia, Moraxella catarrhalis,

and Providencia rettgeri. Addition anaerobic

spectrum includes Bacteroides fragilis, B. distasonis,

B. ovatus, B. thetaiotamicron, B. uniformis, B. vulgatis,

Clostridium clostrioforme, Eubacterium lentum,

Peptostreptococcus, Porphyromonas asaccharolytica,

and Prevotella bivia.

Pharmacokinetics

Absorption: 90% after IM administration; IV administration

results in complete bioavailability.

Distribution: Enters breast milk.

Metabolism and Excretion: Mostly excreted by

the kidneys.

Half-life: 1.8 hr (qin renal impairment).

TIME/ACTION PROFILE (blood levels)

ROUTE ONSET PEAK DURATION

IM rapid 2 hr 24 hr

IV rapid end of infusion

24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Cross-sensitivity

may occur with penicillins, cephalosporins, and

other carbapenems; Hypersensitivity to lidocaine (may

be used as a diluent for IM administration).

Use Cautiously in: History of multiple hypersensitivity

reactions; Seizure disorders; Renal impairment;

OB: Use in pregnancy only if clearly needed; Lactation:

Not expected to cause adverse effects in breast-fed infants

(NIH); Pedi: Safety not established; Geri:qsensitivity

due to age-relatedpin renal function.

Adverse Reactions/Side Effects

CNS: SEIZURES, headache. GI: CLOSTRIDIUM DIFFICILEASSOCIATED

DIARRHEA (CDAD), diarrhea, nausea, vomiting.

GU: vaginitis. Local: phlebitis at IV site, pain at

IM site. Misc: hypersensitivity reaction including ANAPHYLAXIS.

Interactions

Drug-Drug: Probenecidpexcretion andqlevels.

Maypserum valproate levels (qrisk of seizures).

Route/Dosage

IV, IM (Adults and Children 13 yrs): 1 g once

daily for up to 14 days (IV) or 7 days (IM).

IV, IM (Children 3 mo–12 yrs): 15 mg/kg twice

daily (not to exceed 1 g/day) for up to 14 days (IV) or

7 days (IM).

Renal Impairment

IM, IV (Adults): CCr 30 mL/min/1.73 m2—500

mg once daily.

Availability

Powder for injection: 1 g/vial.