Dosing and uses of Invanz (ertapenem)
Adult dosage forms and strengths
powder for injection
- 1g/vial
Community-Acquired Pneumonia
1 g/day IV/IM up to 14 days; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
Complicated Urinary Tract Infections (Including Pyelonephritis)
1 g/day IV/IM up to 14 days; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
Acute Pelvic Infections
1 g/day IV/IM for 3-10 days
Complicated Intra-abdominal Infections
1 g/day IV/IM for 5-14 days
Complicated Skin/Skin Structure Infections
1 g/day IV/IM for 7-14 days; may be continued up to 4 weeks for diabetic foot infections, depending on severity of infection and response to therapy (treatment excludes diabetic foot infections with osteomyelitis)
Dosing Modifications
Renal impairment
- CrCl >30 mL/min/1.73 m²: Dosage adjustment not necessary
- CrCl <30 mL/min/1.73 m² and end-stage renal disease (ESRD): 500 mg/day IV
- Dialysis: 500 mg/day IV; if given ≤6 hr before dialysis, supplemental dose of 150 mg afterward
Pediatric dosage forms and strengths
powder for injection
- 1g/vial
Community-Acquired Pneumonia
<3 years: Safety and efficacy not established
3-12 years: 15 mg/kg IV/IM q12hr up to 14 days; not to exceed 1 g q12hr; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
>12 years: 1 g/day IV/IM up to 14 days; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
Complicated Urinary Tract Infections (Including Pyelonephritis)
<3 years: Safety and efficacy not established
3-12 years: 15 mg/kg IV/IM q12hr up to 14 days; not to exceed 1 g q12hr; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
>12 years: 1 g/day IV/IM up to 14 days; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
Acute Pelvic Infections
<3 years: Safety and efficacy not established
3-12 years: 15 mg IV/IM q12hr for 3-10 days
>12 years: 1 g/day IV/IM for 3-10 days
Complicated Intra-abdominal Infections
<3 years: Safety and efficacy not established
3-12 years: 15 mg IV/IM q12hr for 5-14 days
>12 years: 1 g/day IV/IM for 5-14 days
Complicated Skin/Skin Structure Infections
<3 years: Safety and efficacy not established
3-12 years: 15 mg IV/IM q12hr for 7-14 days; may be continued up to 4 weeks for diabetic foot infections, depending on severity of infection and response to therapy (treatment excludes diabetic foot infections with osteomyelitis)
>12 years: 1 g/day IV/IM for 7-14 days; may be continued up to 4 weeks for diabetic foot infections, depending on severity of infection and response to therapy (treatment excludes diabetic foot infections with osteomyelitis)
Invanz (ertapenem) adverse (side) effects
>10%
Diarrhea (2-12%)
1-10%
Elevated liver function tests (LFTs) (7-9%)
Nausea (6-9%)
Headache (6-7%)
Infused vein complications (5-7%)
Increased platelet count (4-7%)
Increased alkaline phosphatase (4-7%)
Altered mental status (3-5%)
Fever (2-5%)
Abdominal pain (4%)
Vomiting (4%)
Constipation (3-4%)
Insomnia (3%)
Swelling or edema (3%)
Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) (2-3%)
Rash (2-3%)
Vaginitis (1-3%)
Dizziness (2%)
Phlebitis or thrombophlebitis (1.5-2%)
Pruritus (1-2%)
Tachycardia (1-2%)
Acid regurgitation (1-2%)
Eosinophilia (1-2%)
Hypotension (1-2%)
Erythema (1-2%)
Hypertension (0.7-2%)
Chest pain (1%)
Dyspepsia (1%)
Fatigue (1%)
Anxiety (0.8-1%)
Oral candidiasis (0.1-1%)
Postmarketing Reports
Immune system disorders: Anaphylaxis including anaphylactoid reactions
Musculoskeletal and connective tissue disorders: Muscular weakness
Nervous system disorders: Coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor
Psychiatric disorders: Altered mental status (including aggression, delirium), hallucinations
Skin and subcutaneous tissue disorders: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)
Teeth staining
Warnings
Contraindications
Hypersensitivity to ertapenem, beta-lactams, or other drugs in this class
IM administration: Hypersensitivity to amide local anesthetics (eg, lidocaine)
Cautions
Use with caution in CNS disorders (eg., history of seizures); adjust dose in renal impairment to avoid risk of seizures; carbapenem use has been associated with seizures
Do not coinfuse with other medications or use dextrose diluent
Prolonged use increases risk of superinfections
Use caution in renal impairment; adjust dose in moderate to severe renal dysfunction
Carbapenem use may decrease serum levels of divalproex sodium or valproic acid
Pregnancy and lactation
Pregnancy category: B
Lactation: Drug distributed in breast milk; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Invanz (ertapenem)
Mechanism of action
1-beta methyl-carbapenem; inhibits cell-wall synthesis by binding to penicillin-binding proteins; resistant to most beta-lactamases
Absorption
Bioavailability: IM, 90%
Peak plasma time: IM, 2.3 hr
Distribution
Protein bound (concentration dependent): 300 mcg/mL, 85%; <100 mcg/mL, 95%
Vd: 3 months-12 years, 0.2 L/kg; 13-17 years, 0.16 L/kg; adults, 0.12 L/kg
Metabolism
Hydrolyzed to inactive metabolite
Elimination
Half-life: 3 months-12 years, 2.5 hr; >12 years, 4 hr
Excretion: Urine (80% as unchanged drug and metabolite), feces (10%)
Administration
IV Incompatibilities
Do not mix with other medications or use diluents containing dextrose
IV Preparation
Reconstitute 1 g vial with 10 mL SWI, NS, or BWI; shake well; transfer to 50 mL Ns
IV Administration
Infuse over 30 minutes
IM Preparation
Reconstitute 1 g vial with 3.2 mL of 1% lidocaine injection (without epinephrine); shake well; use within 1 hour after preparation
IM Administration
Make sure patient does not have allergy to lidocaine or another amide anesthetic
Administer by deep IM injection into large muscle mass (eg, gluteal muscle or lateral part of thigh)
Do not administer IM preparation or drug reconstituted for IM administration IV
Storage
Before reconstitution, store at <25°C (77°F)
Reconstituted IV solution may be either (a) stored at room temperature and used within 6 hours or (b) refrigerated, stored for up to 24 hours, and used within 4 hours after removal from refrigerator
Do not freeze
