ERTAPENEM SODIUM

ERTAPENEM SODIUM (er-ta-pen'em) Invanz Classifications: beta-lactam antibiotic; Therapeutic: antibiotic Prototype: Imipenem-cilastatin Pregnancy Category: B

Availability

1 g vial

Action

Broad-spectrum carbapenem antibiotic that inhibits the cell wall synthesis of gram-positive and gram-negative bacteria by its strong affinity for penicillin-binding proteins (PBPs) of the bacterial cell wall.

Therapeutic Effect

Effective against both gram-positive and gram-negative bacteria. Highly resistant to most bacterial beta-lactamases.

Uses

Complicated intraabdominal infections, complicated skin and skin structure infections, community-acquired pneumonia, complicated UTI (including pyelonephritis), and acute pelvic infections due to susceptible bacteria.

Contraindications

Hypersensitivity to ertapenem; hypersensitivity to penicillins; hypersensitivity to amide-type local anesthetics such as lidocaine; hypersensitivity to meropenem or imipenem; previous anaphylactic reaction to beta-lactams.

Cautious Use

Renal impairment; history of CNS disorders; history of seizures; hypersensitivity to other beta-lactam antibiotics (penicillins, cephalosporins); hypersensitivity to other allergens; meningitis; pregnancy (category B); lactation (bottle feed during and for 5 d after therapy ends).

Route & Dosage

Community-Acquired Pneumonia; Complicated UTI Adult: IV/IM 1 g q.d. x 10–14 d May switch to appropriate PO antibiotic after 3 d if responding Child/Infant (>3 mo): IV/IM 15 mg/kg q12h x 10–14 d Intraabdominal Infection Adult: IV/IM 1 g q.d. x 5–14 d Child/Infant (>3 mo): IV/IM 15 mg/kg b.i.d. x 5–14 d Skin and Skin Structure Infections Adult: IV/IM 1 g q.d. x 7–14 d Child/Infant (>3 mo): IV/IM 15 mg/kg b.i.d. x 7–14 d Acute Pelvic Infections Adult: IV/IM 1 g q.d. x 3–10 d Renal Impairment Clcr <30 mL/min: reduce dose to 500 mg q.d.

Administration

Intramuscular

• Reconstitute 1 g vial with 3.2 mL of 1.0% lidocaine HCl injection (without epinephrine). Shake vial thoroughly to form solution. Use immediately.
• Inject deep IM into a large muscle mass (such as the gluteal muscles or lateral part of the thigh).
• The reconstituted IM solution should be used within 1 h after preparation. Note: DO NOT use this solution for IV administration.

Intravenous PREPARE: Intermittent for Adult/Child: Reconstitute 1 g vial with 10 mL of sterile water for injection, NS, or bacteriostatic water for injection. Shake well to dissolve.  Intermittent for Adult/Child (≥13 y): Immediately transfer contents to 50 mL of NS injection solution.  Intermittent for Child (3 mo–12 y): Immediately transfer required dose to enough NS injection solution to yield a final concentration of 20 mg/mL or less.   ADMINISTER: Intermittent: Infuse over 30 min. Note: Infusion should be completed within 6 h of reconstitution.   INCOMPATIBILITIES Solution/additive: Dextrose. Y-site: Do not mix or infuse with any other drugs.

• Store lyophilized powder above 25° C (77° F). Must use reconstituted solution stored at room temperature (not greater than 25° C/77° F) within 6 h. May store for 24 h under refrigeration. Use within 4 h of removal from refrigeration. Do not freeze.

Adverse Effects (≥1%)

Body as a Whole: Phlebitis or thrombosis at injection site, asthenia, fatigue, death, fever, leg pain. CNS: Anxiety, altered mental status, dizziness, headache, insomnia. CV: Chest pain, hypertension, hypotension, tachycardia, edema. GI: Abdominal pain, diarrhea, acid regurgitation, constipation, dyspepsia, nausea, vomiting, increased AST and ALT. Respiratory: Cough, dyspnea, pharyngitis, rales/rhonchi, and respiratory distress. Skin: Erythema, pruritus, rash. Urogenital: Vaginitis.

Interactions

Drug: Probenecid decreases renal excretion.

Pharmacokinetics

Absorption: 90% absorbed from IM site. Peak: 2.3 h. Distribution: 95% protein bound, distributes into breast milk, may cross placenta. Metabolism: Hydrolysis of beta-lactam ring. Elimination: 80% in urine, 10% in feces. Half-Life: 4.5 h.

Nursing Implications

Assessment & Drug Effects

• Lab tests: Perform C&S tests prior to therapy. Monitor periodically liver and kidney function.
• Determine history of hypersensitivity reactions to other beta-lactams, cephalosporins, penicillins, or other drugs.
• Discontinue drug and immediately report S&S of hypersensitivity (see Appendix F).
• Report S&S of superinfection or pseudomembranous colitis (see Appendix F).
• Monitor for seizures especially in older adults and those with renal insufficiency.
• Lab tests: Monitor AST, ALT, alkaline phosphatase, CBC, platelet count, and routine blood chemistry during prolonged therapy.

Patient & Family Education

• Learn S&S of hypersensitivity, superinfection, and pseudomembranous colitis (see Appendix F); report any of these to physician promptly.

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Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug