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Meropenem

Pronunciation: (MER-oh-PEN-em)
Class: Carbapenem antibiotic

Trade Names:
Merrem I.V.
- Injection, powder for solution 500 mg
- Injection, powder for solution 1 g

Pharmacology

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Inhibits bacterial cell wall synthesis.

Pharmacokinetics

Absorption

T _max is approximately 1 h after start of infusion. Mean C _max for a 30-min infusion is 23 mcg/mL (500 mg) and 49 mcg/mL (1 g). Mean C _max for a 5-min bolus injection is 45 mcg/mL (500 mg) and 112 mcg/mL (1 g).

Distribution

Protein binding is approximately 2% and penetrates well into most body fluids and tissues, including CSF.

Metabolism

There is 1 metabolite that is inactive.

Elimination

Approximately 70% is excreted in urine unchanged over 12 h. Elimination half-life is approximately 1 h.

Special Populations

Renal Function Impairment

Cl correlates with CrCl in patients with renal function impairment. Dosage adjustments may be necessary.

Hepatic Function Impairment

Hepatic function impairment does not affect the pharmacokinetics.

Children

The half-life in children 3 mo to 2 yr of age is approximately 1.5 h.

Indications and Usage

Single-agent treatment of skin and skin structure infections, intra-abdominal infections, and bacterial meningitis when caused by susceptible microorganisms.

Unlabeled Uses

Empiric therapy in febrile neutropenic patients; community-acquired pneumonia (if Pseudomonas is a concern); nonsocomial pneumonia.

Contraindications

Hypersensitivity to any component of this product or to other drugs in the same class; anaphylactic reactions to beta-lactams.

Dosage and Administration

Intra-Abdominal Infections
Adults

IV 1 g every 8 h.

Children (3 mo of age and older) Weighing more than 50 kg

IV 1 g every 8 h.

Weighing 50 kg or less

IV 20 mg/kg every 8 h.

Max dose

IV 1 g every 8 h

Bacterial Meningitis
Children (3 mo of age and older) Weighing more than 50 kg

IV 2 g every 8 h.

Weighing 50 kg or less

IV 40 mg/kg every 8 h.

Max dose

2 g every 8 h.

Complicated Skin and Skin Structure Infections
Adults

IV 500 mg every 8 h.

Children (3 mo of age and older) Weighing more than 50 kg

IV 500 mg every 8 h.

Weighing 50 kg or less

IV 10 mg/kg every 8 h.

Max dose

IV 500 mg every 8 h.

Renal Function Impairment
Adults CrCl 26 to 50 mL/min

Recommended dose every 12 h.

CrCl 10 to 25 mL/min

50% of recommended dose every 12 h.

CrCl less than 10 mL/min

50% of recommended dose every 24 h.

Continuous renal replacement therapy

1 to 2 g every 12 h. Alternative recommendations that assume ultrafiltration and dialysis flow rates of 1 to 2 L/h.

Loading Dose

IV 1 g.

Maintenance dose.

Continuous venovenous hemofiltration: 550 mg to 1 g IV every 12 h or 500 mg IV every 8 h. Continuous venovenous hemodialysis or continuous venovenous hemodiafiltration: 500 mg to 1 g IV every 8 to 12 h or 500 mg IV every 6 to 8 h or 1 g IV every 8 to 12 h.

Continuous ambulatory peritoneal dialysis

50% of the recommended dose every 24 h.

Intermittent Hemodialysis

500 mg IV every 24 h after dialysis.

Off-Label Dosing
Empiric Therapy in Febrile Neutropenic Patients Adults

IV 1 g every 8 h.

Community-Acquired Pneumonia Adults

Give meropenem in combination with ciprofloxacin, levofloxacin, or an aminoglycoside.

Nosocomial Pneumonia Adults

IV 1 g every 8 h; used in patients with late-onset disease or risk factors for multidrug-resistant pathogens.

Neonates

IV 15 to 20 mg/kg every 12 h.

For neonates weighing more than 2 kg, a dosage of IV 20 mg/kg every 8 h has been suggested. Administer dose over 15 to 30 min.

General Advice

For IV bolus (doses of 1 g) or infusion only. Not for intradermal, subcutaneous, IM, or intra-arterial administration. Do not use a flexible container in series connections.
Administer IV infusion over approximately 15 to 30 min. Administer IV bolus over approximately 3 to 5 min.
To prepare IV bolus: constitute 500 mg injection vial with 10 mL of sterile water for injection; constitute 1 g injection vial with 20 mL of sterile water for injection. Shake to dissolve and let stand until clear.
To prepare IV infusion: add constituted injection solution to an IV container and further dilute with appropriate infusion fluid, or directly constitute with compatible infusion fluid.
Do not mix with or physically add to solutions containing other drugs.

Storage/Stability

Store dry powder at 68° to 77°F. Stability of reconstituted meropenem is dependent on diluent and container (eg, syringe, infusion vial, minibag). Refer to manufacturer's package insert for guidelines.

Drug Interactions

Probenecid

Inhibits renal excretion of meropenem. Coadministration is not recommended.

Valproic acid

Meropenem may decrease valproic acid levels, resulting in a loss of seizure control.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Bradycardia, cardiac arrest, heart failure, hypertension, hypotension, MI, pulmonary embolus, syncope, tachycardia (1% or less).

CNS

Headache (8%); agitation/delirium, anxiety, asthenia, confusion, depression, dizziness, hallucinations, insomnia, nervousness, paresthesia, seizures, somnolence (1% or less).

Dermatologic

Diaper rash, rash (3%); pruritus (1%); skin ulcer, sweating, urticaria (1% or less); angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).

EENT

Pharyngitis (at least 1%).

GI

Nausea (8%); constipation, diarrhea (7%); vomiting (4%); oral moniliasis (2%); GI disorder (at least 1%); GI hemorrhage, glossitis (1%); abdominal pain/enlargement, anorexia, dyspepsia, flatulence, ileus, intestinal obstruction (1% or less).

Genitourinary

Kidney failure, dysuria, urinary incontinence, vaginal moniliasis (1% or less); presence of RBC in urine (postmarketing).

Hematologic-Lymphatic

Anemia (6%); hypochromic anemia (1% or less); agranulocytosis, hemolytic anemia, leukopenia, neutropenia, positive direct and indirect Coombs test (postmarketing).

Hepatic

Cholestatic jaundice, hepatic failure, jaundice (1% or less).

Lab Tests

Decreased hematocrit, hemoglobin, platelets, and WBC; increased alkaline phosphatase, ALT, AST, bilirubin, BUN, creatinine, eosinophils, LDH, and platelets; hypokalemia, leukocytosis, shortened PT/PTT.

Local

Inflammation at injection site (2%); injection-site reaction, phlebitis/thrombophlebitis (1%).

Metabolic-Nutritional

Hypoglycemia (at least 1%); hypovolemia, hypoxia, peripheral edema (1% or less).

Respiratory

Pneumonia (at least 1%); apnea (1%); asthma, cough increased, dyspnea, lung edema, pleural effusion, respiratory disorder (1% or less).

Miscellaneous

Pain (5%); sepsis (2%); accidental injury, peripheral vascular disorder (at least 1%); shock (1%); back pain, chest pain, chills, fever, pelvic pain (1% or less).

Precautions

Monitor

Monitor patient's response to therapy; periodically monitor renal, hepatic, and hematopoietic function during prolonged therapy.

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy in children 3 mo of age and younger not established.

Elderly

Use care in dose selection because elderly patients are more likely to have decreased renal function; monitor renal function.

Hypersensitivity

Serious and potentially fatal anaphylactic reactions have been reported. Patients with sensitivity to multiple allergens are at greatest risk. Use with caution in penicillin-sensitive patients.

Renal Function

Adjust dose downward accordingly in patients with CrCl less than 51 mL/min. Thrombocytopenia, without bleeding, has been observed.

Superinfection

May result in bacterial or fungal overgrowth of nonsusceptible organisms.

CNS effects

Seizures and other CNS adverse reactions have occurred. Use with caution in patients with CNS disorders, meningitis, or renal function impairment.

Clostridium difficile – associated diarrhea

Consider possibility in patients with diarrhea.

Overdosage

Symptoms

Ataxia, convulsions, dyspnea, mortality.

Patient Information

Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a medical setting.
Advise patient, family, or caregiver to immediately report any of the following to health care provider: black, furry tongue; difficulty breathing or unexplained shortness of breath; foul-smelling stools; hives; rash; vaginal itching or discharge; white patches in mouth; watery or bloody stools (with or without stomach cramps and fever).
Warn patient, family, or caregiver that if diarrhea containing blood or pus develops after discharge, this may be a sign of a serious disorder. Instruct patient to seek medical care if noted and not to treat at home.