Meropenem

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 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

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

Hepatic function impairment does not affect the pharmacokinetics.

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 or in patients who have demonstrated anaphylactic reactions to beta-lactams.

Dosage and Administration

IV 1 g every 8 h.

IV 1 g every 8 h.

IV 20 mg/kg every 8 h.

IV 1 g every 8 h

IV 2 g every 8 h.

IV 40 mg/kg every 8 h.

2 g every 8 h.

IV 500 mg every 8 h.

IV 500 mg every 8 h.

IV 10 mg/kg every 8 h.

IV 500 mg every 8 h.

Recommended dose every 12 h.

50% of recommended dose every 12 h.

50% of recommended dose every 24 h.

In a study of 101 cancer patients with 120 febrile neutropenic episodes, a dosage of 1 g IV every 8 h was shown to be as effective and well tolerated as ceftazidime.

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

As an initial empirical therapy, meropenem in a dosage of 1 g IV every 8 h has been shown to be effective for adults with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and health care–associated pneumonia (HCAP). It should be used in patients with late-onset disease or risk factors for multidrug-resistant pathogens.

15 to 20 mg/kg IV every 12 h. For neonates weighing more than 2 kg, a dosage of 20 mg/kg IV every 8 h has been suggested. Administer dose over 15 to 30 min.

General Advice

• For IV bolus or infusion only. Not for intradermal, subcutaneous, IM, or intra-arterial administration.
• 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. Final concentration is approximately 50 mg/mL.
• 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.
• If other drugs are being administered through same IV line, administer each medication separately.
• Reconstituted meropenem solution is a clear, colorless to yellow solution. Do not administer if solution is cloudy, discolored, or contains particulate matter.

Storage/Stability

Store dry powder for reconstitution at controlled room temperature (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

Inhibits renal excretion of meropenem. Coadministration is not recommended.

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

Incompatibility

Do not physically mix with solutions containing other drugs.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Bradycardia, cardiac arrest, heart failure, hypertension, hypotension, MI, pulmonary embolus, syncope, tachycardia.

CNS

Headache (8%); seizures.

Dermatologic

Diaper rash (3%); rash (2%); pruritus (1%); 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%); glossitis (1%); intestinal obstruction.

Genitourinary

Kidney failure, dysuria, urinary incontinence, vaginal moniliasis.

Hematologic-Lymphatic

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

Hepatic

Cholestatic jaundice, hepatic failure, jaundice.

Lab Tests

Decreased hematocrit, hemoglobin, platelets, and WBC; increased ALT, AST, alkaline phosphatase, bilirubin, BUN, creatinine, LDH, platelets, and eosinophils.

Local

Inflammation at injection site (2%).

Metabolic-Nutritional

Hypoglycemia (at least 1%).

Respiratory

Apnea (1%); pneumonia (at least 1%); cough increased, dyspnea, lung edema, pleural effusion.

Miscellaneous

Pain (5%); sepsis (2%); shock (1%); accidental injury, peripheral vascular disorder (at least 1%).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 3 mo of age 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 because of possible cross-reactivity.

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, and mortality.

Patient Information

• Advise patient, family, or caregiver that medication will be prepared and administered by health care professionals 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.
• Warn patient, family, or caregiver that if diarrhea containing blood or pus develops after discharge, this may be a sign of a serious disorder and to seek medical care if noted and not to treat at home.

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