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Meropenem

Pronunciation

Pronunciation

(mer oh PEN em)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Merrem: 500 mg (1 ea); 1 g (1 ea)

Generic: 500 mg (1 ea); 1 g (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Generic: 500 mg (1 ea); 1 g (1 ea)

Brand Names: U.S.

  • Merrem

Pharmacologic Category

  • Antibiotic, Carbapenem

Pharmacology

Inhibits bacterial cell wall synthesis by binding to several of the penicillin-binding proteins, which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis; bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested

Distribution

Penetrates into most tissues and body fluids including urinary tract, peritoneal fluid, bone, bile, lung, bronchial mucosa, muscle tissue, heart valves (Craig 1997), and CSF (CSF penetration: Neonates and Infants ≤3 months: 70%)

Vd:

Neonates and Infants ≤3 months: Median: ~0.47 L/kg (Smith 2011)

Children: 0.3-0.4 L/kg (Blumer 1995)

Adults: 15 to 20 L

Metabolism

Hepatic; hydrolysis of beta-lactam bond to open beta-lactam form (inactive) (Craig, 1997)

Excretion

Urine (~70% as unchanged drug; ~28% inactive metabolite); feces (2%)

Clearance: Neonates and Infants ≤3 months: 0.12 L/hour/kg (Smith 2011); Infants and Children: 0.26-0.37 L/hour/kg (Blumer 1995)

Time to Peak

Tissue: ~1 hour following infusion except in bile, lung, and muscle; CSF: 2 to 3 hours with inflamed meninges

Half-Life Elimination

Neonates and Infants ≤3 months: Median: 2.7 hours; range: 1.6- 3.8 hours (Smith 2011)

Infants and Children 3 months to 2 years: 1.5 hours

Children 2-12 years and Adults: 1 hour

Protein Binding

~2%

Special Populations: Renal Function Impairment

Clearance correlates with CrCl in patients with renal impairment.

Special Populations: Elderly

Reduction in plasma clearance correlates with age-associated reduction in creatinine clearance (CrCl) (Craig 1997)

Use: Labeled Indications

Bacterial meningitis: Treatment of bacterial meningitis in pediatric patients 3 months and older caused by Haemophilus influenzae, Neisseria meningitidis, and penicillin-susceptible isolates of Streptococcus pneumoniae.

Skin and skin structure infections, complicated: Treatment of complicated skin and skin structure infections in adults and pediatric patients 3 months and older caused by Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.

Intra-abdominal infections: Treatment of complicated appendicitis and peritonitis in adult and pediatric patients caused by viridans group streptococci, E. coli, Klebsiella pneumoniae, P. aeruginosa, B. fragilis, B. thetaiotaomicron, and Peptostreptococcus species.

Off Label Uses

Bacterital meningitis

Based on the Infectious Disease Society of America (IDSA) guidelines for the management of bacterial meningitis, meropenem is an effective and recommended alternative agent for the treatment of meningitis due to Listeria monocytogenes, E. coli, other susceptible Enterobacteriaceae, P. aeruginosa, and methicillin-susceptible S. aureus.

Catheter-related blood stream infections

Based on the Infectious Disease Society of America (IDSA) Diagnosis and Management of Intravascular Catheter-Related Infection guidelines, meropenem given for catheter-related blood stream infections is effective and recommended in the management of this condition.

Cystic fibrosis, pulmonary exacerbation

Data from several randomized trials in patients with cystic fibrosis and infection with Pseudomonas aeruginosa treated with meropenem (with and without the use of tobramycin) supports the use of meropenem in the treatment of this condition [Blumer 2005], [Byrne 1995], [Latzin 2008]. Clinical experience also suggests the use of meropenem for pulmonary exacerbation in patients with cystic fibrosis [Chmiel 2014], [Zobell 2012]. Additional trials may be necessary to further define the role of meropenem in this condition.

Febrile neutropenia

Based on the Infectious Disease Society of America (IDSA) Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update, meropenem given for febrile neutropenia is effective and recommended in the management of this condition.

Gynecologic and pelvis infection

Data from randomized trials support the use of meropenem in the treatment of gynecologic and pelvic infections (eg, endometritis, pelvic cellulitis, pelvic inflammatory disease, salpingitis) [Hemsell 1997], [Maggioni 1998]. Additional trials may be necessary to further define the role of meropenem in this condition.

Melioidosis (Burkholderia pseudomallei)

Melioidosis is a worldwide subtropic and tropic bacterial disease due to contact with Burkholderia pseudomallei contaminated water or soil [Lipsitz 2012]. Data from a limited number of patients treated with meropenem (case series of 63 patients in a single institution) suggest that meropenem may be beneficial for the treatment of this condition [Cheng 2004].

A DHHS Workshop on Treatment of and Postexposure Prophylaxis for Burkholderia pseudomallei and B. mallei infection also supports the use of meropenem as a second-line agent for initial treatment of melioidosis [Lipsitz 2012]. Additional data may be necessary to further define the role of meropenem for the treatment of melioidosis.

Pneumonia, hospital-acquired or ventilator-associated

Based on the Infectious Diseases Society of America and the American Thoracic Society (IDSA/ATS) guidelines for management of adults with hospital-acquired and ventilator-associated pneumonia, meropenem given for the empiric treatment of hospital-acquired or ventilator-associated pneumonia, alone or in combination with other antimicrobials (dependent on patient factors), is an effective and recommended treatment option in the management of this condition.

Prosthetic joint infection

Based on the Infectious Diseases Society of America (IDSA) Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline, meropenem given for prosthetic joint infection is effective and recommended in the management of this condition.

Skin and soft tissue necrotizing infections

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), meropenem, in combination with an agent effective against methicillin resistant S. aureus (MRSA) (eg, vancomycin, linezolid, daptomycin), is an effective and recommended empiric treatment for polymicrobial (mixed) necrotizing infections of the skin, fascia, and muscle.

Surgical site Infection

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), meropenem is an effective and recommended option for treatment of surgical site infections occurring after intestinal or genitourinary tract surgery. Systemic antibacterials are not routinely indicated for surgical site infections, but may be beneficial (in conjunction with suture removal plus incision and drainage) in patients with significant systemic response (eg, temperature >38.5ºC, heart rate >110 beats per minute, erythema/induration extending >5 cm from incision, WBC >12,000/mm3).

Urinary tract infection

Data from a multicenter, randomized, parallel-group study support the use of meropenem in the treatment of complicated urinary tract infections [Cox 1995]. Clinical experience also suggests the utility of meropenem in the treatment of complicated urinary tract infections [Pallett 2010]. Additional data may be necessary to further define the role of meropenem in this condition.

Contraindications

Hypersensitivity to meropenem, other drugs in the same class, or any component of the formulation; patients who have experienced anaphylactic reactions to beta-lactams

Dosing: Adult

Usual dosage range: IV: 1.5 to 6 g daily divided every 8 hours

Extended infusion method (off-label dosing): IV: 0.5 to 2 g over 3 hours every 8 hours (Crandon 2011; Dandekar 2003). Note: Dosing used at some centers and is based on pharmacokinetic/pharmacodynamic modeling and not clinical efficacy data. Meropenem stability (admixed with NS at a concentration of 20 mg/mL) at room temperature for >1 hour or under refrigeration for >15 hours is not supported by the manufacturer. Data exist supporting stability (admixed with NS at a concentration of 20 mg/mL) at room temperature for ≤4 hours and under refrigeration ≤24 hours (Patel 1997).

Indication-specific dosing:

Bacterial meningitis (off-label use): IV: 2 g every 8 hours; duration of therapy dependent upon pathogen: N. meningitidis, H. influenza: 7 days; S. pneumoniae: 10 to 14 days; Listeria monocytogenes, aerobic gram-negative bacilli: 21 days (IDSA [Tunkel 2004])

Catheter-related bloodstream infections (off-label use): IV: 1 g every 8 hours (Mermel 2009)

Cholangitis, intra-abdominal infections, complicated: IV: 1 g every 8 hours. Note: 2010 IDSA guidelines recommend treatment duration of 4 to 7 days (provided source controlled). Not recommended for mild-to-moderate, community-acquired intra-abdominal infections due to risk of toxicity and the development of resistant organisms (Solomkin 2010).

Cystic fibrosis, pulmonary exacerbation (off-label use): IV: 2 g every 8 hours (Chmiel 2014)

Febrile neutropenia (off-label use): IV: 1 g every 8 hours (Ohata 2011; Paul 2010)

Gynecologic and pelvic infections (off-label use): IV: 500 mg every 8 hours (Hemsell 1997; Maggioni 1998)

Melioidosis (Burkholderia pseudomallei) (off-label use): IV: Initial treatment (intensive-phase): 1 g every 8 hours (Cheng 2004; Inglis 2006; Lipsitz 2012). Note: Meropenem is an alternative treatment to ceftazidime for melioidosis; continued treatment with oral antibiotics is recommended after intensive-phase is completed (Lipsitz 2012).

Pneumonia (hospital-acquired, healthcare-associated, or ventilator-associated) (off-label use): IV: 1 g every 8 hours (ATS/IDSA 2005)

Prosthetic joint infection, Pseudomonas aeruginosa (off-label use): IV: 1 g every 8 hours for 4 to 6 weeks (consider addition of aminoglycoside) (IDSA [Osmon 2013])

Skin and skin structure infections, complicated: IV:

Pseudomonas aeruginosa-suspected or confirmed: 1 g every 8 hours

Pseudomonas aeruginosa not suspected: 500 mg every 8 hours

Skin and soft tissue necrotizing infections (off-label use): IV: 1 g every 8 hours in combination with an agent effective against MRSA (eg, vancomycin, linezolid, daptomycin) for empiric therapy of polymicrobial (mixed) infections. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).

Surgical site infection (intestinal or genitourinary tract surgery) (off-label use): IV: 1 g every 8 hours (IDSA [Stevens 2014])

Urinary tract infections, complicated (off-label use): IV: 500 mg to 1 g every 8 hours (Pallett 2010)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Usual dosage range:

Infants <3 months: IV:

Gestational age <32 weeks:

Postnatal age <14 days: 20 mg/kg/dose every 12 hours

Postnatal age ≥14 days: 20 mg/kg/dose every 8 hours

Gestational age ≥32 weeks:

Postnatal age <14 days: 20 mg/kg/dose every 8 hours

Postnatal age ≥14 days: 30 mg/kg/dose every 8 hours

Infants ≥3 months, Children, and Adolescents (≤50 kg): IV: 30 to 120 mg/kg/day divided every 8 hours (maximum dose: 6 g daily)

Children and Adolescents (>50 kg): IV: 1.5 to 6 g daily divided every 8 hours

Indication-specific dosing:

Catheter-related blood stream infections (off-label use): IV:

Infants ≥3 months, Children, and Adolescents (≤50 kg): IV: 20 mg/kg every 8 hours; maximum single dose: 1,000 mg (Mermel 2009)

Children and Adolescents (>50 kg): Refer to adult dosing.

Cholangitis, intra-abdominal infections, complicated: IV: Children and Adolescents (>50 kg): Refer to adult dosing.

Cystic fibrosis, pulmonary exacerbation (off-label use): IV:

Infants ≥3 months, Children, and Adolescents (≤50 kg): 40 mg/kg every 8 hours; maximum single dose: 2,000 mg (Zobell 2012)

Children and Adolescents (>50 kg): Refer to adult dosing.

Febrile neutropenia (off-label use): IV:

Infants ≥3 months, Children, and Adolescents (≤50 kg): 20 mg/kg every 8 hours (maximum dose: 1,000 mg every 8 hours) (Lehrnbecher 2012; Yildirim 2008)

Children and Adolescents (>50 kg): Refer to adult dosing.

Intra-abdominal infections (complicated): IV:

Infants <3 months: IV: Note: Administer as an IV infusion over 30 minutes; do not administer as an IV bolus

Gestational age <32 weeks:

Postnatal age <14 days: 20 mg/kg/dose every 12 hours

Postnatal age ≥14 days: 20 mg/kg/dose every 8 hours

Gestational age ≥32 weeks:

Postnatal age <14 days: 20 mg/kg/dose every 8 hours

Postnatal age ≥14 days: 30 mg/kg/dose every 8 hours

Infants ≥3 months, Children, and Adolescents: 20 mg/kg every 8 hours (maximum dose: 1,000 mg every 8 hours) for 4 to 7 days (Solomkin 2010)

Melioidosis (Burkholderia pseudomallei) (off-label use): IV:

Infants ≥6 months, Children, and Adolescents (≤40 kg): Initial treatment (intensive-phase): 25 mg/kg (up to 1 g) every 8 hours (Cheng 2004). Note: Meropenem is an alternative treatment to ceftazidime for melioidosis; continued treatment with oral antibiotics is recommended after intensive-phase is completed (Lipsitz 2012).

Children and Adolescents (>50 kg): Refer to adult dosing.

Meningitis: IV:

Infants ≥3 months, Children, and Adolescents (≤50 kg): 40 mg/kg every 8 hours (maximum dose: 2,000 mg every 8 hours)

Children and Adolescents (>50 kg): 2 g every 8 hours

Prosthetic joint infection, Pseudomonas aeruginosa (off-label use): Children and Adolescents (>50 kg): Refer to adult dosing.

Skin and skin structure infections: IV:

Infants ≥3 months, Children, and Adolescents (≤50 kg):

Complicated:

Pseudomonas aeruginosa-suspected or confirmed: 20 mg/kg every 8 hours (maximum dose: 1,000 mg every 8 hours)

Pseudomonas aeruginosa not suspected: 10 mg/kg every 8 hours (maximum dose: 500 mg every 8 hours)

Children and Adolescents (>50 kg): Refer to adult dosing.

Skin and soft tissue necrotizing infections (off-label use): IV: 20 mg/kg every 8 hours in combination with an agent effective against MRSA (eg, vancomycin, linezolid, daptomycin) for empiric therapy of polymicrobial (mixed) infections. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014])

Urinary tract infection (complicated): IV: Children and Adolescents (>50 kg): Refer to adult dosing

Dosing: Renal Impairment

Adults:

Manufacturer’s labeling:

CrCl >50 mL/minute: No dosage adjustment necessary.

CrCl 26 to 50 mL/minute: Administer recommended dose based on indication every 12 hours

CrCl 10 to 25 mL/minute: Administer one-half recommended dose based on indication every 12 hours

CrCl <10 mL/minute: Administer one-half recommended dose based on indication every 24 hours

Alternative recommendations: Note: Renally adjusted dose recommendations are based on doses of 1 to 2 g every 8 hours.

GFR 10 to 50 mL/minute: Administer recommended dose based on indication every 12 hours (Aronoff 2007)

GFR <10 mL/minute: Administer recommended dose based on indication every 24 hours (Aronoff 2007)

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Meropenem and its metabolite are readily dialyzable: 500 mg every 24 hours (Heintz, 2009). Note: Dosing dependent on the assumption of 3 times weekly, complete IHD sessions.

Peritoneal dialysis (off-label dose): Administer recommended dose (based on indication) every 24 hours (Aronoff, 2007).

Continuous renal replacement therapy (CRRT) (Heintz 2009; Kuti 2005; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH: Consider loading dose of 1 g followed by either 500 mg every 8 hours or 1 g every 8 to 12 hours

CVVHD/CVVHDF: Consider loading dose of 1 g followed by either 500 mg every 6 to 8 hours or 1 g every 8 to 12 hours

Note: Consider giving patients receiving CVVHDF dosages of 750 mg every 8 hours or 1.5 g every 12 hours (Heintz, 2009). Substantial variability exists in various published recommendations, ranging from 1 to 3 g daily in 2 to 3 divided doses. One gram every 12 hours achieves a target trough of ~4 mg/L.

Children:

Manufacturer’s labeling: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied)

Alternate recommendations (off-label dosing; Aronoff 2007):

GFR 30 to 50 mL/minute: Administer 20 to 40 mg/kg every 12 hours

GFR 10 to 29 mL/minute: Administer 10 to 20 mg/kg every 12 hours

GFR <10 mL/minute: Administer 10 to 20 mg/kg every 24 hours

Intermittent hemodialysis (IHD): 10 to 20 mg/kg every 24 hours administer after hemodialysis on dialysis days)

Peritoneal dialysis (PD): 10 to 20 mg/kg every 24 hours

Continuous renal replacement therapy (CRRT): 20 to 40 mg/kg every 12 hours

Dosing: Hepatic Impairment

No dosage adjustment necessary.

Reconstitution

Meropenem infusion vials may be reconstituted with SWFI. The 500 mg vials should be reconstituted with 10 mL, and 1 g vials with 20 mL. May be further diluted to a final concentration ranging from 1 to 20 mg/mL with a compatible solution for infusion. Consult detailed reference/product labeling for compatibility.

Duplex: Unlatch side tab, unfold, remove foil strip from drug chamber. Point set port in downward direction, fold container just below the diluent meniscus, and squeeze the diluent chamber until the seal between the diluent and drug powder opens. Agitate until dissolved.

Administration

IV:

Infants <3 months: Administer as an IV infusion over 30 minutes

Infants ≥3 months, Children, Adolescents, and Adults: Administer IV infusion over 15 to 30 minutes; IV bolus injection (5 to 20 mL) over 3 to 5 minutes

Extended infusion administration (off-label dosing): Adults: Administer over 3 hours (Crandon 2011; Dandekar, 2003). Note: Must consider meropenem’s limited room temperature stability if using extended infusions

Dietary Considerations

Some products may contain sodium.

Storage

Freshly prepared solutions should be used. However, constituted solutions maintain satisfactory potency under the conditions described below. Solutions should not be frozen.

Store intact vials and unactivated Duplex containers at 20°C to 25°C (68°F to 77°F). Unactivated duplex units with foil strip removed from the drug chamber must be protected from light and used within 7 days at room temperature. Once activated, must be used within 1 hour if stored at room temperature or within 15 hours if stored under refrigeration. Do not freeze.

Dry powder should be stored at controlled room temperature 20°C to 25°C (68°F to 77°F).

Injection reconstitution: Stability in vial when constituted (up to 50 mg/mL) with:

SWFI: Stable for up to 3 hours at up to 25°C (77°F) or for up to 13 hours at up to 5°C (41°F).

Infusion admixture (1 to 20 mg/mL): Solution is stable when diluted in NS for 1 hour at up to 25°C (77°F) or 15 hours at up to 5°C (41°F). Solutions constituted with dextrose injection 5% should be used immediately. Note: Meropenem stability (admixed with NS at a concentration of 20 mg/mL) at room temperature for >1 hour or under refrigeration for >15 hours is not supported by the manufacturer. Data exist supporting stability (admixed with NS at a concentration of 20 mg/mL) at room temperature for ≤4 hours and under refrigeration ≤24 hours (Patel, 1997).

Duplex container: Following reconstitution/activation, use within 1 hour if stored at room temperature or 15 hours refrigerated

Drug Interactions

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Probenecid: May increase the serum concentration of Meropenem. Avoid combination

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Valproate Products: Carbapenems may decrease the serum concentration of Valproate Products. Management: Concurrent use of carbapenem antibiotics with valproic acid is generally not recommended. Alternative antimicrobial agents should be considered, but if a concurrent carbapenem is necessary, consider additional anti-seizure medication. Consider therapy modification

Test Interactions

Positive Coombs' [direct]

Adverse Reactions

1% to 10%:

Cardiovascular: Peripheral vascular disease (>1%), shock (1%), bradycardia (≤1%), cardiac arrest (≤1%), cardiac failure (≤1%), chest pain (≤1%), hypertension (≤1%), hypotension (≤1%), myocardial infarction (≤1%), peripheral edema (≤1%), pulmonary embolism (≤1%), syncope (≤1%), tachycardia (≤1%)

Central nervous system: Headache (2% to 8%), convulsions (neonates and infants <3 months: 5%), pain (≤5%), agitation (≤1%), anxiety (≤1%), chills (≤1%), confusion (≤1%), delirium (≤1%), depression (≤1%), dizziness (≤1%), drowsiness (≤1%), hallucination (≤1%), insomnia (≤1%), nervousness (≤1%), paresthesia (≤1%), seizure (≤1%)

Dermatologic: Skin rash (2% to 3%, includes diaper-area moniliasis in infants), pruritus (1%), dermal ulcer (≤1%), diaphoresis (≤1%), urticaria (≤1%)

Endocrine & metabolic: Hypoglycemia (>1%), hypervolemia (≤1%)

Gastrointestinal: Nausea (≤8%), diarrhea (4% to 7%), constipation (1% to 7%), vomiting (≤4%), oral candidiasis (≤2%), gastrointestinal disease (>1%), glossitis (1%), abdominal pain (≤1%), anorexia (≤1%), dyspepsia (≤1%), enlargement of abdomen (≤1%), flatulence (≤1%), intestinal obstruction (≤1%)

Genitourinary: Dysuria (≤1%), pelvic pain (≤1%), urinary incontinence (≤1%), vulvovaginal candidiasis (≤1%)

Hematologic & oncologic: Anemia (≤6%), hypochromic anemia (≤1%)

Hepatic: Hyperbilirubinemia (conjugated; neonates and infants <3 months: 5%), cholestatic jaundice (≤1%), hepatic failure (≤1%), jaundice (≤1%)

Infection: Sepsis (2%)

Local: Inflammation at injection site (2%)

Neuromuscular & skeletal: Back pain (≤1%), weakness (≤1%)

Renal: Renal failure (≤1%)

Respiratory: Pharyngitis (>1%), pneumonia (>1%), apnea (1%), asthma (≤1%), cough (≤1%), dyspnea (≤1%), hypoxia (≤1%), pleural effusion (≤1%), pulmonary edema (≤1%), respiratory tract disease (≤1%)

Miscellaneous: Accidental injury (>1%), fever (≤1%)

<1% (Limited to important or life-threatening): Agranulocytosis, angioedema, change in platelet count, Clostridium difficile associated diarrhea, decreased hematocrit, decreased hemoglobin, decreased partial thromboplastin time, decreased prothrombin time, decreased white blood cell count, DRESS syndrome, edema at injection site, eosinophilia, epistaxis, erythema multiforme, gastrointestinal hemorrhage, hematuria, hemolytic anemia, hemoperitoneum, hypokalemia, increased blood urea nitrogen, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, increased serum creatinine, injection site reaction, leukocytosis, leukopenia, localized phlebitis, melena, neutropenia, positive direct Coombs test, positive indirect Coombs test, Stevens-Johnson syndrome, toxic epidermal necrolysis

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported (some without a history of previous allergic reactions to beta-lactams).

• CNS effects: Carbapenems have been associated with CNS adverse effects, including confusional states and seizures (myoclonic); use caution with CNS disorders (eg, brain lesions and history of seizures) and adjust dose in renal impairment to avoid drug accumulation, which may increase seizure risk. Outpatient use may result in paresthesias, seizures, delirium and/or headaches that can impair neuromotor function and alertness; patients should not operate machinery or drive until it is established that meropenem is well tolerated.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required in patients with creatinine clearance ≤50 mL/minute. Increased seizure risk and thrombocytopenia have been reported in patients with renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions. Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Lower doses (based upon renal function) are often required in the elderly.

Monitoring Parameters

Perform culture and sensitivity testing prior to initiating therapy. Monitor for signs of anaphylaxis during first dose. During prolonged therapy, monitor renal function, liver function, CBC.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Incomplete transplacental transfer of meropenem was found using an ex vivo human perfusion model.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, diarrhea, or constipation. Have patient report immediately to prescriber seizures, muscle rigidity, tremors, abnormal movements, burning or numbness feeling, severe loss of strength and energy, confusion, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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