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Carbapenems

Disclaimer - Please see package insert if applicable for additional information. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer   |   <BACK

Carbapenems

Background:     
"Carbapenems are a class of beta-lactam antibiotics with a broad spectrum of antibacterial activity. They have a structure that renders them highly resistant to most beta-lactamases. Carbapenem antibiotics were originally developed from the carbapenem thienamycin, a naturally derived product of Streptomyces cattleya."

"Carbapenems are one of the antibiotics of last resort for many bacterial infections, such as Escherichia coli (E. coli) and Klebsiella pneumoniae. Recently, alarm has been raised over the spread of drug resistance to carbapenem antibiotics among these coliforms, due to production of the New Delhi metallo-beta-lactamase, NDM-1. There are currently no new antibiotics in development to combat bacteria resistant to carbapenems, and worldwide spread of the resistance gene is considered a potential nightmare scenario."

Approved for clinical use
The following drugs belong to the carbapenem class and are approved for use by health authorities:
Imipenem, in general given as part of Imipenem/cilastatin (FDA approval 1985).  Imipenem can be hydrolysed in the mammalian kidney by a dehydropeptidase enzyme to a nephrotoxic metabolite, and so is given with a dehydropeptidase inhibitor, cilastatin
Meropenem (FDA approval 1996)
Ertapenem (FDA approval 2001, since approved for multiple indications)
Doripenem (FDA Approval 2007)

 [Source: (direct quotes: http://en.wikipedia.org/wiki/Carbapenems]
Doripenem - Doribax® Ertapenem - Invanz® Imipenem-Cilastatin - Primaxin®
  Meropenem - Merrem® Infectious Disease -ALL Agents (INDEX)
     

Antimicrobials - Infectious Disease

Aminoglycosides Ansamycins/Rifamycins Antibiotics (Other)
Anti- Fungals Anti-Herpetic Agents Anti-Influenza Agents
Anti-Malarials Carbapenems Cephalosporins
Fluoroquinolones Glycopeptides HIV (anti) Agents
Lincosamides Lipopeptides Macrolides
Monobactams Oxazolidones Penicillins
Sulfonamide antibiotics Tetracyclines Tuberculosis (anti) agents

doripenem - DORIBAX®: top of page

INDICATIONS AND USAGE
DORIBAX® is a penem antibacterial indicated in the treatment of the following infections caused by designated susceptible bacteria:

Complicated intra-abdominal infections
Complicated urinary tract infections, including pyelonephritis

FDA warning: Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients

[Posted 03/06/2014]

AUDIENCE: Pulmonology, Infectious Disease, Pharmacy

ISSUE: The FDA has concluded that Doribax (doripenem), an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin). Based on an FDA analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA approved changes to the Doribax drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doribax is not approved to treat any type of pneumonia.

BACKGROUND: In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day Doribax treatment or 10-day treatment with imipenem and cilastatin. In the intent-to-treat population, the 28-day all-cause mortality was higher in the Doribax arm (23.0%; n=31/135) than in the imipenem and cilastatin arm (16.7%; n=22/132). Clinical cure rates were also lower in the Doribax arm.

RECOMMENDATION: Health care professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators. Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections (pyelonephritis).


DOSAGE AND ADMINISTRATION
Dosage of DORIBAX® by Infection
Infection Dosage Frequency Infusion Time
(hours)
Duration
Complicated intra-abdominal infection 500 mg every 8 hours 1 5-14 days*
Complicated UTI, including pyelonephritis 500 mg every 8 hours 1 10 days*†
*Duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated.
†Duration can be extended up to 14 days for patients with concurrent bacteremia.


Dosage of DORIBAX® in Patients with Renal Impairment
Estimated CrCl (mL/min) Recommended Dosage Regimen of DORIBAX®
> 50 No dosage adjustment necessary
geq 30 to leq 50 250 mg administered intravenously (over 1 hour) every 8 hours
> 10 to < 30 250 mg administered intravenously (over 1 hour) every 12 hours

Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula.
Creatinine clearance for males = [140-age (years)]× [body wt (kg)]
72 × [serum creatinine (mg/dL)]
Creatinine clearance for females = [140-age (years)]× [body wt (kg)]× 0.85
72 × [serum creatinine (mg/dL)]

DOSAGE FORMS AND STRENGTHS
250 mg single-use vial, 500 mg single-use vial

ertapenem - INVANZ®: top of page

INDICATIONS AND USAGE
INVANZ is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria:
-Complicated intra-abdominal infections.
-Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis.
-Community-acquired pneumonia.
-Complicated urinary tract infections including pyelonephritis.
-Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections.

INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

DOSAGE AND ADMINISTRATION
Do not mix or co-infuse INVANZ with other medications. Do not use diluents containing dextrose (a-D-glucose).

INVANZ should be infused over 30 minutes in both the Treatment and Prophylactic regimens.

Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis.

Treatment regimen:
Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly.

Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 g/day intravenously or intramuscularly.)

Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days.

Prophylaxis regimen for adults:
1 gram single dose given 1 hour prior to elective colorectal surgery.

Patients with Renal Impairment
INVANZ may be used for the treatment of infections in adult patients with renal impairment. In patients whose creatinine clearance is >30 mL/min/1.73 m2, no dosage adjustment is necessary. Adult patients with severe renal impairment (creatinine clearance leq30 mL/min/1.73 m2) and end-stage renal disease (creatinine clearance leq10 mL/min/1.73 m2) should receive 500 mg daily. A supplementary dose of 150 mg is recommended if ertapenem is administered within 6 hours prior to hemodialysis. There are no data in pediatric patients with renal impairment.

Patients on Hemodialysis:
When adult patients on hemodialysis are given the recommended daily dose of 500 mg of INVANZ within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is recommended following the hemodialysis session. If INVANZ is given at least 6 hours prior to hemodialysis, no supplementary dose is needed. There are no data in patients undergoing peritoneal dialysis or hemofiltration. There are no data in pediatric patients on hemodialysis.

When only the serum creatinine is available, the following formula (see below) may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function.
 
Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula.
Creatinine clearance for males = [140-age (years)]× [body wt (kg)]
72 × [serum creatinine (mg/dL)]
Creatinine clearance for females = [140-age (years)]× [body wt (kg)]× 0.85
72 × [serum creatinine (mg/dL)]


DOSAGE FORMS AND STRENGTHS
Vial 1 gram.
ADD-Vantage® vial: 1 gram.

Imipenem/cilistatin (Primaxin ®): top of page


INDICATIONS AND USAGE
PRIMAXIN I.V. is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

1. Lower respiratory tract infections. Staphylococcus aureus (penicillinase-producing strains), Acinetobacter species, Enterobacter species, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae2, Klebsiella species, Serratia marcescens

2. Urinary tract infections (complicated and uncomplicated). Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)2 , Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii2 , Proteus vulgaris2 , Providencia rettgeri2 , Pseudomonas aeruginosa

3. Intra-abdominal infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)2 , Staphylococcus epidermidis, Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii2 , Proteus species, Pseudomonas aeruginosa, Bifidobacterium species, Clostridium species, Eubacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species2 , Bacteroides species including B. fragilis, Fusobacterium species

4. Gynecologic infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)2 , Staphylococcus epidermidis, Streptococcus agalactiae (Group B streptococci), Enterobacter species2 , Escherichia coli, Gardnerella vaginalis, Klebsiella species2 , Proteus species, Bifidobacterium species2 , Peptococcus species2 , Peptostreptococcus species, Propionibacterium species2 , Bacteroides species including B. fragilis

5. Bacterial septicemia. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Enterobacter species, Escherichia coli, Klebsiella species, Pseudomonas aeruginosa, Serratia species2 , Bacteroides species including B. fragilis2

6. Bone and joint infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Enterobacter species, Pseudomonas aeruginosa

7. Skin and skin structure infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Acinetobacter species, Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii, Proteus vulgaris, Providencia rettgeri2 , Pseudomonas aeruginosa, Serratia species, Peptococcus species, Peptostreptococcus species, Bacteroides species including B. fragilis, Fusobacterium species2

8. Endocarditis. Staphylococcus aureus (penicillinase-producing strains)

9. Polymicrobic infections. PRIMAXIN I.V. is indicated for polymicrobic infections including those in which S. pneumoniae (pneumonia, septicemia), S. pyogenes (skin and skin structure), or nonpenicillinase-producing S. aureus is one of the causative organisms. However, monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G.

[2.  Efficacy for this organism in this organ system was studied in fewer than 10 infections.]


PRIMAXIN I.V. is not indicated in patients with meningitis because safety and efficacy have not been established.

For Pediatric Use information, see PRECAUTIONS, Pediatric Use, and DOSAGE AND ADMINISTRATION sections.

Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic bacteria, PRIMAXIN I.V. is useful for the treatment of mixed infections and as presumptive therapy prior to the identification of the causative organisms.

Although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections caused by Pseudomonas aeruginosa, bacterial eradication may not necessarily be achieved.

As with other beta-lactam antibiotics, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with PRIMAXIN I.V. During therapy of Pseudomonas aeruginosa infections, periodic susceptibility testing should be done when clinically appropriate.

Infections resistant to other antibiotics, for example, cephalosporins, penicillin, and aminoglycosides, have been shown to respond to treatment with PRIMAXIN I.V.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN I.V. and other antibacterial drugs, PRIMAXIN I.V. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.


DOSAGE AND ADMINISTRATION
Adults
The dosage recommendations for PRIMAXIN I.V. represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.

The total daily dosage for PRIMAXIN I.V. should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance less than or equal70 mL/min/1.73 m2, require adjustment of dosage as described in the succeeding section of these guidelines.

Intravenous Dosage Schedule for Adults with Normal Renal Function and Body Weight greater than or equal70 kg
Doses cited in Table I are based on a patient with normal renal function and a body weight of 70 kg. These doses should be used for a patient with a creatinine clearance of greater than or equal71 mL/min/1.73 m2 and a body weight of greater than or equal70 kg. A reduction in dose must be made for a patient with a creatinine clearance of less than or equal70 mL/min/1.73 m2 and/or a body weight less than 70 kg. (See Tables II and III.)

Dosage regimens in column A of Table I are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table I are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.

TABLE I: INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT greater than or equal70 kg
Type or
Severity of Infection
A
Fully susceptible organisms including gram-positive and gram-negative aerobes and anaerobes
B
MODERATELY SUSCEPTIBLE ORGANISMS, PRIMARILY SOME STRAINS OF P. aeruginosa
Mild 250 mg q6h
(TOTAL DAILY DOSE = 1.0g)
500 mg q6h
(TOTAL DAILY DOSE = 2.0g)
Moderate 500 mg q8h
(TOTAL DAILY DOSE = 1.5g)
or
500 mg q6h
(TOTAL DAILY DOSE = 2.0g)
500 mg q6h
(TOTAL DAILY DOSE = 2.0g)
or
1 g q8h
(TOTAL DAILY DOSE = 3.0g)
Severe, life threatening only 500 mg q6h
(TOTAL DAILY DOSE = 2.0g)
1 g q8h
(TOTAL DAILY DOSE = 3.0g)
or
1 g q6h
(TOTAL DAILY DOSE = 4.0g)
Uncomplicated urinary tract infection 250 mg q6h
(TOTAL DAILY DOSE = 1.0g)
250 mg q6h
(TOTAL DAILY DOSE = 1.0g)
Complicated urinary tract infection 500 mg q6h
(TOTAL DAILY DOSE = 2.0g)
500 mg q6h
(TOTAL DAILY DOSE = 2.0g)

Due to the high antimicrobial activity of PRIMAXIN I.V., it is recommended that the maximum total daily dosage not exceed 50 mg/kg/day or 4.0 g/day, whichever is lower. There is no evidence that higher doses provide greater efficacy. However, patients over twelve years of age with cystic fibrosis and normal renal function have been treated with PRIMAXIN I.V. at doses up to 90 mg/kg/day in divided doses, not exceeding 4.0 g/day.

Reduced Intravenous Schedule for Adults with Impaired Renal Function and/or Body Weight <70 kg

Patients with creatinine clearance of less than or equal70 mL/min/1.73 m2 and/or body weight less than 70 kg require dosage reduction of PRIMAXIN I.V. as indicated in the tables below. Creatinine clearance may be calculated from serum creatinine concentration by the following equation:

Creatinine clearance for males = [140-age (years)]× [body wt (kg)]
72 × [serum creatinine (mg/dL)]
Creatinine clearance for females = [140-age (years)]× [body wt (kg)]× 0.85
72 × [serum creatinine (mg/dL)]


To determine the dose for adults with impaired renal function and/or reduced body weight:
1. Choose a total daily dose from Table I based on infection characteristics.
2. a) If the total daily dose is 1.0 g, 1.5 g, or 2.0 g, use the appropriate subsection of Table II and continue with step 3.
b) If the total daily dose is 3.0 g or 4.0 g, use the appropriate subsection of Table III and continue with step 3.
3. From Table II or III:
a) Select the body weight on the far left which is closest to the patient's body weight (kg).
b) Select the patient's creatinine clearance category.
c) Where the row and column intersect is the reduced dosage regimen.

TABLE II: REDUCED INTRAVENOUS DOSAGE OF PRIMAXIN I.V. IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT <70 kg

If TOTAL DAILY DOSE from TABLE I is:
  1.0 g/day 1.5 g/day 2.0 g/day
And Body Weight (kg) is: and creatinine clearance (mL/min/1.73 m2) is: and creatinine clearance (mL/min/1.73 m2) is: and creatinine clearance (mL/min/1.73 m2) is:
  greater than or equal71 41-70 21-40 6-20 greater than or equal71 41-70 21-40 6-20 greater than or equal71 41-70 21-40 6-20
  then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is:
greater than or equal70 250
q6h
250
q8h
250
q12h
250
q12h
500
q8h
250
q6h
250
q8h
250
q12h
500
q6h
500
q8h
250
q6h
250
q12h
60 250
q8h
125
q6h
250
q12h
125
q12h
250
q6h
250
q8h
250
q8h
250
q12h
500
q8h
250
q6h
250
q8h
250
q12h
50 125
q6h
125
q6h
125
q8h
125
q12h
250
q6h
250
q8h
250
q12h
250
q12h
250
q6h
250
q6h
250
q8h
250
q12h
40 125
q6h
125
q8h
125
q12h
125
q12h
250
q8h
125
q6h
125
q8h
125
q12h
250
q6h
250
q8h
250
q12h
250
q12h
30 125
q8h
125
q8h
125
q12h
125
q12h
125
q6h
125
q8h
125
q8h
125
q12h
250
q8h
125
q6h
125
q8h
125
q12h


TABLE III: REDUCED INTRAVENOUS DOSAGE OF PRIMAXIN I.V. IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT <70 kg
If TOTAL DAILY DOSE from TABLE I is:
  3.0 g/day 4.0 g/day
And Body Weight (kg) is: and creatinine clearance (mL/min/1.73 m2) is: and creatinine clearance (mL/min/1.73 m2) is:
  greater than or equal71 41-70 21-40 6-20 greater than or equal71 41-70 21-40 6-20
  then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is:
greater than or equal70 1000
q8h
500
q6h
500
q8h
500
q12h
1000
q6h
750
q8h
500
q6h
500
q12h
60 750
q8h
500
q8h
500
q8h
500
q12h
1000
q8h
750
q8h
500
q8h
500
q12h
50 500
q6h
500
q8h
250
q6h
250
q12h
750
q8h
500
q6h
500
q8h
500
q12h
40 500
q8h
250
q6h
250
q8h
250
q12h
500
q6h
500
q8h
250
q6h
250
q12h
30 250
q6h
250
q8h
250
q8h
250
q12h
500
q8h
250
q6h
250
q8h
250
q12h

Patients with creatinine clearances of 6 to 20 mL/min/1.73 m2 should be treated with PRIMAXIN I.V. 125 mg or 250 mg every 12 hours for most pathogens. There may be an increased risk of seizures when doses of 500 mg every 12 hours are administered to these patients.

Patients with creatinine clearance less than or equal5 mL/min/1.73 m2 should not receive PRIMAXIN I.V. unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of PRIMAXIN I.V. for patients undergoing peritoneal dialysis.

Hemodialysis
When treating patients with creatinine clearances of less than or equal5 mL/min/1.73 m2 who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of 6-20 mL/min/1.73 m2. (See Reduced Intravenous Dosage Schedule for Adults with Impaired Renal Function and/or Body Weight <70 kg.) Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive PRIMAXIN I.V. after hemodialysis and at 12 hour intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, PRIMAXIN I.V. is recommended only when the benefit outweighs the potential risk of seizures. (See PRECAUTIONS.)

Pediatric Patients
See package insert for PRECAUTIONS, Pediatric Patients.

For pediatric patients greater than or equal3 months of age, the recommended dose for non-CNS infections is 15-25 mg/kg/dose administered every six hours. Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2.0 g per day, and of infections with moderately susceptible organisms (primarily some strains of P. aeruginosa) is 4.0 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.

For pediatric patients less than or equal3 months of age (weighing greater than or equal1,500 gms), the following dosage schedule is recommended for non-CNS infections:
<1 wk of age: 25 mg/kg every 12 hrs
1-4 wks of age: 25 mg/kg every 8 hrs
4 wks-3 mos. of age: 25 mg/kg every 6 hrs.

Doses less than or equal to 500 mg should be given by intravenous infusion over 15 to 30 minutes. Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes.

PRIMAXIN I.V. is not recommended in pediatric patients with CNS infections because of the risk of seizures.

PRIMAXIN I.V. is not recommended in pediatric patients<30 kg with impaired renal function, as no data are available.

Meropenem - Merrem®: top of page

 INDICATIONS AND USAGE
Meropenem for injection (I.V.) is a penem antibacterial indicated as single agent therapy for the treatment of:

Complicated skin and skin structure infections (adult patients and pediatric patients greater than or equal 3 months only).
Complicated intra-abdominal infections (adult patients and pediatric patients greater than or equal 3 months only).
Bacterial meningitis (pediatric patients greater than or equal 3 months only).


DOSAGE AND ADMINISTRATION
Adults

The recommended dose of MERREM I.V. is 500 mg given every 8 hours for skin and skin structure infections and 1 g given every 8 hours for intra-abdominal infections. MERREM I.V. should be administered by intravenous infusion over approximately 15 to 30 minutes. Doses of 1 g may also be administered as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes.

Use in Adults with Renal Impairment
Dosage should be reduced in patients with creatinine clearance less than 51 mL/min. (see dosing table below).

Recommended MERREM I.V.
Dosage Schedule for Adults With Impaired Renal Function .
Creatinine
Clearance
(mL/min)
Dose (dependent on type of infection) Dosing Interval
greater than or equal51 Recommended dose (500 mg cSSSI and 1 g Intra-abdominal) Every 8 hours
26-50 Recommended dose Every 12 hours
10-25 One-half recommended dose Every 12 hours
<10 One-half recommended dose Every 24 hours

When only serum creatinine is available, the following formula (Cockcroft and Gault equation) may be used to estimate creatinine clearance.

Creatinine clearance for males = [140-age (years)]× [body wt (kg)]
72 × [serum creatinine (mg/dL)]
Creatinine clearance for females = [140-age (years)]× [body wt (kg)]× 0.85
72 × [serum creatinine (mg/dL)]


There is inadequate information regarding the use of MERREM I.V. in patients on hemodialysis.

There is no experience with peritoneal dialysis.

Use in Adults With Hepatic Insufficiency
No dosage adjustment is necessary in patients with impaired hepatic function.

Use in Elderly Patients
No dosage adjustment is required for elderly patients with creatinine clearance values above 50 mL/min.

Use in Pediatric Patients
For pediatric patients from 3 months of age and older, the MERREM I.V. dose is 10, 20 or 40 mg/kg every 8 hours (maximum dose is 2 g every 8 hours), depending on the type of infection (complicated skin and skin structure, intra-abdominal or meningitis). (See dosing table below.) Pediatric patients weighing over 50 kg should be administered MERREM I.V. at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 g every 8 hours for intra-abdominal infections and 2 g every 8 hours for meningitis. MERREM I.V. should be given as intravenous infusion over approximately 15 to 30 minutes or as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes.

Recommended MERREM I.V. Dosage Schedule for Pediatrics with Normal Renal Function
Type of Infection Dose (mg/kg) Up to Maximum Dose Dosing Interval
Complicated skin and skin structure 10 500 mg Every 8 hours
Intra-abdominal 20 1 g Every 8 hours
Meningitis 40 2 g Every 8 hours

There is no experience in pediatric patients with renal impairment.

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.

David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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