Primaxin Iv
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Questions & Answers
Side Effects & Adverse Reactions
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH BETA-LACTAMS. THESE REACTIONS ARE MORE APT TO OCCUR IN PERSONS WITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.
THERE HAVE BEEN REPORTS OF PATIENTS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE HYPERSENSITIVITY REACTIONS WHEN TREATED WITH ANOTHER BETA-LACTAM. BEFORE INITIATING THERAPY WITH PRIMAXIN I.V., CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OTHER BETA‑LACTAMS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PRIMAXIN SHOULD BE DISCONTINUED.
SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, MAY ALSO BE ADMINISTERED AS INDICATED.
Seizures and other CNS adverse experiences, such as confusional states and myoclonic activity, have been reported during treatment with PRIMAXIN I.V. (See PRECAUTIONS and ADVERSE REACTIONS.)
Case reports in the literature have shown that co-administration of carbapenems, including imipenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of imipenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of PRIMAXIN I.V. is necessary, supplemental anti-convulsant therapy should be considered (see PRECAUTIONS, Drug Interactions).
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including PRIMAXIN I.V., and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PRIMAXIN I.V. is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
- Lower respiratory tract infections. Staphylococcus aureus (penicillinase-producing strains), Acinetobacter species, Enterobacter species, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae1, Klebsiella species, Serratia marcescens
- Urinary tract infections (complicated and uncomplicated). Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii1, Proteus vulgaris1, Providencia rettgeri1, Pseudomonas aeruginosa
- Intra-abdominal infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Staphylococcus epidermidis, Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii1, Proteus species, Pseudomonas aeruginosa, Bifidobacterium species, Clostridium species, Eubacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species1, Bacteroides species including B. fragilis, Fusobacterium species
- Gynecologic infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Staphylococcus epidermidis, Streptococcus agalactiae (Group B streptococci), Enterobacter species1, Escherichia coli, Gardnerella vaginalis, Klebsiella species1, Proteus species, Bifidobacterium species1, Peptococcus species1, Peptostreptococcus species, Propionibacterium species1, Bacteroides species including B. fragilis1
- Bacterial septicemia. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Enterobacter species, Escherichia coli, Klebsiella species, Pseudomonas aeruginosa, Serratia species1, Bacteroides species including B. fragilis1
- Bone and joint infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Enterobacter species, Pseudomonas aeruginosa
- 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 rettgeri1, Pseudomonas aeruginosa, Serratia species, Peptococcus species, Peptostreptococcus species, Bacteroides species including B. fragilis, Fusobacterium species1
- Endocarditis. Staphylococcus aureus (penicillinase-producing strains)
- 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.
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.
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Efficacy for this organism in this organ system was studied in fewer than 10 infections.
History
There is currently no drug history available for this drug.
Other Information
PRIMAXIN I.V. (Imipenem and Cilastatin for Injection) is a sterile formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase l), with sodium bicarbonate added as a buffer. PRIMAXIN I.V. is a potent broad spectrum antibacterial agent for intravenous administration.
Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R ,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4S•H2O, and its structural formula is:
Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z )-7[[(R )-2-amino-2-carboxyethyl]thio]-2-[(S )-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is:
PRIMAXIN I.V. is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. (See COMPATIBILITY AND STABILITY.) PRIMAXIN I.V. 250 contains 18.8 mg of sodium (0.8 mEq) and PRIMAXIN I.V. 500 contains 37.5 mg of sodium (1.6 mEq). Solutions of PRIMAXIN I.V. range from colorless to yellow. Variations of color within this range do not affect the potency of the product.
Sources
Primaxin Iv Manufacturers
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Merck Sharp & Dohme Corp.
![Primaxin Iv (Imipenem And Cilastatin Sodium) Injection, Powder, For Solution [Merck Sharp & Dohme Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Primaxin Iv | Merck Sharp & Dohme Corp.
AdultsThe 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 ≤70 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 ≥70 kgDoses cited in Table 3 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 ≥71 mL/min/1.73 m2 and a body weight of ≥70 kg. A reduction in dose must be made for a patient with a creatinine clearance of ≤70 mL/min/1.73 m2 and/or a body weight less than 70 kg. (See Tables 4 and 5.)
Dosage regimens in column A of Table 3 are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table 3 are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.
TABLE 3: INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT ≥70 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 kgPatients with creatinine clearance of ≤70 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:
Tcc (Males) = (wt. in kg) (140 - age)
(72) (creatinine in mg/dL)Tcc (Females) = 0.85 x above value
To determine the dose for adults with impaired renal function and/or reduced body weight:
Choose a total daily dose from Table 3 based on infection characteristics. a) If the total daily dose is 1.0 g, 1.5 g, or 2.0 g, use the appropriate subsection of Table 4 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 5 and continue with step 3. From Table 4 or 5:
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 4: 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 3 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: ≥71 41-70 21-40 6-20 ≥71 41-70 21-40 6-20 ≥71 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: ≥70 250
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 5: 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 3 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: ≥71 41-70 21-40 6-20 ≥71 41-70 21-40 6-20 then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is: ≥70 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
q12hPatients 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 ≤5 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.
HemodialysisWhen treating patients with creatinine clearances of ≤5 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 PatientsSee PRECAUTIONS, Pediatric Patients.
For pediatric patients ≥3 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 ≤3 months of age (weighing ≥1,500 g), 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.
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Cardinal Health
Primaxin Iv | Cardinal Health
AdultsThe 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 ≤70 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 ≥70 kgDoses cited in Table 3 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 ≥71 mL/min/1.73 m2 and a body weight of ≥70 kg. A reduction in dose must be made for a patient with a creatinine clearance of ≤70 mL/min/1.73 m2 and/or a body weight less than 70 kg. (See Tables 4 and 5.)
Dosage regimens in column A of Table 3 are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table 3 are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.
TABLE 3: INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT ≥70 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 kgPatients with creatinine clearance of ≤70 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:
Tcc (Males) = (wt. in kg) (140 - age)
(72) (creatinine in mg/dL)Tcc (Females) = 0.85 x (above value)
To determine the dose for adults with impaired renal function and/or reduced body weight:
Choose a total daily dose from Table 3 based on infection characteristics. a) If the total daily dose is 1.0 g, 1.5 g, or 2.0 g, use the appropriate subsection of Table 4 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 5 and continue with step 3. From Table 4 or 5:
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 4: 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 3 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: ≥71 41-70 21-40 6-20 ≥71 41-70 21-40 6-20 ≥71 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: ≥70 250
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 5: 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 3 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: ≥71 41-70 21-40 6-20 ≥71 41-70 21-40 6-20 then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is: ≥70 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
q12hPatients 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 ≤5 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.
HemodialysisWhen treating patients with creatinine clearances of ≤5 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 PatientsSee PRECAUTIONS, Pediatric Patients.
For pediatric patients ≥3 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 ≤3 months of age (weighing ≥1,500 g), 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.
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Merck Sharp & Dohme Corp.
Primaxin Iv | Merck Sharp & Dohme Corp.
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Merck Sharp & Dohme Corp.
Primaxin Iv | Merck Sharp & Dohme Corp.
There is currently no dosage information available for this product. We apologize for any inconvenience.
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![Primaxin Iv (Imipenem) Injection, Powder, For Solution [Merck Sharp & Dohme Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=51194fbc-8ed7-4c58-b45f-e34de5a8e5a4&name=imipenem-01.jpg)
![Primaxin Iv (Cilastatin Sodium) Injection, Powder, For Solution [Merck Sharp & Dohme Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=01b8ca04-ab97-4c2e-a4b4-b67f8f92330e&name=cilastatin-01.jpg)
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