PRIMAXIN IV- imipenem and cilastatin sodium injection, powder, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

IMIPENEM (UNII: 71OTZ9ZE0A) (IMIPENEM ANHYDROUS - UNII:Q20IM7HE75), CILASTATIN SODIUM (UNII: 5428WXZ74M) (CILASTATIN - UNII:141A6AMN38)

Dostupné s:

Merck Sharp & Dohme LLC

INN (Mezinárodní Name):

IMIPENEM

Složení:

IMIPENEM ANHYDROUS 250 mg in 100 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

PRIMAXIN for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains of Staphylococcus aureus (penicillinase-producing isolates), Acinetobacter species, Enterobacter species, Escherichia coli , Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella species, Serratia marcescens. PRIMAXIN is indicated for the treatment of urinary tract infections (complicated and uncomplicated) caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Enterobacter species, Escherichia coli , Klebsiella species, Morganella morganii , Proteus vulgaris , Providencia rettgeri , Pseudomonas aeruginosa. PRIMAXIN is indicated for the treatment of intra-abdominal infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus epidermidis , Citrobacter species, Enterobacter species, Escherichia coli , Klebsiella species, Morganella morganii , Proteus species, Pseudomonas aeruginosa , Bifidobacterium species, Clostridium species, Eubacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species, Bacteroides species including B. fragilis , Fusobacterium species. PRIMAXIN is indicated for the treatment of gynecologic infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus epidermidis , Streptococcus agalactiae (Group B streptococci), Enterobacter species, Escherichia coli , Gardnerella vaginalis , Klebsiella species, Proteus species, Bifidobacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species, Bacteroides species including B. fragilis. PRIMAXIN is indicated for the treatment of bacterial septicemia caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Enterobacter species, Escherichia coli , Klebsiella species, Pseudomonas aeruginosa , Serratia species, Bacteroides species including B. fragilis. PRIMAXIN is indicated for the treatment of bone and joint infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus epidermidis , Enterobacter species, Pseudomonas aeruginosa. PRIMAXIN is indicated for the treatment of skin and skin structure infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus epidermidis , Acinetobacter species, Citrobacter species, Enterobacter species, Escherichia coli , Klebsiella species, Morganella morganii , Proteus vulgaris , Providencia rettgeri , Pseudomonas aeruginosa , Serratia species, Peptococcus species, Peptostreptococcus species, Bacteroides species including B. fragilis , Fusobacterium species. PRIMAXIN is indicated for the treatment of endocarditis caused by susceptible strains of Staphylococcus aureus (penicillinase-producing isolates). - PRIMAXIN is not indicated in patients with meningitis because safety and efficacy have not been established. - PRIMAXIN is not recommended in pediatric patients with CNS infections because of the risk of seizures [see Dosage and Administration (2.2), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)]. - PRIMAXIN is not recommended in pediatric patients less than 30 kg with impaired renal function, as no data are available [see Use in Specific Populations (8.4), and Dosage and Administration (2.2)]. - Periodic assessment of organ system functions, including renal, hepatic and hematopoietic, is advisable during prolonged therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN and other antibacterial drugs, PRIMAXIN should be used only to treat 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. PRIMAXIN is contraindicated in patients who have shown hypersensitivity to any component of this product. Risk Summary Available data from a small number of postmarketing cases with PRIMAXIN use in pregnancy are not sufficient to identify any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Developmental toxicity studies with imipenem and cilastatin sodium (alone or in combination) administered to mice, rats, rabbits, and monkeys at doses 0.4 to 2.9 times the recommended human dose (RHD), (based on body surface area), showed no drug-induced fetal malformations. Embryofetal development studies with imipenem/cilastatin administered to cynomolgus monkeys at doses similar to the RHD (based on body surface area) showed an increase in embryonic loss (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population. Data Animal Data Reproductive toxicity studies with imipenem and cilastatin (alone or in combination) administered to mice, rats, and rabbits showed no evidence of effects on embryofetal (mice, rats and rabbits) or pre/postnatal (rats) development. Imipenem was administered intravenously to rats (gestation days (GD) 7 to 17) and rabbits (GD 6 to 18) at doses up to 900 and 60 mg/kg/day, respectively, approximately 2.9 and 0.4 times the RHD (based on body surface area). Cilastatin was administered subcutaneously to rats (GD 6 to 17) and intravenously to rabbits (GD 6 to 18) at doses up to 1000 and 300 mg/kg/day, respectively, approximately 3.2 and 1.9 times the RHD (based on body surface area). Imipenem/cilastatin was administered intravenously to mice at doses up to 320 mg/kg/day (GD 6 to 15). In two separate studies, imipenem/cilastatin was administered to rats (GD 6 to 17 and GD 15 to day 21 postpartum) both intravenously at doses up to 80 mg/kg/day and subcutaneously at 320 mg/kg/day. The higher dose is approximately equal to the RHD (based on body surface area). Imipenem/cilastatin administered intravenously to pregnant cynomolgus monkeys during organogenesis at 100 mg/kg/day, approximately 0.6 times the RHD (based on body surface area), at an infusion rate mimicking human clinical use, was not associated with fetal malformations, but there was an increase in embryonic loss relative to controls. Imipenem/cilastatin administered to pregnant cynomolgus monkeys during organogenesis at 40 mg/kg/day by bolus intravenous injection caused significant maternal toxicity including death and embryofetal loss. Risk Summary There are insufficient data on the presence of imipenem/cilastatin in human milk, and no data on the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PRIMAXIN and any potential adverse effects on the breastfed child from PRIMAXIN or from the underlying maternal condition. Use of PRIMAXIN in pediatric patients is supported by evidence from adequate and well-controlled trials of PRIMAXIN in adults and clinical studies in pediatric patients [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)] . PRIMAXIN is not recommended in pediatric patients with CNS infections because of the risk of seizures. PRIMAXIN is not recommended in pediatric patients less than 30 kg with renal impairment, as no data are available. Of the approximately 3600 subjects ≥18 years of age in clinical studies of PRIMAXIN, including postmarketing studies, approximately 2800 received PRIMAXIN. Of the subjects who received PRIMAXIN, data are available on approximately 800 subjects who were 65 and over, including approximately 300 subjects who were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. No dosage adjustment is required based on age [see Clinical Pharmacology (12.3)] . Dosage adjustment in the case of renal impairment is necessary [see Dosage and Administration (2.3)]. Dosage adjustment is necessary in patients with renal impairment [see Dosage and Administration (2.3)] . Adult patients with creatinine clearances of less than or equal to 30 mL/min, whether or not undergoing hemodialysis, had a higher risk of seizure activity than those without impairment of renal function [see Warnings and Precautions (5.2)] . Therefore, close adherence to the dosing guidelines and regular monitoring of creatinine clearance for these patients is recommended.

Přehled produktů:

PRIMAXIN is supplied as a sterile powder mixture in single dose containers including vials containing imipenem (anhydrous equivalent) and cilastatin (free acid equivalent) as follows: Before Reconstitution: PRIMAXIN dry powder should be stored at a temperature below 25°C (77°F).

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

PRIMAXIN IV- IMIPENEM AND CILASTATIN SODIUM INJECTION, POWDER, FOR
SOLUTION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRIMAXIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRIMAXIN.
PRIMAXIN® (IMIPENEM AND CILASTATIN) FOR INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
PRIMAXIN for intravenous use is a combination of imipenem, a penem
antibacterial, and cilastatin, a renal
dehydropeptidase inhibitor, indicated for the treatment of the
following serious infections caused by
designated susceptible bacteria:
Lower respiratory tract infections. (1.1)
Urinary tract infections. (1.2)
Intra-abdominal infections. (1.3)
Gynecologic infections. (1.4)
Bacterial septicemia. (1.5)
Bone and joint infections. (1.6)
Skin and skin structure infections. (1.7)
Endocarditis. (1.8)
Limitations of Use:
PRIMAXIN is not indicated in patients with meningitis because safety
and efficacy have not been
established (1.9).
PRIMAXIN is not recommended in pediatric patients with CNS infections
because of the risk of seizures
(1.9).
PRIMAXIN is not recommended in pediatric patients weighing less than
30 kg with impaired renal
function (1.9).
Usage:
To reduce the development of drug resistant bacteria and maintain the
effectiveness of PRIMAXIN and
other antibacterial drugs, PRIMAXIN should be used only to treat
infections that are proven or strongly
suspected to be caused by bacteria (1.10).
DOSAGE AND ADMINISTRATION
The dosage of PRIMAXIN in adult patients should be based on suspected
or confirmed pathogen
susceptibility (2.1).
For adult patients with normal renal function (creatinine clearance of
greater than or equal to 90
mL/min), the recommended dosage regimens are: 500 mg every 6 hours OR
1000 mg every 8 hours
OR 1000 mg every 6 hours (2.1).
See full prescribing information for dosage recommendations in
pediatric patients (2.2).
A reduction in dose must be made for a patient with a creatinine
cle