MEROPENEM injection, powder, for solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

meropenem (UNII: FV9J3JU8B1) (meropenem anhydrous - UNII:YOP6PX0BAO)

Pieejams no:

Sagent Pharmaceuticals

SNN (starptautisko nepatentēto nosaukumu):

meropenem

Kompozīcija:

meropenem 500 mg

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Meropenem for Injection is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to 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. Meropenem for Injection is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli , Klebsiella pneumoniae , Pseudomonas aeruginosa , Bacteroides fragilis , B. thetaiotaomicron , and Peptostreptococcus species. Meropenem for Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae , Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae . Meropenem for Injection has been found to be effective in eliminating concurrent bacteremia i

Produktu pārskats:

Meropenem for Injection, USP is supplied as follows: Meropenem for Injection, USP is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. Storage Conditions Store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

MEROPENEM- MEROPENEM INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEROPENEM FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEROPENEM FOR
INJECTION
MEROPENEM FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Meropenem for Injection is a penem antibacterial indicated for the
treatment of:
Complicated skin and skin structure infections (adult patients and
pediatric patients 3 months of age and older only).
(1.1)
Complicated intra-abdominal infections (adult and pediatric patients).
(1.2)
Bacterial meningitis (pediatric patients 3 months of age and older
only). (1.3)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Meropenem for Injection and
other antibacterial drugs, Meropenem for Injection should only be used
to treat or prevent infections that are proven or
strongly suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for
complicated skin and skin structure infections
(cSSSI) for adult patients. When treating infections caused by
_Pseudomonas aeruginosa_, a dose of 1 gram every 8
hours is recommended. (2.1)
1 gram every 8 hours by intravenous infusion over 15 minutes to 30
minutes for intra-abdominal infections for adult
patients. (2.1)
1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL)
over 3 minutes to 5 minutes for adult patients.
(2.1)
Dosage should be reduced in adult patients with renal impairment.
(2.2)
RECOMMENDED MEROPENEM FOR INJECTION DOSAGE SCHEDULE FOR ADULT PATIENTS
WITH RENAL IMPAIRMENT
CREATININE CLEARANCE
(ML/MIN)
DOSE (DEPENDENT ON TYPE OF INFECTION)
DOSING INTERVAL
Greater than 50
Recommended dose (500 mg cSSSI and 1 gram Intra-
abdominal)
Every 8 hours
26 to 50
Recommended dose
Every 12 hours
10 to 25
One-half recommended dose
Every 12 hours
Less than 10
One-half recom