MEROPENEM injection, powder, for solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

MEROPENEM (UNII: FV9J3JU8B1) (MEROPENEM ANHYDROUS - UNII:YOP6PX0BAO)

Prieinama:

Hospira, Inc.

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Meropenem for injection, USP (I.V.) 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, USP (I.V.) 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, USP (I.V.) is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae , Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae . Meropenem for injection, USP (I.V.) has been found to be

Produkto santrauka:

Meropenem for injection, USP (I.V.) is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) [see USP]. Strength Unit of Sale Each 500 mg/vial 0409-1390-51 Unit of 10 0409-1390-21 1 g/vial 0409-1391-22 Unit of 10 0409-1391-21 The container closure is not made with natural rubber latex.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

MEROPENEM- MEROPENEM INJECTION, POWDER, FOR SOLUTION
HOSPIRA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEROPENEM FOR INJECTION
(I.V.) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MEROPENEM FOR INJECTION
(I.V.).
MEROPENEM FOR INJECTION, USP (I.V.), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Cutaneous Adverse Reactions (5.2)
9/2018
INDICATIONS AND USAGE
Meropenem for injection (I.V.) is a penem antibacterial indicated for
the treatment of:
4.
5.
6.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Meropenem for
injection (I.V.) and other antibacterial drugs, Meropenem for
injection (I.V.) should only be used to treat or
prevent infections that are proven or strongly suspected to be caused
by susceptible bacteria.
DOSAGE AND ADMINISTRATION
5.
6.
7.
8.
RECOMMENDED MEROPENEM FOR INJECTION (I.V.) 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 recommended dose
Every 24 hours
2.
RECOMMENDED MEROPENEM FOR INJECTION (I.V.) DOSAGE SCHEDULE FOR
PEDIATRIC PATIENTS 3
MONTHS OF AGE AND OLDER WITH NORMAL RENAL FUNCTION (2.3)
TYPE OF INFECTION
DOSE
(MG/KG)
UP TO A
MAXIMUM
DOSE
DOSING
INTERVAL
Complicated skin and skin structure*
10
500 mg
Every 8
hours
Intra-abdominal
20
1 gram
Every 8
hours
Meningitis
40
2 gram
Every 8
hours
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)
500 mg every 8 hours by intravenous infusion over