MEROPENEM injection powder for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Cardinal Health

INN (Διεθνής Όνομα):

MEROPENEM

Σύνθεση:

MEROPENEM 500 mg in 10 mL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MEROPENEM- MEROPENEM INJECTION, POWDER, FOR SOLUTION
CARDINAL HEALTH
----------
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.)
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Indications and Usage, Intra-Abdominal Infections, Pediatric
Patients (less than 3 months of age) (1.2) 12/2014
Dosage and Administration, Use in Pediatric Patients
(less than 3 months of age) (2.3) 12/2014
INDICATIONS AND USAGE
Meropenem for Injection I.V. is a penem antibacterial indicated as
single agent therapy for the treatment of:
•
•
•
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
•
•
•
•
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
Pediatric patients 3 months of age and older.
RECOMMENDED MEROPENEM FOR INJECTION I.V. DOSAGE SCHEDULE FOR PEDIATRIC
PATIENTS WITH NORMAL RENAL
FUNCTION (2.3)
TYPE OF
INFE C TIO N
DOSE
(M G /KG )
UP TO A
MAXIMUM
DO SE
DOSING INTERVAL
Complicated skin and skin
structure *
10
500 mg
Every 8 hours
Intra-abdominal
20
1 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