PIPERACILLIN AND TAZOBACTAM- piperacillin sodium and tazobactam sodium injection, powder, lyophilized, for solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

PIPERACILLIN SODIUM (UNII: M98T69Q7HP) (PIPERACILLIN ANHYDROUS - UNII:9I628532GX), TAZOBACTAM SODIUM (UNII: UXA545ABTT) (TAZOBACTAM - UNII:SE10G96M8W)

Dostupné z:

Mitim S.r.l.

INN (Medzinárodný Name):

PIPERACILLIN SODIUM

Zloženie:

PIPERACILLIN ANHYDROUS 2 g in 10 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Piperacillin and tazobactam for injection, USP is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below. Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis , B. ovatus , B. thetaiotaomicron , or B. vulgatus . The individual members of this group were studied in fewer than 10 cases. Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus . Postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli . Community-acquired pneumo

Prehľad produktov:

Piperacillin and tazobactam for injection, USP are supplied as single-dose vials in the following sizes: Each piperacillin and tazobactam for injection, USP 2.25 g vial provides piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.87 mEq (112 mg) of sodium. Supplied 10 per box - NDC 64679-034-01 Each piperacillin and tazobactam for injection, USP 3.375 g vial provides piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.30 mEq (168 mg) of sodium. Supplied 10 per box - NDC 64679-056-01 Each piperacillin and tazobactam for injection, USP 4.5 g vial provides piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.74 mEq (224 mg) of sodium. Supplied 10 per box - NDC 64679-012-01 Piperacillin and tazobactam for injection vials should be stored at controlled room temperature (20°C to 25°C [68°F to 77°F]) prior to reconstitution.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

PIPERACILLIN AND TAZOBACTAM- PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM
INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
MITIM S.R.L.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIPERACILLIN AND TAZOBACTAM FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PIPERACILLIN AND TAZOBACTAM
FOR INJECTION.
PIPERACILLIN AND TAZOBACTAM FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.2) 06/2016
INDICATIONS AND USAGE
Piperacillin and tazobactam for injection, USP is a combination
penicillin-class antibacterial and β-lactamase inhibitor
indicated for treatment of:
Intra-abdominal infections (1.1)
Skin and skin structure infections (1.2)
Female pelvic infections (1.3)
Community-acquired pneumonia (1.4)
Nosocomial pneumonia (1.5)
Usage (1.6)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of piperacillin and tazobactam for
injection and other antibacterial drugs, piperacillin and tazobactam
for injection should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria. (1.6)
DOSAGE AND ADMINISTRATION
The usual daily dose of piperacillin and tazobactam for injection for
adults is 3.375 g every six hours totaling 13.5 g (12
g piperacillin/1.5 g tazobactam) (2.1)
Initial presumptive treatment of patients with nosocomial pneumonia
should start with piperacillin and tazobactam for
injection at a dosage of 4.5 g every six hours plus an aminoglycoside,
totaling 18 g (16 g piperacillin/2 g tazobactam).
(2.2)
Dosage in patients with renal impairment (≤40 mL/min of CRCL) and
dialysis patients should be reduced, based on the
degree of actual renal function impairment. (2.3)
For children with appendicitis and/or peritonitis the recommended
piperacillin and tazobactam for injection dosage is
100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight,
every 8 h