ANTIBACTERIAL

4g/500mg Sterile Powder for Injection IV

TAZOBACTAM SODIUM
PIPERACILLIN SODIUM

PIPERACILLIN SODIUM 10 Vials FORMULATION: PIPERACILLIN SODIUM 10 Vials

DIRECTION FOR RECONSTITUTION:
Reconstitute with 5 mL of diluent per 1 g of piperacillin and then further dilute. After
Each vial contains: reconstitution, vials or solution are stable in NS or D5W for 24 hours at room
FED PHARMA
TAZOBACTAM SODIUM Piperacillin (as Sodium) ......…..…....................................................………… 4 g
Tazobactam (as Sodium) .......…..................................................….…… 500 mg FED PHARMA
TAZOBACTAM SODIUM temperature and 48 hours (vials) or 7 days (solution) when refrigerated.

4g/500mg Sterile Powder for Injection IV 4g/500mg Sterile Powder for Injection IV STORAGE:
INDICATIONS: Store at controlled room temperature of 20°C to 25°C (68°F to 77°F). Use single-
ANTIBACTERIAL Treatment of infections in the lower respiratory tract e.g. severe community-
ANTIBACTERIAL dose vials immediately after reconstitution (discard unused portions after 24
acquired pneumonia & healthcare pneumonia; uncomplicated & complicated hours at room temperature and 48 hours if refrigerated).
skin & skin structure infections; intra-abdominal infections with peritonitis e.g.
complicated appendicitis; complicated & uncomplicated UTI; gynecologic WARNING:

X X
infection e.g. postpartum endometritis or pelvic inflammatory disease; bacterial For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph

X X
infection in neutropenic patients; bone & joint infection; bacterial sepsis. Seek medical attention right away if any of the adverse reaction occurs.

ADMINISTRATION AND DOSAGE: CAUTION:

Community-acquired pneumonia; ruptured appendix; peritonitis; pelvic FOODS, DRUGS, DEVICES & COSMETICS ACT
inflammatory disease; skin-structure infections: prohibits dispensing without prescription.
Manufactured by: Manufactured by: Adults and children older than age 12: 3.375g (3 g piperacillin and 0.375 g Manufactured by: Manufactured by:
CSPC Zhongnuo Pharmaceutical CSPC Zhongnuo Pharmaceutical tazobactam) I.V. q6 hours for 7 to 10 days CSPC Zhongnuo Pharmaceutical CSPC Zhongnuo Pharmaceutical
(Shijiazhuang) Co., Ltd Reg No.:
(Shijiazhuang) Co., Ltd (Shijiazhuang) Co., Ltd (Shijiazhuang) Co., Ltd Batch No.:
CSPC No. 47 Fengshou Road, Shijiazhuang City, P.R. of China CSPC Nosocomial pneumonia: CSPC No. 47 Fengshou Road, Shijiazhuang City, P.R. of China CSPC Mfg. Date:
Distributed by: Adults and children ages 12 and older: 3.375 g (3 g piperacillin and 0.375 g
Distributed by: Exp. Date:
Imported by: tazobactam) I.V. over 30 minutes q 4 hours for 7 to 14 days, given with an
MMG-FED PHARMA Imported by: aminoglycosides Imported by: MMG-FED PHARMA
AMB HK Enterprises Inc. 4/F Rm. 406 Mission
AMB Medical Plaza, Inc.
HK Enterprises AMB HK Enterprises Inc. 4/F Rm. 406 Mission Medical Plaza, 4 806524 140002
No. 6 Felipe Pike St.,Bagong Ilog, Pasig City FED PHARMA Km. 17 Ortigas Ave.,
No. 6Ext., Rosario,
Felipe Pasig CityIlog, Pasig City
Pike St.,Bagong No. 6 Felipe Pike St.,Bagong Ilog, Pasig City FED PHARMA Km. 17 Ortigas Ave., Ext., Rosario, Pasig City
 FORMULATION:
Each vial contains:
Piperacillin (as Sodium) ......…..…..............................................................................………… 4 g

PIPERACILLIN SODIUM
TAZOBACTAM SODIUM
Tazobactam (as Sodium) .......…..….......................................................................….…… 500 mg

INDICATIONS:

4g/500mg Sterile Powder for injection IV

Treatment of infections in the lower respiratory tract e.g. severe community-acquired pneumonia
& healthcare pneumonia; uncomplicated & complicated skin & skin structure infections; intra-
abdominal infections with peritonitis e.g. complicated appendicitis; complicated & uncomplicated
UTI; gynecologic infection e.g. postpartum endometritis or pelvic inflammatory disease; bacterial

AMRACITAM
infection in neutropenic patients; bone & joint infections; bacterial sepsis.

ANTIBACTERIAL
ADMINISTRATION AND DOSAGE:
Community-acquired pneumonia; ruptured appendix; peritonitis; pelvic inflammatory disease;
skin-structure infections:
Adults and children older than age 12: 3.375g (3 g piperacillin and 0.375 g tazobactam) I.V. q6
hours for 7 to 10 days

Nosocomial pneumonia:
Adults and children ages 12 and older: 3.375 g (3 g piperacillin and 0.375 g tazobactam) I.V. over
30 minutes q 4 hours for 7 to 14 days, given with an aminoglycosides

DIRECTION FOR RECONSTITUTION:

Reconstitute with 5 mL of diluent per 1 g of piperacillin and then further dilute. After reconstitution,
vials or solution are stable in NS or D5W for 24 hours at room temperature and 48 hours (vials) or 7
days (solution) when refrigerated.

STORAGE:
Store at controlled room temperature of 20°C to 25°C (68°F to 77°F). Use single-dose vials
immediately after reconstitution (discard unused portions after 24 hours at room temperature and
48 hours if refrigerated).

CAUTION:
FOODS, DRUGS, DEVICES & COSMETICS ACT
prohibits dispensing without prescription.

1 Vial
PIPERACILLIN SODIUM
TAZOBACTAM SODIUM

PIPERACILLIN SODIUM
4g/500mg Sterile Powder for injection IV

TAZOBACTAM SODIUM
AMRACITAM

AMRACITAM
ANTIBACTERIAL

4g/500mg Sterile Powder for injection IV

ANTIBACTERIAL

Manufactured by: Imported & Distributed by:

CSPC
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd
No. 47 Fengshou Road, Shijiazhuang City, Hebei Province, China AMB HK
AMB HK Enterprises Inc.
No. 6 Felipe Pike St., Bagong Ilog, Pasig City 60 mm
FORMULATION
Each vial contains:.
1 Vial DOSAGE AND
ADMINISTRATION
Piperacillin (as Sodium) ............. 4 g See package insert for full
Tazobactam (as Sodium) .... 500 mg information.

INDICATIONS PIPERACILLIN SODIUM DIRECTION FOR

RECONSTITUTION:
Treatment of infections in the lower
TAZOBACTAM SODIUM

30 mm
respiratory tract e.g. severe Reconstitute with 5 mL of
community-acquired pneumonia & diluent per 1 g of piperacillin
healthcare pneumonia; and then further dilute. After
uncomplicated & complicated skin AMRACITAM reconstitution, vials or
& skin structure infections; intra- solution are stable in NS or
D5W for 24 hours at room
abdominal infections with peritonitis
e.g. complicated appendicitis;
4g/500mg Sterile Powder for injection IV temperature and 48 hours
complicated & uncomplicated UTI; ANTIBACTERIAL (vials) or 7 days (solution)

Reg No.: DRP-3555 gynecologic infection

postpartum endometritis or pelvic
e.g. when refrigerated.

CAUTION
inflammatory disease; bacterial Manufactured by:
infection in neutropenic patients; Foods, Drugs, Devices &
CSPC Zhongnuo Pharmaceutical
bone & joint infection; bacterial Cosmetics Act prohibits
(Shijiazhuang) Co., Ltd
dispensing without
Batch No.: 773120601 sepsis.
CSPC No. 47 Fengshou Road, Shijiazhuang City,
Hebei Province, China prescription.
STORAGE Reg No.: DRP-3555
Mfg. Date: 06/2012 Store at controlled room
temperature of 20°C to 25°C. AMB
Imported & Distributed by:
AMB HK Enterprises Inc.
No. 6 Felipe Pike St., Bagong Ilog, Pasig City
Batch No.: 773120601
Mfg. Date: 06/2012
4 806524 140019
HK

Exp. Date: 06/2014 Exp. Date: 06/2014

 97.82 mm

PIPERACILLIN SODIUM ADVERSE REACTIONS

Upset stomach, diarrhea, constipation
TAZOBACTAM SODIUM Vomiting
AMRACITAM Unpleasant or abnormal taste
Gas
4g/500mg Sterile Powder for injection IV
Headache
ANTIBACTERIAL
Insomnia
Rash, Itching skin, Swelling
FORMULATION Shortness of breath
Each vial contains: Unusual bruising or bleeding
Piperacillin (as Sodium) ……..................................................………..…… 4g
Tazobactam (as Sodium) ........................…………………………………500mg CONTRAINDICATIONS
Hypersensitivity to penicillins or beta-lactamase inhibitors.
PHARMACOLOGIC/PHARMACOKINETIC ACTION
Both AUC and peak concentrations are dose proportional; hepatic impairment PRECAUTIONS
does not affect kinetics. Use cautiously in:
Distribution: Well into lungs, intestinal mucosa, skin, muscle, uterus, ovary, Heart failure, renal insufficiency (in children), seizures. Bleeding disorders,
prostate, gallbladder, and bile; penetration into CSF is low in subject with uremia, hypokalemia, cystic fibrosis
160.00 mm

noninflamed meninges. Patients with sodium restrictions

Protein binding: Piperacillin: ~ 26% to 33%; Tazobactam: 31% to 32% Pregnant or breast feeding patients
Metabolism: Piperacillin: 6% to 9%; Tazobactam:~ 26% Children younger than age 12
Half-life elimination: Piperacillin: 1 hour; Metabolite: 1-1.5 hours; Tazobactam :
0.7-0.9 hour AVAILABILITY
Excretion: Both Piperacillin and Tazobactam are directly proportional to renal 4.5g powder for injection 25ml vial (box of 10's)
function
Piperacillin: Urine (50% to 70%); feces (10% to 20%) STORAGE
Tazobactam: Urine (26% as inactive metabolite) within 24 hours. Store at controlled room temperature of 20°C to 25°C. Use single-dose vials
immediately after reconstitution (discard unused portions after 24 hours at
INDICATIONS room temperature and 48 hours if refrigerated).
Treatment of infections in the lower respiratory tract e.g. severe community-
acquired pneumonia & healthcare pneumonia; uncomplicated & complicated CAUTION
skin & skin structure infections; intra-abdominal infections with peritonitis Foods, Drugs, Devices & Cosmetics Act prohibits dispensing without
e.g. complicated appendicitis; complicated & uncomplicated UTI; prescription.
gynecologic infection e.g. postpartum endometritis or pelvic inflammatory
disease; bacterial infection in neutropenic patients; bone & joint infection; WARNING:
bacterial sepsis. For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph
Seek medical attention right away if any of the adverse reaction occurs.
DIRECTION FOR RECONSTITUTION
Reconstitute with 5 mL of diluent per 1 g of piperacillin and then further dilute.
After reconstitution, vials or solution are stable in NS or D5W for 24 hours at
room temperature and 48 hours (vials) or 7 days (solution) when refrigerated.

DOSAGE AND ADMINISTRATION

Community-acquired pneumonia; ruptured appendix; peritonitis; pelvic
inflammatory disease; skin-structure infections:
Adults and children older than age 12: 3.375g (3 g piperacillin and 0.375 g
tazobactam) I.V. q6 hours for 7 to 10 days
Manufactured by:
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd
Nosocomial pneumonia: No. 47 Fengshou Road, Shijiazhuang City, Hebei Province, China
CSPC
Adults and children ages 12 and older: 3.375 g (3 g piperacillin and 0.375 g
tazobactam) I.V. over 30 minutes q 4 hours for 7 to 14 days, given with an Imported & Distributed by:
aminoglycosides AMB HK
AMB HK Enterprises Inc.
No. 6 Felipe Pike St., Bagong Ilog, Pasig City