Nubac

Composition :

Each vial NUBAC® contain dry powder which contain Cefoperazone sodium and Sulbactam sodium equivalent with Cefoperazone 500 mg and Sulbactam 500 mg

 

Pharmacology :

Cefoperazone is a third generation cephalosporin, which is sensitive to inhibit organisms during the multiplication phase by inhibiting cell wall synthesis of mucopeptides. Sulbactam has no antibacterial effect except for Neisseriaceae and Acinetobacter.

Sulbactam potency prevents the deterioration of penicillin and cephalosporin has been shown in several studies. Sulbactam also binds some penicillin protein receptors, so the combination of Cefoperazone and Sulbactam is more sensitive than the single Ceforerazone.

Combination Cefoperazone and Sulbactam are active against all organisms that are sensitive to Cefoperazone.

In addition, the combination looks at synergistic activity in variants of microorganisms such as: Haemophilus influenza, Bacteroides species, Staphylococcus species, Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Proteus mirabilis, Klebsiella pneumonia, Morganella morganii, Citrobacter freundii, Enterobacter cloacae, Citrobacter diversus.

 

NUBAC® are in vitro active against a variety of clinically significant organisms.

Gram Positive Organisms:

Staphylococcus aureus, strains which produce penicillinase and non-penicillinase, Staphylococcus epidermidis, Streptococcus pneumonia (known as Diplococcus pneumonia), Streptococcus pyogenes (Grup A β-hemolytic streptococci, Streptococcus agalactiae (Grup B β-hemolytic streptococci), most strains β-hemolytic streptococci, several strains Streptococcus faecalis (enterococcus).

 

Gram Negative Organisms:

Escherichia coli, Klebsiella species, Enterobacter species, Citrobacter species, Haemophilus influenza, Proteus mirabilis, Proteus vulgaris, Morganella morganii (known as Proteus morganii), Providencia rettgeri (known as Proteus rettgeri), Providencia species, Serratia species ( include S.marcescens), Salmonella andn Shigella species, Pseudomonas aeruginosa and several Pseudomonas species, Acinetobacter calcoaceticus, Neisseria gonorrhoeae, Neisseria meningitis, Bordetella pertussis, Yersinia enterocolitica.

 

Anaerobic organisms:

Gram negative bacteria in the form of bacilli (Bacteroides fragilis, other spesies Bacteroides, and Fusobacterium species), Gram positive bacteria and Gram Negative in the form of coccus (Peptococcus, Peptostreptococcus, and Spesies Veillonella), Gram-positive bacteria in the form of bacilli (Clostridium, Eubacterium and Spesies Lactobacillus).

 

Indication :

– Lower and upper respiratory tract infection

– Lower and upper urinary tract infection

– Peritonitis, cholecystitis, cholangitis, and other intra-abdominal infections

– Skin and soft tissue infection

 

Due to the broad antibacterial spectrum activity NUBAC®, many infections can be treated with these antibiotics alone. However, NUBAC® may be used in conjunction with other antibiotics if such a combination is necessary. If aminoglycosides are used (see the Aminoglycoside Incompatibility section), renal function should be monitored during therapy (see the section on Use in Patients with Renal Disorders).

 

Dosage :

Adult

The recommended daily dose for adult patients is as follows:

Ratio                NUBAC® (gr)                  Dose Sulbactam (gr)                  Dose Cefoperazone (gr)

1:1                    2,0 – 4,0                             1,0 – 2,0                                         1,0 – 2,0

Dosage should be given every 12 hours with divided dose.

Inn severe or refractory infections, the daily dose of NUBAC® can be increased to 8 g at a 1: 1 ratio (eg, 4 g of Cefoperazone dose). Patients receive ratio 1: 1 that may require additional Cefoperazone administered separately. Dosage should be given every 12 hours with a divided dose.

Maximum daily dose Sulbactam allowed is 4 g.

Patients with Liver Disorders

See Warning and Caution

Patients with Renal Disorder

Regimen dose NUBAC® should be adjusted for patients with reduced renal function (creatinine clearance less than 30 ml / min) to compensate for decreased Sulbactam clearance. Patients with creatinine clearance between 15 and 30 ml / min should receive 1 g of maximum Sulbactam per 12 hours (maximum daily dose of Sulbactam 2 g), in patients with creatinine clearance of less than 15 ml / min should receive a maximum of 500 mg of Sulbactam every 12 hour (maximum daily dose of Sulbactam 1 g).

In severe infections should be given additional Cefoperazone.

The pharmacokinetic profile of Sulbactam is significantly altered by hemodialysis. The half-life of Cefoperazone decreases slightly during hemodialysis. Thus, the administration of Cefoperazone should be scheduled to follow the dialysis period.

Children

The recommended daily dose for pediatric patients is as follows:

Ratio                                NUBAC®                      Dose Sulbactam             Doses Cefoperazone

(mg/kg/day)                   (mg/kg/day)                (mg/kg/day)

1:1                                    40 – 80                          20 – 40                             20 – 40

Dosage should be administered every 6 – 12 hours with divided dose.

In severe or refractory infections, the dose may be increased to 160 mg / kg / day at ratio 1: 1. The dose should be administered in 2-4 times with divided dose (See Warning and Caution for Use in children).

Neonates

In first-week neonates, medication should be administered every 12 hours. Maximum daily dose of Sulbactam in children should not exceed 80 mg / kg / day. For requiring doses NUBAC® more than 80 mg / kg / day of Cefoperazone dose, additional Cefoperazone should be administered separately. (See Warnings and Caution for Use in Children).

 

Intravenous Administration

For intermittent infusion, each vial NUBAC® should be reconstituted with 5% dextrose in water, 0.9% NaCl injection or aqua pro injection and then dissolved in 20 ml of the same solution with administration for 15 to 60 minutes with the appropriate amounts (See Usage / Reconstitution Handling).

The Ringer Lactate solution is a suitable carrier for intravenous infusion, but not for early reconstitution. (See Incompatibility of Ringer Lactate Solution and Ringer Lactate Use / Handling Instruction).

For intravenous injection, each vial should be reconstituted as above and administered for a minimum of 3 minutes.

Intramuscular administration

Lidocaine HCl 2% is a suitable carrier for intramuscular administration, but not for early reconstitution. (See Lidocaine Incompatibility and Lidocaine User Guidelines/Handling).

 

 

Usage / Handling Instructions

Reconstitution

Total                 Dose Sulbactam +           Vol. Solvent                               Maximum

Doses (gr)         Cefoperazone (gr)                                             Final Concentration (mg/ml)

1,0                   0,5 +0,5                           3,4                                        125 + 125

NUBAC® show compatible with aqua pro injection, dextrose 5% in saline 0.225%, and dextrose 5% in normal saline at concentrations of 10 mg Cefoperazone and 5 mg Sulbactam per ml and increased to 250 mg Cefoperazone and 125 mg Sulbactam per ml.

Ringer Lactate Solution

Aqua sterile pro injection should be used for reconstitution (See Ringer Lactate Solution Drug Interactions). Two stages of dissolution are recommended using a sterile pro-injection aqua (shown in the above table), then dissolved with Ringer Lactate Solution so that the concentration of Sulbactam 5 mg / ml (use 2 ml at the beginning of dissolution in 50 ml or 4 ml at the beginning of dissolution in 100 ml Ringer Lactate Solution).

 

Lidocaine

Aqua sterile pro injection should be used for reconstitution (See Lidocaine Drug Interactions). For Cefoperazone concentrations of 250 mg / ml or greater, two dissolution stages are recommended using sterile pro-injection aqua (shown in the above table), then dissolved with 2% lidocaine to yield a solution containing up to 250 mg of Cefoperazone and 125 mg Sulbactam per ml in solution of lidocaine HCl 5%.

 

Incompatibility :

Aminoglikoside

NUBAC® solution and aminoglikoside should not be mixed directly, because of the physical interaction between them. If there is a combination therapy NUBAC® and an aminoglycoside, it should be noted that it may be performed by intravenous infusion sequentially with the use of a separate secondary intravenous line and a good intravenous channel intravenous flow with the solvent in between. Use of NUBAC® with aminoglycosides should be administered separate as possible from the time of administration of the aminoglycosides.

Ringer Lactate Solution

Initial reconstitution with Ringer Lactate Solution should be avoided as this mixture indicates an interaction. However, a two-stage dissolving process including initial reconstitution with aqua pro injection will produce a compatible mixture and then dissolved with a Ringer Lactate Solution (See Ringer Lactate Solution / Handling Instructions Ringer Lactate Solution)

Lidocaine

Initial reconstitution with 2% lidocaine HCl solution should be avoided because the mixture indicates interaction. However, a two-stage dissolving process including initial reconstitution with aqua pro injection will yield a compatible mixture and then dissolved with a 2% lidocaine HCl solution (See Lidocaine Direction for use/Lidocaine Handling)

 

Presentation and Registration Number:

NUBAC® Powder Injection Box, vial @ 1 gr + 1 ampoule aqua pi. @ 5 ml; DKL1608024044A1

 

ON MEDICAL PRESCRIPTION ONLY

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