Unozen Dosage

• Dosage of Unozen in details
• Unozen interactions
• Unozen reviews

Dosage of Unozen in details

Unozen should be administered by intravenous infusion over 30 minutes.

The usual daily dose of Unozen for adults is 3.375 g every six hours totaling 13.5 g (12.0 g Piperacillin (Unozen)/1.5 g Tazobactam (Unozen)).

Nosocomial Pneumonia

Initial presumptive treatment of patients with nosocomial pneumonia should start with Unozen at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g Piperacillin (Unozen)/2.0 g Tazobactam (Unozen)). Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeruginosa is isolated. If Pseudomonas aeruginosa is not isolated, the aminoglycoside may be discontinued at the discretion of the treating physician.

Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Unozen and the aminoglycoside are recommended for separate administration. Unozen and the aminoglycoside should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated.

In circumstances where coadministration via Y-site is necessary, reformulated Unozen containing EDTA supplied in Galaxy containers is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:

The following compatibility information does not apply to the Unozen (Unozen) formulation not containing EDTA. This information does not apply to Unozen in vials or bulk pharmacy containers. Refer to the package insert for Unozen vials or bulk pharmacy containers for instructions.

Unozen is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of Unozen with other aminoglycosides has not been established. Only the concentration and diluents for amikacin or gentamicin with the dosages of Unozen listed above have been established as compatible for coadministration via Y-site infusion. Simultaneous coadministration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by Unozen.

Renal Insufficiency

In patients with renal insufficiency (Creatinine Clearance ≤ 40 mL/min), the intravenous dose of Unozen should be adjusted to the degree of actual renal function impairment. In patients with nosocomial pneumonia receiving concomitant aminoglycoside therapy, the aminoglycoside dosage should be adjusted according to the recommendations of the manufacturer. The recommended daily doses of Unozen for patients with renal insufficiency are as follows:

For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g Unozen should be administered following each dialysis period on hemodialysis days. No additional dosage of Unozen is necessary for CAPD patients.

Duration of Therapy

The usual duration of Unozen treatment is from seven to ten days. However, the recommended duration of Unozen treatment of nosocomial pneumonia is 7 to 14 days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriological progress.

Pediatric Patients

For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended Unozen dosage is 100 mg Piperacillin (Unozen)/12.5 mg Tazobactam (Unozen) per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended Unozen dosage based on pharmacokinetic modeling, is 80 mg Piperacillin (Unozen)/10 mg Tazobactam (Unozen) per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. There are no dosage recommendations for Unozen in pediatric patients with impaired renal function.

Unozen in Galaxy containers should not be used in pediatric patients who require less than the full adult dose of Unozen in order to prevent unintentional overdose. The other available formulations of Unozen can be used in this population.

DIRECTIONS FOR USE OF Unozen (Unozen INJECTION) IN GALAXY CONTAINERS (PL 2040 PLASTIC)

Unozen Injection (PL 2040 Plastic) is to be administered using sterile equipment after thawing to room temperature.

Unozen containg EDTA is compatible for co-administration via a Y-site intravenous tube with Lactated Ringer's injection, USP.

Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

Unozen should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

Unozen is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

Unozen should not be added to blood products or albumin hydrolysates.

What other drugs will affect Unozen?

Unozen may cause bleeding, especially in people who have kidney disease or use certain medicines. Tell your doctor if you are using any medication to prevent blood clots, such as:

• heparin or warfarin (Coumadin);

• argatroban, bivalirudin, dabigatran, fondaparinux, lepirudin, rivaroxaban;

• abciximab, eptifibatide, tirofiban;

• dalteparin, enoxaparin, tinzaparin;

• anagrelide, cilostazol, clopidogrel, dipyridamole, eltrombopag, oprelvekin, prasugrel, romiplostim, ticagrelor, ticlopidine; or

• alteplase, reteplase, tenecteplase, urokinase.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Unozen, especially:

• methotrexate; or

• probenecid.

These lists are not complete. Other drugs may interact with Unozen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Unozen interactions

Concurrent administration of probenecid and Unozen produced a longer t_½ and lower renal clearance for both Unozen. However, peak plasma concentrations of neither medicine are affected. No kinetic interaction is found between Unozen and vancomycin.

Concurrent administration of Piperacillin (Unozen) and tobramycin in patients with severe renal dysfunction (ie, chronic haemodialysis patients) has been reported to reduce the elimination t_½ and significantly increase the total body clearance of tobramycin.

The alteration of tobramycin pharmacokinetics in patients with mild to moderate renal dysfunction who are taking Piperacillin (Unozen) concomitantly is unknown. However, reports suggest that the aminoglycoside inactivation in patients concomitantly taking an aminoglycoside with broad spectrum β-lactam penicillin is only clinically significant in patients with severe renal dysfunction.

The inactivation of aminoglycosides in the presence of penicillin class medicines has been recognized. It has been postulated that penicillin/aminoglycoside complexes form, these complexes are microbiologically inactive and of unknown toxicity.

Piperacillin (Unozen) when used concomitantly with vecuronium, has been implicated in the prolongation of the neuromuscular blockade of vecuronium. Unozen (Unozen) could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the nondepolarising muscle relaxants could be prolonged in the presence of Piperacillin (Unozen).

Piperacillin (Unozen) may reduce the excretion of methotrexate. Therefore, serum levels of methotrexate should be monitored in patients to avoid medicine toxicity.

If Unozen is used concurrently with another antibiotic, especially an aminoglycoside, the drugs must not be mixed in IV solutions or administered concurrently, due to physical incompatibility.

During simultaneous administration of Unozen and high doses of heparin, oral anticoagulants and other drugs that may affect the blood coagulation system and/or the thrombocyte function, the coagulation parameters should be tested more frequently and monitored regularly.

Laboratory Tests: As with other penicillins, the administration of Unozen may result in a false-positive reaction for glucose in the urine using a copper reduction method. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

There have been reports of positive test results using Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving Unozen, who were subsequently found to be free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results in patients receiving Unozen should be interpreted cautiously and confirmed by other diagnostic methods.

Incompatibilities: Unozen should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established. Whenever Unozen is used concurrently with another antibiotic, the drugs must be administered separately.

Because of chemical instability, Unozen should not be used with lactated Ringer's solution, solutions containing only sodium bicarbonate or having a pH in the basic range.

Unozen should not be added to blood products or albumin hydrolysates.

References

1. FDA/SPL Indexing Data. "SE10G96M8W: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
2. MeSH. "beta-Lactamase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

User reports

Consumer reviews

Information checked by Dr. Sachin Kumar, MD Pharmacology