Dosage of Suldiazan in details
Suldiazan should be administered by intravenous infusion over 30 minutes.
The usual daily dose of Suldiazan for adults is 3.375 g every six hours totaling 13.5 g (12.0 g Piperacillin (Suldiazan)/1.5 g Tazobactam (Suldiazan)).
Nosocomial Pneumonia
Initial presumptive treatment of patients with nosocomial pneumonia should start with Suldiazan at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g Piperacillin (Suldiazan)/2.0 g Tazobactam (Suldiazan)). 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, Suldiazan and the aminoglycoside are recommended for separate administration. Suldiazan 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 Suldiazan 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 Suldiazan (Suldiazan) formulation not containing EDTA. This information does not apply to Suldiazan in vials or bulk pharmacy containers. Refer to the package insert for Suldiazan vials or bulk pharmacy containers for instructions.
| Aminoglycoside | Suldiazan Dose (grams) | Aminoglycoside Concentration Range* (mg/mL) | Acceptable Diluents |
|---|---|---|---|
| Amikacin | 2.25, 3.375, 4.5 | 1.75 – 7.5 | 0.9% Sodium Chloride or 5% Dextrose |
| Gentamicin | 2.25, 3.375, 4.5 | 0.7 – 3.32 | 0.9% Sodium Chloride or 5% Dextrose |
| *The concentration ranges in Table 5 are based on administration of the aminoglycoside in divided doses (10-15 mg/kg/day in two daily doses for amikacin and 3-5 mg/kg/day in three daily doses for gentamicin). Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with Suldiazan containing EDTA has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions. | |||
Suldiazan is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of Suldiazan with other aminoglycosides has not been established. Only the concentration and diluents for amikacin or gentamicin with the dosages of Suldiazan 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 Suldiazan.
Renal Insufficiency
In patients with renal insufficiency (Creatinine Clearance ≤ 40 mL/min), the intravenous dose of Suldiazan 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 Suldiazan for patients with renal insufficiency are as follows:
| Renal Function (Creatinine Clearance, mL/min) | All Indications (except nosocomial pneumonia) | Nosocomial Pneumonia |
|---|---|---|
| >40 mL/min | 3.375 q 6 h | 4.5 q 6 h |
| 20-40 mL/min* | 2.25 q 6 h | 3.375 q 6 h |
| <20 mL/min* | 2.25 q 8 h | 2.25 q 6 h |
| Hemodialysis** | 2.25 q 12 h | 2.25 q 8 h |
| CAPD | 2.25 q 12 h | 2.25 q 8 h |
| * Creatinine clearance for patients not receiving hemodialysis ** 0.75 g should be administered following each hemodialysis session on hemodialysis days | ||
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 Suldiazan should be administered following each dialysis period on hemodialysis days. No additional dosage of Suldiazan is necessary for CAPD patients.
Duration of Therapy
The usual duration of Suldiazan treatment is from seven to ten days. However, the recommended duration of Suldiazan 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 Suldiazan dosage is 100 mg Piperacillin (Suldiazan)/12.5 mg Tazobactam (Suldiazan) per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended Suldiazan dosage based on pharmacokinetic modeling, is 80 mg Piperacillin (Suldiazan)/10 mg Tazobactam (Suldiazan) 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 Suldiazan in pediatric patients with impaired renal function.
Suldiazan in Galaxy containers should not be used in pediatric patients who require less than the full adult dose of Suldiazan in order to prevent unintentional overdose. The other available formulations of Suldiazan can be used in this population.
DIRECTIONS FOR USE OF Suldiazan (Suldiazan INJECTION) IN GALAXY CONTAINERS (PL 2040 PLASTIC)
Suldiazan Injection (PL 2040 Plastic) is to be administered using sterile equipment after thawing to room temperature.
Suldiazan 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.
Suldiazan should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Suldiazan is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Suldiazan should not be added to blood products or albumin hydrolysates.
What other drugs will affect Suldiazan?
Suldiazan 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:
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heparin or warfarin (Coumadin);
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argatroban, bivalirudin, dabigatran, fondaparinux, lepirudin, rivaroxaban;
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abciximab, eptifibatide, tirofiban;
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dalteparin, enoxaparin, tinzaparin;
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anagrelide, cilostazol, clopidogrel, dipyridamole, eltrombopag, oprelvekin, prasugrel, romiplostim, ticagrelor, ticlopidine; or
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alteplase, reteplase, tenecteplase, urokinase.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Suldiazan, especially:
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methotrexate; or
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probenecid.
These lists are not complete. Other drugs may interact with Suldiazan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Suldiazan interactions
Concurrent administration of probenecid and Suldiazan produced a longer t½ and lower renal clearance for both Suldiazan. However, peak plasma concentrations of neither medicine are affected. No kinetic interaction is found between Suldiazan and vancomycin.
Concurrent administration of Piperacillin (Suldiazan) and tobramycin in patients with severe renal dysfunction (ie, chronic haemodialysis patients) has been reported to reduce the elimination t½ 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 (Suldiazan) 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 (Suldiazan) when used concomitantly with vecuronium, has been implicated in the prolongation of the neuromuscular blockade of vecuronium. Suldiazan (Suldiazan) 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 (Suldiazan).
Piperacillin (Suldiazan) may reduce the excretion of methotrexate. Therefore, serum levels of methotrexate should be monitored in patients to avoid medicine toxicity.
If Suldiazan 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 Suldiazan 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 Suldiazan 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 Suldiazan, 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 Suldiazan should be interpreted cautiously and confirmed by other diagnostic methods.
Incompatibilities: Suldiazan should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established. Whenever Suldiazan is used concurrently with another antibiotic, the drugs must be administered separately.
Because of chemical instability, Suldiazan should not be used with lactated Ringer's solution, solutions containing only sodium bicarbonate or having a pH in the basic range.
Suldiazan should not be added to blood products or albumin hydrolysates.
References
- 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).
- MeSH. "beta-Lactamase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
