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Rociject Dosage |
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Rociject Injection and Dextrose Injection is intended for intravenous administration only.
ADULTS: The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. The total daily dose should not exceed 4 grams.
If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because Rociject (Rociject sodium and dextrose injection ) sodium has no activity against this organism. For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.
PEDIATRIC PATIENTS: Rociject for Injection and Dextrose Injection (Rociject (Rociject sodium and dextrose injection ) sodium and dextrose injection ) in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of Rociject (Rociject sodium and dextrose injection ). To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of Rociject (Rociject sodium and dextrose injection ).
For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should.not exceed 2 grams.
For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams.
In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours). The usual duration of therapy is 7 to 14 days.
Generally, Rociject for Injection and Dextrose Injection (Rociject (Rociject sodium and dextrose injection ) sodium and dextrose injection ) therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.
No dosage adjustment is necessary for patients with impairment of renal or hepatic function; however, blood levels should be monitored in patients with severe renal impairment [e.g., dialysis patients) and in patients with both renal and hepatic dysfunctions.
Vancomycin and fluconazole are physically incompatible with Rociject (Rociject sodium and dextrose injection ) in admixtures. When either of these drugs is to be administered concomitantly with Rociject (Rociject sodium and dextrose injection ) by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.
After the indicated stability time periods, unused portions of solutions should be discarded. CAUTION: Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
NOTE:
Parenteral drug products should be inspected visually for particulate matter before administration.
Directions for Use of DUPLEX® Drug Delivery System
Removal from Multi-Pack Tray
Patient Labeling and Drug Powder/Diluent Inspection
Reconstitution (Activation)
Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.
Concretions consisting of the precipitated calcium salt of Rociject (Rociject sodium and dextrose injection ) have been found in the gallbladder bile of dogs and baboons treated with Rociject (Rociject sodium and dextrose injection ).
These appeared as a gritty sediment in dogs that received 100 mg/kg/day for 4 weeks. A similar phenomenon has been observed in baboons but only after a protracted dosing period (6 months) at higher dose levels (335 mg/kg/day or more). The likelihood of this occurrence in humans is considered to be low, since Rociject (Rociject sodium and dextrose injection ) has a greater plasma half-life in humans, the calcium salt of Rociject (Rociject sodium and dextrose injection ) is more soluble in human gallbladder bile and the calcium content of human gallbladder bile is relatively low.
Rociject for Injection and Dextrose Injection (Rociject (Rociject sodium and dextrose injection ) sodium and dextrose injection ) in the DUPLEX® Drug Delivery System is a flexible dual chamber container supplied in two concentrations. After reconstitution, the concentrations are equivalent to 1 g and 2 g Rociject (Rociject sodium and dextrose injection ). The diluent chamber contains approximately 50 mL of Dextrose Injection. Dextrose injection has been adjusted to 3.74% and 2.22% for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic.
Rociject for Injection and Dextrose Injection (Rociject (Rociject sodium and dextrose injection ) sodium and dextrose injection ) is supplied sterile and nonpyrogenic in the DUPLEX Drug Delivery System containers packaged 12 units per tray, 2 trays per case.
NDG | Cat. No. | Dose | Volume |
Rociject for Injection and Dextrose Injection | |||
0264-3153-11 | 3153-11 | 1g | 50 mL |
Rociject for Injection and Dextrose Iniection | |||
0264-3155-11 | 3155-11 | 2g | 50 mL |
Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).
DUPLEX® is a registered trademark of B. Braun Medical Inc. Revised: January 2007 B. Braun Medical Inc. Irvine, CA, USA 92614-5895. FDA Rev date: 9/10/2007
There may be other drugs that can interact with Rociject. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
No impairment of renal function has so far been observed after concurrent administration of large doses of Rociject and potent diuretics (eg, furosemide). There is no evidence that Rociject increases renal toxicity of aminoglycosides. No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol subsequent to the administration of Rociject. Rociject does not contain an N-methylthiotetrazole moiety associated with possible ethanol intolerance and bleeding problems of certain other cephalosporins. The elimination of Rociject is not altered by probenecid. In an in vitro study, antagonistic effects have been observed with the combination of chloramphenicol and Rociject.
Do not use diluents containing calcium eg, Ringer's or Hartmann's solution, to reconstitute Rociject vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of Rociject-calcium can also occur when Rociject is mixed with calcium-containing solutions in the same IV administration line.
Rociject must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions eg, parenteral nutrition via a Y-site. However, in patients other than neonates, Rociject and calcium-containing solutions may be administered sequentially of one another, if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord, blood demonstrated that neonates have an increased risk of precipitation of Rociject-calcium.
Based on literature reports, Rociject is incompatible with amsacrine, vancomycin, fluconazole and aminoglycosides.
In patients treated with Rociject, the Coombs' test may in rare cases be false-positive. Rociject, like other antibiotics, may result in false-positive tests for galactosemia. Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results. For this reason, glucose level determination in urine during therapy with Rociject should be carried out enzymatically.
Rociject may adversely affect the efficacy of oral hormonal contraceptives.
Consequently, it is advisable to use supplementary (nonhormonal) contraceptive measures during treatment and in the month following treatment.
Incompatibilities: Solutions containing Rociject should not be mixed with or added to other agents. In particular, diluents containing calcium (eg, Ringer's or Hartmann's solution), should not be used to reconstitute Rociject vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Rociject must not be mixed or administered simultaneously with calcium-containing solutions. Based on literature reports, Rociject is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.
Users | % | ||
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501mg-1g | 1 | 50.0% | |
1-5mg | 1 | 50.0% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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