Rocéphine Dosage

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Dosage of Rocéphine in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Rocéphine 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 Rocéphine (Rocéphine 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: Rocéphine for Injection and Dextrose Injection (Rocéphine (Rocéphine and dextrose injection ) sodium and dextrose injection ) in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of Rocéphine (Rocéphine 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 Rocéphine (Rocéphine 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, Rocéphine for Injection and Dextrose Injection (Rocéphine (Rocéphine 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 Rocéphine (Rocéphine and dextrose injection ) in admixtures. When either of these drugs is to be administered concomitantly with Rocéphine (Rocéphine 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.

Administration

Precautions

Animal Pharmacology

Concretions consisting of the precipitated calcium salt of Rocéphine (Rocéphine and dextrose injection ) have been found in the gallbladder bile of dogs and baboons treated with Rocéphine (Rocéphine 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 Rocéphine (Rocéphine and dextrose injection ) has a greater plasma half-life in humans, the calcium salt of Rocéphine (Rocéphine and dextrose injection ) is more soluble in human gallbladder bile and the calcium content of human gallbladder bile is relatively low.

How supplied

Rocéphine for Injection and Dextrose Injection (Rocéphine (Rocéphine 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 Rocéphine (Rocéphine 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.

Rocéphine for Injection and Dextrose Injection (Rocéphine (Rocéphine 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
Rocéphine for Injection and Dextrose Injection
0264-3153-11 3153-11 1g 50 mL
Rocéphine 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

What other drugs will affect Rocéphine?

There may be other drugs that can interact with Rocéphine. 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.

Rocéphine interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Rocéphine, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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No impairment of renal function has so far been observed after concurrent administration of large doses of Rocéphine and potent diuretics (eg, furosemide). There is no evidence that Rocéphine increases renal toxicity of aminoglycosides. No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol subsequent to the administration of Rocéphine. Rocéphine does not contain an N-methylthiotetrazole moiety associated with possible ethanol intolerance and bleeding problems of certain other cephalosporins. The elimination of Rocéphine is not altered by probenecid. In an in vitro study, antagonistic effects have been observed with the combination of chloramphenicol and Rocéphine.

Do not use diluents containing calcium eg, Ringer's or Hartmann's solution, to reconstitute Rocéphine vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of Rocéphine-calcium can also occur when Rocéphine is mixed with calcium-containing solutions in the same IV administration line.

Rocéphine 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, Rocéphine 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 Rocéphine-calcium.

Based on literature reports, Rocéphine is incompatible with amsacrine, vancomycin, fluconazole and aminoglycosides.

In patients treated with Rocéphine, the Coombs' test may in rare cases be false-positive. Rocéphine, 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 Rocéphine should be carried out enzymatically.

Rocéphine 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 Rocéphine 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 Rocéphine vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Rocéphine must not be mixed or administered simultaneously with calcium-containing solutions. Based on literature reports, Rocéphine is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.


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References

  1. DailyMed. "CEFTRIAXONE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. FDA/SPL Indexing Data. "75J73V1629: 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).
  3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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The results of a survey conducted on ndrugs.com for Rocéphine are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Rocéphine. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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