Rolisporin Dosage

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Dosage of Rolisporin in details

infoThe 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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Rolisporin for injection may be administered intravenously or intramuscularly.

Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute Rolisporin for injection vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of Ceftriaxone-calcium can also occur when Rolisporin for injection is mixed with calcium-containing solutions in the same IV administration line. Rolisporin for injection must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, Rolisporin for injection and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

There have been no reports of an interaction between Rolisporin and oral calcium-containing products or interaction between intramuscular Rolisporin and calcium-containing products (IV or oral).

Neonates

Hyperbilirubinemic neonates, especially prematures, should not be treated with Rolisporin for injection. Rolisporin for injection is contraindicated in premature neonates.

Rolisporin for injection is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium- containing infusions such as parenteral nutrition because of the risk of precipitation of Ceftriaxone-calcium.

Intravenous doses should be given over 60 minutes in neonates to reduce the risk of bilirubin encephalopathy.

Pediatric Patients

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 acute bacterial otitis media, a single intramuscular dose of 50 mg/kg (not to exceed 1 gram) is recommended.

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.

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 Rolisporin sodium has no activity against this organism.

For the treatment of uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended.

For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.

Generally, Rolisporin for 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.

The dosages recommended for adults require no modification in elderly patients, up to 2 gm per day, provided there is no severe renal and hepatic impairment.

Directions For Use

Intramuscular Administration:

Reconstitute Rolisporin for injection powder with the appropriate diluent.

Inject diluent into vial, shake vial thoroughly to form solution. Withdraw entire contents of vial into syringe to equal total labeled dose.

After reconstitution, each 1 mL of solution contains approximately 250 mg or 350 mg equivalent of Rolisporin according to the amount of diluent indicated below. If required, more dilute solutions could be utilized.

As with all intramuscular preparations, Rolisporin for injection should be injected well within the body of a relatively large muscle; aspiration helps to avoid unintentional injection into a blood vessel.

Intravenous Administration:

Rolisporin for injection should be administered intravenously by infusion over a period of 30 minutes, except in neonates where administration over 60 minutes is recommended to reduce the risk of bilirubin encephalopathy. Concentrations between 10 mg/mL and 40 mg/mL are recommended; however, lower concentrations may be used if desired. Reconstitute vials with an appropriate IV diluent.

After reconstitution, each 1 mL of solution contains approximately 100 mg equivalent of Rolisporin. Withdraw entire contents and dilute to the desired concentration with the appropriate IV diluent.

Compatibility and Stability

Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute Rolisporin for injection vials or to further dilute a reconstituted vial for IV administration. Particulate formation can result.

Rolisporin has been shown to be compatible with Flagyl®* IV (metronidazole hydrochloride). The concentration should not exceed 5 to 7.5 mg/mL metronidazole hydrochloride with Rolisporin 10 mg/mL as an admixture. The admixture is stable for 24 hours at room temperature only in 0.9% sodium chloride injection or 5% dextrose in water (D5W). No compatibility studies have been conducted with the Flagyl®* IV RTU®(metronidazole) formulation or using other diluents. Metronidazole at concentrations greater than 8 mg/mL will precipitate. Do not refrigerate the admixture as precipitation will occur.

Vancomycin, amsacrine, aminoglycosides, and fluconazole are incompatible with Rolisporin in admixtures. When any of these drugs are to be administered concomitantly with Rolisporin 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.

Rolisporin for injection solutions should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, due to possible incompatibility.

Rolisporin for injection sterile powder should be stored at 20° to 25°C (68° to 77°F) and protected from light. After reconstitution, protection from normal light is not necessary. The color of solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

Rolisporin for injection intramuscular solutions remain stable (loss of potency less than 10%) for the following time periods:

Rolisporin for injection intravenous solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable (loss of potency less than 10%) for the following time periods stored in glass or PVC containers:

The following intravenous Rolisporin for injection solutions are stable at room temperature (25°C) for 24 hours, at concentrations between 10 mg/mL and 40 mg/mL: Sodium Lactate (PVC container), 10% Invert Sugar (glass container), 5% Sodium Bicarbonate (glass container), Freamine III (glass container), Normosol-M in 5% Dextrose (glass and PVC containers), Ionosol-B in 5% Dextrose (glass container), 5% Mannitol (glass container), 10% Mannitol (glass container).

After the indicated stability time periods, unused portions of solutions should be discarded.

NOTE:

Parenteral drug products should be inspected visually for particulate matter before administration.

Rolisporin for injection reconstituted with 5% Dextrose or 0.9% Sodium Chloride solution at concentrations between 10 mg/mL and 40 mg/mL, and then stored in frozen state (-20°C) in PVC or polyolefin containers, remains stable for 26 weeks.

Frozen solutions of Rolisporin for injection should be thawed at room temperature before use. After thawing, unused portions should be discarded. DO NOT REFREEZE.

What other drugs will affect Rolisporin?

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

Rolisporin interactions

infoInteractions 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 Rolisporin, 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 Rolisporin and potent diuretics (eg, furosemide). There is no evidence that Rolisporin increases renal toxicity of aminoglycosides. No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol subsequent to the administration of Rolisporin. Rolisporin does not contain an N-methylthiotetrazole moiety associated with possible ethanol intolerance and bleeding problems of certain other cephalosporins. The elimination of Rolisporin is not altered by probenecid. In an in vitro study, antagonistic effects have been observed with the combination of chloramphenicol and Rolisporin.

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

Rolisporin 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, Rolisporin 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 ceftriaxone-calcium.

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

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

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


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References

  1. PubMed Health. "Rocephin: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhealth... (accessed September 18, 2017).
  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/DataStan... (accessed September 18, 2017).

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