What is Rolisporin?
Rolisporin is used to treat bacterial infections in many different parts of the body. Rolisporin is also given before certain types of surgery to prevent infections.
Rolisporin belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Rolisporin will not work for colds, flu, or other virus infections.
Rolisporin is available only with your doctor's prescription.
Before instituting treatment with Rolisporin, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Rolisporin for injection USP and other antibacterial drugs, Rolisporin for injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Rolisporin for injection USP is indicated for the treatment of the following infections when caused by susceptible organisms:
Lower Respiratory Tract Infections
caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens.
Acute Bacterial Otitis Media
caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains).
NOTE: In one study lower clinical cure rates were observed with a single dose of Rolisporin for injection USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose Rolisporin for injection USP and the comparator. The potentially lower clinical cure rate of Rolisporin for injection USP should be balanced against the potential advantages of parenteral therapy.
Skin and Skin Structure Infections
caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii*, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus species.
Urinary Tract Infections (complicated and uncomplicated)
caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae.
Uncomplicated Gonorrhea (cervical/urethral and rectal)
caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae.
Pelvic Inflammatory Disease
caused by Neisseria gonorrhoeae. Rolisporin sodium, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.
caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae.
Bone and Joint Infections
caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species.
caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species.
caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Rolisporin for injection USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.*
*Efficacy for this organism in this organ system was studied in fewer than ten infections.
The preoperative administration of a single 1 g dose of Rolisporin for injection USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although Rolisporin for injection USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery.
When administered prior to surgical procedures for which it is indicated, a single 1 g dose of Rolisporin for injection USP provides protection from most infections due to susceptible organisms throughout the course of the procedure.
How should I use Rolisporin?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Rolisporin is injected into a muscle, or into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Rolisporin must be given slowly, and the IV infusion can take at least 30 minutes to complete.
You may need to mix Rolisporin with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Use only the diluent your doctor has recommended.
After mixing your medicine, you will need to use it within a certain number of hours or days. This will depend on the diluent and how you store the mixture (at room temperature, in a refrigerator, or frozen). Carefully follow the mixing and storage instructions provided with your medicine. Ask your pharmacist if you have questions.
Do not mix Rolisporin in the same injection with other antibiotics, or with any diluent that contains calcium, including a TPN (total parenteral nutrition) solution.
If you use other injectable medications, be sure to flush your intravenous catheter between injections of each medication.
Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Rolisporin will not treat a viral infection such as the common cold or flu.
This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Rolisporin.
Store unmixed Rolisporin powder at room temperature, away from moisture, heat, and light.
If your medicine was provided in a frozen form or was frozen after mixing, thaw it in a refrigerator or at room temperature. Do not warm in a microwave or boiling water. Use the medicine as soon as possible after thawing it. Do not refreeze.
Uses of Rolisporin in details
Rolisporin is used to treat bacterial infections of the brain respiratory tract ear abdomen abdominal wall, urinary tract and kidney, bones, joints, and skin or soft tissues. It is also used in the management of fever with low white blood cells (neutropenia), surgical site infections, joint pain caused by parasite ticks (Lyme disease), typhoid, paratyphoid and sexually transmitted infections (gonorrhea, syphilis).
B Braun Rolisporin is a sterile, nonpyrogenic, single use, packaged combination of Rolisporin sodium and dextrose injection (diluent) in the Duplex sterile container. The Duplex container is a flexible dual chamber container.
The drug chamber is filled with Rolisporin sodium, a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for IV administration. Rolisporin sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate.
Its chemical formula is C18H16N8Na2O7S3·3.5H2O. It has a calculated molecular weight of 661.6.
Rolisporin sodium is supplied as a dry powder form equivalent to either 1 or 2 g of Rolisporin. It is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Rolisporin sodium solutions ranges from light yellow to amber, depending on the length of storage and concentration.
Rolisporin sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of Rolisporin activity.
The diluent chamber contains dextrose injection. The concentration of hydrous dextrose in water for injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose USP has been added to adjust osmolality (approximately 1.87 g and 1.11 g to 1 g and 2 g dosages, respectively). Dextrose injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.
The molecular weight of hydrous dextrose USP is 198.17.
After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single IV use. When reconstituted, the approximate osmolality for the reconstituted solution for B Braun Rolisporin is 290 mOsmol/kg.
The Duplex container is latex-free, PVC-free, and DEHP-free.
The Duplex dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.
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).
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.
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.
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
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.
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.
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.
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.
Rolisporin side effects
Post-Marketing: During the use of Rolisporin, the following side effects, which were reversible either spontaneously or after withdrawal of the drug, have been observed: Systemic Side Effects: Gastrointestinal complaints (about 2% of the cases): loose stools or diarrhea, nausea, vomiting, stomatitis and glossitis.
Hematological changes (about 2%): eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia. Isolated cases of agranulocytosis (<500/mm3) have been reported, most of them after 10 days of treatment and following total doses of 20 g or more.
Skin reactions (about 1%): exanthema, allergic dermatitis, pruritus, urticaria, edema. Isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens Johnson syndrome or Lyell's Syndrome/toxic epidermal necrolysis) have been reported.
Other, Rare Side Effects: Headache and dizziness, symptomatic precipitation of Rolisporin calcium salt in the gallbladder, increase in liver enzymes, oliguria, increase in serum creatinine, genital mycosis, fever, shivering and anaphylactic or anaphylactoid reactions.
Interaction with Calcium: Two in vitro studies, one using adult plasma and the other neonatal plasma from umbilical cord blood have been carried out to assess interaction of Rolisporin and calcium. Rolisporin concentrations up to 1 mM (in excess of concentrations achieved in vivo following administration of 2 grams Rolisporin infused over 30 minutes) were used in combination with calcium concentrations up to 12 mM (48 mg/dL). Recovery of Rolisporin from plasma was reduced with calcium concentrations of 6 mM (24 mg/dL) or higher in adult plasma or 4 mM (16 mg/dL) or higher in neonatal plasma. This may be reflective of ceftriaxone-calcium precipitation.
A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Rolisporin and calcium containing fluids. In some of these cases, the same intravenous infusion line was used for both Rolisporin and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Rolisporin and calcium-containing fluids were administered at different autopsy in this neonate. There have been no similar reports in patients other than neonates.
Pseudomembranous enterocolitis and coagulation disorders have been reported as very rare side effects.
Very rare cases of renal precipitation have been reported, mostly in children older than 3 years and who have been treated with either high daily doses (e.g. ≥80 mg/kg/day) or total doses exceeding 10 grams and presenting other risk factors (e.g. fluid restrictions, confinement to bed, etc.). This event may be symptomatic or asymptomatic, may lead to renal insufficiency, and is reversible upon discontinuation of Rolisporin.
Local Side Effects: In rare cases, phlebitis reactions occurred after i.v. administration. These may be minimized by slow (2-4 minutes) injection.
Intramuscular injection without lidocaine solution is painful.
Laboratory Abnormalities: Influence on Diagnostic Tests: In patients treated with Rolisporin the Coombs' test may rarely become false-positive.
Rolisporin, like other antibiotics, may result in false-positive tests for galactosemia.
Likewise, nonenzymatic methods for the glucose determination in urine may give false positive results. For this reason, urine-glucose determination during therapy with Rolisporin should be done enzymatically.
Rolisporin for injection is contraindicated in patients with known hypersensitivity to Rolisporin, any of its excipients or to any other cephalosporin. Patients with previous hypersensitivity reactions to penicillin and other beta lactam antibacterial agents may be at greater risk of hypersensitivity to Rolisporin.
Rolisporin for injection is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).
Hyperbilirubinemic neonates should not be treated with Rolisporin for injection. Rolisporin can displace bilirubin from its binding to serum albumin, leading to a risk of bilirubin encephalopathy in these patients.
Neonates Requiring Calcium Containing IV Solutions
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.
Cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Rolisporin for injection and calcium- containing fluids.
In some of these cases, the same intravenous infusion line was used for both Rolisporin for injection and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. There have been no similar reports in patients other than neonates.
Intravenous administration of Rolisporin solutions containing lidocaine is contraindicated. When lidocaine solution is used as a solvent with Rolisporin for intramuscular injection, exclude all contraindications to lidocaine. Refer to the prescribing information of lidocaine.
Active ingredient matches for Rolisporin:
Ceftriaxone in Greece.
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ReviewsThe results of a survey conducted on ndrugs.com for Rolisporin 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 Rolisporin. 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.
Information checked by Dr. Sachin Kumar, MD Pharmacology