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What is Rolisporin?
Rolisporin is used to treat bacterial infections in many different parts of the body. This medicine 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, this medicine will not work for colds, flu, or other virus infections.
This medicine 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 and other antibacterial drugs, Rolisporin 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 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.
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 spp.
Urinary tract infections (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae.
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.
Bacterial septicemia 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 spp.
Intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium spp (Note: Most strains of Clostridium difficile are resistant) or Peptostreptococcus spp.
Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae.
Rolisporin sodium 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 10 infections.
Surgical Prophylaxis: The preoperative administration of a single 1 g dose of Rolisporin may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (eg, vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients eg, those >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 (eg, during coronary artery bypass surgery). Although Rolisporin sodium 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 provides protection from most infections due to susceptible organisms throughout the course of the procedure.
How should I use Rolisporin?
Use Rolisporin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Rolisporin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Rolisporin at home, a health care provider will teach you how to use it. Be sure you understand how to use Rolisporin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Rolisporin is light yellow to amber in color. Do not use Rolisporin if it contains particles, is cloudy or discolored, or if the vial or container is cracked or damaged in any way.
- To clear up your infection completely, use Rolisporin for the full course of treatment. Keep using it even if you feel better in a few days.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Rolisporin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Rolisporin.
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).
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 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.
Active ingredient matches for Rolisporin:
Ceftriaxone in Greece.
- 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/dailymed/se... (accessed September 18, 2017).
- Wikipedia. "ceftriaxone: Link to the compound information in Wikipedia.". https://en.wikipedia.org/wiki/Ceftriaxon... (accessed September 18, 2017).
- PubChem. "ceftriaxone". https://pubchem.ncbi.nlm.nih.gov/compoun... (accessed September 18, 2017).
- FDA Orange Book. "CEFTRIAXONE SODIUM; LIDOCAINE: The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).". https://www.fda.gov/Drugs/InformationOnD... (accessed September 18, 2017).
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.
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