What happens if I overdose Rolisporin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include muscle spasms; seizures.
Proper storage of Rolisporin:
Rolisporin is usually handled and stored by a health care provider. If you are using Rolisporin at home, store Rolisporin as directed by your pharmacist or health care provider. Keep Rolisporin, as well as needles and syringes, out of the reach of children and away from pets.
Overdose of Rolisporin in details
In the case of overdose, nausea, vomiting and diarrhea can occur. Rolisporin concentration can not be reduced by hemodialysis or peritoneal dialysis.
There is no specific antidote. Treatment is symptomatic.
What should I avoid while taking Rolisporin?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
Before therapy with Rolisporin for injection is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins and other beta-lactam agents or other drugs. This product should be given cautiously to penicillin and other beta-lactam agent-sensitive patients. Antibacterial drugs should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures.
As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions (i.e., anaphylaxis) have been reported. In case of severe hypersensitivity reactions, treatment with Rolisporin must be discontinued immediately and adequate emergency measures must be initiated.
Interaction with Calcium-Containing Products
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. In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of Ceftriaxone-calcium.
Clostridium difficile - Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Rolisporin for injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including Rolisporin for Injection. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anemia while on Rolisporin, the diagnosis of a cephalosporin associated anemia should be considered and Rolisporin stopped until the etiology is determined.
What should I discuss with my healthcare provider before taking Rolisporin?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Rolisporin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to Rolisporin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Rolisporin in children. Because of ceftriaxone's toxicity, use in newborn and premature babies is not recommended.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Rolisporin in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving Rolisporin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Rolisporin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Calcium Acetate
- Calcium Chloride
- Calcium Gluceptate
- Calcium Gluconate
- Lactated Ringer's Solution
- Ringer's Solution
Using Rolisporin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Rolisporin. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia or
- Diarrhea or
- Gallbladder disease or
- Pancreatitis (inflammation of the pancreas) or
- Stomach or bowel disease (e.g., colitis), history of—Use with caution. May make these conditions worse.
- Hyperbilirubinemia (high bilirubin in the blood)—Should not be used in newborn (less than 28 days of age) and premature infants with this condition.
- Kidney disease or
- Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
- Liver disease, severe or
- Undernourished condition—May be worsened by Rolisporin and you may need to take Vitamin K.
Development of Drug-resistant Bacteria
Prescribing Rolisporin for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of Rolisporin for injection may result in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Patients with Renal or Hepatic Impairment
Rolisporin is excreted via both biliary and renal excretion. Therefore, patients with renal failure normally require no adjustment in dosage when usual doses of Rolisporin for injection are administered.
Dosage adjustments should not be necessary in patients with hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, caution should be exercised and the Rolisporin for injection dosage should not exceed 2 gm daily.
Rolisporin is not removed by peritoneal- or hemodialysis. In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.
Effect on Prothrombin Time
Alterations in prothrombin times have occurred in patients treated with Rolisporin for injection. Monitor prothrombin time during Rolisporin for injection treatment in patients with impaired vitamin K synthesis or low vitamin K stores (eg, chronic hepatic disease and malnutrition). Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.
Concomitant use of Rolisporin with Vitamin K antagonists may increase the risk of bleeding. Coagulation parameters should be monitored frequently, and the dose of the anticoagulant adjusted accordingly, both during and after treatment with Rolisporin.
Ceftriaxone-calcium precipitates in the gallbladder have been observed in patients receiving Rolisporin FOR INJECTION. These precipitates appear on sonography as an echo without acoustical shadowing suggesting sludge or as an echo with acoustical shadowing which may be misinterpreted as gallstones. The probability of such precipitates appears to be greatest in pediatric patients. Patients may be asymptomatic or may develop symptoms of gallbladder disease. The condition appears to be reversible upon discontinuation of Rolisporin sodium and institution of conservative management. Discontinue Rolisporin sodium in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above.
Urolithiasis and Post-Renal Acute Renal Failure
Ceftriaxone-calcium precipitates in the urinary tract have been observed in patients receiving Rolisporin FOR INJECTION and may be detected as sonographic abnormalities. The probability of such precipitates appears to be greatest in pediatric patients. Patients may be asymptomatic or may develop symptoms of urolithiasis, and ureteral obstruction and post-renal acute renal failure. The condition appears to be reversible upon discontinuation of Rolisporin sodium and institution of appropriate management. Ensure adequate hydration in patients receiving Rolisporin FOR INJECTION. Discontinue Rolisporin FOR INJECTION in patients who develop signs and symptoms suggestive of urolithiasis, oliguria or renal failure and/or the sonographic findings described above.
Cases of pancreatitis, possibly secondary to biliary obstruction, have been reported in patients treated with Rolisporin for injection. Most patients presented with risk factors for biliary stasis and biliary sludge (preceding major therapy, severe illness, total parenteral nutrition). A cofactor role of Rolisporin for injection -related biliary precipitation cannot be ruled out.
Information for Patients
Information for Patients:
• Patients should be counseled that antibacterial drugs including Rolisporin for injection should only be used to treat bacterial infections. They do not treat viral infections (eg, common cold).
• When Rolisporin for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Rolisporin for injection or other antibacterial drugs in the future.
• Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Carcinogenesis, Mutagenesis, Impairment of FertilityCarcinogenesis
Considering the maximum duration of treatment and the class of the compound, carcinogenicity studies with Rolisporin in animals have not been performed. The maximum duration of animal toxicity studies was 6 months.
Genetic toxicology tests included the Ames test, a micronucleus test and a test for chromosomal aberrations in human lymphocytes cultured in vitro with Rolisporin. Rolisporin showed no potential for mutagenic activity in these studies.
Impairment of Fertility
Rolisporin produced no impairment of fertility when given intravenously to rats at daily doses up to 586 mg/kg/day, approximately 20 times the recommended clinical dose of 2 g/day.
Pregnancy Category B:
Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
In rats, in the Segment I (fertility and general reproduction) and Segment III (perinatal and postnatal) studies with intravenously administered Rolisporin, no adverse effects were noted on various reproductive parameters during gestation and lactation, including postnatal growth, functional behavior and reproductive ability of the offspring, at doses of 586 mg/kg/day or less.
Low concentrations of Rolisporin are excreted in human milk. Caution should be exercised when Rolisporin for injection is administered to a nursing woman.
Safety and effectiveness of Rolisporin for injection in neonates, infants and pediatric patients have been established for the dosages described in the section. In vitro studies have shown that Rolisporin, like some other cephalosporins, can displace bilirubin from serum albumin. Rolisporin for injection should not be administered to hyperbilirubinemic neonates, especially prematures.
Of the total number of subjects in clinical studies of Rolisporin for injection, 32% were 60 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
The pharmacokinetics of Rolisporin were only minimally altered in geriatric patients compared to healthy adult subjects and dosage adjustments are not necessary for geriatric patients with Rolisporin dosages up to 2 grams per day provided there is no severe renal and hepatic impairment..
Influence on Diagnostic Tests:
In patients treated with Rolisporin FOR INJECTION the Coombs' test may become positive. Rolisporin, like other antibacterial drugs, may result in positive test results for galactosemia.
Nonenzymatic methods for the glucose determination in urine may give false-positive results. For this reason, urine-glucose determination during therapy with Rolisporin for injection should be done enzymatically.
The presence of Rolisporin may falsely lower estimated blood glucose values obtained with some blood glucose monitoring systems. Please refer to instructions for use for each system. Alternative testing methods should be used if necessary.
What happens if I miss a dose of Rolisporin?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
- DrugBank. "ceftriaxone". http://www.drugbank.ca/drugs/DB01212 (accessed September 18, 2017).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/680009... (accessed September 18, 2017).
Information checked by Dr. Sachin Kumar, MD Pharmacology