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Iothalamate meglumine
Overview
What is Cysto-Conray II?
Cysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt) and has the following structural formula:
Each milliliter of Cysto-Conray II contains 172 mg of iothalamate meglumine, equivalent to 81 mg (8.1% w/v) of organically bound iodine, 0.110 mg edetate calcium disodium as a stabilizer and 0.115 mg of monobasic sodium phosphate as a buffer.
Cysto-Conray II is hypertonic under conditions of use and is supplied in containers from which the air has been displaced by nitrogen. The pH of Cysto-Conray II is 6.6 to 7.6.
What does Cysto-Conray II look like?
What are the available doses of Cysto-Conray II?
Sorry No records found.
What should I talk to my health care provider before I take Cysto-Conray II?
Sorry No records found
How should I use Cysto-Conray II?
Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.
Unless contraindicated, an appropriate laxative is given the night before the examination.
What interacts with Cysto-Conray II?
See concerning inadvertant intrathecal administration.
What are the warnings of Cysto-Conray II?
SEVERE ADVERSE EVENTS – INADVERTENT INTRATHECAL ADMINISTRATION:
What are the precautions of Cysto-Conray II?
General
Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. After administration of the radiocontrast agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since delayed reactions have occurred (
).
The possibility of an idiosyncratic reaction in susceptible patients should always be considered (
). The susceptible population includes patients with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se and patients with a known clinical hypersensitivity: bronchial asthma, hay fever and food allergies.
A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is thought essential, but caution should be exercised (
). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pre-treatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.
Since these procedures require instrumentation, special precautions should be observed in those patients known to have an acute urinary tract infection.
Filling of the bladder should be done at a steady rate, exercising caution to avoid excessive pressure. Sterile procedures should be employed in administration.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential or whether this drug affects fertility in males or females.
Use in Pregnancy
Category C. Animal reproduction studies have not been conducted with Cysto-Conray II. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cysto-Conray II should be used in pregnant women only if clearly needed.
Nursing Mothers
Iothalamate salts are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, because of the potential for adverse reactions, caution should be exercised when Cysto-Conray II is administered to a nursing woman.
Information for the Patient
- Inform your physician if you are pregnant.
- Inform your physician if you are allergic to any food, drugs or dyes used for x-ray procedures ( ).
- Consult with your physician if, at some future date, any thyroid tests are planned. The iodine in this agent may interfere with later thyroid tests.
- Inform your physician about any other medications you are currently taking.
Patients receiving diagnostic agents for instillation urography should be instructed to:
Drug/Laboratory Test Interaction
Thyroid Function Tests –
3
What are the side effects of Cysto-Conray II?
Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur.
As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest.
Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection.
In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.
What should I look out for while using Cysto-Conray II?
See concerning inadvertant intrathecal administration.
What might happen if I take too much Cysto-Conray II?
Sorry No Records found
How should I store and handle Cysto-Conray II?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast.
Following instillation by sterile catheter, Cysto-Conray II provides for visualization of the lower urinary tract. Clinical literature reports indicate that routinely less than 1 percent of a retrograde urographic radiopaque is absorbed systemically, however, as much as 12 percent absorption was observed with pyelorenal back flow and may produce iodine medicated thyrotropic effects described under .
Non-Clinical Toxicology
See concerning inadvertant intrathecal administration.The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
The sedative effect of intravenous midazolam is accentuated by any concomitantly administered medication, which depresses the central nervous system, particularly narcotics (e.g., morphine, meperidine and fentanyl) and also secobarbital and droperidol. Consequently, the dosage of midazolam should be adjusted according to the type and amount of concomitant medications administered and the desired clinical response (see ).
Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. These drug interactions may result in prolonged sedation due to a decrease in plasma clearance of midazolam.
The effect of single oral doses of 800 mg cimetidine and 300 mg ranitidine on steady-state concentrations of midazolam was examined in a randomized crossover study (n=8). Cimetidine increased the mean midazolam steady-state concentration from 57 to 71 ng/mL. Ranitidine increased the mean steady-state concentration to 62 ng/mL. No change in choice reaction time or sedation index was detected after dosing with the H2 receptor antagonists.
In a placebo-controlled study, erythromycin administered as a 500 mg dose, tid, for 1 week (n=6), reduced the clearance of midazolam following a single 0.5 mg/kg IV dose. The half-life was approximately doubled.
Caution is advised when midazolam is administered to patients receiving erythromycin since this may result in a decrease in the plasma clearance of midazolam.
The effects of diltiazem (60 mg tid) and verapamil (80 mg tid) on the pharmacokinetics and pharmacodynamics of midazolam were investigated in a three-way crossover study (n=9). The half-life of midazolam increased from 5 to 7 hours when midazolam was taken in conjunction with verapamil or diltiazem. No interaction was observed in healthy subjects between midazolam and nifedipine.
In a placebo-controlled study, saquinavir administered as a 1200 mg dose, tid, for 5 days (n=12), a 56% reduction in the clearance of midazolam following a single 0.05 mg/kg IV dose was observed. The half-life was approximately doubled.
A moderate reduction in induction dosage requirements of thiopental (about 15%) has been noted following use of intramuscular midazolam hydrochloride for premedication in adults.
The intravenous administration of midazolam hydrochloride decreases the minimum alveolar concentration (MAC) of halothane required for general anesthesia. This decrease correlates with the dose of midazolam hydrochloride administered; no similar studies have been carried out in pediatric patients but there is no scientific reason to expect that pediatric patients would respond differently than adults.
Although the possibility of minor interactive effects has not been fully studied, midazolam and pancuronium have been used together in patients without noting clinically significant changes in dosage, onset or duration in adults. Midazolam hydrochloride does not protect against the characteristic circulatory changes noted after administration of succinylcholine or pancuronium and does not protect against the increased intracranial pressure noted following administration of succinylcholine. Midazolam does not cause a clinically significant change in dosage, onset or duration of a single intubating dose of succinylcholine; no similar studies have been carried out in pediatric patients but there is no scientific reason to expect that pediatric patients would respond differently than adults.
No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropine, scopolamine, glycopyrrolate, diazepam, hydroxyzine, d-tubocurarine, succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine, dyclonine HCl and Cetacaine) have been observed in adults or pediatric patients. In neonates, however, severe hypotension has been reported with concomitant administration of fentanyl. This effect has been observed in neonates on an infusion of midazolam who received a rapid injection of fentanyl and in patients on an infusion of fentanyl who have received a rapid injection of midazolam.
Caution is advised when midazolam is administered to patients receiving erythromycin since this may result in a decrease in the plasma clearance of midazolam.
Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. After administration of the radiocontrast agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since delayed reactions have occurred ( ).
The possibility of an idiosyncratic reaction in susceptible patients should always be considered ( ). The susceptible population includes patients with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se and patients with a known clinical hypersensitivity: bronchial asthma, hay fever and food allergies.
A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is thought essential, but caution should be exercised ( ). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pre-treatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.
Since these procedures require instrumentation, special precautions should be observed in those patients known to have an acute urinary tract infection.
Filling of the bladder should be done at a steady rate, exercising caution to avoid excessive pressure. Sterile procedures should be employed in administration.
Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur.
As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest.
Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection.
In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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