Hypaque – Cysto
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Questions & Answers
Side Effects & Adverse Reactions
Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.
Ionic iodinated contrast media inhibit blood coagulation, in vitro, more than nonionic contrast media. Nonetheless, it is prudent to avoid prolonged contact of blood with syringes containing ionic contrast media.
Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringe in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.
Serious or fatal reactions have been associated with the vascular entry of radiopaque media. It is important that a course of action be carefully planned in advance for the treatment of possible serious reactions.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
HYPAQUE-CYSTO is indicated for retrograde cystourethrography in adult and pediatric patients.
History
There is currently no drug history available for this drug.
Other Information
HYPAQUE-CYSTO, brand of diatrizoate meglumine, is a water-soluble radiopaque diagnostic medium. It is a triiodinated benzoic acid derivative. It is constituted as a radiopaque iodinated anion (diatrizoate) and a radiolucent cation (meglumine). It is a colorless, microcrystalline solid which is readily soluble in water.
HYPAQUE-CYSTO is a sterile aqueous solution containing 30 g (w/v) of the meglumine salt of diatrizoic acid per 100 mL aqueous solution. The sterile solution is clear and colorless to pale yellow. The pH is adjusted between 6.5 and 7.7 with hydrochloric acid, or diatrizoic acid, or meglumine. It does not contain an antibacterial preservative. It is relatively thermostable and may be autoclaved. Edetate calcium disodium 1:10,000 has been added as a sequestering stabilizing agent. Each 1 mL contains approximately 141 mg of organically bound iodine.
It has an osmolality of 633 mosm/kg (determined by VPO) and is hypertonic to blood.
The viscosity of the solution is 1.94 cp at 25°C and 1.42 cp at 37°C.
HYPAQUE-CYSTO is a 30 percent solution of 1-Deoxy-l (methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodobenzoate (C11H9I3N2O4 • C7H17NO5) with a molecular weight of 809.13, and has the following structural formula:
Sources
Hypaque – Cysto Manufacturers
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Amersham Health Inc.
![Hypaque – Cysto (Diatrizoate Meglumine) Injection, Solution [Amersham Health Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hypaque – Cysto | Amersham Health Inc.
After the bladder is emptied, HYPAQUE-CYSTO is gently instilled without force, often beyond the first desire to micturate, but not beyond the point of urgency or mild discomfort. The volume required to fill the bladder to slightly less than capacity may vary from patient to patient.
Bladder capacity in normal adults is generally 200 mL to 300 mL, and rarely, up to 600 mL. Capacity at birth is 20 mL to 50 mL, and increases about 400 percent in the first year. In children 3 to 5 years old, bladder capacity is 150 mL to 180 mL. In children older than 8 years, it is in the low adult range.
In disease, bladder capacity in adults may vary from 50 mL in a hypertonic reflex bladder to over 1000 mL in an atonic or sensory paralytic bladder or chronic lower urinary tract obstruction.
Repeat examination may be required to detect reflux, or in function studies.
The concentration varies with technique and equipment used. HYPAQUE-CYSTO may be diluted with sterile water or 5 percent dextrose solution, as indicated in the following table. A 10 percent solution is isotonic.
STANDARD PACKAGE (250 mL of HYPAQUE-CYSTO in 500 mL bottle) TO MAKE ADD FINAL SOLUTION CONTAINS Final conc. Final volume Sterile water or 5% dextrose solution Iodine 30% 250 mL _ 141 mg/mL 25% 300 mL 50 mL 118 mg/mL 21.4% 350 mL 100 mL 101 mg/mL 20% 375 mL 125 mL 94 mg/mL 18.8% 400 mL 150 mL 88 mg/mL 16.7% 450 mL 200 mL 78 mg/mL 15% 500 mL 250 mL 71 mg/mLNote: To achieve the following concentrations some of the contrast agent must be removed prior to dilution.
TO MAKE REMOVE ADD FINAL SOLUTION CONTAINS Final conc. Final volume Sterile water or 5% dextrose solution Iodine 12% 500 mL 50 mL 300 mL 56 mg/mL 12% 375 mL 100 mL 225 mL 56 mg/mL 10% 450 mL 100 mL 300 mL 47 mg/mLDilution and withdrawal of the contrast agent should be accomplished under aseptic conditions with sterile syringes. The solution should be inspected visually for particulate matter and discoloration prior to administration.
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