Sensodyne Repair And Protect
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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 inadvertently administered intrathecally.
The possibility exists for inadvertent administration into the intrathecal space during epidural administrations. Therefore, epidural administration procedures, such as pain management catheter placement, should not be performed with use of this product.
Administration of radiopaque materials to patients known or suspected to have pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure and measures for treatment of a hypertensive crisis should be available.
Contrast media have been shown to promote the phenomenon of sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra-arterially.
Since iodine-containing contrast agents may alter the results of thyroid function tests, such tests, if indicated, should be performed prior to the administration of this preparation.
A history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of iodipamide meglumine, but calls for extreme caution in administration.
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
Cholografin Meglumine is indicated for intravenous cholangiography and cholecystography as follows: (a) visualization of the gallbladder and biliary ducts in the differential diagnosis of acute abdominal conditions, (b) visualization of the biliary ducts, especially in patients with symptoms after cholecystectomy, and (c) visualization of the gallbladder in patients unable to take oral contrast media or to absorb contrast media from the gastrointestinal tract.
History
There is currently no drug history available for this drug.
Other Information
Cholografin Meglumine (lodipamide Meglumine Injection 52%) is a radiopaque contrast agent for rapid intravenous cholangiography and cholecystography supplied as a sterile, aqueous solution. Each mL provides 520 mg iodipamide meglumine; at manufacture, 3.2 mg sodium citrate buffer and 0.4 mg edetate disodium sequestering agent are added per mL. The pH has been adjusted between 6.5 and 7.7 with meglumine and iodipamide. Each mL of solution also contains approximately 0.91 mg (0.039 mEq) sodium [18.2 mg/20 mL] and 257 mg organically bound iodine (5.2 g/20 mL). At the time of manufacture, the air in the container is replaced by nitrogen.
The appearance of the solution may vary from essentially colorless to light amber. Solutions which have become substantially darker, however, should not be used.
Sources
Sensodyne Repair And Protect Manufacturers
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Glaxosmithkline Consumer Healthcare Lp
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Sensodyne Repair And Protect | Bracco Diagnostics Inc
Cholografin Meglumine (lodipamide Meglumine Injection USP 52%) is for intravenous use only.
Directions For UsePreparation of the Patient: For best results, the usual preliminary measures for cholecystography are recommended, particularly in cholecystectomized patients, i.e., a low residue diet on the day before examination and administration of castor oil the night before or neostigmine at the time of examination to dispel excess intestinal gas. Cholecystography is preferably carried out in the morning with the patient fasting.
Dose: The usual adult dose is 20 mL. For infants and children, the suggested dose is 0.3 to 0.6 mL/kg of body weight; the dosage for infants and children should not exceed 20 mL.
Note: The dose should not be repeated for 24 hours.
Administration: After warming to body temperature, Cholografin Meglumine should be given by slow intravenous injection, following the usual precautions of intravenous administration. It is important that the preparation be injected slowly over a period of 10 minutes. Use of a narrow bore hypodermic needle will ensure a slow rate of injection. During the injection, the patient should be watched for untoward reactions such as a feeling of warmth, flushing and occasionally nausea. Nausea indicates that the injection rate is too rapid.
Radiography: A scout film should be exposed routinely before the intravenous injection is made.
Position of the Patient: With the patient prone and the right side elevated, radiographs are made in the posterior-anterior projection. Some radiologists prefer the supine position with the left side elevated. Serial 10-minute exposures should be started 10 minutes after the injection is made and continued until optimal visualization of the biliary ducts is obtained. Wet films should be examined immediately by the radiologist. In some cases a 15-degree rotation or the upright position may prove helpful. Depending on the situation revealed by the roentgenograms in which the duct is first seen, the position of the subject should be changed to displace the shadow of the common bile duct from that of the spine. Tomography is a useful technique for enhancing bile duct visualization after administration of the radiopaque medium.
Examination of the gallbladder should be started about two hours after administration. The standard positions in routine examination of the gallbladder should be used unless otherwise indicated. There is no need for the patient to remain quiet awaiting the time for the gallbladder film to be exposed. Moderate activity on the part of the patient will, in most cases, preclude “stratification” of the contrast agent in the gallbladder. If the contrast medium should stratify in the gallbladder, decubitus as well as upright films should be obtained. Additional exposures may be made after the ingestion of a fatty meal.
If visualization is not achieved after two and one-half hours, the patient should be returned for a 24-hour film, whenever possible. Occasionally, delayed opacification of the gallbladder will occur in 24 hours.
In infants and children, gallbladder visualization may be expected to occur 30 minutes to four hours after administration.
Note: In the presence of liver disease (BSP retention greater than 30 to 40 percent), the contrast medium is not excreted efficiently by the liver and visualization is usually not achieved. Visualization is rarely achieved in the presence of a serum bilirubin of 3.0 mg per 100 mL if the elevated bilirubin level is due to mechanical obstruction or hepatocellular damage. In the presence of severe liver damage, the contrast agent is excreted by the kidneys.
Interpretation: When intravenous cholecystography and cholangiography are used as an aid in the differential diagnosis of acute abdominal conditions, visualization of the gallbladder is considered strong evidence against a diagnosis of acute cholecystitis, while nonvisualization of the gallbladder two and one-half hours after administration with visualization of the bile ducts is considered strong evidence in favor of a diagnosis of acute cholecystitis (if the bile ducts are only faintly visualized, gallbladder films four hours after administration may occasionally show visualization of the gallbladder). When neither the bile ducts nor the gallbladder is visualized, the study provides no definitive information with regard to determining the presence or absence of acute cholecystitis.
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