INDIVIDUAL INDICATIONS AND USAGE
Oral Use
Adults
OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL is indicated in adults for use in oral pass-thru examination of the gastrointestinal tract. OMNIPAQUE diluted to concentrations from 6 mg Iodine/mL to 9 mg Iodine/mL administered orally in conjunction with OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL administered intravenously are indicated in adults for use in contrast enhanced computed tomography of the abdomen. Dilute oral plus intravenous OMNIPAQUE may be useful when unenhanced imaging does not provide sufficient delineation between normal loops of the bowel and adjacent organs or areas of suspected pathology.
Pediatric patients
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL administered orally or rectally is indicated in pediatric patients for use in examination of the gastrointestinal tract. OMNIPAQUE diluted to concentrations from 9 mg Iodine/mL to 21 mg Iodine/mL administered orally in conjunction with OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL administered intravenously are indicated in pediatric patients for use in contrast enhanced computed tomography of the abdomen.
Precautions
See PRECAUTIONSGeneral.
Adverse Reactions
Oral administration of OMNIPAQUE is most often associated with mild, transient diarrhea especially when high concentrations and large volumes are administered. Nausea, vomiting, and moderate diarrhea have also been reported following orally administered OMNIPAQUE, but much less frequently. For CT examinations using dilute oral plus intravenous contrast medium, adverse events are more likely to be associated with the intravenous injection than the hypotonic oral solution. It should be noted that serious or anaphylactoid reactions that may occur with intravascular iodinated media are possible following administration by other routes.
Adults
In controlled clinical trials involving 54 adult patients for oral pass-thru examination of the gastrointestinal tract using OMNIPAQUE 350, the following adverse reactions were reported:
diarrhea (42%), nausea (15%), vomiting (11%), abdominal pain (7%), flatulence (2%), and headache (2%). In controlled clinical studies involving 44 adult patients for dilute oral plus intravenous CT examination of the gastrointestinal tract using OMNIPAQUE 300, adverse reactions were limited to a single report of vomiting (2%).
Pediatric patients
In controlled clinical studies involving 58 pediatric patients for examination of the gastrointestinal tract at a concentration of 300 mg Iodine/mL, the following adverse reactions were reported: diarrhea (36%), vomiting (9%), nausea (5%), fever (5%), hypotension (2%), abdominal pain (2%), and urticaria (2%). In clinical studies an increased frequency and severity of diarrhea was noted with an increase in the administered concentration and dose of the radiocontrast agent. In controlled clinical studies involving 69 pediatric patients for dilute oral plus intravenous CT examination of the gastrointestinal tract using OMNIPAQUE 300, adverse reactions were limited to a single report of vomiting (1.4%).
Dosage and Administration
Adults
The recommended dosage of undiluted OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL for oral pass-thru examination of the gastrointestinal tract in adults is 50 mL to 100 mL depending on the nature of the examination and the size of the patient. The recommended oral dosage of OMNIPAQUE diluted to concentrations of 6 mg Iodine/mL to 9 mg Iodine/mL for contrast enhanced computed tomography of the abdomen in adults is 500 mL to 1000 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). In conjunction with dilute oral administration, the recommended dosage of OMNIPAQUE 300
intravenously is 100 mL to 150 mL. The oral dose is administered about 20 to 40 minutes prior to the intravenous dose and image acquisition.
Pediatric Patients
The dosage of undiluted OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL, is dependent on the nature of the examination and the size of the patient. Based on clinical experience, it is recommended that OMNIPAQUE 180 (available in single use vials), be used in pediatric patients less than 3 months of age. OMNIPAQUE 300 may be used in pediatric patients 3 months of age and older.
The following dosage guidelines are recommended:
Age
Volume of OMNIPAQUE
Less than 3 months
5
30 mL
Three months to 3 years
Up to 60 mL
Four years to 10 years
Up to 80 mL
Greater than 10 years
Up to 100 mL
When given rectally, larger volumes may be used.
The recommended oral dosage of OMNIPAQUE diluted to concentrations of 9 mg Iodine/mL to 21 mg Iodine/mL for contrast
computed tomography of the abdomen in pediatric patients is 180 mL to 750 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). The total oral dose in grams of iodine should generally not exceed 5 g Iodine for pediatric patients under 3 years of age and 10 g Iodine for pediatric patients from 3 to 18 years of age. The oral dosage may be given all at once or over a period of 30 to 45 minutes if there is difficulty in consuming the required volume. In conjunction with dilute oral administration the recommended dosage of OMNIPAQUE 300 is 2mL/kg when administered intravenously with a range of 1 mL/kg to 2 mL/kg. Dosage pediatric patients should be administered in proportion to age and body weight. The total intravenously administered dose should not exceed 3 mL/kg. The oral dose is administered about 30 to 60 minutes prior to the intravenous dose and image acquisition.
OMNIPAQUE may be diluted with water or beverage as follows:
To Achieve
Add
To
One Liter of Contrast Medium at A Final Concentration(mg Iodine/mL) of
Stock Concentration of OMNIPAQUE(mg Iodine/mL)
Volume(mL)
Water, Carbonated Beverage, Milk, or Juice(mL)
6
300
20
980
350
17
983
9
300
30
970
350
26
974
12
300
40
960
350
35
965
15
300
50
950
350
43
957
18
300
60
940
350
52
948
21
300
70
930
350
60
940
Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.
VOIDING CYSTOURETHROGRAPHY (VCU)
OMNIPAQUE diluted to concentrations from 50 mg Iodine/mL to 100 mg Iodine/mL is indicated in pediatric patients for voiding cystourethrography. VCUs are often performed in conjunction with excretory urography.
Precautions
See PRECAUTIONSGeneral.
Since the VCU procedure requires 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 are essential.
Adverse Reactions
See ADVERSE REACTIONSGeneral.
Dosage and Administration
OMNIPAQUE may be diluted, utilizing aseptic technique, with Sterile Water for Injection to a concentration of 50 mg Iodine/mL to 100 mg Iodine/mL for voiding cystourethrography. The concentration may vary depending upon the patient's size and age and also with the technique and equipment used. Sufficient volume of contrast medium should be administered to adequately fill the bladder. The usual volume ranges from 50 mL to 300 mL of OMNIPAQUE at a concentration of 100 mg Iodine/mL and 50 mL to 600 mL of OMNIPAQUE at a concentration of 50 mg Iodine/mL.
OMNIPAQUE may be diluted with Sterile Water for Injection as indicated in the table below:
To Achieve
Add To
A Final Concentration
Each 100 mL of OMNIPAQUE Sterile Water for Injection, USP (mL)
(mg Iodine/mL)
OMNIPAQUE 300
OMNIPAQUE 350
100
200
250
90
233
289
80
275
338
70
330
400
60
400
483
50
500
600
Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.
ARTHROGRAPHY
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL or OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL is indicated in radiography of the knee joint in adults, and OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL is indicated in radiography of the shoulder joint in adults, and OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL is indicated in radiography of the temporomandibular joint in adults. Arthrography may be helpful in the diagnosis of posttraumatic or degenerative joint diseases, synovial rupture, the visualization of communicating bursae or cysts, and in meniscography.
Precautions
See PRECAUTIONSGeneral.
Strict aseptic technique is required to prevent infection. Fluoroscopic control should be used to ensure proper needle placement, prevent extracapsular injection, and prevent dilution of contrast medium. Undue pressure should not be exerted during injection.
Adverse Reactions
Injection of OMNIPAQUE into the joint is associated with transient discomfort, ie, pain, swelling. However, delayed, severe or persistent discomfort may occur occasionally. Severe pain may often result from undue use of pressure or the injection of large volumes. Joint swelling after injection is less with OMNIPAQUE than with high osmolar ionic contrast medium. These types of reactions are generally procedurally dependent and of greater frequency when double-contrast technique is employed.
Nervous system: Swelling sensation (42%), pain (29%), heat sensation (13%), and muscle weakness (0.7%).
Skin and appendages: Hematoma at injection site (0.7%).
Dosage and Administration
Arthrography is usually performed under local anesthesia. The amount of OMNIPAQUE injected is dependent on the size of the joint to be examined and the technique employed. Lower volumes of contrast medium are usually injected for knee and shoulder arthrography when double-contrast examinations using 15 mL to 100 mL of air are performed.
The following concentrations and volumes are recommended for normal adult knee, shoulder, and temporomandibular joints but should serve as guidelines since joints may require more or less contrast medium for optimal visualization.
KNEE
OMNIPAQUE 3005 mL to 15 mLOMNIPAQUE 3505 mL to 10 mL
Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations.
SHOULDER
OMNIPAQUE 30010 mL
TEMPOROMANDIBULAR
OMNIPAQUE 3000.5 mL to 1 mL
Passive or active manipulation is used to disperse the medium throughout the joint space.
Figure
HYSTEROSALPINGOGRAPHY
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL is indicated in radiography of the internal group of adult female reproductive organs; ovaries, fallopian tubes, uterus, and vagina. Hysterosalpingography is utilized as a diagnostic and therapeutic modality in the treatment of infertility and other abnormal gynecological conditions.
Contraindications
OMNIPAQUE 300 for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent , within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm.
Adverse Reactions
Injection of OMNIPAQUE for hysterosalpingography is associated with immediate, transient pain. Monitor injection pressure and volume instilled to minimize pain and to avoid disruptive distention of the uterus and fallopian tubes. Fluoroscopic monitoring is recommended. Nervous system: Pain (49%), somnolence and fever each with an individual incidence of 3%. Gastrointestinal system: Nausea (3%).
Dosage and Administration
The recommended dosage of OMNIPAQUE 300 is 15 mL to 20 mL but will vary depending on individual anatomy and/or disease state.