Diatrizoates (Local)


VA CLASSIFICATION
Primary: DX102

Commonly used brand name(s): Cystografin; Cystografin Dilute; Hypaque Sodium 20%; Hypaque Sodium 50%; Hypaque-Cysto; Hypaque-M 18%; Hypaque-M 30%; Hypaque-M 60%; Reno-M-30; Urovist Cysto; Urovist Cysto Pediatric; Urovist Sodium 300.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:

Note: Diatrizoate is an ionic radiopaque contrast agent.



Diagnostic aid, radiopaque (urinary tract disorders)—Diatrizoate Meglumine Injection; Diatrizoate Sodium Injection{01}{02};

Diagnostic aid, radiopaque (uterus and fallopian tube disorders)—Diatrizoate Meglumine Injection; Diatrizoate Sodium Injection;

Indications

Accepted

Cystourethrography, retrograde—Diatrizoate meglumine is indicated in retrograde cystourethrography to evaluate abnormalities of the urethra, bladder, and ureters; and to demonstrate the presence and extent of cystoureteric reflux. {02} {03} {06} {31}

Pyelography, retrograde—Diatrizoate meglumine and diatrizoate sodium solutions are indicated in retrograde pyelography to evaluate abnormalities of the kidneys and ureter. {06} {32} {33}

Hysterosalpingography—Diatrizoate meglumine and diatrizoate sodium are indicated for intrauterine instillation to determine the patency of the fallopian tubes and to visualize the uterine and tubal cavities for evaluation of abnormal conditions, such as tumors, of the uterus and fallopian tubes. Hysterosalpingography is used as a diagnostic tool in cases of infertility and other abnormal gynecological conditions; it serves as an adjunct to laparoscopy and ultrasound imaging in discovering subtle abnormalities, such as endometrial polyps and salpingitis isthmica nodosa. {06} {34} {36} {37} {38} {39} {40} {41} {42} {43}
—Hysterosalpingography is not recommended during the menstrual period or when menstrual flow is imminent, during pregnancy, for at least 6 months after termination of pregnancy, or for 30 days after conization or curettage. {01} {06} {37}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Diatrizoate meglumine: 809.13 {30}
    Diatrizoate sodium: 635.90

Mechanism of action/Effect:

Organic iodine compounds block x-rays as they pass through the body, thereby allowing body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. The instillation of diatrizoate into the urinary bladder, kidneys, ureters, uterus, and fallopian tubes allows visualization of these areas. {02} {03} {12} {24} {26} {31}

Absorption:

Intravesical instillation—Small amounts (less than 2%) absorbed through the bladder. {03} {06} {31}

Intrauterine instillation—Most of the medium within the uterine cavity is discharged into the vagina immediately upon termination of procedure. However, any medium retained in the uterine or peritoneal cavity is absorbed systemically within 60 minutes. May not be absorbed for up to 24 hours if tubes are obstructed and dilated. {04} {08} {34}

Protein binding:

Very low. {14} {31} {32}

Elimination:
    Absorbed diatrizoate—Eliminated unchanged through the kidneys by glomerular filtration. {03} {06} {31}
    Unabsorbed diatrizoate—Expelled by spontaneous voiding or vaginally, depending on procedure. {03} {06}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to iodine or other iodinated contrast media may be sensitive to diatrizoates also. {01} {02} {03}

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of diatrizoates have not been performed. {06}

Pregnancy/Reproduction

Pregnancy—
Diatrizoates cross the placenta and are evenly distributed in fetal tissue. Other organically bound iodine-containing preparations administered near term by intra-amniotic injection have caused hypothyroidism in some newborns. {10} {31}

Also, elective contrast radiography of the abdomen is usually not recommended during pregnancy because of the risks to the fetus from radiation exposure. {01} {02} {03}


For intravesical instillation

Studies with diatrizoates administered by intravesical instillation have not been done in humans.

Studies have not been done in animals.

FDA Pregnancy Category C. {06} {31} {32}



For intrauterine instillation

Intrauterine instillation is not recommended during pregnancy since diatrizoates may cross the placenta, or for at least 6 months after the termination of pregnancy since the procedure may increase the risk of complications such as intrauterine infection. {06} {34}


Breast-feeding

Problems in humans have not been documented. However, breast-feeding is not recommended for at least 24 hours following administration of diatrizoates, since small amounts of this medium may be absorbed and diatrizoates are known to be distributed unchanged into breast milk when administered intravascularly. {06} {32}

Pediatrics

For intravesical instillation—Appropriate studies on the relationship of age to the effects of diatrizoates have not been performed in pediatric patients. However, no pediatrics-specific problems have been documented to date. {24}

For intrauterine instillation—No information is available on the relationship of age to the effects of diatrizoates for intrauterine instillation in pediatric patients. {24}


Geriatrics


Appropriate studies on the relationship of age to the effects of diatrizoates for intrauterine or intravesical instillation have not been performed in geriatric patients. However, no geriatrics-specific problems have been documented to date. {24}

Drug interactions and/or related problems
See Diagnostic interference.

Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With results of retrograde pyelography

Due to other medications
Dyclonine    (may interfere with visualization when used as a local anesthetic in cystoscopic procedures following pyelography because of possible reaction with the iodine in diatrizoate, which may result in precipitation of iodine {07} {35})


Sodium alginate    (may interfere with visualization when used as a lubricant in retrograde pyelography because of possible reaction with diatrizoate, which may result in the formation of a white precipitate {09})

With other diagnostic test results
Thyroid function determinations and
Thyroid imaging    (absorbed diatrizoates may cause an increase of serum protein–bound iodine [PBI] and a decrease in radioactive iodine or pertechnetate ion uptake for up to 16 days; thyroid test should be performed prior to administration of contrast medium; other thyroid function tests not based on measurement of iodine, such as resin triiodothyronine uptake, are not affected {06} {32})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:

For retrograde pyelography:
» Obstruction to endoscopy or ureteral catheterization, such as in extensive urinary tuberculosis, bladder tumors, ureteral obstructions, and prostate enlargement{06}{33}
» Urinary tract infection, upper, acute    (procedure may increase risk of complications {01} {03} {06} {33})


For hysterosalpingography:
» Genital tract infection    (procedure may increase risk of complications {06} {36})


Risk-benefit should be considered when the following medical problems exist
Allergic reaction (anaphylaxis) to penicillins or to skin allergens, previous    (increased risk of anaphylactoid reaction {27})


Allergies or asthma, history of    (increased risk of idiosyncratic response or anaphylactoid reaction {01} {03} {06} {31})


» Sensitivity to iodinated contrast media    (increased risk of anaphylactoid reaction in patients with a history of anaphylactoid reaction to iodinated contrast media {27} {31})


For retrograde pyelography:
Renal function impairment, severe    (increased risk of oliguria or anuria {01} {03} {06} {33})


For hysterosalpingography:
» Pelvic inflammatory disease, acute    (condition may be aggravated {01} {03} {06} {37})


Caution is also recommended just after cervical or uterine surgery to avoid the risk of complications.{06}{36}


Side/Adverse Effects

Note: Adverse effects associated with the mechanics of retrograde genitourinary procedures include injury to the urethra, bladder, and ureter, and introduction of infection. {03} {06} {31}
Systemic adverse effects, similar to those that occur with direct intravascular injection of the diatrizoate salts, may also occur with intravesical or intraureteral instillation as a result of inadvertent intravascular entry of the contrast solution due to either bladder absorption or pyelorenal backflow. {06} {31}
Systemic adverse effects, although rare, are possible with intrauterine instillation if medium is absorbed systemically after being retained in the uterine cavity or spilled into the peritoneal cavity. {06} {34}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Pyelorenal distention (severe abdominal or stomach pain and discomfort, backache)—resulting from the instillation of an excess volume of contrast solution; renal colic and shock may follow{06}{33}

Incidence rare
    
Pseudo-allergic reaction (continuing chills, continuing fever, increased sweating, skin rash or hives, sneezing, swelling of face or skin, swelling of larynx, wheezing, tightness in chest, or troubled breathing)—may be due to entry of medium into venous or lymphatic system{09}{13}{14}{15}{23}{33}{37}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Abdominal or stomach pain and discomfort{01}{06}{34}{36}
Note: Abdominal pain and discomfort may be associated with the insertion and positioning of the instillation device. If occurring later during the procedure, may indicate spillage of contrast medium into the peritoneal cavity. {37}



Incidence less frequent
    
Chills
    
fever
    
nausea and vomiting{06}{09}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopaque Agents (Diagnostic, Local)

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Instillation into bladder or ureters; visualization of radiopacity possible with x-rays

Instillation into uterus and fallopian tubes; visualization of radiopacity possible with x-rays

Before having this test
»   Conditions affecting use, especially:
Sensitivity to iodine or other iodinated contrast media

Pregnancy—Diatrizoates cross the placenta; risk to the fetus from radiation exposure; intrauterine instillation contraindicated during pregnancy and for at least 6 months after





Breast-feeding—Small amount absorbed and distributed into breast milk; temporary discontinuation of breast-feeding for at least 24 hours is recommended
Other medical problems, especially obstruction or acute upper urinary tract infection (for retrograde pyelography); genital tract infection and acute pelvic inflammatory disease (for hysterosalpingography)

Preparation for this test
Voiding before procedure {09}

For retrograde cystourethrography and pyelography
Special diet, use of laxative, and/or other preparatory instructions may apply; patient should inquire in advance

For hysterosalpingography
Enema, vaginal douche, and/or other preparatory instructions may apply; patient should inquire in advance

Precautions after having this test
Possible interference with future thyroid tests


Side/adverse effects
Signs of potental side effects, especially pyelorenal distention or pseudo-allergic reaction


General Dosing Information
Manufacturer's package insert or other appropriate literature should be consulted for specific techniques and procedures for the administration of contrast media.

Sensitivity test doses are not usually recommended since severe or fatal reactions to contrast media are not predictable from a patient's history or a sensitivity test. On some occasions severe or fatal reactions have occurred with a test dose or with a full dose in patients who did not react to the test dose. {03} {04} {14} {31}

Pretreatment with corticosteroids and/or antihistamines is recommended to minimize the incidence and severity of reactions in patients with a history of severe reactions to contrast media or with other high-risk conditions (e.g., asthma or history of allergies, positive allergy history to skin allergens or penicillin). In some studies, the additional use of ephedrine has been shown to be beneficial in preventing anaphylactoid reactions (except in patients with a history of hypertension or cardiovascular disease). When considering the use of a contrast agent, the following protocols are recommended: {13} {14} {15} {16} {17} {18} {19} {20} {21} {22} {23} {27} {28} {29} For high-risk patients—

   • Use of a high-osmolality contrast agent plus pretreatment with a corticosteroid (oral prednisone, 50 mg administered 13 hours, 7 hours, and 1 hour before procedure) and an antihistamine (intramuscular, intravenous, or oral diphenhydramine, 50 mg administered 1 hour before procedure); or
   • Use of a low-osmolality contrast agent if pretreatment is not feasible; or
   • Use of a low-osmolality contrast agent plus corticosteroid pretreatment.
For low-risk patients—

   • Use of a high-osmolality contrast agent; or
   • Use of a high-osmolality contrast agent and corticosteroid pretreatment.


During and for at least 30 to 60 minutes after administration of contrast media, the patient should be observed for possible severe reactions; competent personnel and emergency facilities should be available during this period. {03} {31}

For retrograde cystourethrography and pyelography
A low-residue diet the day before and a laxative the night before the procedure are generally recommended. {03} {06} {33}

Diatrizoate meglumine or diatrizoate sodium labeled for retrograde cystourethrography or retrograde pyelography is not for intravascular injection. It is to be instilled, after the bladder is emptied {09} {31} {32}, directly into the bladder or ureter and renal pelvis by gravity flow, using an appropriate venoclysis set or syringe. Excessive pressure should be avoided with either method of administration. {06} {31}

Dosage and concentration of diatrizoates for intravesical instillation should be individualized and are usually in proportion to the age of the patient and the technique and equipment used. {03} {06} {31}

For hysterosalpingography
An enema and vaginal douche before the examination are optional. Patient should empty her bladder before the procedure. {34}

Diatrizoate solutions when used for hysterosalpingography are to be instilled directly into the uterus via a sterile syringe attached to a uterine cannula, or via a tubal insufflator with a salpingogram attachment. It is recommended that instillation into the uterine cavity be performed under controlled pressure with fluoroscopic monitoring. Excessive pressure and overfilling should be avoided. {04} {08} {37}

Any unabsorbed contrast medium is expelled spontaneously upon removal of the cannula. {04} {08}


Local Dosage Forms

DIATRIZOATE MEGLUMINE INJECTION USP

Usual adult and adolescent dose
Cystourethrography, retrograde
Intravesical instillation, 25 to 300 mL or more, depending on age and bladder capacity, of a solution containing the equivalent of 85 mg or 141 mg of iodine per mL. {31}

Pyelography, retrograde
Intraureteral instillation, 6 to 10 mL, up to 15 mL, of a solution containing the equivalent of 85 mg or 141 mg of iodine per mL for unilateral pyelograms. Dose may be doubled for bilateral pyelograms. {06} {09} {33}

Note: The 60% solution (containing the equivalent of 283 mg of iodine per mL) must be diluted to a 20 to 30% solution (containing the equivalent of 94 mg to 141 mg of iodine per mL, respectively) with sterile distilled water prior to use. {09}
In patients with reduced renal function, repeat retrograde pyelography is not recommended for at least 48 hours, because of the possibility of temporary oliguria or anuria. {06} {33}


Hysterosalpingography
Intrauterine instillation, up to 3 to 4 mL of a solution containing the equivalent of 283 mg of iodine per mL to fill the uterine cavity and up to an additional 3 to 4 mL to fill the Fallopian tubes, administered slowly in fractional doses of 1 mL. {06} {36}


Usual pediatric dose
Cystourethrography, retrograde
See Usual adult and adolescent dose.
Pyelography, retrograde
Intraureteral instillation, 1 to 10 mL of a solution containing the equivalent of 85 or 141 mg of iodine per mL. Dosage must be individualized by physician according to size of child. {33}
Hysterosalpingography
Dosage has not been established.




Usual geriatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


18% (180 mg per mL) of diatrizoate meglumine with 8.5% (85 mg per mL) of iodine (Rx) [Cystografin Dilute]


30% (300 mg per mL) of diatrizoate meglumine with 14.1% (141 mg per mL) of iodine (Rx) [Cystografin] [Hypaque-Cysto] [Reno-M-30 (0.3 mg propylparaben and 1 mg methylparaben, per mL)] [Urovist Cysto] [Urovist Cysto Pediatric]

Canada—


18% (180 mg per mL) of diatrizoate meglumine with 8.5% (85 mg per mL) of iodine (Rx) [Hypaque-M 18%]


30% (300 mg per mL) of diatrizoate meglumine with 14.1% (141 mg per mL) of iodine (Rx) [Hypaque-M 30%]


60% (600 mg per mL) of diatrizoate meglumine with 28.3% (283 mg per mL) of iodine (Rx) [Hypaque-M 60%]

Note: May also contain edetate disodium or edetate calcium disodium as a sequestering stabilizing agent. {02} {06}


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from light. Protect from freezing. {25}

Preparation of dosage form:
The 30% solution (containing the equivalent of 141 mg of iodine per mL) may be diluted to a 10 to 25% solution (containing the equivalent of 47 mg to 118 mg of iodine per mL, respectively) with sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection, according to the manufacturer's instructions. {03} {06} {31}

Stability:
The sterile solution of diatrizoate meglumine is clear and colorless to pale yellow; do not use if discolored. {06} {31}

Crystals may form in the solution at very cold temperatures but are readily redissolved by bringing the container of solution to room temperature and gently shaking it. {34}

Diluted solutions should be used immediately. {03}

Any unused portion remaining in the container should be discarded.


DIATRIZOATE SODIUM INJECTION USP

Usual adult and adolescent dose
Pyelography, retrograde
Intraureteral instillation, 6 to 10 mL of a solution containing the equivalent of 120 mg of iodine per mL for unilateral pyelograms. Dose may be doubled for bilateral pyelograms. {32}

Note: For patients with hydronephrosis, the dose may be increased to 20 mL or more. {02} {32}
The 50% solution (containing the equivalent of 300 mg of iodine per mL) must be diluted to a 20% solution (containing the equivalent of 120 mg of iodine per mL) with sterile distilled water prior to use. {09}
In patients with reduced renal function, repeat retrograde pyelography is not recommended for at least 48 hours, because of the possibility of temporary oliguria or anuria. {06}


Hysterosalpingography
Intrauterine instillation, up to 3 or 4 mL of a solution containing the equivalent of 300 mg of iodine per mL to fill the uterine cavity and up to an additional 3 or 4 mL to fill the fallopian tubes, administered slowly in fractional doses of 1 mL. {06} {34}


Usual pediatric dose
Pyelography, retrograde (unilateral)
Intraureteral instillation of a solution containing the equivalent of 120 mg of iodine per mL for: {32}

Children up to 1 year of age—Less than 1.5 mL.

Children 1 to 5 years of age—1.5 to 3 mL.

Children 5 years of age and over—4 to 5 mL.

Hysterosalpingography
Dosage has not been established.


Usual geriatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


20% (200 mg per mL) of diatrizoate sodium with 12% (120 mg per mL) of iodine (Rx) [Hypaque Sodium 20%]


50% (500 mg per mL) of diatrizoate sodium with 30% (300 mg per mL) of iodine (Rx) [Hypaque Sodium 50%] [Urovist Sodium 300]

Canada—


50% (500 mg per mL) of diatrizoate sodium with 30% (300 mg per mL) of iodine (Rx) [Hypaque Sodium 50%]

Note: May also contain edetate disodium or edetate calcium disodium as a sequestering stabilizing agent.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing. {25}

Stability:
The diatrizoate sodium injection is clear and pale yellow to light brown; do not use if discolored. {06}

Crystals may form in the solution at very cold temperatures but are readily redissolved by bringing the container of solution to room temperature and gently shaking it.

Any unused portion remaining in the container should be discarded.



Revised: 05/11/1995



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