Basic Info.
Application
Contrast Agent
Suitable for
Children, Adult
Pharmaceutical Technology
Chemical Synthesis
Drug Reg./Approval No.
H10970327
Strength
17.5g/50ml/Vial/Box
Description
Colorless to Pale-Yellow Clear Solution
Administration
Intravascular, Under Arachnoid, Body Cavity
Transport Package
Carton Packaging
Specification
50ml: 17.5g
Product Description
Drug NamesGeneric name: Iohexol.
Composition The major active ingredient is Iohexol. Its Chemical Name is N, N' - Bis(2,3-2-dihydroxypropyl)-5-[N-(2,3-
dihydroxypropyl) acetylamino]-2,4,6- Triiodo-1,3- phthalamide
Molecular formula: C19H26I3N3O9
Molecular weight: 821.14
Description
The product is colorless to pale-yellow clear solution.
Clinical Pharmacology
Pharmacology:
Mechanism of action/Effect:
Iohexol Injection is provided as a commonly used contrast agent for X-ray and CT examination, applicable for intravascular,
intraspinal and body cavity use.
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. After intrathecal
administration into the subarachnoid space, diffusion of iohexol in the CSF allows the visualization of the subarachnoid spaces of the
head and spinal canal. After intravascular administration, iohexol makes opaque those vessels in its path of flow, allowing
visualization of the internal structures until significant hemodilution occurs.
Pharmacokinetics:
After Intrathecal, Iohexol diffuses upward through the CSF; penetrates into nerve root sleeves, nerve rootlets, and narrow areas of
the subarachnoid space. Also, enters extracellular fluid of the brain tissue and pial surface of cerebral and cerebellar tissue adjacent
to subarachnoid areas. In patients with normal CSF dynamics, it is eliminated from CSF into the blood within several hours.
After intravascular, Iohexol was rapidly distributed throughout extracellular fluid following intravenous administration. No significant
deposition in tissues. Does not cross blood-brain barrier, but accumulates within the interstitial tissues of malignant tumors of the
brain due to the break in the blood-brain barrier caused by the tumor.
After intravascular, Plasma Cmax attained Immediately, but concentration falls rapidly as iohexol is distributed throughout the
extravascular compartment.
Following intravascular use, 90% or more of iohexol is eliminated unchanged in the urine within 24 hours. An elimination half-life of
approximately 2 hours in patients with normal renal function has been reported. Protein binding in blood is reported to be very low, is
less than 2%. In patients with impaired renal function, the elimination of iohexol is prolonged depending upon the degree of
impairment, thus, resulting in prolonged plasma iohexol levels. Excretion through the gallbladder and into the small intestine may
increase.
Time to peak opacification depended on the manner and where was take X.
Standard myelography: Immediate and for up to 30 minutes.
CT myelography: Thoracic region: 1 hour, Cervical region: 2 hours, Basal cisterns: 3 to 4 hours, Ventricles and sulci: 5 to 6 hours,
Arteriography: Immediate, Urography: 5 to 15 minutes.
Indication
1. Intravascular administration
Iohexol Injection is clinically applicable for adults' and children' s urography and angiocardiography, adults' brain angiography,
periphery and various kinds of arteriography, phlebography, digital subtraction radiography and CT enhancement scanning.
2. Under arachnoid administration
Iohexol Injection is applicable for adults' and children' s myelography, cistern CT scanning examinations after under arachnoid
injection.
3. Body cavity administration
Iohexol Injection is applicable for various kinds of body cavity examinations, including oral taking, such as arthrography; endoscopicretrograde cholangiopancreatography (ERCP); herniography; urography; hysterosalpingography uterosalpingography; sialography as
well as all gastrointestinal examination with orally taken water-soluble contrast agent.
Dosage and Administration
1. Reference dosage chart for intravascular administrationApplication Item | Concentration | Dosage | Notes |
Urography Adults Children >7kg <7kg | 300mgI/ml or 350mgI/ml 240mgI/ml or 300mgI/ml 240mgI/ml or 300mgI/ml | 40 ~ 80ml 40 ~ 80ml 4ml/kg 3ml/kg 3ml/kg 2ml/kg(Max.40ml ) | In case of large dosage urethrography, relatively high-concentration contrast agent can be applied. |
Arteriography Aorta and angiography Selectivity arteriography of cerebral arteries Aortic angiography Arteriography of extremities Other arteriography Phlebography (extremities) | 300mgI/ml 300mgI/ml 350mgI/ml 300mgI/ml or 350mgI/ml 300mgI/ml 240mgI/ml or 300mgI/ml | 30 ~ 40ml per injection 5 ~ 10ml per injection 40 ~ 60ml per injection Depends on the check item 20 ~ 100ml (extremities) | |
Angiocardiography Adults Left ventricle aortic root injection Selectivity coronary arteriography Children | 350mgI/ml 350mgI/ml 300mgI/ml or 350mgI/ml | 30 ~ 60ml per injection 4 ~ 8ml per injection Depends on age, weight and entity (Max. 8ml/kg) | |
Digital substraction radiography Intraarterial injection | 140mgI/ml or 240mgI/ml or 300mgI/ml 300mgI/ml or 350mgI/ml | 1 ~ 15ml per injection 1 ~ 15m per injection 1 ~ 15ml per injection 20 ~ 60ml per injection 20 ~ 60ml per injection | Depends on the opacification position |
CT enhancement scanning | 140mgI/ml or 240mgI/ml or 300mgI/ml or 350mgI/ml | 100 ~ 400ml 100 ~ 250ml 100 ~ 200ml 100 ~ 150ml | The total iodine usually is 30-60g; low concentration contrast agent is suitable for intravenous drip, high concentration contrast agent is suitable for quick intravenous infusion. Dosage shall be discounted for children. |
2. Under arachnoid administration
The dosage and concentration will depend on the type of examination, employed technique and the size of cavitas
subarachnoidealis.
Lumbar puncture is the general injection method, which is performed between the 3rd and 4th internode of the lumbar (lumbar and
chest myelography), or side cervical puncture, which is performed between the 1rt and 2ed internode of the cervical vertebra
(cervical myelography).
When the lumbar puncture is performed for cervical myelography, the patient shall be laid down with great caution, so as to prevent
massive high-concentration contrast agent entering the brain.
To reduce the mixture between contrast agent and cerebrospinal fluid, the injection shall be performed within 1 to 2 minutes. The
dosage of contrast agent is shown in the table below.
Reference dosage chart for contrast agent Application Item
| Concentration
| Dosage
|
Lumbar and chest myelography
(Lumbar puncture)
Cervical myelography
(Lumbar puncture)
Cervical myelography
(Cervical side puncture)
CT ventriculography
(Lumbar puncture)
| 180mgI/ml
or 240mgI/ml
240mgI/ml
or 300mgI/ml
240mgI/ml
or 300mgI/ml
180mgI/ml
or 240mgI/ml
| 10 ~ 15ml
8 ~ 12ml
10 ~ 12ml
7 ~ 10ml
6 ~ 10ml
6 ~ 8ml
5 ~ 15ml
4 ~ 12ml
|
Pediatric myelography
< 2 years' old
Between 2 and 6 years' old
> 6 year' s old
| 180mgI/ml
180mgI/ml
180mgI/m
| 2 ~ 6ml
4 ~ 8ml
6 ~ 12ml
|
The total iodine shall not exceed 3g so as to reduce the possibility of adverse reactions.
3. Body cavity administration
Reference dosage chart for contrast agent Application Item
| Concentration
| Dosage
|
Arthrography
| 240mgI/ml
or 300mgI/ml
or 350mgI/ml
| 5 ~ 20ml
5 ~ 15ml
5 ~ 10ml
|
Endoscopic retrograde pancreatography
/cholangiography and combined
cholangiopancreatography
| 240mgI/ml
| 20 ~ 50ml
|
Herniography
| 240mgI/ml
| 50ml
|
Hysterosalpingography
uterosalpingography
| 240mgI/ml
or 300mgI/ml
| 15 ~ 50ml
15 ~ 25ml
|
Sialography
| 240mgI/ml
or 300mgI/ml
| 0.5 ~ 2ml
0.5 ~ 2ml
|
Gastrointestinal examination
(taken orally)
| 180mgI/ml
or 350mgI/ml
| 10 ~ 200ml
10 ~ 200ml
|
Contraindications
1. Patients with evident disorder of thyroid gland.
2. Patients with a history of severe reaction to Iohexol Injection.
3. Patients with a history of epilepsy shall not be applied with Iohexol in cavitas subarachnoidealis.
4. Lumbar puncture should not be performed in the presence of significant local or systemic infection where bacteremia is likely.
5. Respecting that the contact of radioactive ray shall be avoid as far as possible in gestation period, so the advantages and
disadvantages of X-ray examination shall be considered with caution. Use in pregnant women shall be prohibited except the doctors
believe it is necessary.
6. Because of the possibility of overdosage, immediate repeat myelography in the event of technical failure is contraindicated.
Adverse Reactions
1. A few patients may have slight reactions, such as transient sensation of heat, slight pain, blush, nausea/vomiting, slight chest pain, itch
of skin and bastard measles.
2. Headache, nausea and vomiting are the most frequent adverse reactions following myelography. Severe headache lasting for several
days may occur intermittently. Other slight adverse reactions occurred so far including transient dizziness, backache, neckache or pain of
extremities as well as various kinds of paresthesia. There has been indefinite transient change demonstrated by electroencephalogram
records (slow wave). Aseptic meningitis has been reported after myelography with water-soluble contrast agent. There were also reports
on similar cases involving myelography with Iohexol Injection, but it is much slight with transient duration.
3. There were reports about tardive adverse reactions occurred several hours or several days after opacification.
4. Severe adverse reactions occurred scarcely, but shock, convulsion, coma, severe laryngeal edema, bronchial spasm, renal failure and
death have also been reported. According to 300,000 cases gathered by Japanese Professor Katayama, the incidence of slight adverse
reactions of non-ion contrast agent (including Iohexol) is about 3.08 percent, the medium adverse reactions incidence 0.04 percent and
the severe adverse reactions incidence 0.004 percent.
Keep your doctor informed of adverse reaction, which occur in during course of treatment.
Drug interaction
1. Patients with diabetes who take antidiabetic (Metformin) may lead to lactic acidosis, because of application of contrast agent may lead
to transient renal inadequacy. To prevent beforehand, patients shall stop taking biguanides hypoglycemic agent 48 hours before
application of contrast agent, and it shall not be resumed until the renal function is stable.
2. There is growing danger of delayed reaction for patients who have been treated with interleukin-2 within two weeks (common cold liked
syndrome and skin reaction)
3. All iodine-containing contrast agents may interfere the examination of thyroid function. The iodine combination ability of thyroid tissue
may be reduced influenced by the agent and the recovery may need several days or even two weeks.
4. High-concentration contrast agent in serum and urine will affect the lab determination results of bilirubin, albumen or minerals (such as
iron, copper, calcium and phosphor). Such examinations shall not be taken in the same day of applying contrast agent.
OverdoseClinical consequences of overdosage with Iohexol Injection have not been reported.
Strength(1)17.5g(I)/50ml (2)35g(I)/100ml
StorageStore below 30ºC. Preserve in well-closed containers and protect from light
Shelf life24 months
Manufacturer
Name: Yangtze River Pharmaceutical (Group) Co., Ltd.
Address: 1 South Yangtze River Road, Taizhou, Jiangsu, China
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