Omnipack
Omnipak: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Omnipaque
ATX code: V08AB02
Active ingredient: iohexol (iohexol)
Manufacturer: GE HEALTHCARE IRELAND (Ireland)
Description and photo update: 2019-26-08
Prices in pharmacies: from 7036 rubles.
Buy
Omnipak is a radiopaque non-ionic triiodinated drug.
Release form and composition
Dosage form of Omnipak - solution for injection: transparent, colorless or yellowish liquid (140 mg each: in glass bottles - 50 ml each, in a cardboard box 10 pcs., 200 ml each, in a cardboard box 6 pcs.; in polypropylene bottles, 50 ml, in a cardboard box 10 pcs.; 180 mg each: in glass or propylene bottles of 10, 15 or 50 ml, in a cardboard box 10 pcs.; 240 mg each: in glass bottles - in a cardboard box 10 pcs. 10 ml each and 50 ml, 6 pcs. 20 ml and 200 ml, 6 or 25 pcs. 20 ml; in polypropylene bottles of 10 ml, 20 ml or 50 ml, in a cardboard box 10 pcs.; 300 mg each: in glass bottles - in a cardboard box 10 pcs. 10 ml each, 6 or 25 pcs. 20 ml each, 6 or 10 pcs. 100 ml each or 10 pcs. 50 ml each; in polypropylene bottles of 10, 20, 40, 50, 100 or 200 ml, in a cardboard box 10 pcs.; 350 mg each: in glass bottles - in a cardboard box 10 pcs.10 ml, 6 or 25 pcs. 20 ml, 10 pcs. 50 ml, 10 pcs. 100 ml or 6 pcs. 200 ml each; in polypropylene bottles of 20, 40, 50, 100 or 200 ml, in a cardboard box 10 pcs.).
The active substance of Omnipak is iohexol (INN), its content in 1 ml of solution depends on the concentration of iodine in the preparation:
- 302 mg with 140 mg iodine in 1 ml;
- 388 mg with 180 mg of iodine in 1 ml;
- 518 mg at 240 mg of iodine in 1 ml;
- 647 mg at 300 mg of iodine in 1 ml;
- 755 mg at 350 mg of iodine in 1 ml.
Auxiliary components: sodium-calcium edetate (EDTA), hydrochloric acid, trometamol, water for injection.
Pharmacological properties
Pharmacodynamics
The active component of Omnipak - iohexol - is a non-ionic, monomeric, triiodinated, water-soluble radiopaque contrast agent with a pH of 6.8–7.6.
Osmolarity values (Osm / kg Н 2 O at 37 ° С) and viscosity (mPa s) of the preparation depending on the iodine concentration:
- 140 mg iodine / ml: osmolarity - 0.29, viscosity - 2.3 (20 ° C), 1.5 (37 ° C);
- 180 mg iodine / ml: osmolarity - 0.36, viscosity - 3.2 (20 ° C), 2 (37 ° C);
- 240 mg iodine / ml: osmolarity - 0.51, viscosity - 5.6 (20 ° C), 3.3 (37 ° C);
- 300 mg iodine / ml: osmolarity - 0.64, viscosity - 11.6 (20 ° C), 6.1 (37 ° C);
- 350 mg iodine / ml: osmolarity - 0.78, viscosity - 23.3 (20 ° C), 10.6 (37 ° C).
With conventional myelography, the maximum radiopacity is achieved within 30 minutes (after 1 hour it is no longer visualized).
In the case of computed tomography, contrast visualization is possible in the thoracic region for 1 hour, in the cervical region - within 2 hours, in the basal cisterns - within 3-4 hours.
Contrasting of the bladder, bile and pancreatic ducts, articular cavities, fallopian tubes, uterine cavity, peritoneal protrusions is achieved immediately after injection.
Pharmacokinetics
After intravenous administration, iohexol is noted immediately. Distributed in the extracellular fluid. It rapidly accumulates in the kidneys: the contrasting of the renal passage begins within 1 min after the administration of Omnipak, and reaches the optimal level in 5–15 min.
In urine, the maximum concentration is determined approximately 1 hour after administration of the drug. No metabolites were found. The plasma protein binding of iohexol is too low (<2%) to be of clinical significance, and therefore not taken into account. The drug crosses the placental barrier by simple diffusion. Does not penetrate the blood-brain barrier if it is not damaged.
Iohexol is excreted (about 90%) by glomerular filtration unchanged (provided that the kidneys function normally) within 24 hours.
The half-life (T ½) in patients with normal renal function in the initial phase is about 20 minutes, the extra- and intravascular concentrations equalize within 10 minutes, then the concentration decreases exponentially with T ½ of about 2 hours.
Renal clearance is 120 min, total clearance is 131 ml / min, volume of distribution is 165 ml / kg.
With the intrathecal administration of Omnipaque, iohexol is absorbed from the cerebrospinal fluid into the bloodstream. It is completely excreted unchanged by the kidneys (approximately 88% on the first day). The total clearance is 109 ml / min, the renal clearance is 99 ml / min. The volume of distribution is 157 ml / kg. The maximum concentration in the blood, which is 119 μg / ml, is reached within 2-6 hours. The half-life is 3-4 hours.
When Omnipak is taken orally, iohexol increases the visualization of the gastrointestinal tract and is almost not absorbed. Its absorption increases significantly with intestinal obstruction or intestinal perforation. The kidneys excrete 0.1–0.5% of the drug dose.
Indications for use
According to the instructions, Omnipak is prescribed for adults and children before carrying out the following diagnostic tests:
- Computed tomography (CT) - for contrast enhancement;
- Cardioangiography, urography, arteriography, phlebography;
- Myelography of the lumbar, thoracic and cervical spine;
- CT cisternography with subarachnoid administration;
- Arthrography, endoscopic retrograde pancreatography (ERPT), endoscopic retrograde cholangiopancreatography (ERCP), salpingography, sialography;
- Studies of the gastrointestinal tract.
Contraindications
- Severe thyrotoxicosis;
- Infectious pathologies of local or systemic etiology;
- Pregnancy period;
- Cerebral infections, epilepsy - for subarachnoid administration;
- Intrathecal re-introduction immediately after failed myelography;
- Hypersensitivity to drug components.
Omnipak should be used with caution in patients with a history of adverse reactions (including bronchospasm, allergies) to the use of iodine-containing contrast agents, with pheochromocytoma, pulmonary hypertension, decompensated pathologies of the cardiovascular system, bronchial asthma, myeloma, macroglobulinemia, food pollidenstreum allergies, dehydration, liver failure, multiple sclerosis, thromboangiitis obliterans (Buerger's disease), acute cerebral pathologies, brain tumors, epilepsy, severe atherosclerosis, sickle cell anemia, acute thrombophlebitis, diabetes mellitus, diabetic renal dysfunction, drug addiction, in old age, during breastfeeding.
In addition, careful monitoring is required when carrying out lumbar punctures against the background of local or systemic infections.
Instructions for use of Omnipak: method and dosage
Omnipak is intended for intravenous, intra-arterial, intracavitary, intrathecal, rectal, and oral administration.
Before use, check the integrity of the package, make sure that there are no insoluble particles or discoloration in the preparation.
The solution is drawn into a syringe before direct administration, the remainder of the drug in the vial is disposed of.
The introduction should be made with the patient in a horizontal position, then within 0.5 hours it is necessary to monitor his condition, since it is during this period that adverse reactions may develop.
The dose of Omnipaque is prescribed individually, depending on the type of study, hemodynamic state, age, body weight, patient's health, as well as the method and technique used for performing the study.
After intrathecal administration, to perform myelography, the patient must be at rest for 1 hour, in the supine position with the head raised by 20 °. The examinee requires medical supervision for 6 hours in case of suspicion of a low threshold for the development of seizures. The patient should avoid bending the body.
Side effects
Common side effects when using Omnipaque are usually reversible and moderate in severity:
- Feeling of a transient metallic taste in the mouth, heat throughout the body;
- Nausea, vomiting; rarely - pain or discomfort in the abdomen;
- Hypersensitivity reactions: moderately severe breathing disorders in the form of shortness of breath, bronchospasm; skin reactions - itching, rash, urticaria, erythema, angioedema; rarely - laryngeal edema, pulmonary edema, anaphylactic shock;
- Allergic reactions: Stevens-Johnson syndrome, toxic epidermal necrosis;
- Vasovagal reactions in the form of bradycardia and arterial hypotension;
- Others: rarely - fever, convulsive syndrome, temporary hearing loss or deafness after myelography, iodism (mumps iodine).
Side effects of Omnipak associated with intra-arterial administration:
- Selective angiography and other studies with the administration of a high concentration drug: often - pain along the vessel, a feeling of warmth, increased serum creatinine levels (transient); dysfunction of the examined organ; very rarely - renal failure;
- Introduction into the cerebral, coronary or renal arteries: possibly - arterial spasm, transient ischemia in the examined organ, heart rhythm disturbance, decreased myocardial contractile function, myocardial ischemia; very rarely - neurological reactions in the form of transient disorders of motor function and sensitivity, seizures; in isolated cases, the accumulation of the drug in the cerebral cortex leads to cortical blindness, transient disturbances in spatial orientation.
Adverse reactions with intrathecal administration of Omnipak:
- Often: nausea, vomiting, headache (sometimes severe), dizziness;
- Sometimes: moderate local pain, radicular pain at the injection site, paresthesia, leg pain, convulsions;
- In some cases: symptoms of irritation of the dura mater - meningism, photophobia;
- Rarely: transient dysfunction of the central nervous system - disorientation, disorder of motor functions and sensitivity, seizures, changes in electroencephalogram indicators;
- Very rare: meningitis.
With intravenous administration of Omnipak, in very rare cases, postphlebographic thrombophlebitis, thrombosis, arthralgia may develop.
With intracavitary administration, except for rare cases of the development of general hypersensitivity reactions to Omnipak, side effects depend on the research method:
- Endoscopic retrograde cholangiopancreatography: often - a slight increase in serum amylase activity; in rare cases - the development of pancreatic necrosis;
- Oral intake: possibly - gastrointestinal upset;
- Hysterosalpingography (HSG): often - transient moderate pain in the abdomen (lower sections);
- Arthrographic examination: often - pain; rarely - arthritis; possibly - the development of infectious arthritis;
- Herniographic research: it is possible - the development of a moderate pain reaction;
- Extravascular administration of a contrast agent (extravasation): rarely - the development of transient local pain and edema; possibly - inflammation and tissue necrosis.
Overdose
The likelihood of developing overdose symptoms is low, only if the patient is not administered more than 2000 mg iodine / kg for a short period of time. When using Omnipaque in high doses, the duration of the study may affect renal function.
Accidental overdose is possible during complex angiographic procedures in children, especially with multiple injections of large doses of an x-ray. Symptoms: insomnia or drowsiness, weakness, stupor, fatigue, increased epileptic syndrome, cyanosis, acidosis, pulmonary bleeding, mental disorders [photophobia, speech, auditory or visual impairment, echolalia, fear, depersonalization, disorientation, hallucinations, psychosis, hyperesthesia diplopia, amblyopia, depression, amnesia, tremor, hemiplegia, quadriplegia, areflexia, paralysis, meningism, hyperreflexia, changes in the electroencephalogram (EEG), cerebral hemorrhages], bradycardia, cardiac arrest, coma.
There is no specific antidote for iohexol. If necessary, hemodialysis is performed. The measures for correcting the developed violations of the water-electrolyte balance are shown. Kidney function should be monitored for 3 days.
Diazepam is administered at a dose of 10 mg (slowly intravenously), 20-30 minutes after the cessation of the seizure - phenobarbital at a dose of 200 mg (intramuscularly). Symptomatic and supportive therapy is carried out under the control of vital body functions.
special instructions
The use of Omnipak is possible if there is complete information about the patient's clinical condition, including laboratory data on water-electrolyte balance, serum creatinine level, electrocardiogram, history of allergies, and pregnancy.
The imbalance in the water and electrolyte balance should be eliminated before the study and ensure the intake of a sufficient amount of fluid and electrolytes before and after the administration of Omnipaque, especially in elderly patients, children (including newborns and infants), with diabetes mellitus, polyuria, gout, multiple myeloma, violation kidney function.
Food intake should be stopped 2 hours before administration of the solution.
It is not recommended to conduct preliminary tests using small doses of Omnipaque to determine individual sensitivity.
Premedication with sedatives is shown to patients with a feeling of fear from the upcoming procedure.
The treatment room should be equipped with equipment and medicines necessary for carrying out therapeutic measures in the development of anaphylactoid reactions and other manifestations of hypersensitivity.
Omnipak should not be mixed in the same syringe with other drugs.
To reduce the risk of thrombosis and embolism, angiographic studies should be performed under conditions of careful adherence to the technique, monitor the sterility of the catheters used.
Omnipaque affects the results of thyroid function tests, with a high concentration of an X-ray contrast agent in urine and blood plasma, the results of biochemical studies to determine the level of concentration of proteins, bilirubin, inorganic substances may be distorted.
The use of biguanides should be discontinued 48 hours before the administration of Omnipaque and resumed after stabilization of renal function. To ensure adequate hydration in a patient with diabetes mellitus, intravenous infusion can be used, starting before the administration of the solution, it must be continued until the drug is completely eliminated by the kidneys.
Repeated X-ray contrast studies are possible only after the restoration of renal function to its original level.
In severe form of simultaneous impairment of liver and kidney function, special care should be taken, since the patient's clearance of contrast agents is significantly reduced. For patients on hemodialysis, X-ray contrast studies can be carried out, provided dialysis is provided immediately after the study.
Influence on the ability to drive vehicles and complex mechanisms
It is not recommended to drive vehicles or machinery within 24 hours after the administration of Omnipak.
Application during pregnancy and lactation
Omnipaque is contraindicated during pregnancy, unless the expected benefit is definitely higher than the potential risks. The study is prescribed by a doctor.
Yogeksol penetrates into mother's milk to a small extent, so the likelihood of negative effects on the infant is low. Nevertheless, it is recommended to refrain from breastfeeding within 24 hours after the administration of Omnipaque.
Pediatric use
There are no age restrictions for the use of Omnipak. The dose of the X-ray agent is determined by the doctor depending on the child's age, body weight and state of health, hemodynamic state, the type of upcoming study, the methodology and technique used for the study.
With impaired renal function
Omnipak should be used with caution in patients with impaired renal function.
For violations of liver function
Omnipak should be used with caution in patients with impaired liver function.
Use in the elderly
Omnipak should be used with caution in elderly patients.
Drug interactions
Omnipak is pharmaceutically incompatible with drugs of other groups, in addition, with intrathecal administration, with glucocorticosteroids.
Against the background of the use of biguanides (metformin) in diabetes mellitus, the risk of transient renal dysfunction and the development of lactic acidosis increases.
Taking interleukin-2 less than 2 weeks prior to Omnipaque administration may increase the incidence of delayed side effects such as skin reactions or flu-like conditions.
With simultaneous use with phenothiazine derivatives and other neuroleptics, tetracyclic antidepressants, monoamine oxidase inhibitors, analeptics, stimulants of the central nervous system, the risk of epileptic seizures increases.
Taking beta-blockers and other antihypertensive drugs increases the likelihood of developing arterial hypotension, and while taking beta-blockers, the manifestations of anaphylaxis in patients can be mistaken for vagal reactions, since they are atypical.
Omnipaque enhances the nephrotoxic effect of other drugs.
Analogs
Omnipak analogues are: Tomogeksol, Unipak, Yogeksol, Introviz, Iobriks, Unigexol.
Terms and conditions of storage
Store out of reach of children, protected from light at temperatures up to 30 ° C. Protect from secondary X-ray radiation.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Omnipack
In messages on various forums and specialized sites, patients usually compare Omnipaque with other radiopaque contrast agents, most often with Urografin, which has a clear advantage in lower cost. However, both doctors and patients themselves in reviews of Omnipak describe its better tolerance, since the procedure for conducting a study is usually unpleasant, regardless of the drug chosen. In this regard, for patients who are not allergic to iodine, doctors usually recommend a study using iohexol.
Omnipack price in pharmacies
The cost of the drug depends on the dosage, the volume of the vials and their quantity in the package, as well as the pharmacy network and the region of sale. Approximate prices of Omnipaque: 300 mg of iodine / ml - 8147 rubles. for 10 bottles of 50 ml, 8714 rubles. for 25 vials of 20 ml, 15 499 rubles. for 10 bottles of 100 ml; 350 mg iodine / ml - 10 380 rubles. for 10 bottles of 50 ml, 11,197 rubles. for 25 vials of 20 ml, 19,030 rubles. for 10 bottles of 100 ml, 36 797 rubles. for 10 bottles of 200 ml.
Omnipack: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Omnipak 300 mg iodine / ml injection 50 ml 10 pcs. RUB 7036 Buy |
|
Omnipak 350 mg iodine / ml injection 50 ml 10 pcs. 8546 RUB Buy |
|
Omnipak 350 mg iodine / ml solution for injection 20 ml 25 pcs. 12832 RUB Buy |
|
Omnipak 300 mg iodine / ml injection 100 ml 10 pcs. RUB 13395 Buy |
|
Omnipak 350 mg iodine / ml solution for injection 100 ml 10 pcs. RUB 16253 Buy |
|
Omnipak 350 mg iodine / ml solution for injection 200 ml 10 pcs. RUB 30896 Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
