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Visipaque

Visipaque

Manufacturer:

A. Menarini

Distributor:

Zuellig
Concise Prescribing Info
Contents
Iodixanol
Indications/Uses
X-ray contrast medium for use in adults for cardioangiography, cerebral angiography (conventional), peripheral angiography (conventional), abdominal angiography (i.a. DSA), urography, venography, CT enhancement & studies of the GIT. For use in childn for cardioangiography, urography, CT enhancement & studies of the GIT. Lumbar, thoracic & cervical myelography. Arthrography & hysterosalpingography (HSG).
Dosage/Direction for Use
Intra-arterial Selective cerebral arteriography 270/320 mg iodine/mL, vol: 5-10 mL/inj. Aortography 270/320 mg iodine/mL, vol: 40-60 mL/inj. Peripheral arteriography 270/320 mg iodine/mL, vol: 30-60 mL/inj. Selective visceral i.a. DSA 270 mg iodine/mL, vol: 10-40 mL/inj. Left ventricle & aortic root cardioangiography Adult 320 mg iodine/mL, vol: 30-60 mL/inj. Selective coronary arteriography Adult 320 mg iodine/mL, vol 4-8 mL/inj. Cardioangiography Childn 270/320 mg iodine/mL, vol: depending on age, wt & pathology (max: 10 mL/kg). IV Urography Adult 270/320 mg iodine/mL, vol: 40-80 mL. Childn >7 kg 270/320 mg iodine/mL, vol: 2-3 mL/kg, <7 kg 270/320 mg iodine/mL, vol: 2-4 mL/kg. All doses depending on age & pathology (max: 50 mL). Venography 270/320 mg iodine/mL, vol: 50-150 mL/leg. CT enhancement Adult CT of the head 270/320 mg iodine/mL, vol: 50-150 mL. CT of the body 270/320 mg iodine/mL, vol: 75-150 mL. Childn CT of the head & body 270/320 mg iodine/mL, vol: 2-3 mL/kg up to 50 mL (in few cases, up to 150 mL may be given). Intrathecal Lumbar & thoracic myelography (lumbar inj) & cervical myelography (cervical or lumbar inj) 270 mg iodine/mL, vol: 10-12 mL; or 320 mg iodine/mL, vol: 10 mL. Use in body cavities Arthrography 270 mg iodine/mL, vol: 1-15 mL. HSG 270 mg iodine/mL, vol: 5-10 mL. Venography 270/320 mg iodine/mL, vol: 50-150 mL/leg. Oral GI studies Adult Follow through 320 mg iodine/mL, vol: 80-200 mL. Oesophagus 320 mg iodine/mL, vol: 10-200 mL. Stomach 320 mg iodine/mL, vol: 20-200 mL. Childn 270/320 mg iodine/mL, vol: 5 mL/kg (10-240 mL). Rectal GI studies Childn 270/320 mg iodine/mL, vol: 30-400 mL.
Contraindications
Hypersensitivity. Manifest thyrotoxicosis.
Special Precautions
Patients w/ history of allergy, asthma or untoward reactions to iodinated contrast media; homocystinuria; conditions that disrupt the integrity of the blood-brain barrier; severe disturbance of both renal & hepatic function; known or suspected phaeochromocytoma; patients w/ manifest but not yet diagnosed hyperthyroidism, latent hyperthyroidism (eg, nodular goitre) & functional autonomy (often eg, elderly patients, especially in regions w/ iodine deficiency). May provoke anaphylactoid reactions or other manifestations of hypersensitivity. Reports of clotting when blood remains in contact w/ syringes containing contrast media; serious thromboembolic events causing MI & stroke during angio-cardiographic procedures; encephalopathy. Risk of haemodynamic changes or arrhythmias in patients w/ serious cardiac disease & pulmonary HTN; contrast medium-induced nephropathy. Ensure adequate hydration before & after contrast media administration, especially in patients w/ multiple myeloma, DM, renal dysfunction, as well as in infants, small childn & elderly patients. Risk of acute alteration of renal function & lactic acidosis in patients w/ renal impairment receiving metformin. Discontinue metformin 48 hr before contrast medium in patients receiving intra-arterial contrast medium, & those receiving IV contrast medium w/ eGFR 30-44 mL/min/1.73 m2; resume 48 hr after contrast medium if renal function has not deteriorated. Avoid iodinate contrast media in patients w/ eGFR <30 mL/min/1.73 m2 or w/ intercurrent illness causing reduced liver function or hypoxia. May aggravate symptoms of myasthenia gravis. Perform thyroid function testing prior to contrast medium administration &/or consider preventative thyreostatic medication in patients w/ suspected hyperthyroidism. Reports of hypothyroidism or transient thyroid suppression following iodinated contrast media administration to adult & paed patients, including infants. Evaluate thyroid function in all ped patients <3 yr following exposure to iodinated contrast media. HSG should not be performed during pregnancy or in the presence of acute pelvic inflammatory disease. Not advisable to drive a car or use machines during the 1st 24 hr following intrathecal exam. Should not be used during pregnancy unless considered essential. Intrathecal use: Following myelography, patient should rest w/ head & thorax elevated by 20° for 1 hr; thereafter patient may ambulate carefully but avoid bending down. Elevate head & thorax for the 1st 6 hr if remaining in bed. Observe patients suspected of having low seizure threshold during this period. Outpatients should not be completely alone for the 1st 24 hr.
Adverse Reactions
HSG: Abdominal pain; vag haemorrhage. Headache; nausea; pyrexia. Arthrography: Inj site pain. Exam of GI tract: Diarrhoea, abdominal pain, nausea. Intravascular use: Uncommon: Hypersensitivity; headache; flushing; nausea, vomiting; rash or drug eruption, pruritus, urticaria; acute kidney injury or toxic nephropathy; feeling hot, chest pain. Intrathecal use & use in body cavities: Uncommon: Headache; vomiting.
Drug Interactions
Interference w/ tests on thyroid function. High conc of contrast media in serum & urine can interfere w/ lab tests for bilirubin, proteins or inorganic substances (eg, Fe, Cu, Ca & phosphate). Transient impairment of renal function & may precipitate lactic acidosis in diabetics taking metformin. Increased risk for delayed reactions (flu-like symptoms or skin reactions) in patients treated w/ interleukin-2 <2 wk previous to iodinated contrast medium inj.
MIMS Class
Radiographic & Diagnostic Agents
ATC Classification
V08AB09 - iodixanol ; Belongs to the class of watersoluble, nephrotropic, low osmolar preparations used as X-ray contrast media.
Presentation/Packing
Form
Visipaque soln for inj 320 mg iodine/mL
Packing/Price
100 mL x 10 × 1's;50 mL x 10 × 1's
/philippines/image/info/visipaque-soln-for-inj-320-mg-iodine-ml/625-mg-ml-x-50-ml?id=2546722b-7556-4fc8-9774-a67800b3deb3
/philippines/image/info/visipaque-soln-for-inj-320-mg-iodine-ml/625-mg-ml-x-100-ml?id=177df065-5c01-4c6f-a729-a67800b3deb3
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