PAMISOL Iopamidol 612mg / mL Solution for IV Injection 50mL
RXDRUG-DRP-1160-50
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Features
Brand
Pamisol
Full Details
Dosage Strength
612 mg / ml (equivalent to 300 mg Iodine)
Drug Ingredients
- Iopamidol
Drug Packaging
Solution for Injection (I.V.) 50ml
Generic Name
Iopamidol
Dosage Form
Solution For Injection (I.V.)
Registration Number
DRP-1160
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Iopamidol Injection is an iodinated nonionic monomeric contrast medium used by injection for a variety of radiographic procedures: Angiography, Arthrography, Myelography and Urography. It is also used for contrast enhancement during computed tomography.
Dosage/Direction for Use
Iopamidol Injection is available as solutions containing 61.2% and 75.5% of Iopamidol (equivalent to 300 and 370 mg of iodine per mL, respectively) and the dose and strength used vary according to the procedure and route of administration. Or as prescribed by a physician.
Overdosage
Treatment for Overdosage: Adverse effects are treated symptomatically and adequately resuscitative facilities should be available when radiographic procedures are to be employed.
Contraindications
Iopamidol is contraindicated in patients with known hypersensitivity to contrast media or to iodine.
Special Precautions
Iodinated contrast media should be administered with great caution to patients with asthma, history of allergy, drug hypersensitivity, adrenal suppression, previous reaction to contrast medium, and those receiving beta-blockers or interleukin-2 therapy. An intravenous injection of 0.5 to 1 mL of contrast medium has been given as a test for sensitivity before administration of the main dose but it does not predict hypersensitivity with certainty and severe reactions and fatalities have followed the test dose. Pretreatment with corticosteroids may be considered for preventing anaphylactoid reactions in high-risk patients and an antihistamine may be given.
Caution is needed in patients with severe hepatic or renal impairment or others who may be at increased risk of renal failure. Dehydrated patients should have their fluid and electrolyte balance corrected before administration of contrast medium. Patients with multiple myeloma may be at particular risk if dehydrated, since precipitation of protein in the renal tubules may lead to anuria and fatal renal failure.
An increased risk of adverse effects has also been reported in patients with severe hypertension, advanced cardiac disease, phaeochromocytoma, sickle-cell disease, or hyperthyroidism. Debilitated, severely ill, very old, or very young patients are also at risk.
The administration of iodine-containing contrast media may interfere with thyroid function tests. There may also be interference with blood coagulation tests and certain urine tests.
Caution is needed in patients with severe hepatic or renal impairment or others who may be at increased risk of renal failure. Dehydrated patients should have their fluid and electrolyte balance corrected before administration of contrast medium. Patients with multiple myeloma may be at particular risk if dehydrated, since precipitation of protein in the renal tubules may lead to anuria and fatal renal failure.
An increased risk of adverse effects has also been reported in patients with severe hypertension, advanced cardiac disease, phaeochromocytoma, sickle-cell disease, or hyperthyroidism. Debilitated, severely ill, very old, or very young patients are also at risk.
The administration of iodine-containing contrast media may interfere with thyroid function tests. There may also be interference with blood coagulation tests and certain urine tests.
Adverse Reactions
Hyperthyroidism has been reported following administration of iodinated contrast media. When given by injection, the Iopamidol may cause nausea, a metallic taste, vomiting, flushing and sensations of heat, weakness, dizziness, headache, coughing, rhinitis, sweating, sneezing, lachrymation, visual disturbances, pruritus, salivary gland enlargement, pallor, tachycardia, bradycardia, transient ECG abnormalities, haemodynamics disturbances, and hypotension. Rarely, more severe adverse effects, including convulsions, paralysis, coma, rigors, ventricular fibrillation, pulmonary edema, circulatory failure, and cardiac arrest have occurred. Occasionally anaphylactoid or hypersensitivity reactions occur; dyspnoea, bronchospasm, angioedema, and severe Urticaria have been reported, and reactions have sometimes been fatal. Injection of Iopamidol produces severe neurotoxicity.
Deaths have also been recorded due to acute renal failure, which may follow intravenous administration, particularly in dehydrated patients and patients with other predisposing factors.
Pain may occur at the injection site; extravasation may be followed by tissue damage, thrombophlebitis, thrombosis, venospasm, and embolism.
Fibrinolysis and a possible depressant effect on blood coagulation factors have been reported. Disseminated intravascular coagulation has occurred.
Neurological effects may occur when Iopamidol is used for Myelography. These include severe headache, backache, neck stiffness, dizziness, and leg or sciatic-type pain. Convulsions, aseptic meningitis, and mild and transitory perceptual aberrations, such as visual and speech disturbances, and confusion may occur occasionally. Rarely, more severe mental disturbances have occurred. Urinary retention has also been reported.
Deaths have also been recorded due to acute renal failure, which may follow intravenous administration, particularly in dehydrated patients and patients with other predisposing factors.
Pain may occur at the injection site; extravasation may be followed by tissue damage, thrombophlebitis, thrombosis, venospasm, and embolism.
Fibrinolysis and a possible depressant effect on blood coagulation factors have been reported. Disseminated intravascular coagulation has occurred.
Neurological effects may occur when Iopamidol is used for Myelography. These include severe headache, backache, neck stiffness, dizziness, and leg or sciatic-type pain. Convulsions, aseptic meningitis, and mild and transitory perceptual aberrations, such as visual and speech disturbances, and confusion may occur occasionally. Rarely, more severe mental disturbances have occurred. Urinary retention has also been reported.
Storage
Store at temperatures not exceeding 30°C.
MedsGo Class
Radiographic & Diagnostic Agents
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