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Visipaque
Overview
What is Visipaque?
What does Visipaque look like?
What are the available doses of Visipaque?
Injection: In concentrations of 270 and 320 mg of organically bound iodine per mL (550 mg and 642 ml of Iodixanol per mL).
What should I talk to my health care provider before I take Visipaque?
How should I use Visipaque?
VISIPAQUE is indicated in for:
Individualize the combination of volume and concentration of VISIPAQUE Injection considering age, body weight, size of the vessel, rate of blood flow within the vessel, and other applicable factors. (, , , )
For the adult patients, the maximum recommended total dose of iodine is 80 grams. ()
Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents. (, )
What interacts with Visipaque?
Sorry No Records found
What are the warnings of Visipaque?
Sorry No Records found
What are the precautions of Visipaque?
Sorry No Records found
What are the side effects of Visipaque?
Sorry No records found
What should I look out for while using Visipaque?
VISIPAQUE is contraindicated for Intrathecal use [
]:
Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. (
)
4
5.1
What might happen if I take too much Visipaque?
The adverse effects of overdosage of any contrast agent may be life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. VISIPAQUE Injection does not bind to plasma or serum protein and can be dialyzed.
How should I store and handle Visipaque?
Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Manufactured For:Manufactured By:10 0258 0 665786Issued January 2016100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Manufactured For:Manufactured By:10 0258 0 665786Issued January 2016100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Manufactured For:Manufactured By:10 0258 0 665786Issued January 2016100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Manufactured For:Manufactured By:10 0258 0 665786Issued January 2016100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Manufactured For:Manufactured By:10 0258 0 665786Issued January 2016100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Manufactured For:Manufactured By:10 0258 0 665786Issued January 2016100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Manufactured For:Manufactured By:10 0258 0 665786Issued January 2016100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Manufactured For:Manufactured By:10 0258 0 665786Issued January 2016
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Intravascular injection of iodixanol opacifies vessels in the path of flow of the contrast agent, permitting visualization of internal structures.
In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space. In a normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with a disrupted blood-brain barrier, contrast agent accumulates in the interstitial space in the region of disruption.
Non-Clinical Toxicology
VISIPAQUE is contraindicated for Intrathecal use [ ]:Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. (
)
4
5.1
Drug Interactions:
It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy.
Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and allopurinol has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with allopurinol alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on allopurinol alone or in combination with uricosuric agents, the possibility should be kept in mind.
The reports that the concomitant use of allopurinol and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of allopurinol was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and allopurinol even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of the reported association has not been established.
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.
Tolbutamide's conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of these observations is unknown.
Chlorpropamide's plasma half-life may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.
Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.
VISIPAQUE is for intravascular use only and is contraindicated for intrathecal use [ ] Inadvertent Intrathecal administration can cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.
The following clinically significant adverse reactions are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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