Dixanol Injection 50 ml/vial

Uses

Dixanol Injection 50 ml/vial injection is a radiographic contrast agent used for the following:

Intra-arterial Procedures:

Adults and pediatric patients 12 years of age and over:

• Intra-arterial digital subtraction angiography (270 and 320 mg Iodine/mL).
• Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL).

Pediatric patients less than 12 years of age:

• Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL).

Intravenous Procedures:

Adults and pediatric patients 12 years of age and over:

• Computed tomography (CT) imaging head and body and excretory urography (270 and 320 mg Iodine/mL).
• CT imaging peripheral venography (270 mg Iodine/mL).
• Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of patients with suspected coronary artery disease (320 mg Iodine/mL).

Pediatric patients less than 12 years of age:

• CT imaging of the head and body and excretory urography (270 mg Iodine/mL).

How Dixanol Injection 50 ml/vial works

Organic iodine compounds attenuate x-rays as they pass through the body, thereby allowing the 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 intravascular administration, iodixanol makes opaque those internal structures in its path of flow, allowing their visualization until significant hemodilution and elimination occur.

Dosage

Dixanol Injection 50 ml/vial dosage

Individualize the combination of volume and concentration ofDixanol Injection 50 ml/vialInjection 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.

Side Effects

Most common adverse reactions (incidence greater than 0.5%) in adult patients after Dixanol Injection 50 ml/vial injection: Discomfort, warmth, pain

Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting.

Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning.

Skin: itchy rash, severe itching, hives.

Special Senses: Smell, taste, and vision alteration. Pediatric patients experienced similar adverse reactions.

Toxicity

Non-ionic radiocontrast agents like iodixanol are cytotoxic to renal cells. The toxic effects include apoptosis, cellular energy failure, disruption of calcium homeostasis, and disturbance of tubular cell polarity, and are thought to be linked to oxidative stress.

Precaution

Hypersensitivity Reactions: life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available.

Contrast Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk.

Cardiovascular reactions: hemodynamic disturbances including shock and cardiac arrest may occur during or after administration.

Food Interaction

Dixanol Injection 50 ml/vial Hypertension interaction

[Moderate] In patients with advanced renal disease, iodinated contrast media should be used with caution, and only when the need for the examination dictates, since the excretion of the medium may be impaired.

Patients with combined renal and hepatic disease, severe hypertension or congestive heart failure, and those with recent renal transplant may present an additional risk.

Dixanol Injection 50 ml/vial Drug Interaction

Unknown: charcoal, charcoal, sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprim, ubiquinone, ubiquinone, copper gluconate, copper gluconate, ivabradine, ivabradine, sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprim, glucose, glucose, diltiazem, diltiazem, sodium iodide, sodium iodide, acetaminophen, acetaminophen

Dixanol Injection 50 ml/vial Disease Interaction

Major: hyperthyroidism, pheochromocytomaModerate: sickle cell disease, multiple myeloma, myasthenia gravis, renal disease, allergies

Volume of Distribution

• 0.26 L/kg

Half Life

2.1 hours. In patients with significantly impaired renal function (mean creatinine clearance rate, 9.91 [± 3.58] mL per minute), the plasma half-life is increased to 23 hours.

Elimination Route

In adults, approximately 97% of the injected dose of iodixanol is excreted unchanged in urine within 24 hours, with less than 2% excreted in feces within five days post-injection.

Pregnancy & Breastfeeding use

Pregnancy:There are no data with iodixanol use in pregnant women to inform any drug-associated risks.

Lactation: A lactating woman may pump and discard breast milk for 10 hours after Dixanol Injection 50 ml/vial administration

Contraindication

Not indicated for intrathecal use

Special Warning

Geriatrics: Exercise caution in dose selection for elderly patients

Pediatric Use: The safety and efficacy of Dixanol Injection 50 ml/vial have been established in pediatric patients down to birth for angiocardiography, cerebral arteriography, visceral arteriography, CT imaging of the head and body, and excretory urography. The safety and efficacy of Dixanol Injection 50 ml/vial have also been established in pediatric patients 12 years and older for intra-arterial digital subtraction angiography, peripheral arteriography, CT imaging peripheral venography and CCTA.

Acute Overdose

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. Dixanol Injection 50 ml/vial Injection does not bind to plasma or serum protein and can be dialyzed.

Storage Condition

Store Dixanol Injection 50 ml/vial at controlled room temperature, 20°C-25°C; excursions permitted to 15°C-30°C

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