VA Class:DX900

AHFS Class:

• Kidney Function 36:40

Generic Name(s):

• Indigotindisulfonate Sodium

Indigotindisulfonate sodium is a dye.

Indigotindisulfonate sodium was originally used as an index of renal function. Because excretion of the dye does not correlate with renal function, its use for that purpose has largely been replaced by other agents that yield more precise results.

Indigotindisulfonate sodium is used to localize ureteral orifices during cystoscopy and ureteral catheterization, and as a marker dye to identify severed ureters and fistulous communications.

Indigotindisulfonate sodium may be administered by IM or, preferably, IV injection.

The usual dose of indigotindisulfonate sodium is 40 mg. Larger doses may be required when the drug is given IM. Smaller doses may be desirable in infants, children, and underweight patients to prevent skin discoloration. (See Cautions: Adverse Effects.) Appearance of the dye at the ureteral orifices is observed with the cystoscope in place.

Adverse Effects

Occasional idiosyncratic reactions to indigotindisulfonate sodium such as rash, pruritus, and bronchoconstriction may occur. The manufacturer states that idiosyncratic reactions may be treated with antihistamines or epinephrine if needed.

Other reported adverse effects of indigotindisulfonate sodium include a mild pressor effect, bradycardia, nausea, and vomiting. Because the dye retains its blue color during passage through the body, infants, children, and underweight patients may experience skin discoloration following large doses.

Pregnancy, Fertility, and Lactation

Pregnancy

Animal reproduction studies have not been performed with indigotindisulfonate sodium, and it is also not known whether the drug can cause fetal harm when administered to pregnant women. Indigotindisulfonate sodium should be used during pregnancy only when clearly needed.

Fertility

It is not known whether the drug can affect reproduction capacity

Lactation

Since it is not known whether indigotindisulfonate sodium is distributed into human milk, the drug should be used with caution in nursing women.

Laboratory Test Interferences

Because of its properties as a dye, indigotindisulfonate sodium may interfere with colorimetric methods of urinalysis.

Pharmacology

The use of indigotindisulfonate sodium is based on its elimination from the body.

Pharmacokinetics

In patients with normal renal function, indigotindisulfonate sodium is cleared rapidly from the circulation after IV administration and has a plasma half-life of 4.5 minutes. The dye is excreted principally by the kidneys. It usually appears in urine within 10 minutes after IV injection, and approximately 10% of a dose is eliminated during the first hour. Excretion of indigotindisulfonate sodium is delayed following IM injection.

Chemistry and Stability

Chemistry

Indigotindisulfonate sodium is a dye. Indigotindisulfonate sodium occurs as a dusky, purplish-blue powder or blue granules having a coppery luster and is slightly soluble in alcohol and has a solubility of approximately 10 mg/mL in water at 25°C. The dye forms blue or bluish-purple solutions. Indigotindisulfonate sodium injections have a pH of 3-6.5.

Stability

Solutions of indigotindisulfonate sodium must be stored in light-resistant containers to prevent fading.