Isosulfan Blue (Lymphazurin)
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Isosulfan Blue (Lymphazurin)

LYMPHAZURIN™
1% (Isosulfan Blue) AQUEOUS SOULTION

DRUG DESCRIPTION

The chemical name of Lymphazurin 1% (isosulfan blue) is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5- cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is:

Lymphazurin (isosulfan blue) structural formula illustration

Lymphazurin (isosulfan blue) 1% is a sterile aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8-7.4. Each ml of solution contains 10 mg Isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. The solution contains no preservative. Lymphazurin (isosulfan blue) 1% is a contrast agent for the delineation of lymphatic vessels.

Last reviewed on RxList: 2/13/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Lymphatic Vessel Delineation

Lymphazuirn™ 1% (isosulfan blue) upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities.

DOSAGE AND ADMINISTRATION

Subcutaneous administration

Lymphazurin™ 1% (isosulfan blue) is to be administered subcutaneously, one- half (1/2) ml into three (3) interdigital spaces of each extremity per study. A maximum dose of 3 ml (30 mg) isosulfan blue is, therefore, injected.

HOW SUPPLIED

Dosage Forms And Strengths

1% aqueous solution (isosulfan blue)

Lymphazurin (isosulfan blue) 1% is supplied as a 5 ml single dose vial, 1% aqueous solution in a phosphate buffer prepared by appropriate manufacturing to be sterile and pyrogen-free.

FDA Rev date: October 2007

Last reviewed on RxList: 2/13/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Postmarketing Experience

Hypersensitivity Reactions: Case series report an overall incidence of hypersensitivity reactions in approximately 2% of patients. Life- threatening anaphylactic reactions have occurred. Manifestations include respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following administration of a similar compound employed to estimate the depth of a severe burn. Reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions or previous reactions to triphenylmethane dyes [see WARNINGS and PRECAUTIONS].

Laboratory Tests: Lymphazurin (isosulfan blue) 1% interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer [see WARNINGS and PRECAUTIONS].

Skin: transient or long-term (tattooing) blue coloration.

Read the Lymphazurin (isosulfan blue) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No drug interactions have been identified with Lymphazurin (isosulfan blue) 1%.

Last reviewed on RxList: 2/13/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after Lymphazurin (isosulfan blue) 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to triphenylmethane dyes. Monitor patients closely for at least 60 minutes after administration of Lymphazurin (isosulfan blue) 1%. Trained personnel should be available to administer emergency care including resuscitation.

Precipitation of Lymphazurin (isosulfan blue) 1% by Lidocaine

The admixture of Lymphazurin (isosulfan blue) 1% (with local anesthetics (i.e. lidocaine)) in the same syringe results in an immediate precipitation of 4 - 9% drug complex. Use a separate syringe to administer a local anesthetic.

Interference with Oxygen Saturation and Methemoglobin Measurements

Lymphazurin (isosulfan blue) 1% interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and minimal generally by four hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.

Lymphazurin (isosulfan blue) 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, co-oximetry may be needed to verify methemoglobin level.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Lymphazurin (isosulfan blue) 1%. Reproduction studies in animals have not been conducted and, therefore, it is unknown if a problem concerning mutagenesis or impairment of fertility in either males or females exists.

Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with Lymphazurin (isosulfan blue) 1%. It is not known whether Lymphazurin (isosulfan blue) 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lymphazurin (isosulfan blue) 1% should be given to a pregnant woman only if clearly needed.

Use In Specific Populations

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lymphazurin™ 1% (isosulfan blue) is administered to a nursing mother.

Pediatric Use

Safety and effectiveness of Lymphazurin™ 1% (isosulfan blue) in children have not been established.

Last reviewed on RxList: 4/21/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Do not exceed indicated recommended dosage as overdosage levels have not been identified for Lymphazurin (isosulfan blue) 1%.

CONTRAINDICATIONS

Lymphazurin™ 1% (isosulfan blue) is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds.

Last reviewed on RxList: 2/13/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Pharmacodynamics

Following subcutaneous administration, Lymphazurin (isosulfan blue) 1% binds to serum proteins and is picked up by the lymphatic vessels. Thus, the lymphatic vessels are delineated by the blue dye.

Pharmacokinetics

Up to 10% of the subcutaneously administered dose of Lymphazurin (isosulfan blue) 1% is excreted unchanged in the urine in 24 hours in human.

Last reviewed on RxList: 2/13/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Inform patients that urine color may be blue for 24 hours following administration of Lymphazurin (isosulfan blue) 1%.

Last reviewed on RxList: 2/13/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Inform patients that urine color may be blue for 24 hours following administration of Lymphazurin (isosulfan blue) 1%.

Last reviewed on RxList: 2/13/2008
This monograph has been modified to include the generic and brand name in many instances.

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