Lymphazurin™ 1% (isosulfan blue)
用途：辅助在淋巴 
主治：辅助在皮下给药，以淋巴Lymphazurin（异硫蓝），描绘的淋巴管。它是一种辅助淋巴造影（四肢原发性和继发性淋巴水肿，乳糜尿，乳糜腹水或乳糜胸;由原发性或继发性肿瘤淋巴结受累;和淋巴结反应治疗方法）的淋巴系统引流的区域的可视化注射。

Lymphazurin
Generic Name: isosulfan blue
Dosage Form: injection, solution
Indications and Usage for Lymphazurin
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.
Lymphazurin Dosage and Administration
Subcutaneous administration
Lymphazurin™ 1% 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.
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Dosage Forms and Strengths
1% aqueous solution (isosulfan blue)
Contraindications
Lymphazurin™ 1% (isosulfan blue) is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds.
Warnings and Precautions
Hypersensitivity Reactions
Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after Lymphazurin 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 1%. Trained personnel should be available to administer emergency care including resuscitation.
Precipitation of Lymphazurin 1% by Lidocaine
The admixture of Lymphazurin 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 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 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, co-oximetry may be needed to verify methemoglobin level.
Adverse Reactions
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 (5)].
Laboratory tests: Lymphazurin 1% interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer [see Warnings and Precautions (5)].
Skin: transient or long-term (tattooing) blue coloration.
Drug Interactions
No Drug Interactions have been identified with Lymphazurin 1%.
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.
Overdosage
Do not exceed indicated recommended dosage as overdosage levels have not been identified for Lymphazurin 1%.
Lymphazurin 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-ethylehananamunium hydroxide, inner salt, sodium salt. Its structural formula is:
Lymphazurin 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 1% is a contrast agent for the delineation of lymphatic vessels.
Lymphazurin - Clinical Pharmacology
Pharmacodynamics
Following subcutaneous administration, Lymphazurin 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 1% is excreted unchanged in the urine in 24 hours in human.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Lymphazurin 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 1%. It is not known whether Lymphazurin 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lymphazurin 1% should be given to a pregnant woman only if clearly needed.
How Supplied/Storage and Handling
Lymphazurin 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.
Patient Counseling Information
Inform patients that urine color may be blue for 24 hours following administration of Lymphazurin 1%.
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类别: 心血管系统药物->血管性水肿
产地国家: 美国
原产地英文商品名:
LYMPHAZURIN 1% 5ml 5 Vials
原产地英文药品名:
ISOSULFAN BLUE
中文参考商品译名:
LYMPHAZURIN 1% 5毫升/瓶 5瓶/盒
中文参考药品译名:
异硫蓝
生产厂家英文名:
COVIDIEN