PATENT BLUE V

MIMS Revision Date: 01 January 2022

1 Name of Medicine

Patent Blue V.

2 Qualitative and Quantitative Composition

Patent Blue V injection solution contains 25 mg/mL (2.5% w/v) of Patent Blue V (sodium salt) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Patent Blue V injection solution is a deep blue sterile, isotonic solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Colours the lymph vessels so that they can then be injected with an X-ray contrast medium.

4.2 Dose and Method of Administration

For subcutaneous use only.
2 mL of Patent Blue V injection solution is diluted with an equal volume of sterile normal saline (an alternative method advocates dilution with 1% lignocaine hydrochloride solution) and 0.5 mL of diluted dye is injected into the subcutaneous tissue of each interdigital web space.
When the lower extremities are being examined, 1 mL is also injected below the tip of each malleolus. The lymphatics should then be visible through the skin and it is important that there should be no accidental spillage of the dye.
Patent Blue V may be used for children at the surgeon's discretion.
After the administration of Patent Blue V, the patient must be monitored for at least 30 minutes.
Note. After injection of the dye a bluish coloration of the skin occurs, which normally disappears within 24 to 48 hours. More persistent coloration which should not be confused with cyanosis, may occasionally be seen in cases of lymphatic stasis or circulatory disorder, this persistence may be avoided by using the minimum quantity of dye. An area of blue coloration can persist around the injection site for 8 to 10 days.

4.3 Contraindications

Hypersensitivity to Patent Blue V, triphenylmethane dyes or any of the excipients listed (see Section 6.1).
Pregnancy.

4.4 Special Warnings and Precautions for Use

There is a risk of allergic reactions regardless of the administration route or dose. Patent Blue V may cause minor or major immediate allergic reactions that may be life-threatening or even fatal (anaphylactic shock). They are often unpredictable, but they occur more frequently in patients with a history of hypersensitivity reactions to Patent Blue V or related triphenylmethane dyes contained in medicine, food and cosmetics. The indication should be very carefully assessed in these predisposed patients. In such circumstances it is advisable to administer a corticosteroid or H1-type antihistamine premedication. The preventative effect of premedication with corticosteroids and H1-type antihistamines is not entirely dependable, as only a partial (though significant) inhibition of mediators involved in anaphylactoid reactions can be attained.
The risk of a major reaction implies that emergency measures must be immediately available especially in patients on beta blockers in whom adrenaline and vascular perfusion would be insufficiently effective. Therefore, Patent Blue V must only be administered in hospital or a clinic capable of adequate treatment.
It would also seem prudent to test for hypersensitivity by injecting a very small volume of the solution and waiting a few moments to ascertain if there is a reaction.
Before administration of Patent Blue V:
Identify patients at risk by enquiring if there is a previous history of allergy or intolerance to Patent Blue V or related triphenylmethane dyes.
Insert an indwelling venous catheter.
Throughout the examination, maintain:
Medical monitoring.
An indwelling intravenous catheter.
Medicines and equipment for resuscitation readily available.
After administration of Patent Blue V, the patient must be monitored for at least 30 minutes.
Use in the elderly. No data available.
Paediatric use. Patent Blue V may be used for children at the surgeon's discretion.
Effects on laboratory tests. The measurement of partial oxygen pressure measured by spectrophotometry may show a transient false decrease of 5 to 10% below baseline values, during an examination with Patent Blue V. When in doubt, arterial blood gases should be checked. The value of serum methaemoglobin measured by the same spectrophotometric method may be falsely increased.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Beta blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists.
These medicinal products reduce the efficacy of cardiovascular compensation mechanisms for haemodynamic disorders. The physician must be aware of this before injecting Patent Blue V and emergency measures must be available.
The value of partial oxygen pressure measured by spectrophotometry may show a transient false decrease of 5 to 10% below baseline values during examinations with Patent Blue. When in doubt, it is advisable to check by arterial blood gas analysis. The value of serum methaemoglobin measured by the same spectrophotometric method may be falsely increased.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. No reliable animal teratogenesis data are available. The currently available relevant data are not sufficient to evaluate a possible malformative or foetotoxic effect of Patent Blue V when it is administered during pregnancy. Consequently, the use of this medicinal product is contraindicated during pregnancy.
Use in lactation. It is not known whether Patent Blue V is excreted in breast milk.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Patent Blue V solution can provoke allergic reactions of varying degrees of severity. These reactions are rare and can be rapidly controlled with a corticosteroid. They occur immediately or a few minutes to several hours after injection of the dye.
Immediate hypersensitivity reactions are possible. These reactions may involve one or more effects, occurring concomitantly or successively, and usually including cutaneous, respiratory and/or cardiovascular manifestations, each of which can be a warning sign of incipient shock and, in very rare instances, can even prove fatal. The most frequently reported effects in a context of hypersensitivity reaction include rash, pruritus, erythema, urticaria, angioedema (such as face oedema or laryngeal oedema), bronchospasm, tachycardia, blood pressure decreased, and circulatory collapse.
A bluish colouring of the integuments is observed after the injection, which disappears within 24 to 48 hours. In patients with lymph stasis or circulatory disorders, the colouring may last longer.
Nausea, hypotension and generalised muscle tremors have also been reported; laryngeal spasm, if it occurs, requires the use of a muscle relaxant and intubation. Rare but more serious allergic reactions include circulatory failure with a state of shock, dyspnoea and oedema of the glottis.
Post-marketing experience. The adverse effects are presented in Table 1, by system organ class and by frequency using the following categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/100), very rare (< 1/10,000), not known (cannot be estimated from the available data).

Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: lymphotropic dye.
The lymphotropic property of Patent Blue V 2.5% w/w results in the staining of local lymph vessels after subcutaneous injection.
Mechanism of action. No data available.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Carcinogenicity. No data available.
Genotoxicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, dibasic sodium phosphate dodecahydrate, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Patent Blue V is packed in type I clear glass ampoules of 2 mL volume fill.
Available in packs of 5.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure. Patent Blue V (sodium salt) is N-(4-((4-(diethylamino)phenyl) (5-hydroxy-2,4-disulfophenyl) methylene)-2,5-cyclohexadien-1-ylidene) -N-ethylethanaminium, hydroxide, sodium salt.
CAS number. 20262-76-4.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Date of First Approval

21 October 1991

Date of Revision

18 November 2021

Summary Table of Changes