Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Indigo carmine 40 mg/5 mL, solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Indigo carmine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR Pharmacotherapeutic class: diagnostic agent, ATC code: V04CH02 Indigo carmine 40 mg/5 mL solution for injection contains the active substance indigotin (indigo carmine). This medicine is for a diagnostic use only in adults. It is a dye used by the surgeon and anaesthetist during abdominal surgery. The product discolours urine (to dark blue) within 5 to 15 minutes after injection. This colour allows the identification of the ureter track (channels that evacuate urine from the kidneys to the bladder) and check that they have not been damaged during the surgery.
What you need to know before you take it
E Indigo carmine 40 mg/5 mL solution for injection Do not use Indigo carmine 40 mg/5 mL solution for injection: •
If you are allergic to indigo carmine (the drug substance).
Warnings and precautions Talk to your doctor or pharmacist before using Indigo carmine 40 mg/5 mL solution for injection: •
if you suffer from arterial hypertension (excessively high pressure of the blood in the arteries),
•
if you suffer from heart failure (impairment of the heart functions) or angina pectoris (heart disease characterised by a sharp pain in the chest that can irradiate towards neighbouring regions),
•
if you suffer from heart rhythm disorders (heart beats that are too fast, too slow or irregular) or cardiac conduction disorders,
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•
if you take medicines that slow your heart rhythm, affect your blood pressure or nitric oxide production (nitric oxide is a naturally occurring chemical in the body, which causes the muscles in the lining of the blood vessels to relax),
•
if your blood pressure is instable,
•
if you have a history of allergy,
•
if you are pregnant,
•
if you breast-feed.
You should observe a discolouration of urine after administration of this medicinal product. Other medicines and Indigo carmine 40 mg/5 mL solution for injection: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding As a precaution, it is preferable not to use this product during pregnancy or if you breast-feed. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
How to take it
Indigo carmine 40 mg/5 mL solution for injection Posology and method of administration A healthcare professional will administer this medicine to you by slow injection into a vein. Your doctor will determine the dose you will receive and will control the injection of this medicine. The dose usually injected is of 1 ampoule of 5 mL and may be repeated once if necessary. If you were administered more Indigo carmine 40 mg/5 mL solution for injection than you should:
- your doctor will check your blood pressure and your heart rate,
- an overdose could induce a hypertensive crisis (sudden increase in blood pressure) and bradycardia (low heart rate). A treatment with peripheral vasodilator may be considered (which will help lowering the blood pressure). If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them:
- very commonly, the following reactions can occur: o increase in blood pressure, o slow down of the pulse,
- very rarely, the following reactions can occur: o anaphylactoid reactions, o breath discomfort, o cardiac conduction disorder, o decrease in blood pressure, o rash, erythema or skin discolouration, o acceleration of the pulse. Reporting of side effects If you get any side effect, tell your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report the side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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How to store it
Indigo carmine 40 mg/5 mL solution for injection Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton or ampoule after "EXP". The expiry date refers to the last day of that month. Before opening: this medicinal product does not require any special storage conditions. After opening the ampoule: this medicine must be used immediately. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Indigo carmine 40 mg/5 mL solution for injection contains −
The active substance is indigotin (indigo carmine). Each ampoule of 5 mL contains 40 mg.
−
The other ingredient is water for injections.
What Indigo carmine 40 mg/5 mL solution for injection looks like and content of the pack This medicine is available as a solution for injection in ampoule. One box contains 10 ampoules. Marketing Authorisation Holder SERB S.A. Avenue Louise 480 1050 Brussels Belgium Manufacturer SERB 32 rue de Monceau 75008 Paris France Or SERB S.A. Avenue Louise 480 1050 Brussels Belgium
This leaflet was last revised in November 2025. The following information is intended for healthcare professionals only: Considering the dark blue colour of Indigo carmine, a filtration is necessary during the intravenous administration (for example a filter of 0.45 μm, with a filtering surface of at least 2.8 cm2, or a filter of 0.2 μm with a filtering surface of 4.3 cm2, composed of a hydrophilic polyethersulfone membrane). Dosage This medicinal product is to be injected by intravenous route. The initial recommended dosage is 1 ampoule of 5 mL by slow intravenous injection. A second ampoule may be injected 20 to 30 minutes after the first injection, if necessary. In children:
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The efficacy and safety of Indigo carmine in children has not been established. In patients with renal insufficiency: Indigo carmine 40 mg/5 mL solution for injection is not recommended for use in patients with glomerular filtration rate (GFR) < 30 mL/min. In elderly: No dosage adjustment is necessary. In patients with liver insufficiency: The excretion of Indigo carmine is mainly renal. Although there is no data in patients with hepatic failure, no dosage adjustment is required. Storage Before opening: this medicinal product does not require any special storage conditions. After opening the ampoule: this medicine should be used immediately. The solution must only be used if the ampoule is not damaged. Any unused solution should be thrown away.
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Frequently asked questions about Indigo carmine 40 mg/5 mL, solution for injection
How do I take Indigo carmine 40 mg/5 mL, solution for injection?
Indigo carmine 40 mg/5 mL, solution for injection comes as injection containing 40mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Indigo carmine 40 mg/5 mL, solution for injection?
The active substance in Indigo carmine 40 mg/5 mL, solution for injection is indigo carmine.
Are there equivalent medicines to Indigo carmine 40 mg/5 mL, solution for injection?
Medicines with the same active substance, strength and form include: Blumyne 40 mg/5 mL, solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Indigo carmine 40 mg/5 mL, solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Indigo carmine 40 mg/5 mL, solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: indigo carmine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
This medicinal product is for diagnostic use only.
Indigo carmine is indicated in adults for the intra-operative detection of suspected ureteral injuries during abdominal and pelvic surgery.
4.2. Posology and method of administration
Posology
This medicinal product is to be injected by intravenous route. The recommended initial dosage is 1 ampoule of 5 mL by slow intravenous injection.
A second ampoule may be injected 20 to 30 minutes after the first injection if necessary.
Paediatric population
The efficacy and safety of Indigo carmine in children has not been established (see section 4.4).
Patients with renal impairment
Carmyne is not recommended for use in patients with glomerular filtration rate (GFR) < 30 mL/min (see section 4.4).
Elderly
No dosage adjustment is necessary.
Patients with liver impairment
The excretion of Indigo carmine is mainly renal. There is no data in patients with liver impairment, however no dosage adjustment is necessary.
Method of administration
Slow intravenous injection under monitoring of arterial pressure and heart rate.
Precautions to be taken before administering the medicinal product
Considering the dark blue colour of Indigo carmine, a filtration is necessary during the intravenous administration (for example a filter of 0.45 µm, with a filtering surface of at least 2.8 cm², or a filter of 0.2 µm with a filtering surface of 4.3 cm², composed of a hydrophilic polyethersulfone membrane).
4.3. Contraindications
Hypersensitivity to the active substance.
4.4. Special warnings and precautions for use
Special warnings
Indigotin (indigo carmine) may cause a transient elevation of blood pressure and reflex bradycardia especially in patients under general anaesthesia or under spinal anaesthesia. Rare idiosyncratic reactions with bradycardia and hypotension have also been reported. It is therefore necessary to monitor heart rate and blood pressure during and a few minutes after the injection.
Intravenous injection should be stopped if the following symptoms occur: bradycardia, tachycardia, hypotension, hypertension, rash or erythema, respiratory symptoms such as dyspnea or bronchospasm.
The efficacy and safety of Indigo carmine in children has not been established.
Carmyne has not formally been studied in patients with glomerular filtration rate (GFR) < 30 mL/min. Therefore, it should not be used in these patients with GFR < 30 mL/min.
Indigotin (indigo carmine) may interfere with pulse or cerebral oximetric methods.
A discolouration of urine may be observed following administration of indigotin (indigo carmine).
Precautions for use
Indigotin (indigo carmine) should be used with caution in case of:
• high blood pressure,
• low heart rate,
• heart rate and conduction disorders,
• concomitant use of medicines inducing bradycardia or affecting blood pressure or nitric oxide production,
• coronary disorders due to its peripheral vasoconstrictor effect.
The use of indigotin (indigo carmine) should be avoided in patients with:
• hemodynamic instability,
• uncontrolled heart failure,
• history of allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of indigotin (indigo carmine) in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Indigo carmine is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
It is unknown whether indigotin (indigo carmine) or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to abstain from indigotin (indigo carmine) administration taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
No fertility studies have been performed.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The most common adverse reactions of indigotin (indigo carmine) are mainly related to its alpha-adrenergic activity and are of cardiovascular origin.
Other idiosyncratic reactions such as changes in blood pressure or heart rate or anaphylactoid reactions have also been described. Serious adverse reactions of indigotin (indigo carmine) are very rare.
Frequencies are defined as:
Very common (≥ 1/10)
Common (≥ 1/100 to <1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to <1/1,000)
Very rare (<1/10,000)
Frequency not known (cannot be estimated from the available data)
Cardiac disorders
Very common:
• Hypertension (transient)
• Bradycardia
Very rare:
• Tachycardia
• Hypotension
• Atrioventricular block
Respiratory, thoracic and mediastinal disorders
Very rare:
• Dyspnea
• Bronchial hyperreactivity
Skin and subcutaneous tissue disorders
Very rare:
• Rash and erythema
• Skin discolouration
Immune system disorders
Very rare:
• Anaphylactoid reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
No case of overdose has been reported in the literature for doses up to 80 mg of indigotin (indigo carmine) administered intravenously.
Symptoms
An overdose could induce a hypertensive crisis and severe bradycardia.
Management
In case of overdose, a peripheral vasodilator therapy may be considered.
💬 Ask about this leaflet
Ask anything about Indigo carmine 40 mg/5 mL, solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.