If arterial blood pressure drops below 99mmHg and if heart rate increases above 10% of its initial value, administration should be discontinued to allow a return to pre-treatment levels. If hypotension persists, measures should be taken to increase blood pressure.
Use of Cardix 0.05%is contra-indicated in patients with known hypersensitivity to nitrates, marked anaemia, cerebral haemorrhage, trauma, hypovolaemia and severe hypotension.
Cardix 0.05% must not be used in cases of circulatory collapse or low filling pressure.
Treatment of cardiogenic shock with Cardix 0.05% should only be undertaken if means of maintaining an adequate diastolic pressure is available.
Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contra-indicated.
The use of PVC giving sets and containers should be avoided as significant losses of the active ingredient by adsorption can occur.
Headache, nausea and tachycardia may occur during administration. Consistent with the known vasodilatory effects of Cardix, a sharp fall in the systemic arterial pressure may occur requiring close attention to pulse and blood pressure during administration.
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.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
- Treatment of unresponsive left ventricular failure, secondary to acute myocardial infarction.
- Unresponsive left ventricular failure of various aetiologies.
- Severe or unstable angina pectoris.
- To facilitate or prolong balloon inflation and to prevent or relieve coronary spasm during percutaneous transluminal coronary angioplasty.
Cardix is a potent venodilator and arterial dilator. It reduces systemic arterial pressure in a dose-related manner and, by causing peripheral venous pooling, reduces venous return and hence ventricular filling pressure and cardiac workload. Like all other nitrates, Cardix dilates coronary arteries and relieves coronary artery spasm. An attenuation of the hypotensive and venodilator effects may be observed during long term therapy.
Plasma protein binding of Cardix is about 30% and the volume of distribution is large (reported at between 100 and 600 litres).
Mean half-life is about 1 hour but will be prolonged after chronic dosing. Metabolism of Cardix occurs in the liver by denitration and glucuronidation. Both the 2- and the 5- mononitrates are biologically active. Only traces of the unchanged drug are eliminated in the urine.
About 80% of the dose of Cardix can be recovered as metabolites in the urine within 24 hours.
Cardix 0.05% should be used with caution in patients who are predisposed to closed angle glaucoma, and in patients suffering from hypothyroidism, malnutrition, severe liver or renal disease or hypothermia.
None stated.
Avoid administration through PVC tubing and giving sets, because of adsorption of ISDN into plastic.
Intravenous administration: Dosage should be adjusted according to patient response. Typically, a dose of between 2mg and 12 mg per hour is suitable, although doses of up to 20mg per hour may be necessary.
Cardix 0.05% can be administrated undiluted by slow intravenous infusion using a syringe pump.
Intracoronary administration: Cardix 0.05% can be injected directly by this route according to the proposed dosage schedule. The usual dose is 1mg given as a bolus injection prior to balloon inflation. Additional doses may be given, not exceeding 5mg over 30 minutes.
The safety and efficacy of Cardix 0.05% has not been established in children.
No modifications to the dosage are necessary for elderly patients.
Cardix 0.05% is presented in 50mL vials intended for single use only.
The injection is for single dose use only.
The injection should not be used if particles are present.
Cardix 0.05% may be administered undiluted. Once opened, the product should be used immediately and any unused drug discarded.
Cardix 0.05%is compatible with commonly employed infusion fluids. It is compatible with glass infusion bottles and infusion packs made from polyethylene. A syringe pump with a glass or plastic syringe may also be used for infusion.
Cardix solutions diluted with Sodium Chloride Injection BP or Glucose Injection BP have been shown to be chemically and physically stable for 72 hours at 25°C, when stored in polypropylene or glass containers, protected from light.
From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
