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Sdhc isosorbide 0.1% ds10/

ISOSORBIDE DINITRATE INJECTION
1mg per ml (0.1%)
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
NAME OF THE MEDICINAL PRODUCT
Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 1mg of isosorbide dinitrate (0.1%w/v)Each 10ml ampoule contains 10mg of isosorbide dinitrate and 36mg of sodium.
Each 50ml vial contains 50mg of isosorbide dinitrate and 180mg of sodium.
PHARMACEUTICAL FORM
Concentrate for solution for injection.
CLINICAL PARTICULARS
Therapeutic indications
• Treatment of unresponsive left ventricular failure, secondary to acute myocardial infarction. • Unresponsive left ventricular failure of various aetiologies.
• To facilitate or prolong balloon inflation and to prevent or relieve coronary spasm during percutaneous transluminal coronary angioplasty. Posology and method of administration
Isosorbide Dinitrate 0.1% is a concentrated solution. It should never be injected directly and must be diluted.
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 12mg per hour is
suitable, although doses of up to 20mg per hour may be necessary.
Prepared admixtures are always given by intravenous infusion or using a syringe pump incorporating a glass or rigid plastic syringe. The patient’s blood pressure and pulse should be monitored closely during administration.
Intracoronary administration: A dilution of 50% is recommended. 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 Isosorbide Dinitrate 0.1% has not been established in children. No modifications to the dosage are necessary for elderly patients. Isosorbide Dinitrate 0.1% is presented in 10ml ampoules and 50ml vials intended for single use only. Contra-indications
Use of Isosorbide Dinitrate 0.1% is contra-indicated in patients with known hypersensitivity to nitrates, marked anaemia, cerebral haemorrhage,trauma, hypovolaemia and severe hypotension. Isosorbide Dinitrate 0.1% must not be used in cases of circulatory collapse or low filling pressure. Treatment of cardiogenic shock with Isosorbide Dinitrate 0.1% should only be undertaken if means of maintaining an adequate diastolicpressure 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.
Special warnings and precautions for use
Isosorbide Dinitrate 0.1% 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.
Interactions with other medicaments and other forms of interactions
Some of the effects of alcohol may be potentiated by this medication. The effects of anti-hypertensive drugs may be enhanced. Hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil (Viagra). This might also occur with neuroleptics and tricyclic antidepressants.
Pregnancy and lactation
The safety of this medicinal product for human use in pregnancy has not been established. However, no data have been reported that suggest adverse effects occur as a result of using isosorbide dinitrate during pregnancy. Isosorbide dinitrate should only be used during pregnancy and lactation if the benefits of treatment outweigh the possible hazards. Effects on ability to drive and use machines
Undesirable effects
Headache, nausea and tachycardia may occur during administration. Consistent with the known vasodilatory effects of isosorbide dinitrate, a sharp fall in the systemic arterial pressure may occur requiring close attention to pulse and blood pressure during administration. Overdose
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 pretreatment levels. If hypotension persists, measures should be taken to increase blood pressure.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Isosorbide dinitrate 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, isosorbide dinitrate dilates coronary arteries and relieves coronary artery spasm. An attenuation of the hypotensive and venodilator effects may be observed during long term therapy. Pharmacokinetic properties
Plasma protein binding of isosorbide dinitrate 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 isosorbide dinitrate 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 isosorbide dinitrate can be recovered as metabolites in the urine within 24 hours. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics. PHARMACEUTICAL PARTICULARS
List of excipients
Incompatibilities
The use of PVC giving sets and containers should be avoided as significant losses of the active ingredient by adsorption can occur.
Shelf-life
After first opening: once opened, the product should be used immediately and any unused drug discarded. Special precautions for storage
Keep container (ampoules or vials) in the outer carton to protect from light. Store vials upright.
Nature and contents of container
Isosorbide Dinitrate 0.1% is presented in 10ml clear Type I glass ampoules and in 50ml vials made from clear Type II glass, sealed with abromobutyl rubber stopper and an aluminium tamper proof flip-top cap. Each outer carton contains 10 ampoules or vials.
Instructions for use/handling
The injection is for single dose use only. The injection should not be used if particles are present. Isosorbide Dinitrate 0.1% is a concentrate. Once opened, the product should be used immediately and any unused drug discarded.
Isosorbide Dinitrate 0.1% 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.
Isosorbide Dinitrate 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 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 incontrolled and validated aseptic conditions. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
South Devon HealthcareTorbay PMULong RoadPaigntonDevon TQ4 7TW MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATE OF (PARTIAL) REVISION OF THE TEXT

Source: http://www.torbaypmu.nhs.uk/Products/LicencedProducts/Documents/ISDN%200.1%20DS10-3.pdf

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