1. Name Of The Medicinal Product
TRANSIDERM NITRO® 5.
TRANSIDERM NITRO® 10.
2. Qualitative And Quantitative Composition
Transiderm Nitro 5: Nitroglycerin on lactose 250mg equivalent to nitroglycerin 25mg.
Transiderm Nitro 10: Nitroglycerin on lactose 500mg equivalent to nitroglycerin 50mg.
For excipients see section 6.1.
3. Pharmaceutical Form
Transdermal patch.
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylactic treatment of attacks of angina pectoris, as monotherapy or in combination with other anti-anginal agents.
Transiderm Nitro 5 only : Prophylactic treatment of phlebitis and extravasation secondary to venous cannulation for intravenous fluid and drug administration when the duration of treatment is expected to last for 2 days or longer.
4.2 Posology And Method Of Administration
For dermal administration
Adults:
Angina: Treatment should be initiated with one TRANSIDERM-NITRO 5 patch daily. If a higher dosage is required a TRANSIDERM-NITRO 10 patch may be substituted. The dosage may be increased to a maximum of two TRANSIDERM-NITRO 10 patches daily in resistant cases. TRANSIDERM-NITRO may be given either continuously, or intermittently with a patch off period of 8-12 hours, usually at night, during each 24 hour period. Development of tolerance or attenuation of therapeutic effect commonly occurs with prolonged or frequent administration of all long-acting nitrates. Recent evidence suggests that intermittent therapy with TRANSIDERM-NITRO may reduce the incidence of tolerance.
Prior to the use of intermittent therapy, the clinical benefits to the patients should be weighed against the risks of angina in the patch-free interval. In patients considered to be at risk, concomitant anti-anginal therapy should be implemented (see “Precautions”).
It is recommended that the patch is applied to the lateral chest wall. The replacement patch should be applied to a new area of skin. Allow several days to elapse before applying a fresh patch to the same area of skin. If acute attacks of angina pectoris occur, rapidly acting nitrates may be required.
Phlebitis and extravasation: One TRANSIDERM-NITRO 5 patch is to be applied distal to the site of intravenous cannulation at the time of venepuncture. The patch should be removed after 3-4 days and a new replacement patch applied to a different area of skin. Treatment with TRANSIDERM-NITRO should be discontinued once intravenous therapy has stopped.
Use in the elderly
No specific information on use in the elderly is available; however no evidence exists to suggest that an alteration in dosage is required.
Use in children
There is insufficient knowledge of the effects of TRANSIDERM-NITRO in children and therefore recommendations for its use cannot be made.
4.3 Contraindications
TRANSIDERM-NITRO should not be prescribed to patients hypersensitive to nitrates or to any excipient present in the product. Severe hypotension. Increased intracranial pressure. Myocardial insufficiency due to obstruction (eg in the presence of aortic or mitral stenosis or of constrictive pericarditis).
Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil have been shown to potentiate the hypotensive effects of nitrates and its co-administration with nitrates or nitric oxide donors is therefore contraindicated
4.4 Special Warnings And Precautions For Use
In recent myocardial infarction or acute heart failure, TRANSIDERM-NITRO should be employed only under careful surveillance.
As with all anti-anginal nitrate preparations, withdrawal of long-term treatment should be gradual, by replacement with decreasing doses of long-acting oral nitrates.
The TRANSIDERM-NITRO patch contains an aluminium layer. Therefore the patch must be removed before applying magnetic or electrical fields to the body during procedures such as MRI (Magnetic Resonance Imaging), cardioversion, DC defibrillation or diathermy treatment.
Caution should be exercised in patients with arterial hypoxaemia due to severe anaemia because, in such patients the biotransformation of nitroglycerin is reduced. Similarly, caution is called for in patients with hypoxaemia and a ventilation/perfusion imbalance due to lung disease or ischaemic heart failure.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
The possibility of increased frequency of angina during patch-off periods should be considered. In such cases, the use of concomitant anti-anginal therapy is desirable.
If tolerance to nitroglycerin patches develops, the effects of sublingual nitroglycerin on exercise tolerance may be partially diminished.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Concomitant treatment with other vasodilators, calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the blood pressure lowering effects of TRANSIDERM-NITRO.
Concurrent administration of TRANSIDERM-NITRO with dihydroergotamine may increase the bioavailability of dihydroergotamine and lead to coronary vasoconstriction.
The possibility that the ingestion of acetylsalicylic acid and non-steroidal anti-inflammatory drugs might diminish the therapeutic response to TRANSIDERM-NITRO cannot be excluded.
The hypotensive effects of nitrates are potentiated by concurrent administration of PDE5 inhibitors such as sildenafil.
4.6 Pregnancy And Lactation
As with all drugs, TRANSIDERM-NITRO should not be prescribed during pregnancy, particularly during the first trimester, unless there are compelling reasons for doing so.
It is not known whether the active substance passes into the breast milk. The benefits for the mother must be weighed against the risks for the child.
4.7 Effects On Ability To Drive And Use Machines
Postural hypotension has been reported rarely following initiation of treatment with TRANSIDERM-NITRO and care is advised when driving or operating machinery.
4.8 Undesirable Effects
Adverse reactions are ranked in descending order of frequency, as follows: Very common (=1/10); common (=1/100, <1/10); uncommon (=1/1000, <1/100); rare (=1/10,000, <1/1000); very rare (<1/10,000), including isolated reports.
Table 1
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Like other preparations, TRANSIDERM-NITRO may give rise to headache, which is due to cerebral vasodilation and is dose-dependent. Such headaches, however, may regress after a few days despite continuation of the therapy. If they do not disappear, they should be treated with mild analgesics. In cases where headaches are unresponsive to treatment, the dosage of nitroglycerin should be reduced or use of the product discontinued.
Upon removal of the patch, any slight reddening of the skin will usually disappear within a few hours. The application site should be changed on patch replacement to prevent local irritation.
Reflex tachycardia can be controlled by concomitant treatment with a beta-blocker.
4.9 Overdose
Signs:
High doses of glyceryl trinitrate are known to cause pronounced systemic side effects, eg a marked fall in blood pressure and reflex tachycardia resulting in collapse and syncope. Methemoglobinaemia has also been reported following accidental overdosage of nitroglycerin. However, with TRANSIDERM-NITRO, the release membrane will reduce the likelihood of overdosage occurring.
Management:
In contrast to long acting oral nitrate preparations, the effect of TRANSIDERM-NITRO can be rapidly terminated simply by removing the system. Any fall in blood pressure or signs of collapse that may occur, may be managed by general resuscitative measures.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC code: C01DA02
Nitroglycerin relaxes smooth muscle. It acts chiefly on systemic veins and large coronary arteries, with more predominant effects on the former. In angina pectoris the fundamental mechanism of action of nitroglycerin is based on an increase in venous capacitance leading to a decreased return of blood to the heart. Owing to this, preload and hence filling volume diminishes, resulting in a decreased myocardial oxygen requirement at rest and especially during exercise.
In the coronary arterial circulation nitroglycerin dilates extramural conductance and small resistance vessels. It appears to cause redistribution of coronary blood flow to the ischaemic subendocardium by selectively dilating large epicardial vessels and also relaxes vasospasm.
Nitroglycerin dilates the arteriolar vascular bed, as a result of which afterload and left ventricular systolic wall tension decrease, leading to a reduction in myocardial oxygen consumption.
5.2 Pharmacokinetic Properties
Following single application, plasma concentrations of nitroglycerin reach a plateau within 2 hours, which is maintained throughout the day until patch removal. The height of this plateau is directly proportional to the size of the system's drug-releasing area.
The same plasma levels are attained regardless of whether the system is applied to the skin of the upper arm, pelvis or chest. Upon removal of TRANSIDERM-NITRO the plasma level falls rapidly. After repeated application of TRANSIDERM-NITRO no cumulation occurs.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose, silicone oil, silica dioxide, ethylene-vinyl acetate coploymer, silicone-based adhesive (medical adhesive CH15).
6.2 Incompatibilities
None.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store below 25ºC.
6.5 Nature And Contents Of Container
Individual patches in a sealed pouch (made of paper/PE/AL/surlyn*). 28 sealed patches in each cardboard container.
* Aluminium 12µm ± 10%, polyethylene 16G/m2± 20%, surlyn 20G/m2± 15%.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Novartis Pharmaceuticals UK Limited
Trading as Ciba Laboratories
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
8. Marketing Authorisation Number(S)
Transiderm Nitro 5 : PL 00101/0464.
Transiderm Nitro 10 : PL 00101/0465.
9. Date Of First Authorisation/Renewal Of The Authorisation
22 June 2004
10. Date Of Revision Of The Text
23 September 2009
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