Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Novartis Pharmaceuticals UK Limited, Trading as Ciba Laboratories, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
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.
For dermal administration
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.
Transiderm Nitro 5 only:
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.
No specific information on use in the elderly is available; however no evidence exists to suggest that an alteration in dosage is required.
There is insufficient knowledge of the effects of Transiderm Nitro in children and therefore recommendations for its use cannot be made.
High doses of nitroglycerin may lead to severe hypotension and reflex tachycardia or to collapse and syncope. Methaemoglobinaemia has also been reported following accidental overdosage.
The nitrate effect of Transiderm Nitro can be rapidly terminated simply by removing the system(s).
Hypotension or collapse can be treated by elevation or, if necessary, compression bandaging of the patient’s legs.
36 months.
Store below 25°C.
Individual patches in a sealed pouch (made of paper/PE/AL/surlyn*).
Transiderm Nitro 5 only: 28 or 30 sealed patches in each cardboard container.
Transiderm Nitro 10 only: 28 sealed patches in each cardboard container.
* Aluminium 12µm ± 10%, polyethylene 16G/m² ± 20%, surlyn 20G/m² ± 15%.
None stated.
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