Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland LOCAL REPRESENTATIVE: Novartis Pharma Services Inc., Methonis Tower, 73 Archibishop Makarios III Avenue, 1070 Nicosia ...
Prophylactic treatment of attacks of angina pectoris, as monotherapy or in combination with other anti-anginal agents.
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.
Angina: Treatment should be initiated with one NITRODERM TTS 5 patch daily. If a higher dosage is required a NITRODERM TTS 10 patch may be substituted. The dosage may be increased to a maximum of two NITRODERM TTS 10 patches daily in resistant cases. NITRODERM TTS 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 NITRODERM TTS 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 NITRODERM TTS 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 NITRODERM TTS 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 NITRODERM TTS in children and therefore recommendations for its use cannot be made.
High doses of glyceryl trinitrate may lead to severe hypotension and reflex tachycardia or to collapse and syncope. Methemoglobinaemia has also been reported following accidental overdosage of nitroglycerin.
The effect of NITRODERM TTS can be rapidly terminated simply by removing the system.
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*). 10, 28 or 30 sealed patches in each cardboard container.
Not all pack sizes may be marketed.
Each Nitroderm TTS patch is sealed in a separate sachet with a tear-off edge to facilitate removal. After removing the white protective backing, apply the Nitroderm TTS patch to a clean, non-hairy, dry area of intact skin on the trunk or upper arm. Hold the patch in position for 10-20 seconds with the palm of the hand. Switch application sites daily, wait several days before using the same area again.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
