TRANSIDERM NITRO Transdermal patch (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

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 ...

3. Pharmaceutical form

Transdermal patch.

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 ...

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 ...

4.3. Contraindications

Known hypersensitivity to nitroglycerin, and related organic nitrates or any excipient. Acute circulatory failure associated with marked hypotension (shock). Conditions associated with elevated intracranial ...

4.4. Special warnings and precautions for use

Warnings As with other nitrate preparations, when transferring the patient on long-term therapy to another form of medication, nitroglycerin should be gradually withdrawn and overlapping treatment started. ...

4.5. Interaction with other medicinal products and other forms of interaction

Concomitant administration of Transiderm Nitro and other vasodilators e.g PDE5 inhibitors such as sildenafil potentiates the blood pressure lowering effects of Transiderm Nitro. Concomitant treatment with ...

4.6. Fertility, pregnancy and lactation

Women of child-bearing potential There is no data supporting any special recommendations in women of child-bearing potential. Pregnancy Like any drug, Transiderm Nitro should be employed with caution during ...

4.7. Effects on ability to drive and use machines

Transiderm Nitro, especially at the start of treatment or dose adjustments, may impair the reactions or might rarely cause orthostatic hypotension and dizziness (as well as exceptionally syncope after ...

4.8. Undesirable effects

Adverse drug 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), ...

4.9. Overdose

Signs 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. Management ...

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 ...

5.2. Pharmacokinetic properties

Following a 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 ...

5.3. Preclinical safety data

Mutagenicity Standard mutagenicity tests provided contradictory results in vitro. Cell culture and in vivo studies revealed no evidence of mutagenic activity of nitroglycerin, and therefore its use is ...

6.1. List of excipients

Lactose Silicone oil Silica dioxide Ethylene-vinyl acetate copolymer Silicone-based adhesive (medical adhesive CH15)

6.2. Incompatibilities

None.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

None stated.

7. Marketing authorization holder

Novartis Pharmaceuticals UK Limited, Trading as Ciba Laboratories, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom

8. Marketing authorization number(s)

PL 00101/0464 PL 00101/0465

9. Date of first authorization / renewal of the authorization

22 June 2004

10. Date of revision of the text

23 December 2019

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