Nitroderm TTS 5

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Glyceryl trinitrate 25mg (releasing 5mg/24h)

Available from:

Sandoz New Zealand Limited

INN (International Name):

Glyceryl trinitrate 25 mg (releasing 5mg/24h)

Dosage:

5 mg/24h

Pharmaceutical form:

Transdermal patch

Composition:

Active: Glyceryl trinitrate 25mg (releasing 5mg/24h)

Units in package:

Sachet, laminate, 1 x 10, 10 patches

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Dynamit Nobel GmbH

Therapeutic indications:

Treatment of angina pectoris as monotherapy or in combination with other anti-anginal drugs such as beta-blockers and/or calcium antagonists.

Product summary:

Package - Contents - Shelf Life: Sachet, laminate, - 10 patches - 36 months from date of manufacture stored at or below 30°C - Sachet, laminate, - 30 patches - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1983-03-10

Patient Information leaflet

___________________________________________________________________________________________________
Nitroderm TTS

1
NITRODERM TTS

_5mg and 10mg transdermal patches _
_glyceryl trinitrate_
_____________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
_____________________
WHAT IS IN THIS LEAFLET
__________________________________
This leaflet answers some common
questions about Nitroderm TTS
.
It does not contain all the available
information
.
It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Nitroderm TTS
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
_______________________
WHAT NITRODERM TTS IS
USED FOR
________________________
Nitroderm TTS is an adhesive patch
that delivers a medicine called
nitroglycerin through the skin and
into the bloodstream.
Nitroderm TTS is used to prevent or
reduce the frequency of angina
attacks (chest pain or discomfort). .
Nitroderm TTS is also used as a
supplementary medicine for the
treatment of patients suffering from
heart failure who do not respond
adequately to conventional therapy.
Nitroderm TTS belongs to a group of
medicines called nitrates. Nitrates
work by widening blood vessels,
letting more blood and oxygen reach
the heart.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.

Summary of Product characteristics

1
230828-Nitroderm TTS-ds
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
NITRODERM® TTS 5: 25 mg Transdermal Patch
NITRODERM® TTS 10: 50 mg Transdermal Patch
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1,2,3-Propanetriol trinitrate (= nitroglycerin), 25 mg or 50 mg in a
transdermal therapeutic
system (TTS). Nitroglycerin is an organic nitrate derivative.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Flat multilayer system designed to deliver nitroglycerin continuously
through a release
membrane following application to the skin. The release membrane
limits delivery through
hyperpermeable skin. The active substance penetrates the skin and thus
becomes directly
bioavailable to the systemic circulation at relatively constant
concentrations during the
recommended application period. The following three systems are
available:
TABLE 1
NITRODERM PHARMACEUTICAL FORMS
NITRODERM TTS 5
NITRODERM TTS 10
Nitroglycerin content
25 mg
50 mg
Drug-releasing area
10 cm
2
20 cm
2
Imprint (backing side)
CG
CG
DOD
DPD
Colour of the release lineroff-white to yellowish
The numeric components of the product designations TTS 5 and TTS 10
denote the nominal
amount of nitroglycerin in mg delivered by the system per 24 hours.
The remainder of the nitroglycerin in each system serves as a reserve
and is not delivered in
normal use. After 12 hours, for example, each system has delivered 10%
of its original content
of nitroglycerin. Since nitroglycerin is released from Nitroderm TTS
at a constant rate per cm

,
the dose administered is related to the size of the drug-releasing
area. The nominal rate of
nitroglycerin release in vivo is approximately 20-25 microgram/cm

.h.
2
230828-Nitroderm TTS-ds
The following cross-sectional diagram shows the composition of
Nitroderm TTS.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF ANGINA PECTORIS
As monotherapy or in combination with other anti anginal drugs such as
beta blockers and/or
calcium antagonists.
TREATMENT OF CONGESTIVE HEART FAILURE
As supplementary medi