NITRODERM TTS 10

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

GLYCERYL TRINITRATE

Inapatikana kutoka:

NOVARTIS ISRAEL LTD

ATC kanuni:

C01DA02

Dawa fomu:

PATCHES

Tungo:

GLYCERYL TRINITRATE 50 MG/PATCH

Njia ya uendeshaji:

TRANSDERMAL

Dawa ya aina:

Required

Viwandani na:

LTS LOHMANN THERAPIE SYSTEME AG, GERMANY

Eneo la matibabu:

GLYCERYL TRINITRATE

Matibabu dalili:

Prophylaxis of angina pectoris.

Idhini ya tarehe:

2021-01-14

Tabia za bidhaa

NIT API JUN21 V4.1
Page 1 of 11
NITRODERM
® TTS
(nitroglycerin)
25 mg or 50 mg transdermal patch
PRESCRIBING INFORMATION
1
TRADE NAME
NITRODERM
®
TTS 5
NITRODERM
®
TTS 10
2
DESCRIPTION AND COMPOSITION
ACTIVE SUBSTANCE
Nitroderm TTS contains Nitroglycerin (25mg or 50mg) in a transdermal
therapeutic system
(TTS).
LIST OF EXCIPIENTS
Lactose monohydrate, Dimeticone / Dimethicone, Silica, colloidal
anhydrous / Colloidal
silicon dioxide / Light Anhydrous Silicic Acid.
PHARMACEUTICAL FORM
Transdermal Patch
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 two systems are
available:
TABLE 2-1
NITRODERM TTS 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
liner
off-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
during normal use. After 12 hours, for example, each system has
delivered 10% of its original
nitroglycerin content. 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.
The following cross-sectional diagram shows the composition of
Nitroderm TTS.
NIT API JUN21 V4.1
Page 2 of 11
3
INDICATIONS
Prophylaxis of angina pectoris
4
DOSAGE AND ADMINISTRATION
GENERAL RULES
Nitroderm TTS is not intended for the immediate relief of acute
at