Rasilez Film Coated Tablet 150mg
Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
Taarifa za kipeperushi
(PIL)
16-09-2014
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Viambatanisho vya kazi:
Aliskiren
Inapatikana kutoka:
NOVARTIS (SINGAPORE) PTE LTD
ATC kanuni:
C09XA02
Kipimo:
150mg
Dawa fomu:
TABLET, FILM COATED
Njia ya uendeshaji:
ORAL
Dawa ya aina:
Prescription Only
Viwandani na:
Novartis Pharma Stein AG
Idhini ya tarehe:
2008-07-09
Taarifa za kipeperushi
RASILEZ
Renin inhibitor
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablet.
ACTIVE SUBSTANCE
The active substance is 2(S),4(S),5(S),7(S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-
hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide
hemifumarate (INN – Aliskiren hemifumarate).
One film-coated tablet contains 150 mg or 300 mg
aliskiren hemifumarate. .
Certain dosage strengths may not be available
in all countries.
ACTIVE MOIETY
Aliskiren
EXCIPIENTS
Standard film-coated tablet: Crospovidone; magnesium stearate; microcrystalline cellulose;
povidone; silica, colloidal anhydrous; hypromellose; macrogol; talc; iron oxide, black (E
172); iron oxide, red (E 172); titanium dioxide (E 171).
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of essential hypertension.
DOSAGE AND ADMINISTRATION
DOSAGE
GENERAL TARGET POPULATION
The recommended starting dose of Rasilez is 150 mg once daily. In patients whose blood
pressure is not
adequately controlled, the dose may be increased to 300 mg once daily.
The antihypertensive effect is substantially present within 2 weeks (85 to 90%) after initiating
therapy with 150 mg once daily.
Rasilez may be used alone or in combination with other antihypertensive agents (diuretics,
and calcium channel blockers) (See section PHARMACODYNAMICS). It must not be used
in combination with Angiotensin Converting Enzyme Inhibitors (ACEIs) or Angiotensin II
Receptor Blockers (ARB) in patients with type 2 diabetes mellitus. (see sections
CONTRAINDICATIONS and INTERACTIONS).
METHOD OF ADMINISTRATION
Patients should establish a routine pattern for
taking Ra
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