Adcirca

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Tadalafil 20mg

Inapatikana kutoka:

Eli Lilly and Company (NZ) Limited

INN (Jina la Kimataifa):

Tadalafil 20 mg

Kipimo:

20 mg

Dawa fomu:

Film coated tablet

Tungo:

Active: Tadalafil 20mg Excipient: Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry orange 32K97462 Purified talc Sodium laurilsulfate

Vitengo katika mfuko:

Blister pack, PVC/PE/Aclar/Al, starter pack, 14 tablets

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Evonik Corporation

Matibabu dalili:

ADCIRCA is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Blister pack, PVC/PE/Aclar/Al, starter pack - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/Aclar/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/Aclar/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C

Idhini ya tarehe:

2011-09-07

Tabia za bidhaa

 
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DATA SHEET 

ADCIRCA
®

(tadalafil) 

NAME OF THE MEDICINE 

ADCIRCA
®
 (tadalafil). 

Chemically, tadalafil is pyrazino[1’, 2’:1, 6]pyrido[3, 4-b]indole-1, 4-dione, 6-(1, 3-
benzodioxol-5-yl)-2, 3, 6, 7, 12, 12a-hexahydro-2-methyl-, (6R, 12aR)-. Tadalafil has the 
empirical formula C
22
H
19
N
3
O
4
 representing a molecular weight of 389.41. Tadalafil is a 
crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. The 
CAS number for tadalafil is 171596-29-5. 

Tadalafil has the following structural formula: 

DESCRIPTION 

ADCIRCA 20 mg tablets are orange, almond shaped tablets, for oral administration, marked 
"4467" on one side. The active ingredient in ADCIRCA tablets is tadalafil. ADCIRCA tablets 
also contain the following excipients: croscarmellose sodium, hydroxypropylcellulose, 
hypromellose, lactose, magnesium stearate, cellulose - microcrystalline, sodium lauryl 
sulfate, talc - purified, titanium dioxide,  glycerol triacetate, iron oxide yellow and iron oxide 
red.  

PHARMACOLOGY 

PharmacodynamicsTadalafil is a reversible inhibitor of cyclic guanosine monophosphate 
(cGMP) – specific phosphodiesterase type 5 (PDE5). Pulmonary arterial hypertension is 
associated with impaired release of nitric oxide by the vascular endothelium and consequent 
reduction of cGMP concentrations within the pulmonary vascular smooth muscle. PDE5 is the 
predominant phosphodiesterase in the pulmonary vasculature. Inhibition of PDE5 by tadalafil 
increases the concentrations of cGMP resulting in relaxation of the pulmonary vascular 
smooth muscle cell and vasodilation of the pulmonary vascular bed. 

N
H
N
O
O
H
N
O
O
CH
3

adcirca-ds-v1.1-09dec11 

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Studies 
in