Adcirca
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
07-01-2013
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Active ingredient:
Tadalafil 20mg
Available from:
Eli Lilly and Company (NZ) Limited
INN (International Name):
Tadalafil 20 mg
Dosage:
20 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Tadalafil 20mg Excipient: Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry orange 32K97462 Purified talc Sodium laurilsulfate
Units in package:
Blister pack, PVC/PE/Aclar/Al, starter pack, 14 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Evonik Corporation
Therapeutic indications:
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.
Product summary:
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
Authorization date:
2011-09-07
Summary of Product characteristics
adcirca-ds-v1.1-09dec11
Page 1 of 19
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
Page 2 of 19
Studies
in
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