ENABLEX 7,5 mg TABLET

Quốc gia: Nam Phi

Ngôn ngữ: Tiếng Anh

Nguồn: South African Health Products Regulatory Authority (SAHPRA)

Sẵn có từ:

Pharmacare Limited û Woodmead

Liều dùng:

See ingredients

Dạng dược phẩm:

TABLET

Thành phần:

EACH TABLET CONTAINS DARIFENACIN HYDROBROMIDE EQUIVALENT TO DARIFENACIN 7,5 mg

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2007-05-02

Đặc tính sản phẩm

_ZA_ENABTAB_0602_00 _
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_Page 1 of 16 _
1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
ENABLEX 7,5 MG (controlled-release tablet)
ENABLEX 15 MG (controlled-release tablet)
COMPOSITION
ENABLEX 7,5 MG:
Each film-coated controlled-release tablet of ENABLEX 7,5 mg contains
8,93 mg of
darifenacin as a hydrobromide salt (equivalent to 7,5 mg of
darifenacin free base).
_Excipients: _
Calcium hydrogen phosphate anhydrous, hypromellose, macrogol,
magnesium stearate, talc,
titanium dioxide (C.I. 77891)
Sugar free
ENABLEX 15 MG:
Each film-coated controlled-release tablet of ENABLEX 15 mg contains
17,85 mg of
darifenacin as a hydrobromide salt (equivalent to 15 mg of darifenacin
free base).
_ZA_ENABTAB_0602_00 _
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_Excipients: _
Calcium hydrogen phosphate anhydrous, hypromellose, iron oxide yellow
(C.I. 77492), iron
oxide red (C.I. 77491), macrogol, magnesium stearate, talc, titanium
dioxide (C.I. 77891)
Sugar free
CATEGORY AND CLASS
A 5.4 Medicines affecting autonomic functions - Cholinolytics
(Anticholinergics)
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Darifenacin is a muscarinic M3 selective receptor antagonist that
_in-vitro_ exhibits 9 to 59 fold
selectivity for the human M3 receptor over human M1, M2, M4 and M5
receptors. The M3
receptor is the major subtype that controls the detrusor muscle
contraction in the bladder,
colonic mobility and salivary flow.
In cystometric studies performed with darifenacin in patients with
involuntary bladder
contractions, increased bladder capacity as demonstrated by an
increased volume threshold
for unstable contractions and diminished frequency of unstable
detrusor contractions after
darifenacin treatment, was shown.
PHARMACOKINETIC PROPERTIES
_Absorption: _
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_Page 3 of 16 _
Darifenacin is almost completely (> 98 %) absorbed after oral
administration, although oral
bioavailability is