NTP-INDAPAMIDE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

INDAPAMIDE

Boleh didapati daripada:

TEVA CANADA LIMITED

Kod ATC:

C03BA11

INN (Nama Antarabangsa):

INDAPAMIDE

Dos:

2.5MG

Borang farmaseutikal:

TABLET

Komposisi:

INDAPAMIDE 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

THIAZIDE-LIKE DIURETICS

Ringkasan produk:

Active ingredient group (AIG) number: 0115402001; AHFS:

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2015-08-06

Ciri produk

PRODUCT MONOGRAPH
NTP-INDAPAMIDE
(Indapamide)
Tablets
USP
Diuretic/Antihypertensive Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 167238
Date of Preparation:
August 28, 2013
1
PRODUCT MONOGRAPH
NTP-INDAPAMIDE
(Indapamide)
Tablets
USP
THERAPEUTIC CLASSIFICATION
Diuretic/Antihypertensive Agent
ACTION AND CLINICAL PHARMACOLOGY
Indapamide is a diuretic antihypertensive agent. The mechanism whereby
indapamide exerts its
action in the control of hypertension is not completely elucidated:
both renal and extrarenal
actions may be involved. The renal site of action is the proximal part
of the distal tubule and the
ascending part of Henle's loop. Sodium and chloride ions are excreted
in approximately
equivalent amounts. The increased delivery of sodium to the distal
tubular exchange site results
in increased potassium excretion and hypokalemia.
Pharmacokinetics: Indapamide is rapidly and completely absorbed after
oral administration.
Peak blood levels are obtained after 1 to 2 hours. Indapamide is
concentrated in the erythrocytes
and is 79% bound to plasma proteins and to erythrocytes.
2
It is taken up by the vascular wall in smooth vascular muscle
according to its high lipid
solubility. Seventy per cent of a single oral dose is eliminated by
the kidneys and 23% by the
gastrointestinal tract. Indapamide is metabolized to a marked degree,
the unchanged product
representing approximately 5% of the total dose found in the urine
during the 48 hours following
administration. Elimination of indapamide from the plasma is biphasic
with half-lives of 14 and
25 hours respectively.
A
comparative
two-way,
single-dose
bioavailability
study
was
performed
between
NTP-
INDAPAMIDE (indapamide) 2.5 mg Tablets and Lozide
®
(indapamide) 2.5 mg Tablets. The
pharmacokinetic plasma data calculated for the two formulations are
tabulated below:
Geometric Mean
Arithmetic Mean (C.V.)
Parameter
NTP-INDAPAMIDE
(2 x 2.5 mg)
Lozide
®
**
(2 x 2.5 mg)
Percentage of
Lozide
®
AUCT (ngh/mL)
3374
3545