NTP-INDAPAMIDE TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

INDAPAMIDE

Tillgänglig från:

TEVA CANADA LIMITED

ATC-kod:

C03BA11

INN (International namn):

INDAPAMIDE

Dos:

2.5MG

Läkemedelsform:

TABLET

Sammansättning:

INDAPAMIDE 2.5MG

Administreringssätt:

ORAL

Enheter i paketet:

30/100

Receptbelagda typ:

Prescription

Terapiområde:

THIAZIDE-LIKE DIURETICS

Produktsammanfattning:

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

Bemyndigande status:

CANCELLED PRE MARKET

Tillstånd datum:

2015-08-06

Produktens egenskaper

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