SWILIX SR TABLET 1.5MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Indapamide

Available from:

GOLDPLUS UNIVERSAL PTE LTD

ATC code:

C03BA11

Pharmaceutical form:

TABLET, FILM COATED, EXTENDED RELEASE

Composition:

Indapamide 1.50mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Ind-Swift Limited

Authorization status:

ACTIVE

Authorization date:

2023-03-30

Summary of Product characteristics

SWILIX SR
(INDAPAMIDE SUSTAINED RELEASE TABLETS 1.5MG)
COMPOSITION:
Each sustained release tablet contains:
Indapamide USP/Ph. Eur. 1.5mg
PRODUCT DESCRIPTION:
White colored, round shaped, biconvex, film coated tablets, plain on
both sides.
LIST OF EXCIPIENTS:
_Tablet Core:_
Lactose Monohydrate, Pregelatinized Maize Starch, Purified Water,
Hypromellose
(Methocel K 4 M Premium), Colloidal Anhydrous Silica and Magnesium
Stearate
_Tablet Film Coat: _
Hypromellose (Methocel E 5 LV Premium), Macrogol 6000, Titanium
Dioxide
and Purified Water
DOSAGE FORM:
Sustained Release Tablets
PRESENTATION:
- Alu-Alu blister pack of 10 tablets, 3 blister packs in a carton
along with insert.
- Alu-Alu blister pack of 10 tablets, 100 blister packs per box.
Not all presentations may be available locally.
PROPERTIES:
Indapamide is an oral antihypertensive/diuretic. Its chemical name is
3-(aminosulfonyl)-4-chloro-
N-(2,3-dihydro-2-methyl-1H–indol-yl)benzamide. The molecular weight
is 365.83. Indapamide is
a White to yellowish-white crystalline powder. Its chemical structure
is as follows:
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS:
Pharmacotherapeutic group: Sulfonamides, plain ATC code: C03BA11
MECHANISM OF ACTION
Indapamide is a sulfonamide derivative with an indole ring,
pharmacologically related to thiazide
diuretics, which acts by inhibiting the reabsorption of sodium in the
cortical dilution segment. It
increases the urinary excretion of sodium and chlorides and, to a
lesser extent, the excretion of
potassium and magnesium, thereby increasing urine output and having an
antihypertensive action.
PHARMACODYNAMIC EFFECTS
Phase II and III studies using monotherapy have demonstrated an
antihypertensive effect lasting
24 hours. This was present at doses where the diuretic effect was of
mild intensity.
The antihypertensive activity of indapamide is related to an
improvement in arterial compliance
and a reduction in arteriolar and total peripheral resistance.
Indapamide reduces left ventricular hypertrophy.
Thiazide and related diuretics hav