RATIO-DOCUSATE SODIUM SYRUP

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DOCUSATE SODIUM

MAH:

TEVA CANADA LIMITED

ATC_code:

A06AA02

INN:

DOCUSATE SODIUM

dosage:

20MG

pharmaceutical_form:

SYRUP

composition:

DOCUSATE SODIUM 20MG

administration_route:

ORAL

units_in_package:

25ML/500ML

prescription_type:

OTC

therapeutic_area:

CATHARTICS AND LAXATIVES

leaflet_short:

Active ingredient group (AIG) number: 0104351003; AHFS:

authorization_status:

APPROVED

authorization_date:

2013-06-10

SPC

PRESCRIBING INFORMATION
RATIO-DOCUSATE SODIUM
DOCUSATE SODIUM USP
20 MG / 5 ML SYRUP
100 MG / 25 ML SYRUP UNIDOSE
STOOL SOFTENER
TEVA CANADA LIMITED
DATE OF PREPARATION:
30 NOVOPHARM COURT
June 10, 2013
TORONTO, ONTARIO
M1B 2K9, CANADA
Control #: 165314
Page 2
PRESCRIBING INFORMATION
RATIO-DOCUSATE SODIUM
DOCUSATE SODIUM USP
20 MG / 5 ML SYRUP
100 MG / 25 ML SYRUP UNIDOSE
STOOL SOFTENER
ACTIONS AND CLINICAL PHARMACOLOGY
RATIO-DOCUSATE SODIUM is an anionic surfactant with emulsifying,
wetting and
dispersing properties. In recommended oral doses, it lowers surface
tension in the
gastrointestinal tract, permitting water and fats to penetrate and
soften fecal matter. It
also appears to stimulate the secretion of water and electrolytes in
the intestine.
The extent to which orally administered docusate salts are absorbed
has not been
determined, but these drugs appear to be absorbed to some extent in
the duodenum
and jejunum and subsequently excreted in bile.
Docusate agents do not interfere with the absorption of nutrients from
gastrointestinal
tract; however they increase the systemic absorption and the hepatic
intake of lipids and
other drugs administered concurrently, as well as increasing their
toxicity.
By increasing intestinal motility, RATIO-DOCUSATE SODIUM may
potentially decrease
transit time of concomitantly administered oral drugs and thereby
decreasing their
absorption.
Page 3
INDICATIONS AND CLINICAL USE
The management of constipation due to hard stools. In painful
anorectal conditions, in
cardiac and other conditions in which maximum ease of passage is
desirable to avoid
difficult or painful defecation and when peristaltic stimulants are
contraindicated. Stool
softening generally occurs within 1 to 3 days following initiation of
therapy.
CONTRAINDICATIONS
Presence of abdominal pain, nausea, fever or vomiting.
PRECAUTIONS
Laxatives should not be given to children under 6 years of age unless
prescribed by a
physician. Since children are not usually able to describe their
symptoms precisely,
proper diagnosi