STESOLID ENEMA 5 mg2.5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DIAZEPAM

Available from:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC code:

N05BA01

Dosage:

5 mg/2.5 ml

Pharmaceutical form:

ENEMA

Composition:

DIAZEPAM 5 mg/2.5 ml

Administration route:

RECTAL

Prescription type:

Prescription Only

Manufactured by:

PT Actavis Indonesia

Authorization status:

ACTIVE

Authorization date:

1988-08-30

Patient Information leaflet

STESOLID
Diazepam

1.
 Remove top by turning it
carefully 2-3 times without
pulling.
3.
 Insert the nozzle into the
anus, but only to the first mark 
for children 1-3 years old.
4.
 Always keep the tube
angled with nozzle downwards 
during administration. Like this.
NOTE: Do not squeeze the tube 
before it has been inserted.
5.
 When inserted, empty the 
tube by pressing with your 
thumb and index finger.
6.
 Keep pressing while
withdrawing the tube. Hold the 
buttocks together for a few 
moments to prevent seepage.
7.
 The small amount left in the 
tube will not affect the correct 
dose.
2.
 Put the patient on the
stomach or side with a cushion
under the hip. A small child can 
lie across your knees.
THERAPEUTIC GROUP
Anxiolyticum and anticonvulsant
COMPOSITION
Rectal tubes of 2.5 ml containing 5 and 10 mg of
diazepam in solution.
Also contains benzoic acid, sodium benzoate,
ethanol, propylene glycol, benzyl alcohol.
PHARMACOLOGY
Diazepam has an anxiolytic, sedative, amnestic,
hypnotic, anti convulsant, 
and muscle-relaxing activity.
Diazepam is easily absorbed from the rectal
mucosa. The effects is already seen within 5-10
minutes. Maximal plasma concentration is
attained within 10-20 minutes.
Diazepam is metabolised in the liver and its major 
metabolite, desmethyldiazepam, is
pharmacologically active. The half life of diazepam 
is within a range of 20 hours to a few days; that of 
desmethyldiazepam is longer. Diazepam is
distributed throughout the body and passes 
quickly the blood-brain barrier. In the blood 96-98
per cent of diazepam is bound to plasma proteins.
INDICATIONS
Stesolid rectal tubes are particularly well suited in 
the treatment of convulsion, including febrile 
convulsions in children, where the rapid onset of 
action is imperative.
CONTRAINDICATIONS
Myasthenia gravis
PREGNANCY/LACTATION
Should not be used
SIDE EFFETCS
The side effects are dose-related and are generally
mild and rare. The commonest is drowsiness. Less
common are dizziness, difficulties with 
co

Summary of Product characteristics

3
02.09.2020
KM
19.10.2020
KM
200x210 mm
Actavis Jakarta
9pt
02.09.2020
1.
2.
3.
1. black
2.
3.
4.
5.
6.
AAAM4006 - Diazepam 5 mg -, PIL, Singapore
Therapeutic
g
r
oup
Anxiolyticum and
anticonvulsant
C
omposition
Rectal tubes
of
2.5
ml
containing
5
and 10
mg of
diazepam
in
solution.
Also contains benzoic
acid
,
sodium
benz
oa
t
e
,
ethanol
,
propylene
gly
c
ol
,
benzyl
alc
ohol
.
Pharmacology
Diazepam has an
anxiolytic
,
seda
tiv
e
,
amnestic
,
hypnotic
,
anti
convulsant,
and muscle-relaxing
ac
tivit
y
.
Diazepam is easily absorbed
from the rectal
mucosa. The effects is
already seen
within 5-10
minut
es
.
Maximal plasma concentration
is
attained
within
10-20
minut
es
.
Diazepam is metabolised
in the
liver and
its major metabolit
e
,
desmethyldiazepam,
is
pharmacologically
ac
tiv
e
.
The half
life
of
diaz
epam
is
within
a range
of
20 hours
to
a
few
days;
that of
desmethyldiazepam is
longer
.
Diazepam
is distributed throughout
the body
and
passes
quickly
the
blood-brain
bar
r
ier
.
In
the blood
96-98
per cent
of
diazepam is
bound to
plasma pr
ot
eins
.
Indications
Stesolid rectal tubes are particularly
well
suited
in
the
treatment
of
convulsion,
including febrile
convulsions
in
children, where
the
rapid onset
of
action is
imper
a
tiv
e
.
C
on
tr
aindica
tions
Myasthenia
gravis
Pregnancy/lactation
Should
not be used
Side
effects
The side effects are
dose
-r
ela
t
ed
and are
generally mild
and
r
ar
e
.
The commonest is dr
o
w
siness
.
L
ess
common
are dizziness,
difficulties
with
concentration, and ataxia. Elderly patients
are
especially susceptible
to
these side
eff
ec
ts.
Paradoxical
r
eac
tions
,
such as
excitation,
aggressiveness
and hallucinations are rarely seen.
Confusion may occur
in
elderly patients
taking high
doses.
Dosage
Adult
:
10
-
20
mg
Children 6 -
12 years
of
age:
10
mg
1 - 5 years of age :
5 mg
The dosage may
be
r
epea
t
ed
if
nec
essar
y
.
I
n
t
er
ac
tions
Disulfiram, cimetidine and omeprazole
increases
the
effect
of
diazepam.
R
ifampicin
increases
the
clearanc
e
of diazepam.
Premedication
with
d