Stromectol
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
15-09-2023
Summary of Product characteristics
(SPC)
15-09-2023
Active ingredient:
Ivermectin 3mg
Available from:
Merck Sharp & Dohme (New Zealand) Limited
INN (International Name):
Ivermectin 3 mg
Dosage:
3 mg
Pharmaceutical form:
Tablet
Composition:
Active: Ivermectin 3mg Excipient: Butylated hydroxyanisole Citric acid Magnesium stearate Microcrystalline cellulose Starch
Units in package:
Blister pack, Aluminium foil, 4 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Hovione PharmaScience Limited
Therapeutic indications:
· Treatment of intestinal strongyloidiasis (anguillulosis). · Treatment of proven suspected microfilaraemia in patients with lymphatic filariasis caused by Wuchereria bancrofti. · Treatment of human sarcoptic scabies after prior treatment has failed. Treatment is justified when the diagnosis of scabies has been established clinically and/or by parasitological examination. Without formal diagnosis, treatment is not justified in case of pruritus.
Product summary:
Package - Contents - Shelf Life: Blister pack, Aluminium foil - 4 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, Aluminium foil - 20 tablets - 24 months from date of manufacture stored at or below 30°C
Authorization date:
2003-07-02
Patient Information leaflet
NEW ZEALAND CONSUMER MEDICINE INFORMATION
1
STROMECTOL
®
ivermectin
3 mg tablet
WHAT IS IN THIS LEAFLET
This leaflet answers some common
ques
tions about
STROMECTOL
. It does not contain
all the available information.
It does not take the place of talking to y
our doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
STROMECTOL
against the be
nefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor
or pha
rmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT
STROMECTOL
IS USED FOR
STROMECTOL
is
an antiparasit
ic me
dicine used to treat the following infection
:
•
Treatment
of intestinal strongyloidiasis
.
•
Treatment of
parasites in th
e blood or tissue
caused by Wuchereria bancrofti.
•
Treatment of human scabies
after prior treatment has failed
.
Intestinal Strongyloidi
asis
Strongyloidiasis is an infection caused by the roundworm
Strongyloides stercoralis
. This
tiny worm is barely visible
to the naked eye.
Exposure occurs when skin has direct contact
with contaminated soil. Young roundworms penetrate the skin. They
migra
te through the
bloodstream to the lungs and up the large airways. The worms are then
swallowed, and
the young worms mature
and bury themselves into the intestinal wall. Adult roundworms
begin producing eggs in the intestines.
Wuchereria bancrofti
This is a para
site that is carried a
nd transmitted by the mosquito
.
It travels through the
bloodstream and settles in the lymph and
tissue of the patient, this can lead to fever and
severe inflammation around the area the parasite has migrated to.
Human Scabies
Scabies is a
n infectious disease of the skin caused by a mite barely visible to
the human
eye called
Sarcoptes scabiei var ho
minis.
The mite burrows into the skin and causes a
rash like reaction which can be very itchy and uncomfortable for the
patient.
Human
scab
ies is almost always caught from another person by close contact.
HOW
STROMECTOL WORKS
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
1
PRODUCT
NAME
STROMECTOL
®
ivermectin tablet
s
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ivermectin 3 mg tablet
s
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
A white, round, flat tablet with a bevelled edge, engraved with MSD on
one side and 32
on
the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Treatment of intestinal strongyloidiasis (
anguillulosis).
•
Treatment of proven suspected microfilaraemia in patients with
lymphatic filariasis
caused by
Wuchereria bancrofti
.
•
Treatment of human sarcoptic scabies after prior treatment has failed.
Treatment is
justified when the diagnosis of scabies
has been established clinically and/or by
parasitological examination.
Without formal diagnosis, treatment is not justified in
case of pruritus.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSE
Treatment of intestinal strongyloidiasis
The recommended dosage is one single oral dose of 200
micrograms of ivermectin
per kg
body weight.
For guidance, the dose, as determined by the patient's weight, is as
follows:
BODY
WEIGHT (kg)
DOSE
Number of 3
mg tablets
15 to 24
one
25 to 35
Two
36 to 50
Three
51 to 65
Four
66 to 79
Five
≥80
Six
Treatment of
microfilaraemia caused by Wuchereria bancrofti
The recommended dosage for mass distribution for the treatment of
microfilaraemia
caused by
Wuchereria bancrofti
is a single oral dose once every
6
months designed to
provide approximately 150 to
200
µg/kg of body weight.
In endemic areas where treatment can only be administered once every
12
months, the
recommended dosage is 300 to
400
µg/kg of body weight to maintain adequate
suppression of microfi
laraemia in treated patients.
For guidance, the dose, as determined by the patient's weight, is as
follows:
BODY
WEIGHT(kg)
DOSE when given once every
6 months
Number of
3 mg tablets
DOSE when given once every
12 months
Number of
3 mg tablets
15 to 25
One
Two
26 to 44
Two
four
45 to 64
Three
Six
65 to 84
Four
eight
Alternatively
and if no scales are available
Read the complete document
