PIL
STROMECTOL
®
_Ivermectin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about STROMECTOL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
STROMECTOL against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT STROMECTOL
IS USED FOR
STROMECTOL is used to treat river
blindness (onchocerciasis) and
threadworm involving the intestines
(intestinal strongyloidiasis). These
are caused by worm infections. In
onchocerciasis the worm infection
mainly affects the skin, glands
(lymph nodes) and eyes. Changes to
the skin may include an itchy rash,
pale or dark patches, nodules (small
lumps under the skin), thickening of
the skin and/or loss of elasticity. The
infection can cause enlarged glands
in the neck, armpits or groin. The
infection can also affect the eye and
may cause conjunctivitis, a gritty or
painful eye and may lead to
blindness.
In the form of strongyloidiasis that is
treated with STROMECTOL, the
worm infection mainly affects the
intestines and skin. Symptoms which
may occur include itchy rash,
vomiting, diarrhoea and stomach
pain.
STROMECTOL works by killing the
developing worms.
STROMECTOL is also used to treat
scabies which is caused by the
Sarcoptes scabiei mite.
Infection with the scabies mite
causes discomfort and often intense
itching of the skin, particularly at
night, with irritating blisters or lumps
on the skin. Classical sites of
infestation are between the fingers,
the wrists, underarm areas, female
breasts (particularly the skin of the
nipples), stomach area, penis,
scrotum, and buttocks. Infants are
usually affected on the face, scalp,
palms and soles.
Scabies is usually spread person to
person via direct skin contact,
includin
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SPC
IPC-MK0933-T-062010
1
PRODUCT INFORMATION
STROMECTOL
TABLETS
(ivermectin 3 mg)
NAME OF THE MEDICINE
STROMECTOL
®
(ivermectin) 3 mg tablet
DESCRIPTION
Ivermectin is derived from the avermectins, a class
of highly active broad-spectrum antiparasitic
agents isolated from fermentation broths of _Streptomyces
avermitilis_.
Ivermectin is a white to yellowish-white
non-hygroscopic crystalline powder which is practically
insoluble in water, freely soluble in methanol, and soluble
in 95% ethanol.
The structural and molecular formulae follow.
Molecular Formulae:
Molecular Weight:
22, 23-dihydroavermectin B1
a
C48H74O14 (R=C2H5)
875.10
22, 23-dihydroavermectin B1
b
C47H72O14 (R=CH3)
861.07
Ivermectin
contains a minimum of 90% of 22, 23-dihydroavermectin B1
a
(where the R group is
ethyl) and a maximum of 10% of 22, 23-dihydroavermectin B1
b
(the R group is methyl).
STROMECTOL is supplied as a 3 mg
tablet. STROMECTOL tablets also contain microcrystalline
cellulose, pregelatinised maize
starch, magnesium stearate, butylated hydroxyanisole and citric
acid anhydrous.
IPC-MK0933-T-062010
2
PHARMACOLOGY
Ivermectin inhibits signal transmission from the ventral cord
interneurons to the excitatory motor
neurones in nematodes by stimulating release
of the inhibitory neurotransmitter, gamma-
aminobutyric acid (GABA) from pre-synaptic nerve
terminals. In arthropods, a similar mechanism
inhibits signal transmission at the neuromuscular junction. Ivermectin
does not readily penetrate the
CNS of mammals, and thus does
not interfere with mammalian GABA-dependent
neurotransmission.
PHARMACOKINETICS:
Absorption and Distribution:
Ivermectin is incompletely absorbed (~50% bioavailable relative to
an oral hydroalcoholic solution)
following oral doses
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