STROMECTOL TABLET 3 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IVERMECTIN

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

P02CF01

Dosage:

3 mg

Pharmaceutical form:

TABLET

Composition:

IVERMECTIN 3 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

MERCK SHARP & DOHME B.V.

Authorization status:

ACTIVE

Authorization date:

2002-04-24

Patient Information leaflet

STROMECTOL     

                    SGP-MK0933-T-062010 
(ivermectin, MSD) 

PHYSICIANS CIRCULAR 

TABLETS                            TRADEMARK 

STROMECTOL
®

(IVERMECTIN, MSD) 

INDICATIONS 


Ivermectin is indicated for the treatment
of intestinal strongyloidiasis. 

DOSAGE AND ADMINISTRATION 
Ivermectin is available as a 3-mg tablet.  The dosage table below shows the number of 3-mg tablets recommended for 
various body weights. Patients should take
tablets with water.(See CLINICAL STUDIES.) 

STRONGYLOIDIASIS (See TABLE 1)_ _
The recommended dosage of ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide 
approximately 200 

g of ivermectin per kg of body weight.  See TABLE 1 for dosage guidelines.  In general, additional 
doses  are  not  necessary.    However,  follow-up  stool  examinations  should  be  performed  to  verify  eradication  of 
infection.  (See CLINICAL STUDIES.) 

TABLE 1

Dosage Guidelines for Strongyloidiasis  
Dosage by WEIGHT 

BODY WEIGHT (kg) 
DOSE 
(approx. 200 

g/kg) 
(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 
 Approx. 200 µg/kg 

CLINICAL STUDIES 

Pharmacokinetics, Food Interaction study 

A multiple-dose (30 to 120 mg [333 to 2000 mcg/kg])
clinical safety study has been conducted to
assess the safety and 
pharmacokinetic properties of ivermectin in healthy volunteers.
 Subjects received oral doses of 30 to 120 mg (333 to 
2000 mcg/kg) ivermectin in a fasted state or 30 mg
(333 to 600 mcg/kg) ivermectin following a standard high-fat 
STROMECTOL 
2 

             SGP-MK0933-T-062010 
(iver

Summary of Product characteristics

S-SGP-MK0933-T-032021
PHYSICIANS CIRCULAR
Tablets Trademark
STROMECTOL®
(ivermectin, MSD)
INDICATIONS
•
Ivermectin is indicated for the treatment of intestinal
strongyloidiasis.
DOSAGE AND ADMINISTRATION
Ivermectin is available as a 3-mg tablet. The dosage table below shows
the number of 3-mg tablets
recommended for various body weights.
Patients
should take tablets
with
water. (See
CLINICAL
STUDIES.)
STRONGYLOIDIASIS (See TABLE 1)
The recommended dosage of ivermectin for the treatment of
strongyloidiasis is a single oral dose
designed to provide approximately 200 μ g of ivermectin per kg of
body weight. See TABLE 1 for dosage
guidelines. In general, additional doses are not necessary. However,
follow-up stool examinations should
be performed to verify eradication of infection. (See CLINICAL
STUDIES.)
TABLE 1
Dosage Guidelines for
Strongyloidiasis
Dosage by WEIGHT
BODY WEIGHT (kg)
DOSE
(approx. 200 μ g/kg)
(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
approx. 200 µg/kg
CLINICAL STUDIES
Pharmacokinetics, Food Interaction study
A multiple-dose (30 to 120 mg [333 to 2000 mcg/kg]) clinical safety
study has been conducted to assess
the safety and pharmacokinetic properties of ivermectin in healthy
volunteers. Subjects received oral
doses of 30 to 120 mg (333 to 2000 mcg/kg) ivermectin in a fasted
state or 30 mg (333 to 600 mcg/kg)
ivermectin following a standard high-fat (48.6 g of fat) meal.
Administration of 30 mg ivermectin following
a high-fat meal resulted in an approximate 2.5-fold increase in
bioavailability relative to administration of
30 mg ivermectin in the fasted state.
Strongyloidiasis
Efficacy and safety for the use of ivermectin in the treatment of
strongyloidiasis have been studied in two
controlled clinical studies using albendazole as the comparative
agent, and three controlled studies using
thiabendazole as the comparative agent. Efficacy, as measured by cure
rate, was defined as the absence
of larvae in follow-up stool examinations. Based