A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Stromectol Side Effects, and Drug Interactions - Ivermectin
Stromectol Side Effects, and Drug Interactions - Ivermectin
SIDE EFFECTS
Strongyloidiasis
In four clinical studies involving a total of 109 patients given either
one or two doses of 170 to 200 µg/kg of STROMECTOL, the following adverse
reactions were reported as possibly, probably, or definitely related to
STROMECTOL:
Body as a whole: asthenia/fatigue (0.9 %), abdominal pain
(0.9 %)
Gastrointestinal: anorexia (0.9%), constipation (0.9%),
diarrhea (1.8 %), nausea (1.8 %), vomiting (0.9 %)
Nervous System/Psychiatric: dizziness (2.8 %), somnolence
(0.9 %), vertigo (0.9 %), tremor (0.9 %)
Skin: pruritus (2.8 %), rash (0.9 %), and urticaria (0.9
%)
In comparative trials, patients treated with STROMECTOL experienced more
abdominal distention and chest discomfort than patients treated with albendazole.
However, STROMECTOL was better tolerated than thiabendazole in comparative
studies involving 37 patients treated with thiabendazole.
The Mazzotti-type and ophthalmologic reactions associated with the treatment
of onchocercias is or the disease itself would not be expected to occur
in strongyloidiasis patients treated with STROMECTOL. (See Onchocerciasis
- below)
Laboratory Test Findings
In clinical trials involving 109 patients given either one or two doses
of 170 to 200 µg/kg STROMECTOL, the following laboratory abnormalities
were seen irrespective of drug relationship: elevation in ALT and/or AST
(2 %), decrease in leukocyte count (13 %). Leukopenia and anemia were
seen in one patient.
Onchocerciasis
In clinical trials involving 963 adult patients treated with 100 to 200
µg/kg STROMECTOL, worsening of the following Mazzotti reactions during
the first 4 days post-treatment were reported: arthralgia/synovitis (19.3
%), axillary lymph node enlargement and tenderness (11.0 % and 4.4 %,
respectively), cervical lymph node enlargement and tenderness (5.3 % and
1.2 %, respectively), inguinal lymph node enlargement and tenderness (12.6
% and 13.9 %, respectively), other lymph node enlargement and tenderness
(3.0 % and 1.9 %, respectively), pruritus (27.5 %), skin involvement including
edema, papular and pustular or frank urticarial rash (22.7 %), and fever
(22.6 %). (See WARNINGS.)
In clinical trials, ophthalmological conditions were examined in 963
adult patients before treatment, at day 3, and months 3 and 6 after treatment
with 100 to 200 µg/kg STROMECTOL. Changes observed were primarily deterioration
from baseline 3 days post-treatment. Most changes either returned to baseline
condition or improved over baseline severity at the month 3 and 6 visits.
The percentages of patients with worsening of the following conditions
at day 3, month 3 and 6, respectively, were: limbitis: 5.5 %, 4.8 %, and
3.5 % and punctate opacity: 1.8 %, 1.8 %, and 1.4 %. The corresponding
percentages for patients treated with placebo were: limbitis: 6.2 %, 9.9
%, and 9.4 % and punctate opacity: 2.0 %, 6.4 %, and 7.2 %. (See WARNINGS.)
In clinical trials involving 963 adult patients who received 100 to 200
µg/kg STROMECTOL, the following clinical adverse reactions were reported
as possibly, probably, or definitely related to the drug in 1 % of the
patients: facial edema (1.2 %), peripheral edema (3.2 %), orthostatic
hypotension (1.1 %), and tachycardia (3.5%). Drug- related headache and
myalgia occurred in <1 % of patients (0.2 % and 0.4 %, respectively).
However, these were the most common adverse experiences reported overall
during these trials regardless of causality (22.3 % and 19.7 %, respectively).
A similar safety profile was observed in an open study in pediatric patients
ages 6 to 13.
Additionally, hypotension (mainly orthostatic hypotension) and worsening
of bronchial asthma have been reported since the drug was registered overseas.
The following ophthalmological side effects do occur due to the disease
itself but have also been reported after treatment with STROMECTOL: abnormal
sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis,
limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely
been severe or associated with loss of vision and have generally resolved
without corticosteroid treatment.
Laboratory Test Findings
In controlled clinical trials, the following laboratory adverse experiences
were reported as possibly, probably, or definitely related to the drug
in 1 % of the patients: eosinophilia (3 %) and hemoglobin increase (1
%).
DRUG INTERACTIONS
No information provided.
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