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STROMECTOL is a brand name for Ivermectin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: STROMECTOL® (ivermectin) is indicated for the treatment of: intestinal strongyloidiasis; onchocerciasis; 1.1 Pediatrics Pediatrics (less than 15 kg): Safety and effectiveness of STROMECTOL® in pediatric patients weighing less than 15 kg has not been established (See 7. WARNINGS and PRECAUTIONS). 1.2 Geriatrics…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The dosage tables below show the number of 3-mg tablets recommended for various body weights for each indication. 2 Recommended Dose and Dosage Adjustment Strongyloidiasis (See Table 1) The recommended dosage of STROMECTOL® for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight.
) Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection. (See 14. CLINICAL TRIALS) STROMECTOL® (ivermectin) Page 5 of 19 TABLE 1 Dosage Guidelines for Strongyloidiasis Dosage by WEIGHT BODY WEIGHT (kg) DOSE (approx.
200 mcg/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 mcg/kg Onchocerciasis (See Table 2) The recommended dosage of STROMECTOL® for the treatment of onchocerciasis is a single oral dose designed to provide approximately 150 mcg/kg of body weight.
Patients should take tablets on an empty stomach with water. In mass distribution campaigns for onchocerciasis, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
TABLE 2 Dosage Guidelines for Onchocerciasis Dosage by WEIGHT For Onchocerciasis BODY WEIGHT (kg) DOSE when given once every 12 months (approx. 150 mcg/kg) Number of 3-mg Tablets 15 to 25 one 26 to 44 two 45 to 64 three 65 to 84 four 85 approx.
4 Administration STROMECTOL® is administered as a single oral dose given with water on an empty stomach. 5 Missed Dose The dosing of STROMECTOL® for Onchocerciasis or Strongyloidiasis is a single oral dose (see 4. DOSAGE AND ADMINISTRATION).
1 Adverse Reaction Overview STROMECTOL® (ivermectin) has been demonstrated to be generally well tolerated. For the most part side effects have been mild and transient in nature. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be STROMECTOL® (ivermectin) Page 9 of 19 useful in identifying and approximating rates of adverse drug reactions in real-world use.
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 onchocerciasis or the disease itself would not be expected to occur in strongyloidiasis patients treated with ivermectin. 6%). These signs and symptoms are considered part of the Mazzotti-type reactions.
(See 7. WARNINGS and PRECAUTIONS). 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 mcg/kg ivermectin. 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. 4%. 2%. 5%). 4%, respectively). 7%, respectively). STROMECTOL® (ivermectin) Page 10 of 19 A similar safety profile was observed in an open study in pediatric patients ages 6 to 13.
10/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment.....................................................
4 Administration................................................................................................... 5 Missed Dose ......................................................................................................
6 5 OVERDOSAGE ............................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS ..................................................................................
STROMECTOL® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The following ophthalmological side effects do occur due to the disease itself but have also been reported after treatment with ivermectin: 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. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Strongyloidiasis In clinical trials involving 109 patients given either one or two doses of 170 to 200 mcg/kg ivermectin, the laboratory adverse experiences, reported irrespective of drug relationship, were leukopenia/anemia in one patient and elevated ALT/alkaline phosphatase in one patient.
Onchocerciasis 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%).
5 Post-Market Adverse Reactions Onchocerciasis Conjunctival Haemorrhage All indications Hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, Stevens-Johnson syndrome, seizures, hepatitis, elevation of liver enzymes, and elevation of bilirubin.
Neurological toxicity including depressed level of consciousness and coma (See 7. WARNINGS AND PRECAUTIONS).
1 Special Populations ............................................................................................ 1 Pregnant Women ......................................................................................... 2 Breast-feeding..............................................................................................
3 Pediatrics ..................................................................................................... 4 Geriatrics ..................................................................................................... 8 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
5 Post-Market Adverse Reactions........................................................................ 10 STROMECTOL® (ivermectin) Page 3 of 19 9 DRUG INTERACTIONS................................................................................................
2 Drug Interactions Overview.............................................................................. 4 Drug-Drug Interactions .................................................................................... 5 Drug-Food Interactions ....................................................................................
6 Drug-Herb Interactions .................................................................................... 7 Drug-Laboratory Test Interactions .................................................................... 11 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action.................................................................................. 2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics.......................................................................................
11 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 12 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 12 PART II: SCIENTIFIC INFORMATION ......................................................................................
13 13 PHARMACEUTICAL INFORMATION............................................................................ 13 14 CLINICAL TRIALS........................................................................................................
2 Study Results ............................................................................................. 13 15 MICROBIOLOGY ........................................................................................................
15 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 15 PATIENT MEDICATION INFORMATION ................................................................................. 1 Pediatrics Pediatrics (less than 15 kg): Safety and effectiveness of STROMECTOL® in pediatric patients weighing less than 15 kg has not been established (See 7.
WARNINGS and PRECAUTIONS). 2 Geriatrics Geriatrics (≥65 years of age): Evidence from clinical studies and experience in the geriatric population has not identified differences in responses between the elderly and younger patients. (See 7.
WARNINGS and PRECAUTIONS). 2 CONTRAINDICATIONS […]