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VERMOX is a brand name for Mebendazole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vermox (mebendazole) is indicated for a broad spectrum of anthelmintic activity and is effective in the treatment of single or mixed helminthic infestations. Clinical studies have shown it to be effective in the treatment of Enterobius vermicularis (pinworm); Ascaris lumbricoides (roundworm); Trichuris trichiura…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Adults and Children 2 Years and Older Enterobiasis: 1 tablet (100 mg) given as a single dose. Since reinfections by Enterobius are known to be very frequent, it is recommended that treatment be repeated after 2 and 4 weeks, especially in eradication programs.
Trichuriasis, ascariasis, ankylostomiasis, strongyloidiasis, taeniasis and mixed infestations: 1 tablet (100 mg) two times a day in the morning and evening for 3 consecutive days. No special procedures such as fasting, or purgation are required.
Children Under 2 Years Vermox 100 mg tablets should not be used in children below the age of 1 year. 3 Pediatrics, Use in Children Under 2 Years. 4 Administration Vermox tablets may be chewed or swallowed whole. For children 1 to 6 years old who have difficulty in swallowing tablets, crush the tablet before administering.
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 useful in identifying and approximating rates of adverse drug reactions in real-world use. At the recommended dose, Vermox is generally well tolerated. However, patients with high parasitic burdens have manifested diarrhea, vomiting, and/or abdominal pain when treated with Vermox.
Other adverse reactions reported were drowsiness, itching, headache, flatulence, dizziness, increased SGOT, SGPT, alkaline phosphatase, and BUN. Eosinophilia and decreased hemoglobin and/or white cell count, hematuria, and cylindruria have been reported.
5 Post-Market Adverse Reactions Adverse drug reactions from spontaneous reports during post-marketing experience with Vermox are shown in Table 2 below. 0 Page 7 of 16 Gastrointestinal Disorders Abdominal pain, Nausea, Vomiting Hepatobiliary Disorders Hepatitis, Abnormal liver function tests Skin and Subcutaneous Tissue Disorders Toxic epidermal necrolysis, Stevens-Johnson syndrome, Exanthema, Angioedema, Urticaria, Alopecia Renal and Urinary Disorders Glomerulonephritis* * Observed in patients treated with higher and prolonged doses
, General 08/2024 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 ..........................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................... 4 4 DOSAGE AND ADMINISTRATION ...................... ERROR! BOOKMARK NOT DEFINED. 2 Recommended Dose and Dosage Adjustment .................................................
4 Administration ................................................................................................... 4 5 OVERDOSAGE ................................................................................................................
4 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................... 5 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ...........................................................................................
1 Pregnant Women ............................................................................................... 2 Breast-feeding ................................................................................................... 3 Pediatrics ...........................................................................................................
Vermox is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6 8 ADVERSE REACTIONS ................................................................................................... 2 Clinical Trial Adverse Reactions ....................................................................... 5 Post-Market Adverse Reactions ........................................................................
6 9 DRUG INTERACTIONS .................................................................................................... 4 Drug-Drug Interactions ......................................................................................
5 Drug-Food Interactions ..................................................................................... 6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
7 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ......................................................................................... 2 Pharmacodynamics ...........................................................................................
3 Pharmacokinetics .............................................................................................. 8 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 0 Page 3 of 16 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................
9 PART II: SCIENTIFIC INFORMATION ....................................................................................... 10 13 PHARMACEUTICAL INFORMATION ............................................................................ 10 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication .............................................................................. 10 15 MICROBIOLOGY ............................................................................................................
10 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 10 PATIENT MEDICATION INFORMATION ..................................................................................
0 Page 4 of 16 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Vermox (mebendazole) is indicated for a broad spectrum of anthelmintic activity and is effective in the treatment of single or mixed helminthic infestations. Clinical studies have shown it to be effective in the treatment of Enterobius vermicularis (pinworm); Ascaris lumbricoides (roundworm); Trichuris trichiura (whipworm); Ancylostoma duodenale and Necator americanus (hookworm).
It has also been used to treat infestations due to Strongyloides stercoralis (threadworm) and Taenia solium (large tapeworms). 1 Pediatrics Pediatrics (1 to <18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Vermox in pediatric patients has been established.
3 Pediatrics). 2 CONTRAINDICATIONS Vermox is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.
2 Recommended Dose and Dosage Adjustment Adults and Children 2 Years and Older Enterobiasis: 1 tablet (100 mg) given as a single dose. Since reinfections by Enterobius are known to be very frequent, it is recommended that treatment be repeated after 2 and 4 weeks, especially […]