EMVERM

AbsorptionFollowing oral administration of VERMOX™ CHEWABLE 500 mg tablet, the majority of the dose remains in the gastrointestinal tract where it exerts an anthelmintic effect locally. Dosing the VERMOX™ CHEWABLE 500 mg tablet with a high fat meal increases the bioavailability of mebendazole. In the clinical studies conducted in pediatric patients with soil transmitted helminth infections, the majority of these patients were administered VERMOX™ CHEWABLE 500 mg tablets with food. Mean plasma p...

The efficacy of VERMOX™ CHEWABLE 500 mg tablets was evaluated in a double-blind, randomized, placebo controlled trial conducted in Africa in 295 pediatric patients between the ages of 1 year to 16 years of age with A. lumbricoides and/or T. trichiura infections. Patients were stratified by worm type and randomized to receive either VERMOX™ CHEWABLE 500 mg tablet (N=149) or placebo (N=146) at the baseline visit (double-blind period). After the 19 day double-blind period, all subjects received a single VERMOX™ CHEWABLE 500 mg tablet (open-label period). Clinical cure was defined as zero egg coun...

Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the cli...

VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients. Patients with a known hypersensitivity to the drug or its excipients ( 4 )

Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported ( 5.1 ) Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients ( 5.2 ) Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of m...

7 DRUG INTERACTIONS Concomitant use of mebendazole and metronidazole should be avoided [see Warnings and Precautions (5.3) ] .