VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm).

VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by:

• Ascaris lumbricoides (roundworm) and
• Trichuris trichiura (whipworm) (1).

The recommended dosage in patients one year of age and older is one VERMOX™ CHEWABLE 500 mg tablet taken as a single dose.

Chew VERMOX™ CHEWABLE 500 mg tablet completely before swallowing. Do not swallow the tablet whole.

For patients who have difficulty chewing the tablet, approximately 2 mL to 3 mL of drinking water can be added to a suitably sized spoon and the VERMOX™ CHEWABLE 500 mg tablet placed into the water. Within 2 minutes, the tablet absorbs the water and turns into a soft mass with semi-solid consistency, which can then be swallowed.

VERMOX™ CHEWABLE 500 mg tablet can be taken without regard to food intake [see Clinical Pharmacology (12.3)].

• The recommended dosage in patients one year of age and older is one single tablet of VERMOX™ CHEWABLE 500 mg taken as a single dose, chewed completely before swallowing (2).
• See Full Prescribing Information for administration instructions for patients who have difficulty chewing the tablets (2)

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 mebendazole and metronidazole (5.3)

Convulsions have been reported in infants below the age of 1 year during post-marketing experience with mebendazole [see Adverse Reactions (6.2)].

Agranulocytosis and neutropenia have been reported with mebendazole use at higher doses and for more prolonged durations than is recommended for the treatment of soil-transmitted helminth infections. Monitor blood counts if VERMOX™ CHEWABLE is used at higher doses or for prolonged duration.

Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole and metronidazole.

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.

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 clinical trials of another drug and may not reflect the rates observed in practice.

The safety of mebendazole was evaluated in 6276 adult and pediatric subjects one year of age and older who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract. In these trials, the formulations, dosages and duration of mebendazole treatment varied. Adverse reactions reported in mebendazole-treated subjects from the 39 clinical trials are shown in Table 1 below.

Clinical Studies with Mebendazole Chewable 500 mg Tablet

The safety profile of mebendazole chewable 500 mg tablets administered as a single dose was evaluated in 677 pediatric subjects aged 1 to 16 years and in 34 adults. The safety profile was consistent with the known safety profile of mebendazole.

The following adverse reactions have been identified in adult and pediatric patients postmarketing with mebendazole formulations and dosages other than the VERMOX™ CHEWABLE 500 mg tablet. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.